<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03298022</url>
  </required_header>
  <id_info>
    <org_study_id>2017.008.01</org_study_id>
    <nct_id>NCT03298022</nct_id>
  </id_info>
  <brief_title>Efficacy&amp;Safety of ALTB-168 in Patients With Moderate to Severe Active,Anti-TNF Alpha and/or Anti-integrin Refractory UC</brief_title>
  <acronym>TNF</acronym>
  <official_title>Efficacy and Safety of ALTB-168 in Patients With Moderate to Severe Active, Anti-TNF Alpha and/or Anti-integrin Refractory Ulcerative Colitis: a 26-week, Open-label, Multi-center, Phase II Proof of Principle Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AltruBio Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AltruBio Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the efficacy and safety of Neihulizumab (ALTB-168) administered intravenously in&#xD;
      patients with moderate to severe active ulcerative colitis who are refractory or intolerant&#xD;
      to anti-Tumor Necrosis Factor α and/or anti-integrin treatments.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Phase II, open label, single arm, multiple dose proof of principle study to test&#xD;
      the efficacy and safety of Neihulizumab in patients with moderate to severe active ulcerative&#xD;
      colitis and who has failed or are intolerant to anti-TNFα and/or anti-integrin therapy. A&#xD;
      minimum of 30 patients and a maximum of 40 will be recruited in 1 dosing group. For efficacy&#xD;
      evaluation, the primary endpoint is the proportion of patients with clinical response,&#xD;
      defined as ≥ 3- point reduction in MCS, a 30% or greater decrease from the baseline score,&#xD;
      and with a 1-point or greater decrease of the rectal bleeding subscore or an absolute rectal&#xD;
      bleeding score of 0 or 1 at Week 12. Safety assessments will consist of evaluating physical&#xD;
      examination, vital signs (blood pressure, heart rate, respiratory rate, body temperature and&#xD;
      oxygen saturation), safety laboratory tests, adverse events and tolerability.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    As a consequence of operational difficulties at the clinical sites associated with the COVID-19&#xD;
    pandemic&#xD;
  </why_stopped>
  <start_date type="Actual">May 4, 2018</start_date>
  <completion_date type="Actual">June 1, 2020</completion_date>
  <primary_completion_date type="Actual">April 6, 2020</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Proportion of Patients With Clinical Response at Week 12</measure>
    <time_frame>week 12</time_frame>
    <description>The clinical response is defined as a ≥ 3-point reduction in Mayo Clinic Score, a 30% or greater decrease from the baseline score, and with a 1-point or greater decrease of the rectal bleeding subscore or an absolute rectal bleeding score of 0 or 1,&#xD;
The colonic site with maximum inflammation was determined by Mayo endoscopic subscore (MES) defined as follows: normal (0 points); erythema, decreased vascular pattern, mild friability (1 point); absent vascular pattern, friability, erosions (2 points); and spontaneous bleeding or ulceration (3 points).&#xD;
Lower score means disease improvement.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Proportion of Patients With Clinical Response (mITT)</measure>
    <time_frame>weeks 6,16, 20 and 26</time_frame>
    <description>The proportion of patients with clinical response defined as a ≥2-point decrease in partial MCS (pMCS), and with a 1 point or greater decrease of the rectal bleeding subscale or an absolute rectal bleeding score of 0 or 1.&#xD;
The colonic site with maximum inflammation was determined by Mayo endoscopic subscore (MES) defined as follows: normal (0 points); erythema, decreased vascular pattern, mild friability (1 point); absent vascular pattern, friability, erosions (2 points); and spontaneous bleeding or ulceration (3 points).&#xD;
Lower score means disease improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Proportion of Patients With Clinical Remission</measure>
    <time_frame>weeks 6,16, 20 and 26</time_frame>
    <description>The number of patients with clinical remission, defined as MCS of 2 or lower (or pMCS of 1 or lower) and no subscore higher than 1.&#xD;
The colonic site with maximum inflammation was determined by Mayo endoscopic subscore (MES) defined as follows: normal (0 points); erythema, decreased vascular pattern, mild friability (1 point); absent vascular pattern, friability, erosions (2 points); and spontaneous bleeding or ulceration (3 points).&#xD;
Lower score means disease improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Flexible Sigmoidoscopy Subscore Changes From Baseline</measure>
    <time_frame>Baseline, week 12- and week 26 after the first treatment</time_frame>
    <description>The mean (SD) observed flexible sigmoidoscopy subscore change from baseline (CFB).&#xD;
Baseline is defined as the last available assessment prior to the first administration of the study drug. The sigmoidoscopic improvement is defined as any decrease in Mayo Clinic Score (MCS) endoscopic subscore, at Weeks 12 and 26. MCS range is 1-3.&#xD;
The colonic site with maximum inflammation was determined by Mayo endoscopic subscore (MES) defined as follows: normal (0 points); erythema, decreased vascular pattern, mild friability (1 point); absent vascular pattern, friability, erosions (2 points); and spontaneous bleeding or ulceration (3 points).&#xD;
Lower score means disease improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Number of Patients With Mucosal Healing</measure>
    <time_frame>at 12- and 26-week after the first treatment</time_frame>
    <description>The mucosal healing is defined as an absolute subscore for endoscopy of 0 or 1 The colonic site with maximum inflammation was determined by Mayo endoscopic subscore (MES) defined as follows: normal (0 points); erythema, decreased vascular pattern, mild friability (1 point); absent vascular pattern, friability, erosions (2 points); and spontaneous bleeding or ulceration (3 points).&#xD;
Lower score means disease improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Histological Activity Grade From Baseline Using the Geboes System</measure>
    <time_frame>at 12- and 26-week after the first treatment</time_frame>
    <description>The number of patients with histological activity Geboes Score ≤ 3.1 (worst of both rectum and sigmoid colon).&#xD;
The original Geboes grade system is from Grade 0 to Grade 5.&#xD;
The following are the grades:&#xD;
Grade 0: Architectural changes Grade 1: Chronic inflammatory infiltrate Grade 2A: Eosinophils in lamina propria Grade 2B: Neutrophils in lamina propria Grade 3: Neutrophils in epithelium Grade 4:Crypt destruction Grade 5: Erosions and ulcerations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Number of Patients With Histological Healing</measure>
    <time_frame>at 12- and 26-week after the first treatment</time_frame>
    <description>The histological healing is defined as histological grade = 0</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Inflammatory Bowel Disease Questionnaire (IBDQ) Score From Baseline</measure>
    <time_frame>at 12- and 26-week after the first treatment</time_frame>
    <description>Number of Participants with a Clinically Significant Difference in the Inflammatory Bowel Disease Questionnaire (IBDQ) Score From Baseline, to Week 12 and Week 26.&#xD;
The IBDQ is a questionnaire used for an assessment of Health Related Quality of Life (HRQoL) in patients with the Inflammatory Bowel Disease (IBD). The IBDQ has a possible score range of 32 (minimum) to 224 (maximum), where a higher score indicates better HRQoL. A difference of 16 points from Baseline Assessment (Baseline Score) to Week 12, and Baseline Assessment (Baseline Score) to Week 26, is considered clinically significant. The outcome measure is assessed by comparing each patient's change in individual IBDQ score from Baseline to Week 12, and from Baseline to Week 26. Patients who achieved the 16 point difference (improvement of the IBDQ score from the baseline indicating the Clinically Significant Difference) are included as responders to the treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Number of Patients With Inflammatory IBDQ Response</measure>
    <time_frame>at 12- and 26-week after the first treatment</time_frame>
