<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/NCT03235752</url>
  </required_header>
  <id_info>
    <org_study_id>CTJ301UC201</org_study_id>
    <nct_id>NCT03235752</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of TJ301 IV in Participants With Active Ulcerative Colitis</brief_title>
  <official_title>A Phase II, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of TJ301 (FE 999301) Administered Intravenously in Patients With Active Ulcerative Colitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>I-Mab Biopharma HongKong Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>I-Mab Biopharma HongKong Limited</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a multicenter, randomized, double-blind, placebo-controlled phase II study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      is a multicenter, randomized, double-blind, placebo-controlled phase II study. The trial&#xD;
      includes a Run-in Period (if stable conventional treatment needed), a 4-week Screening&#xD;
      Period, a 12-week Treatment Period, and a 3-week Safety Follow-up Period to Day 105.&#xD;
&#xD;
      90 patients will be centrally, dynamically, randomly assigned to 3 groups (1:1:1) to receive&#xD;
      600mg TJ301 Q2W, 300mg TJ301 Q2W or placebo Q2W.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 6, 2018</start_date>
  <completion_date type="Actual">December 21, 2020</completion_date>
  <primary_completion_date type="Actual">December 21, 2020</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Randomized, Double-blind, Placebo-controlled</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Randomized, Double-blind, Placebo-controlled</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical and endoscopy response</measure>
    <time_frame>Week 12</time_frame>
    <description>Clinical and endoscopy response (decrease from Baseline in full Mayo score ≥3 and ≥30%, including decrease from Baseline in rectal bleeding subscore ≥1 or rectal bleeding subscore ≤1) at Week 12.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical and endoscopy remission at Week 12</measure>
    <time_frame>Week 12.</time_frame>
    <description>Clinical and endoscopy remission at Week 12, defined as a full Mayo score ≤2, no individual subscore &gt;1, rectal bleeding subscore = 0.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical remission at Weeks 4, 6, 8, 10, and 12</measure>
    <time_frame>Weeks 4, 6, 8, 10, and 12</time_frame>
    <description>Clinical remission at Weeks 4, 6, 8, 10, and 12 defined as a stool frequency subscore=0, rectal bleeding subscore = 0, and 9-point partial Mayo score ≤1.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change from Baseline to Weeks 4, 8, and 12 in exploratory biomarkers</measure>
    <time_frame>Baseline to Weeks 4, 8, and 12</time_frame>
    <description>Change from Baseline to Weeks 4, 8, and 12 in exploratory biomarkers (erythrocyte sedimentation rate [ESR], C-reactive protein (CRP), IL-6, IL-6/sIL-6R complex, neutrophil and platelet count, faecal calprotectin).</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">91</enrollment>
  <condition>Active Ulcerative Colitis</condition>
  <arm_group>
    <arm_group_label>TJ301 300mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TJ301 300mg administrations will occur on Days 0, 14, 28, 42, 56, and 70.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TJ301 600mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TJ301 300mg administrations will occur on Days 0, 14, 28, 42, 56, and 70.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo administrations will occur on Days 0, 14, 28, 42, 56, and 70.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TJ301 300mg</intervention_name>
    <description>TJ301 300mg IV infusion</description>
    <arm_group_label>TJ301 300mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TJ301 600mg</intervention_name>
    <description>TJ301 600mg IV infusion</description>
    <arm_group_label>TJ301 600mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo IV infusion</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male and female patients 18-70 (inclusive) years of age.&#xD;
&#xD;
          2. Hisory of active UC of more than 3 months. Active UC confirmed by colonoscopy with&#xD;
             biopsy or flexible sigmoidoscopy with biopsy at Screening, with extending &gt; 15-cm past&#xD;
             the anal verge from endoscopy. Biopsy sample is not necessary if UC is already&#xD;
             confirmed.&#xD;
&#xD;
          3. Active UC with a full Mayo score≥5 and a rectal bleeding subscore ≥1 at screening.&#xD;
&#xD;
          4. During Day -28 to Day -6 prior to Randomisation, an endoscopy subscore ≥2.&#xD;
&#xD;
          5. Treated with conventional non-biological UC therapy: with corticosteroids stable for&#xD;
             at least 2 weeks prior to Randomization at no more than 20 mg prednisone per day (or&#xD;
             equivalent), and/or with medications containing 5-aminosalicylates (5-ASA) at no less&#xD;
             than 2 g 5-ASA per day for at least 3 months and stable for at least 4 weeks prior to&#xD;
             Randomization, and/or with azathioprine (AZA) at no less than 0.75 mg/kg/day or&#xD;
             mercaptopurine (6-MP) at no less than 0.5 mg/kg/day for at least 6 months and stable&#xD;
             for at least 6 weeks prior to Randomization, or MTX no less than 12.5 mg/week and&#xD;
             stable for at least 12 weeks prior to Randomization.&#xD;
&#xD;
          6. Male subjects and female subjects of child bearing potential must have been willing to&#xD;
             practice effective contraception during the study and been willing and able to&#xD;
             continue contraception for 1 month after their last dose of the study treatment.&#xD;
&#xD;
          7. The patient is able and willing to comply with the requirements of this trial&#xD;
             protocol.&#xD;
&#xD;
          8. The subject should be able to read and write to understand and fill out Patient Diary.&#xD;
&#xD;
          9. Voluntarily signed Informed Consent obtained before any trial-related procedures are&#xD;
             performed.&#xD;