    <description>The Inflammatory Bowel Disease Questionnaire (IBDQ) has a possible score range of 32 (minimum) to 224 (maximum), where a higher score indicates better Health Related Quality of Life (HRQoL). A difference of 16 points from Baseline to Week 12 and Baseline to Week 26, is considered clinically significant. The outcome measure will be assessed by comparing each patient's change in individual IBDQ score from Baseline to Week 12, and from Baseline to Week 26, to assess whether a response was seen.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>CRP Changes From Baseline (CFB) (Exploratory)</measure>
    <time_frame>Am 4, Weeks 4, 9, 12, 16, 20, 26; Am 1-3 weeks 4,8,12,16,20, 26</time_frame>
    <description>Change in biomarkers of CRP (C-reactive protein). C-reactive protein (CRP) is a biomarker produced by your liver in response to inflammation. Normal CRP value is below 1 mg/L.&#xD;
1-3 mg/L is in the &quot;yellow zone&quot;, indicating some inflammation &gt;3 mg/L is in the &quot;red zone&quot;, meaning there is significant inflammation</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in Fecal Calprotectin (CFB) - Exploratory Biomarker</measure>
    <time_frame>Am 4, Weeks 4, 9, 12, 16, 20, 26; Am 1-3 weeks 4,8,12,16,20, 26</time_frame>
    <description>Faecal calprotectin changes from the baseline at Week 4, 9, 12, 16, 20, and 26 were measured. Baseline is defined as the last available assessment prior to the first administration of the study drug.&#xD;
Faecal calprotectin is measured as mcg/g, so the results come back as a numeric value. A level under 50 is considered to be 'normal'. A level between 50 and 100, coupled with digestive symptoms, means IBS is likely. Lower level means improvement.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Ulcerative Colitis</condition>
  <arm_group>
    <arm_group_label>ALTB-168</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>intravenous doses of ALTB-168</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>ALTB-168</intervention_name>
    <description>monoclonal antibody</description>
    <arm_group_label>ALTB-168</arm_group_label>
    <other_name>Neihulizumab</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients must provide written informed consent;&#xD;
&#xD;
          2. Age 18-75 years;&#xD;
&#xD;
          3. Diagnosis of UC ≥ 12 weeks prior to screening by full colonoscopy (i.e., ≥ 12 weeks&#xD;
             after first diagnosis by a physician according to American College of Gastroenterology&#xD;
             guidelines);&#xD;
&#xD;
          4. Moderate-to-severe active UC, at time of screening, defined as:&#xD;
&#xD;
               1. Mayo Clinic Score (MCS) of 6 points or higher, AND&#xD;
&#xD;
               2. a centrally read MCS endoscopic subscore of grade 2 or higher, AND&#xD;
&#xD;
               3. MCS rectal bleeding subscore of 1 point or higher, AND&#xD;
&#xD;
               4. disease extending 15 cm or more from the anal verge;&#xD;
&#xD;
          5. Stable doses of concomitant medications, including :&#xD;
&#xD;
               1. Stable oral corticosteroids (i.e., ≤ 20 mg/day of prednisone, ≤ 9 mg/day of&#xD;
                  budesonide) ≥ 2 weeks before D1 dosing; Taper of oral corticosteroids per&#xD;
                  Investigator's discretion during the study is allowed;&#xD;
&#xD;
               2. Stable oral 5-aminosalicylic acid dose ≥ 2 weeks before D1 dosing;&#xD;
&#xD;
               3. Stable immunosuppressant including azathioprine, mercaptopurine, or methotrexate&#xD;
                  ≥ 8 weeks before D1 dosing. Patients taking methotrexate also are advised to take&#xD;
                  folic acid 1 mg/day or equivalent if there is no contraindication;&#xD;
&#xD;
               4. Stable doses of probiotics ≥ 2 weeks before D1 dosing;&#xD;
&#xD;
               5. Stable anti-diarrheas ≥ 2 weeks before D1 dosing;&#xD;
&#xD;
          6. Patients must have previously received anti-tumor necrosis factor alpha (anti-TNF&#xD;
             alpha and/or anti-integrin therapy for UC and demonstrated an inadequate response,&#xD;
             loss of response, or intolerance, and must have discontinued therapy ≥ 8 weeks before&#xD;
             D1 dosing;&#xD;
&#xD;
          7. Patients previously treated with cyclosporine or tacrolimus must have discontinued&#xD;
             therapy ≥ 4 weeks before D1 dosing;&#xD;
&#xD;
          8. Topical corticosteroids and topical 5-amyinosalicylic acid preparations must have been&#xD;
             withdrawn ≥ 2 weeks before D1 dosing;&#xD;
&#xD;
          9. Nonsteroidal anti-inflammatory drugs (NSAIDs) must have been discontinued ≥ 4 weeks&#xD;
             before D1 dosing;&#xD;
&#xD;
         10. Tofacitinib or other Janus kinase (JAK) inhibitors must have been discontinued ≥ 2&#xD;
             weeks before D1 dosing;&#xD;
&#xD;
         11. Patients previously treated with tube feeding, defined formula diets, or parenteral&#xD;
             alimentation/nutrition must have discontinued treatment 3 weeks before D1 dosing;&#xD;
&#xD;
         12. Females with reproductive potential must have a negative pregnancy test result before&#xD;
             enrollment. Men and women with reproductive potential have to be willing to use a&#xD;
             highly effective method of contraception from study start to ≥ 3 months after the&#xD;
             final dose of the study drug. A highly effective method of birth control is defined as&#xD;
             one which results in a low failure rate (less than 1% per year).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - GI related exclusion criteria:&#xD;
&#xD;
          1. Indeterminate colitis (IBD-U) or suspected Crohn's disease&#xD;
&#xD;
          2. Any history of colectomy&#xD;
&#xD;
          3. Presence of an ileostomy or colostomy&#xD;
&#xD;
          4. A history or evidence of colonic mucosal dysplasia&#xD;
&#xD;
          5. Short gut syndrome&#xD;
&#xD;
             -General health related exclusion criteria:&#xD;
&#xD;
          6. Pregnant or lactating&#xD;
&#xD;
          7. Inability to comply with study protocol in the opinion of the investigator&#xD;
&#xD;
          8. History of dysplasia or malignancy in recent 5 years, except completely excised basal&#xD;
             cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the&#xD;
             cervix&#xD;
&#xD;
          9. Cirrhosis or active alcohol abuse per the judgement of investigator&#xD;
&#xD;
         10. Poorly controlled diabetes (HbA1c &gt; 8.0%)&#xD;
&#xD;
         11. Significant screening ECG abnormalities, including evidence of acute myocardial&#xD;
             infarction, complete left bundle branch block, second-degree heart block, or complete&#xD;
             heart block&#xD;
&#xD;
         12. Impaired renal function (calculated creatinine clearance &lt; 60 mL/min)&#xD;
&#xD;
         13. Impaired hepatic function in the absence of diagnosis of primary sclerosing&#xD;
             cholangitis, serum transaminase &gt; 2.5x Upper Limit Normal (ULN), alkaline phosphatase&#xD;
             &gt; 2.5x ULN, or increased total bilirubin judged by the investigator to be clinically&#xD;
             significant, or a diagnosis of primary sclerosing cholangitis, serum transaminases &gt;&#xD;
             3x ULN, alkaline phosphatase &gt; 3x ULN, or total bilirubin &gt; 2.5x ULN judged by the&#xD;
             investigator to be clinically significant&#xD;
&#xD;
         14. Moderate to severe anemia (Hb &lt; 8g/dL)&#xD;
&#xD;
         15. Thrombocytopenia (platelet count &lt; 75,000/uL)&#xD;
&#xD;
         16. Evidence of current or previous clinically significant disease, medical condition or&#xD;
             finding in the medical examination that in the opinion of the investigator, would&#xD;
             compromise the safety of the patient or quality of the data&#xD;
&#xD;
         17. Requiring parenteral corticosteroid treatment.&#xD;
&#xD;
         18. Received any investigational product within 1 year.&#xD;
&#xD;
         19. History of drug abuse according to the Diagnostic and Statistical Manual of Mental&#xD;
             Disorders, 5th edition (DSM-V) criteria within 12 months prior to screening or&#xD;
             positive drug screening tests.&#xD;
&#xD;
             -Infection related exclusion criteria:&#xD;
&#xD;
         20. Human immune deficiency virus (HIV) infection or known HIV-related malignancy.&#xD;
&#xD;
         21. Acute or chronic hepatitis B or C, or carrier status. Patients with anti-HBc Ab but&#xD;
             with undetectable anti-HBs Ab should also be excluded.&#xD;
&#xD;
         22. Positive IgM antibody titers in the presence of negative IgG titers to Epstein-Barr&#xD;
             virus&#xD;
&#xD;
         23. Positive stool test for ova or parasites, positive stool culture for pathogens, or&#xD;
             positive stool toxin assay for Clostridium difficile at screening. Patients with the&#xD;
             positive stool toxin assay for C. difficile at screening could be rescreened if they&#xD;
             are being treated for C. difficile and a repeat stool toxin assay at least 4 weeks&#xD;
             after the completion of treatment is negative with no evidence of recurrence.&#xD;
&#xD;
         24. Intestinal mucosa biopsy positive for cytomegalovirus (CMV) at screening.&#xD;
&#xD;
         25. Positive screening test for latent Mycobacterium tuberculosis (TB) infection. Patients&#xD;
             with a history of latent TB infection who received an appropriate and documented&#xD;
             course of therapy can be included if the screening examination and a chest x-ray&#xD;
             performed ≤ 3 months before screening revealed no evidence of current active&#xD;
             infection. If a Quantiferon TB test is indeterminate, the test should be repeated, and&#xD;
             if the result is again indeterminate, such patient should be excluded.&#xD;
&#xD;
         26. History of any opportunistic infection ≤ 12 weeks before D1 dosing.&#xD;
&#xD;
         27. Any current or recent (≤ 4 weeks before D1 dosing) symptoms/signs of infection.&#xD;
&#xD;
         28. Received oral antibiotics ≤ 4 weeks before D1 dosing or intravenous antibiotics ≤ 8&#xD;
             weeks before D1 dosing.&#xD;
&#xD;
         29. Received a live attenuated vaccine ≤ 4 weeks before D1 dosing.&#xD;
&#xD;
         30. Neutropenia (absolute neutrophil count &lt; 1,500/uL).&#xD;
&#xD;
         31. Lymphocytopenia (absolute lymphocyte count &lt; 500 /uL).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shih-Yao Lin, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>AltruBio Inc.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>David T Rubin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Chicago</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lynn Institute of the Ozarks</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stomach Doctor - Surinder Saini, MD - Fountain Valley</name>
      <address>
        <city>Newport Beach</city>
        <state>California</state>
        <zip>92660</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wellness Clinical Research (WCR)</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33016-2202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wellness Clinical Research (WCR)</name>
      <address>
        <city>Lake Wales</city>
        <state>Florida</state>
        <zip>33853</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern University Feinberg School of Medicine</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Capitol Research</name>
      <address>
        <city>Rockville</city>
        <state>Maryland</state>
        <zip>20850</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Weill Cornell Medical College</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Rochester Medical Center</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor College of Medicine</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Washington Medical Center (UWMC) - Digestive Disease Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wellness Clinical Research (WCR)</name>
      <address>
        <city>Vega Baja</city>
        <zip>00694</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Puerto Rico</country>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>September 27, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 29, 2017</study_first_posted>
  <results_first_submitted>March 7, 2023</results_first_submitted>
  <results_first_submitted_qc>July 4, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">July 6, 2023</results_first_posted>
  <last_update_submitted>July 4, 2023</last_update_submitted>
  <last_update_submitted_qc>July 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ulcerative Colitis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colitis</mesh_term>
    <mesh_term>Colitis, Ulcerative</mesh_term>
    <mesh_term>Ulcer</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 6, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/22/NCT03298022/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 19, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/22/NCT03298022/SAP_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 13, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/22/NCT03298022/ICF_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were enrolled at 12 centers locate in North America and Puerto Rico from May 2018 to June 2020. It was a 24 weeks open label, single arm, multiple dose proof of principle study.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>ALTB-168 in Patients With Refractory Ulcerative Colitis</title>
          <description>Amendment 1~3: 9 mg/kg; total of 8 doses of ALTB-168. Amendment 4: 9 mg/kg; total of 10 doses of ALTB-168.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Number of Participants Who Received 8 Doses of ALTB-168</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Number of Participants Who Received 10 Doses of ALTB-168</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>disease relapse</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety population /The mITT set was defined as all patients who were enrolled and who received at least one dose of ALTB-168 treatment.</population>
      <group_list>
        <group group_id="B1">
          <title>ALTB-168</title>
          <description>Intravenous doses of ALTB-168&#xD;
ALTB-168: monoclonal antibody</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="24"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <population>Total enrolled number of participants is 24. 10 participants were enrolled under Amendment 1-3 14 participants were enrolled under Amendment 4</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Enrolled Under Amendment 1-3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Enrolled Under Amendment 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <population>10 subjects were enrolled under Amendment 1-3 and 14 subjects under Amendment 4.</population>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <title>Amendment 1-3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37" lower_limit="21" upper_limit="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Amendment 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35.5" lower_limit="22" upper_limit="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>Row population does not differ from the Overall population. Altogether 24 participants were enrolled to the study. Out of them 10 were enrolled under protocol Amendments 1-3 and 14 under the Amendment 14.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Enrolled under Amendment 1~3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Enrolled under Amendment 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Ethnicity</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>The Proportion of Patients With Clinical Response at Week 12</title>
        <description>The clinical response is defined as a ≥ 3-point reduction in Mayo Clinic Score, a 30% or greater decrease from the baseline score, and with a 1-point or greater decrease of the rectal bleeding subscore or an absolute rectal bleeding score of 0 or 1,&#xD;
The colonic site with maximum inflammation was determined by Mayo endoscopic subscore (MES) defined as follows: normal (0 points); erythema, decreased vascular pattern, mild friability (1 point); absent vascular pattern, friability, erosions (2 points); and spontaneous bleeding or ulceration (3 points).&#xD;
Lower score means disease improvement.</description>
        <time_frame>week 12</time_frame>
        <population>The full analysis set includes all participants who received at least 1 dose of study drug. The response rates were calculated using non-responder imputation, where participants with a missing scores at week 12 were counted as non-responders.</population>
        <group_list>
          <group group_id="O1">
            <title>Pilot Study (Amendment 1~3: 9 mg/kg; Total 8 Doses)</title>
            <description>10 participants enrolled under protocol Amendments 1-3 received total of 8 doses of ALTB-168</description>
          </group>
          <group group_id="O2">
            <title>Main Study (Amendment 4: 9 mg/kg; Total 10 Doses)</title>
            <description>14 participants enrolled under Amendment 4 received total of 10 doses of ALTB-168</description>
          </group>
        </group_list>
        <measure>
          <title>The Proportion of Patients With Clinical Response at Week 12</title>
          <description>The clinical response is defined as a ≥ 3-point reduction in Mayo Clinic Score, a 30% or greater decrease from the baseline score, and with a 1-point or greater decrease of the rectal bleeding subscore or an absolute rectal bleeding score of 0 or 1,&#xD;
The colonic site with maximum inflammation was determined by Mayo endoscopic subscore (MES) defined as follows: normal (0 points); erythema, decreased vascular pattern, mild friability (1 point); absent vascular pattern, friability, erosions (2 points); and spontaneous bleeding or ulceration (3 points).&#xD;
Lower score means disease improvement.</description>
          <population>The full analysis set includes all participants who received at least 1 dose of study drug. The response rates were calculated using non-responder imputation, where participants with a missing scores at week 12 were counted as non-responders.</population>
          <units>percentage of total number of patients</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.2" lower_limit="2.8" upper_limit="60"/>
                    <measurement group_id="O2" value="50" lower_limit="23" upper_limit="77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Proportion of Patients With Clinical Response (mITT)</title>
        <description>The proportion of patients with clinical response defined as a ≥2-point decrease in partial MCS (pMCS), and with a 1 point or greater decrease of the rectal bleeding subscale or an absolute rectal bleeding score of 0 or 1.&#xD;
The colonic site with maximum inflammation was determined by Mayo endoscopic subscore (MES) defined as follows: normal (0 points); erythema, decreased vascular pattern, mild friability (1 point); absent vascular pattern, friability, erosions (2 points); and spontaneous bleeding or ulceration (3 points).&#xD;
Lower score means disease improvement.</description>
        <time_frame>weeks 6,16, 20 and 26</time_frame>
        <population>The full analysis set includes all participants who received at least 1 dose of study drug. Response rates were calculated using non-responder imputation, where participants with a missing information were counted as non-responders. 23 participants are included in the study analysis. 9 participants from the pilot study (protocol Amendments 1-3) and 14 participants from the main study (protocol Amendment 4).</population>
        <group_list>
          <group group_id="O1">
            <title>Pilot Study (Amendment 1~3: 9 mg/kg; Total 8 Doses)</title>
            <description>10 participants were enrolled under Amendments 1-3 of the study protocol</description>
          </group>
          <group group_id="O2">
            <title>Main Study (Amendment 4: 9 mg/kg; Total 10 Doses)</title>
            <description>14 participants were enrolled under Amendment 4 of the study protocol</description>
          </group>
        </group_list>
        <measure>
          <title>The Proportion of Patients With Clinical Response (mITT)</title>
          <description>The proportion of patients with clinical response defined as a ≥2-point decrease in partial MCS (pMCS), and with a 1 point or greater decrease of the rectal bleeding subscale or an absolute rectal bleeding score of 0 or 1.&#xD;
The colonic site with maximum inflammation was determined by Mayo endoscopic subscore (MES) defined as follows: normal (0 points); erythema, decreased vascular pattern, mild friability (1 point); absent vascular pattern, friability, erosions (2 points); and spontaneous bleeding or ulceration (3 points).&#xD;
Lower score means disease improvement.</description>
          <population>The full analysis set includes all participants who received at least 1 dose of study drug. Response rates were calculated using non-responder imputation, where participants with a missing information were counted as non-responders. 23 participants are included in the study analysis. 9 participants from the pilot study (protocol Amendments 1-3) and 14 participants from the main study (protocol Amendment 4).</population>
          <units>percentage of total number of patients</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Clinical Response at week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.3" lower_limit="7.5" upper_limit="70.1"/>
                    <measurement group_id="O2" value="57.1" lower_limit="28.9" upper_limit="82.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Clinical Response at week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O2" value="64.3" lower_limit="35.1" upper_limit="87.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Clinical Response at week 20</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.1" lower_limit="0.3" upper_limit="48.2"/>
                    <measurement group_id="O2" value="64.3" lower_limit="35.1" upper_limit="87.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Clinical Response at week 26</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.1" lower_limit="0.3" upper_limit="48.2"/>
                    <measurement group_id="O2" value="35.7" lower_limit="12.8" upper_limit="64.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Proportion of Patients With Clinical Remission</title>
        <description>The number of patients with clinical remission, defined as MCS of 2 or lower (or pMCS of 1 or lower) and no subscore higher than 1.&#xD;
The colonic site with maximum inflammation was determined by Mayo endoscopic subscore (MES) defined as follows: normal (0 points); erythema, decreased vascular pattern, mild friability (1 point); absent vascular pattern, friability, erosions (2 points); and spontaneous bleeding or ulceration (3 points).&#xD;
Lower score means disease improvement.</description>
        <time_frame>weeks 6,16, 20 and 26</time_frame>
        <population>The full analysis set includes all participants who received at least 1 dose of study drug. Response rates were calculated using non-responder imputation, where participants with a missing information were counted as non-responders. 23 participants are included in the study analysis. 9 participants from the pilot study (protocol Amendments 1-3) and 14 participants from the main study (protocol Amendment 4).</population>
        <group_list>
          <group group_id="O1">
            <title>Amendment 1~3: 9 mg/kg; Total 8 Doses</title>
            <description>Amendment 1~3: 9 mg/kg; total 8 doses of ALTB-168</description>
          </group>
          <group group_id="O2">
            <title>Amendment 4: 9 mg/kg; Total 10 Doses</title>
            <description>Amendment 4: 9 mg/kg; total 10 doses of ALTB-168</description>
          </group>
        </group_list>
        <measure>
          <title>The Proportion of Patients With Clinical Remission</title>
          <description>The number of patients with clinical remission, defined as MCS of 2 or lower (or pMCS of 1 or lower) and no subscore higher than 1.&#xD;
The colonic site with maximum inflammation was determined by Mayo endoscopic subscore (MES) defined as follows: normal (0 points); erythema, decreased vascular pattern, mild friability (1 point); absent vascular pattern, friability, erosions (2 points); and spontaneous bleeding or ulceration (3 points).&#xD;
Lower score means disease improvement.</description>
          <population>The full analysis set includes all participants who received at least 1 dose of study drug. Response rates were calculated using non-responder imputation, where participants with a missing information were counted as non-responders. 23 participants are included in the study analysis. 9 participants from the pilot study (protocol Amendments 1-3) and 14 participants from the main study (protocol Amendment 4).</population>
          <units>percentage of total number of patients</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Clinical response at week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.1" lower_limit="0.3" upper_limit="48.2"/>
                    <measurement group_id="O2" value="35.7" lower_limit="12.8" upper_limit="64.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Clinical response at week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O2" value="35.7" lower_limit="12.8" upper_limit="64.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Clinical response at week 20</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O2" value="35.7" lower_limit="12.8" upper_limit="64.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Clinical response at week 26</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.1" lower_limit="0.3" upper_limit="48.2"/>
                    <measurement group_id="O2" value="21.4" lower_limit="4.7" upper_limit="50.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Flexible Sigmoidoscopy Subscore Changes From Baseline</title>
        <description>The mean (SD) observed flexible sigmoidoscopy subscore change from baseline (CFB).&#xD;
Baseline is defined as the last available assessment prior to the first administration of the study drug. The sigmoidoscopic improvement is defined as any decrease in Mayo Clinic Score (MCS) endoscopic subscore, at Weeks 12 and 26. MCS range is 1-3.&#xD;
The colonic site with maximum inflammation was determined by Mayo endoscopic subscore (MES) defined as follows: normal (0 points); erythema, decreased vascular pattern, mild friability (1 point); absent vascular pattern, friability, erosions (2 points); and spontaneous bleeding or ulceration (3 points).&#xD;
Lower score means disease improvement.</description>
        <time_frame>Baseline, week 12- and week 26 after the first treatment</time_frame>
        <population>Study participants who entered the study under amendment 1-3 (n=9) and participans who entered the study under amendment 4 (n=14) have been inlcuded in this analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Amendment 1~3: 9 mg/kg; Total 8 Doses</title>
            <description>Amendment 1~3: 9 mg/kg; total 8 doses of ALTB-168</description>
          </group>
          <group group_id="O2">
            <title>Amendment 4: 9 mg/kg; Total 10 Doses</title>
            <description>Amendment 4: 9 mg/kg; total 10 doses of ALTB-168</description>
          </group>
        </group_list>
        <measure>
          <title>Flexible Sigmoidoscopy Subscore Changes From Baseline</title>
          <description>The mean (SD) observed flexible sigmoidoscopy subscore change from baseline (CFB).&#xD;
Baseline is defined as the last available assessment prior to the first administration of the study drug. The sigmoidoscopic improvement is defined as any decrease in Mayo Clinic Score (MCS) endoscopic subscore, at Weeks 12 and 26. MCS range is 1-3.&#xD;
The colonic site with maximum inflammation was determined by Mayo endoscopic subscore (MES) defined as follows: normal (0 points); erythema, decreased vascular pattern, mild friability (1 point); absent vascular pattern, friability, erosions (2 points); and spontaneous bleeding or ulceration (3 points).&#xD;
Lower score means disease improvement.</description>
          <population>Study participants who entered the study under amendment 1-3 (n=9) and participans who entered the study under amendment 4 (n=14) have been inlcuded in this analysis</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Flexible Sigmoidoscopy Score at Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7" spread="0.5"/>
                    <measurement group_id="O2" value="2.6" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Flexible Sigmoidoscopy Score at week 12 CFB</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.7" spread="1.03"/>
                    <measurement group_id="O2" value="-0.6" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Flexible Sigmoidoscopy Score at week 26 CFB</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                    <measurement group_id="O2" value="-0.6" spread="1.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Number of Patients With Mucosal Healing</title>
        <description>The mucosal healing is defined as an absolute subscore for endoscopy of 0 or 1 The colonic site with maximum inflammation was determined by Mayo endoscopic subscore (MES) defined as follows: normal (0 points); erythema, decreased vascular pattern, mild friability (1 point); absent vascular pattern, friability, erosions (2 points); and spontaneous bleeding or ulceration (3 points).&#xD;
Lower score means disease improvement.</description>
        <time_frame>at 12- and 26-week after the first treatment</time_frame>
        <population>Study participants who received at least one dose of ALTB-168. Missing data imputed as non-responders (i.e. Amd 1-3: Week 12 - 3 missing; Week 26 - 8 missing; and Amd 4: Week 12 - 2 missing; Week 26 - 7 missing).</population>
        <group_list>
          <group group_id="O1">
            <title>Amendment 1~3: 9 mg/kg; Total 8 Doses</title>
            <description>Amendment 1~3: 9 mg/kg; total 8 doses of ALTB-168</description>
          </group>
          <group group_id="O2">
            <title>Amendment 4: 9 mg/kg; Total 10 Doses</title>
            <description>Amendment 4: 9 mg/kg; total 10 doses of ALTB-168</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Patients With Mucosal Healing</title>
          <description>The mucosal healing is defined as an absolute subscore for endoscopy of 0 or 1 The colonic site with maximum inflammation was determined by Mayo endoscopic subscore (MES) defined as follows: normal (0 points); erythema, decreased vascular pattern, mild friability (1 point); absent vascular pattern, friability, erosions (2 points); and spontaneous bleeding or ulceration (3 points).&#xD;
Lower score means disease improvement.</description>
          <population>Study participants who received at least one dose of ALTB-168. Missing data imputed as non-responders (i.e. Amd 1-3: Week 12 - 3 missing; Week 26 - 8 missing; and Amd 4: Week 12 - 2 missing; Week 26 - 7 missing).</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 26</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change of Histological Activity Grade From Baseline Using the Geboes System</title>
        <description>The number of patients with histological activity Geboes Score ≤ 3.1 (worst of both rectum and sigmoid colon).&#xD;
The original Geboes grade system is from Grade 0 to Grade 5.&#xD;
The following are the grades:&#xD;
Grade 0: Architectural changes Grade 1: Chronic inflammatory infiltrate Grade 2A: Eosinophils in lamina propria Grade 2B: Neutrophils in lamina propria Grade 3: Neutrophils in epithelium Grade 4:Crypt destruction Grade 5: Erosions and ulcerations</description>
        <time_frame>at 12- and 26-week after the first treatment</time_frame>
        <population>Study participants who received at least one dose of ALTB-168</population>
        <group_list>
          <group group_id="O1">
            <title>Amendment 1~3: 9 mg/kg; Total 8 Doses</title>
            <description>Amendment 1~3: 9 mg/kg; total 8 doses of ALTB-168</description>
          </group>
          <group group_id="O2">
            <title>Amendment 4: 9 mg/kg; Total 10 Doses</title>
            <description>Amendment 4: 9 mg/kg; total 10 doses of ALTB-168</description>
          </group>
        </group_list>
        <measure>
          <title>Change of Histological Activity Grade From Baseline Using the Geboes System</title>
          <description>The number of patients with histological activity Geboes Score ≤ 3.1 (worst of both rectum and sigmoid colon).&#xD;
The original Geboes grade system is from Grade 0 to Grade 5.&#xD;
The following are the grades:&#xD;
Grade 0: Architectural changes Grade 1: Chronic inflammatory infiltrate Grade 2A: Eosinophils in lamina propria Grade 2B: Neutrophils in lamina propria Grade 3: Neutrophils in epithelium Grade 4:Crypt destruction Grade 5: Erosions and ulcerations</description>
          <population>Study participants who received at least one dose of ALTB-168</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Number of Patients With Histological Healing</title>
        <description>The histological healing is defined as histological grade = 0</description>
        <time_frame>at 12- and 26-week after the first treatment</time_frame>
        <population>Study participants who received at least one dose of ALTB-168. Missing data imputed as non-responders (i.e. Amd 1-3: Week 12 - 4 missing; Week 26 - 8 missing; and Amd 4: Week 12 - 2 missing; Week 26 - 7 missing).</population>
        <group_list>
          <group group_id="O1">
            <title>Amendment 1~3: 9 mg/kg; Total 8 Doses</title>
            <description>Amendment 1~3: 9 mg/kg; total 8 doses of ALTB-168</description>
          </group>
          <group group_id="O2">
            <title>Amendment 4: 9 mg/kg; Total 10 Doses</title>
            <description>Amendment 4: 9 mg/kg; total 10 doses of ALTB-168</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Patients With Histological Healing</title>
          <description>The histological healing is defined as histological grade = 0</description>
          <population>Study participants who received at least one dose of ALTB-168. Missing data imputed as non-responders (i.e. Amd 1-3: Week 12 - 4 missing; Week 26 - 8 missing; and Amd 4: Week 12 - 2 missing; Week 26 - 7 missing).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 26</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change of Inflammatory Bowel Disease Questionnaire (IBDQ) Score From Baseline</title>
        <description>Number of Participants with a Clinically Significant Difference in the Inflammatory Bowel Disease Questionnaire (IBDQ) Score From Baseline, to Week 12 and Week 26.&#xD;
The IBDQ is a questionnaire used for an assessment of Health Related Quality of Life (HRQoL) in patients with the Inflammatory Bowel Disease (IBD). The IBDQ has a possible score range of 32 (minimum) to 224 (maximum), where a higher score indicates better HRQoL. A difference of 16 points from Baseline Assessment (Baseline Score) to Week 12, and Baseline Assessment (Baseline Score) to Week 26, is considered clinically significant. The outcome measure is assessed by comparing each patient's change in individual IBDQ score from Baseline to Week 12, and from Baseline to Week 26. Patients who achieved the 16 point difference (improvement of the IBDQ score from the baseline indicating the Clinically Significant Difference) are included as responders to the treatment.</description>
        <time_frame>at 12- and 26-week after the first treatment</time_frame>
        <population>Study participants who received at least one dose of ALTB-168. Missing data imputed as non-responders (i.e. Amd 1-3: Week 12 - 3 missing; Week 26 - 8 missing; and Amd 4: Week 12 - 0 missing; Week 26 - 6 missing).</population>
        <group_list>
          <group group_id="O1">
            <title>Amendment 1~3: 9 mg/kg; Total 8 Doses</title>
            <description>Amendment 1~3: 9 mg/kg; total 8 doses of ALTB-168</description>
          </group>
          <group group_id="O2">
            <title>Amendment 4: 9 mg/kg; Total 10 Doses</title>
            <description>Amendment 4: 9 mg/kg; total 10 doses of ALTB-168</description>
          </group>
        </group_list>
        <measure>
          <title>Change of Inflammatory Bowel Disease Questionnaire (IBDQ) Score From Baseline</title>
          <description>Number of Participants with a Clinically Significant Difference in the Inflammatory Bowel Disease Questionnaire (IBDQ) Score From Baseline, to Week 12 and Week 26.&#xD;
The IBDQ is a questionnaire used for an assessment of Health Related Quality of Life (HRQoL) in patients with the Inflammatory Bowel Disease (IBD). The IBDQ has a possible score range of 32 (minimum) to 224 (maximum), where a higher score indicates better HRQoL. A difference of 16 points from Baseline Assessment (Baseline Score) to Week 12, and Baseline Assessment (Baseline Score) to Week 26, is considered clinically significant. The outcome measure is assessed by comparing each patient's change in individual IBDQ score from Baseline to Week 12, and from Baseline to Week 26. Patients who achieved the 16 point difference (improvement of the IBDQ score from the baseline indicating the Clinically Significant Difference) are included as responders to the treatment.</description>
          <population>Study participants who received at least one dose of ALTB-168. Missing data imputed as non-responders (i.e. Amd 1-3: Week 12 - 3 missing; Week 26 - 8 missing; and Amd 4: Week 12 - 0 missing; Week 26 - 6 missing).</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 26</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Number of Patients With Inflammatory IBDQ Response</title>
        <description>The Inflammatory Bowel Disease Questionnaire (IBDQ) has a possible score range of 32 (minimum) to 224 (maximum), where a higher score indicates better Health Related Quality of Life (HRQoL). A difference of 16 points from Baseline to Week 12 and Baseline to Week 26, is considered clinically significant. The outcome measure will be assessed by comparing each patient's change in individual IBDQ score from Baseline to Week 12, and from Baseline to Week 26, to assess whether a response was seen.</description>
        <time_frame>at 12- and 26-week after the first treatment</time_frame>
        <population>Study participants who received at least one dose of ALTB-168. Missing data imputed as non-responders (i.e. Amd 1-3: Week 12 - 3 missing; Week 26 - 8 missing; and Amd 4: Week 12 - 0 missing; Week 26 - 6 missing).</population>
        <group_list>
          <group group_id="O1">
            <title>Amendment 1~3: 9 mg/kg; Total 8 Doses</title>
            <description>Amendment 1~3: 9 mg/kg; total 8 doses of ALTB-168</description>
          </group>
          <group group_id="O2">
            <title>Amendment 4: 9 mg/kg; Total 10 Doses</title>
            <description>Amendment 4: 9 mg/kg; total 10 doses of ALTB-168</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Patients With Inflammatory IBDQ Response</title>
          <description>The Inflammatory Bowel Disease Questionnaire (IBDQ) has a possible score range of 32 (minimum) to 224 (maximum), where a higher score indicates better Health Related Quality of Life (HRQoL). A difference of 16 points from Baseline to Week 12 and Baseline to Week 26, is considered clinically significant. The outcome measure will be assessed by comparing each patient's change in individual IBDQ score from Baseline to Week 12, and from Baseline to Week 26, to assess whether a response was seen.</description>
          <population>Study participants who received at least one dose of ALTB-168. Missing data imputed as non-responders (i.e. Amd 1-3: Week 12 - 3 missing; Week 26 - 8 missing; and Amd 4: Week 12 - 0 missing; Week 26 - 6 missing).</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 26</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>CRP Changes From Baseline (CFB) (Exploratory)</title>
        <description>Change in biomarkers of CRP (C-reactive protein). C-reactive protein (CRP) is a biomarker produced by your liver in response to inflammation. Normal CRP value is below 1 mg/L.&#xD;
1-3 mg/L is in the &quot;yellow zone&quot;, indicating some inflammation &gt;3 mg/L is in the &quot;red zone&quot;, meaning there is significant inflammation</description>
        <time_frame>Am 4, Weeks 4, 9, 12, 16, 20, 26; Am 1-3 weeks 4,8,12,16,20, 26</time_frame>
        <population>Study participants who received at least one dose of ALTB-168</population>
        <group_list>
          <group group_id="O1">
            <title>Amendment 1~3: 9 mg/kg; Total 8 Doses</title>
            <description>Amendment 1~3: 9 mg/kg; total 8 doses of ALTB-168</description>
          </group>
          <group group_id="O2">
            <title>Amendment 4: 9 mg/kg; Total 10 Doses</title>
            <description>Amendment 4: 9 mg/kg; total 10 doses of ALTB-168</description>
          </group>
        </group_list>
        <measure>
          <title>CRP Changes From Baseline (CFB) (Exploratory)</title>
          <description>Change in biomarkers of CRP (C-reactive protein). C-reactive protein (CRP) is a biomarker produced by your liver in response to inflammation. Normal CRP value is below 1 mg/L.&#xD;
1-3 mg/L is in the &quot;yellow zone&quot;, indicating some inflammation &gt;3 mg/L is in the &quot;red zone&quot;, meaning there is significant inflammation</description>
          <population>Study participants who received at least one dose of ALTB-168</population>
          <units>mg/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.3" spread="5.32"/>
                    <measurement group_id="O2" value="11.29" spread="20.555"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.5" spread="17.30"/>
                    <measurement group_id="O2" value="-1.93" spread="14.403"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Am 4 Week 9, Am 1-3 Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.2" spread="10.65"/>
                    <measurement group_id="O2" value="-0.42" spread="18.821"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.0" spread="8.49"/>
                    <measurement group_id="O2" value="0.12" spread="15.605"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Only 1 participant</measurement>
                    <measurement group_id="O2" value="-0.65" spread="13.450"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Only 1 participant</measurement>
                    <measurement group_id="O2" value="-2.94" spread="14.161"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Only 1 participant</measurement>
                    <measurement group_id="O2" value="-0.42" spread="4.079"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Changes in Fecal Calprotectin (CFB) - Exploratory Biomarker</title>
        <description>Faecal calprotectin changes from the baseline at Week 4, 9, 12, 16, 20, and 26 were measured. Baseline is defined as the last available assessment prior to the first administration of the study drug.&#xD;
Faecal calprotectin is measured as mcg/g, so the results come back as a numeric value. A level under 50 is considered to be 'normal'. A level between 50 and 100, coupled with digestive symptoms, means IBS is likely. Lower level means improvement.</description>
        <time_frame>Am 4, Weeks 4, 9, 12, 16, 20, 26; Am 1-3 weeks 4,8,12,16,20, 26</time_frame>
        <population>Study participants who received at least one dose of ALTB-168</population>
        <group_list>
          <group group_id="O1">
            <title>Amendment 1~3: 9 mg/kg; Total 8 Doses</title>
            <description>Amendment 1~3: 9 mg/kg; total 8 doses of ALTB-168</description>
          </group>
          <group group_id="O2">
            <title>Amendment 4: 9 mg/kg; Total 10 Doses</title>
            <description>Amendment 4: 9 mg/kg; total 10 doses of ALTB-168</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Fecal Calprotectin (CFB) - Exploratory Biomarker</title>
          <description>Faecal calprotectin changes from the baseline at Week 4, 9, 12, 16, 20, and 26 were measured. Baseline is defined as the last available assessment prior to the first administration of the study drug.&#xD;
Faecal calprotectin is measured as mcg/g, so the results come back as a numeric value. A level under 50 is considered to be 'normal'. A level between 50 and 100, coupled with digestive symptoms, means IBS is likely. Lower level means improvement.</description>
          <population>Study participants who received at least one dose of ALTB-168</population>
          <units>mcg/g</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="682.80" spread="548.153"/>
                    <measurement group_id="O2" value="1283.49" spread="758.019"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 (CFB)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="113.89" spread="753.179"/>
                    <measurement group_id="O2" value="-203.30" spread="704.559"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 9 (Am 4, week 8 Am 1-3)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="223.17" spread="605.971"/>
                    <measurement group_id="O2" value="-384.47" spread="662.420"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="923.00" spread="997.162"/>
                    <measurement group_id="O2" value="-584.17" spread="847.809"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Only 1 participant</measurement>
                    <measurement group_id="O2" value="-155.01" spread="1142.984"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Only 1 participant</measurement>
                    <measurement group_id="O2" value="-29.46" spread="477.150"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Only 1 participant</measurement>
                    <measurement group_id="O2" value="-780.30" spread="633.292"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>26 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>ALTB-168 9mg/kg (Amendment 1-3)</title>
          <description>Amendments 1-3: A total of 8 doses of ALTB-168 at 9 mg/kg</description>
        </group>
        <group group_id="E2">
          <title>ALTB-168 9mg/kg (Amendment 4)</title>
          <description>Amendment 4: A total of 10 doses of ALTB-168 at 9 mg/kg</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (Unspecified)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Ulcerative Colitis Flare</sub_title>
                <description>Participant ID AE Term Date of onset AE Outcome Relatedness to IP 1010003 Ulcerative Colitis flare 05AUG2018 Resolved Not related</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 20.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Lymphocyte Count Decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear Swelling</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Oral Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Tongue Ulceration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Vulvovaginal Candidiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Body Tinea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Confusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Palate Injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Road Traffic Accident</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood Creatinine Increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Fecal Calprotectin Increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Blood Pressure Increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Back Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Groin Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="10"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Oropharyngeal Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Sinus Congestion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Rash Pruritic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Vice President of Clinical Operations</name_or_title>
      <organization>AltruBio</organization>
      <phone>17142150224</phone>
      <email>simona.reed@altrubio.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03298022
org study id: 2017.008.01
nct id: NCT03298022
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
To evaluate the efficacy and safety of Neihulizumab (ALTB-168) administered intravenously in
      patients with moderate to severe active ulcerative colitis who are refractory or intolerant
      to anti-Tumor Necrosis Factor α and/or anti-integrin treatments.
This is a Phase II, open label, single arm, multiple dose proof of principle study to test
      the efficacy and safety of Neihulizumab in patients with moderate to severe active ulcerative
      colitis and who has failed or are intolerant to anti-TNFα and/or anti-integrin therapy. A
      minimum of 30 patients and a maximum of 40 will be recruited in 1 dosing group. For efficacy
      evaluation, the primary endpoint is the proportion of patients with clinical response,
      defined as ≥ 3- point reduction in MCS, a 30% or greater decrease from the baseline score,
      and with a 1-point or greater decrease of the rectal bleeding subscore or an absolute rectal
      bleeding score of 0 or 1 at Week 12. Safety assessments will consist of evaluating physical
      examination, vital signs (blood pressure, heart rate, respiratory rate, body temperature and
      oxygen saturation), safety laboratory tests, adverse events and tolerability.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The Proportion of Patients With Clinical Response at Week 12
time frame: week 12
description: The clinical response is defined as a ≥ 3-point reduction in Mayo Clinic Score, a 30% or greater decrease from the baseline score, and with a 1-point or greater decrease of the rectal bleeding subscore or an absolute rectal bleeding score of 0 or 1,
The colonic site with maximum inflammation was determined by Mayo endoscopic subscore (MES) defined as follows: normal (0 points); erythema, decreased vascular pattern, mild friability (1 point); absent vascular pattern, friability, erosions (2 points); and spontaneous bleeding or ulceration (3 points).
Lower score means disease improvement.
measure: The Proportion of Patients With Clinical Response (mITT)
time frame: weeks 6,16, 20 and 26
description: The proportion of patients with clinical response defined as a ≥2-point decrease in partial MCS (pMCS), and with a 1 point or greater decrease of the rectal bleeding subscale or an absolute rectal bleeding score of 0 or 1.
The colonic site with maximum inflammation was determined by Mayo endoscopic subscore (MES) defined as follows: normal (0 points); erythema, decreased vascular pattern, mild friability (1 point); absent vascular pattern, friability, erosions (2 points); and spontaneous bleeding or ulceration (3 points).
Lower score means disease improvement.
measure: The Proportion of Patients With Clinical Remission
time frame: weeks 6,16, 20 and 26
description: The number of patients with clinical remission, defined as MCS of 2 or lower (or pMCS of 1 or lower) and no subscore higher than 1.
The colonic site with maximum inflammation was determined by Mayo endoscopic subscore (MES) defined as follows: normal (0 points); erythema, decreased vascular pattern, mild friability (1 point); absent vascular pattern, friability, erosions (2 points); and spontaneous bleeding or ulceration (3 points).
Lower score means disease improvement.
measure: Flexible Sigmoidoscopy Subscore Changes From Baseline
time frame: Baseline, week 12- and week 26 after the first treatment
description: The mean (SD) observed flexible sigmoidoscopy subscore change from baseline (CFB).
Baseline is defined as the last available assessment prior to the first administration of the study drug. The sigmoidoscopic improvement is defined as any decrease in Mayo Clinic Score (MCS) endoscopic subscore, at Weeks 12 and 26. MCS range is 1-3.
The colonic site with maximum inflammation was determined by Mayo endoscopic subscore (MES) defined as follows: normal (0 points); erythema, decreased vascular pattern, mild friability (1 point); absent vascular pattern, friability, erosions (2 points); and spontaneous bleeding or ulceration (3 points).
Lower score means disease improvement.
measure: The Number of Patients With Mucosal Healing
time frame: at 12- and 26-week after the first treatment
description: The mucosal healing is defined as an absolute subscore for endoscopy of 0 or 1 The colonic site with maximum inflammation was determined by Mayo endoscopic subscore (MES) defined as follows: normal (0 points); erythema, decreased vascular pattern, mild friability (1 point); absent vascular pattern, friability, erosions (2 points); and spontaneous bleeding or ulceration (3 points).
Lower score means disease improvement.
measure: Change of Histological Activity Grade From Baseline Using the Geboes System
time frame: at 12- and 26-week after the first treatment
description: The number of patients with histological activity Geboes Score ≤ 3.1 (worst of both rectum and sigmoid colon).
The original Geboes grade system is from Grade 0 to Grade 5.
The following are the grades:
Grade 0: Architectural changes Grade 1: Chronic inflammatory infiltrate Grade 2A: Eosinophils in lamina propria Grade 2B: Neutrophils in lamina propria Grade 3: Neutrophils in epithelium Grade 4:Crypt destruction Grade 5: Erosions and ulcerations
measure: The Number of Patients With Histological Healing
time frame: at 12- and 26-week after the first treatment
description: The histological healing is defined as histological grade = 0
measure: Change of Inflammatory Bowel Disease Questionnaire (IBDQ) Score From Baseline
time frame: at 12- and 26-week after the first treatment
description: Number of Participants with a Clinically Significant Difference in the Inflammatory Bowel Disease Questionnaire (IBDQ) Score From Baseline, to Week 12 and Week 26.
The IBDQ is a questionnaire used for an assessment of Health Related Quality of Life (HRQoL) in patients with the Inflammatory Bowel Disease (IBD). The IBDQ has a possible score range of 32 (minimum) to 224 (maximum), where a higher score indicates better HRQoL. A difference of 16 points from Baseline Assessment (Baseline Score) to Week 12, and Baseline Assessment (Baseline Score) to Week 26, is considered clinically significant. The outcome measure is assessed by comparing each patient's change in individual IBDQ score from Baseline to Week 12, and from Baseline to Week 26. Patients who achieved the 16 point difference (improvement of the IBDQ score from the baseline indicating the Clinically Significant Difference) are included as responders to the treatment.
measure: The Number of Patients With Inflammatory IBDQ Response
time frame: at 12- and 26-week after the first treatment
description: The Inflammatory Bowel Disease Questionnaire (IBDQ) has a possible score range of 32 (minimum) to 224 (maximum), where a higher score indicates better Health Related Quality of Life (HRQoL). A difference of 16 points from Baseline to Week 12 and Baseline to Week 26, is considered clinically significant. The outcome measure will be assessed by comparing each patient's change in individual IBDQ score from Baseline to Week 12, and from Baseline to Week 26, to assess whether a response was seen.
measure: CRP Changes From Baseline (CFB) (Exploratory)
time frame: Am 4, Weeks 4, 9, 12, 16, 20, 26; Am 1-3 weeks 4,8,12,16,20, 26
description: Change in biomarkers of CRP (C-reactive protein). C-reactive protein (CRP) is a biomarker produced by your liver in response to inflammation. Normal CRP value is below 1 mg/L.
1-3 mg/L is in the "yellow zone", indicating some inflammation >3 mg/L is in the "red zone", meaning there is significant inflammation
measure: Changes in Fecal Calprotectin (CFB) - Exploratory Biomarker
time frame: Am 4, Weeks 4, 9, 12, 16, 20, 26; Am 1-3 weeks 4,8,12,16,20, 26
description: Faecal calprotectin changes from the baseline at Week 4, 9, 12, 16, 20, and 26 were measured. Baseline is defined as the last available assessment prior to the first administration of the study drug.
Faecal calprotectin is measured as mcg/g, so the results come back as a numeric value. A level under 50 is considered to be 'normal'. A level between 50 and 100, coupled with digestive symptoms, means IBS is likely. Lower level means improvement.
arm group label: ALTB-168
arm group type: Experimental
description: intravenous doses of ALTB-168
intervention type: Biological
intervention name: ALTB-168
description: monoclonal antibody
arm group label: ALTB-168
other name: Neihulizumab
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Shih-Yao Lin, MD, PhD
role: Study Director
affiliation: AltruBio Inc.
last name: David T Rubin, MD
role: Principal Investigator
affiliation: University of Chicago
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Puerto Rico
country: United States
responsible party type: Sponsor
mesh term: Colitis
mesh term: Colitis, Ulcerative
mesh term: Ulcer
sharing ipd: No
provided document: 
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 