&#xD;
         10. The subject have not received any biologic therapies OR have received 1 biologic drug&#xD;
             for the treatment of UC or immune diseases and the last dose must be longer than&#xD;
             8-week or a 5 half-life (whichever is longer) period prior to the first dose of study&#xD;
             drug.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant or breastfeeding women.&#xD;
&#xD;
          2. Contraindication to colonoscopy or sigmoidoscopy.&#xD;
&#xD;
          3. Allergies to any component of TJ301.&#xD;
&#xD;
          4. Subject who is likely to receive surgery for UC treatment within 1 month based on&#xD;
             investigator's evaluation.&#xD;
&#xD;
          5. History of colostomy, colectomy or partial colectomy.&#xD;
&#xD;
          6. Current diagnosis of inflammatory bowel disease unclassified, Crohn's disease,&#xD;
             ischemic colitis, fulminant colitis and/or toxic megacolon, patients with ulcerative&#xD;
             colitis limited to the rectum (ulcerative proctitis), infective enteritis, amebic&#xD;
             bowel disease or intestinal schistosomiasis.&#xD;
&#xD;
          7. History of malignancy other than a successfully treated non-metastatic cutaneous&#xD;
             squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the&#xD;
             cervix. If the Screening colonoscopy shows evidence of dysplasia or a malignancy, the&#xD;
             patient is not eligible.&#xD;
&#xD;
          8. Primary or secondary immunodeficiency including neutropenia (absolute neutrophil count&#xD;
             &lt;1500/μL); or lymphopenia (absolute lymphocyte count &lt;500/μL).&#xD;
&#xD;
          9. Moderate to severe anaemia (haemoglobin &lt;9 g/dL), or thrombocytopenia (platelet count&#xD;
             &lt;75 000/μL), or serum creatinine &gt;2 mg/dL.&#xD;
&#xD;
         10. Autoimmune disease besides UC, with the exceptions of Sjogren's syndrome or&#xD;
             hypothyroidism.&#xD;
&#xD;
         11. Clostridium (C.) difficile positive at screening visit or treated for C. difficile&#xD;
             within the 4 weeks prior to Randomization.&#xD;
&#xD;
         12. serum transaminases &gt;2.5 x upper limit of normal [ULN], alkaline phosphatase &gt;2.5 x&#xD;
             ULN.&#xD;
&#xD;
         13. Serious underlying disease other than UC in the opinion of the investigator.&#xD;
&#xD;
         14. History of drug addiction within the last 1 year or current drug addiction or use of&#xD;
             illicit drugs.&#xD;
&#xD;
         15. Any indication of the regular use of more than 40 grams of alcohol every day.&#xD;
&#xD;
         16. Smokers who smoke more than 10 cigarettes per day.&#xD;
&#xD;
         17. Known concurrent acute or chronic viral hepatitis B or C infection or human&#xD;
             immunodeficiency virus (HIV) infection.&#xD;
&#xD;
         18. Presence or history of active tuberculosis (TB) or latent TB infection, defined as 1)&#xD;
             a positive QuantiFERON-TB Gold test at Screening; or 2) a T-spot test within 4 weeks&#xD;
             of Randomisation and evidence of current or previous pulmonary tuberculosis by&#xD;
             low-dose CT or chest X-ray within 12 weeks of Randomisation. Patients with old TB will&#xD;
             also be excluded.&#xD;
&#xD;
         19. Positive immunoglobulin M antibody titres to Epstein-Barr virus (EBV).&#xD;
&#xD;
         20. Subjects with positive results for cytomegalovirus at screening are to be excluded.&#xD;
&#xD;
         21. Receiving any investigational therapy or any approved therapy for investigational use&#xD;
             within 30 days or 5 half-lives prior to Randomization (whichever is longer).&#xD;
&#xD;
         22. Currently taking any medications other than those allowed per protocol guidelines.&#xD;
&#xD;
         23. Infections (including diverticulitis) requiring treatment with antibiotics,&#xD;
             antivirals, or antifungals within 14 days prior to Randomisation.&#xD;
&#xD;
         24. Received any live (attenuated) vaccines within 30 days prior to Randomisation.&#xD;
&#xD;
         25. Recent treatment with medium-to-high-dose intravenous corticosteroids&#xD;
             (methylprednisolone 60 mg/day or hydrocortisone 300 mg/day) within 8 weeks prior to&#xD;
             Randomisation or oral corticosteroids of more than 20 mg prednisone per day (or&#xD;
             equivalent).&#xD;
&#xD;
         26. Receipt of cyclosporine, tacrolimus, sirolimus, thalidomide, or mycophenolate mofetil&#xD;
             within 30 days prior to Randomisation.&#xD;
&#xD;
         27. Treatment with therapeutic enema or suppository, other than required for endoscopy&#xD;
             preparation, within 14 days prior to the screening endoscopy and during the remainder&#xD;
             of the trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Minhu Chen, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>First Affiliated Hospital, Sun Yat-Sen University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Peking University First Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100034</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Friendship Hospital Affiliated to the Capital University of Medical Sciences</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Seventh Medical Center of PLA Army General Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West China Hospital of Sichuan University</name>
      <address>
        <city>Sichuan</city>
        <state>Chengdu</state>
        <zip>610000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Sixth Affiliated Hospital of Sun Yat-sen University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangzhou</state>
        <zip>510655</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guangdong Provincial People's Hospital</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangzhou</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nanfang Hospital of SMU</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangzhou</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital, Sun Yat-sen University</name>
      <address>
        <city>Guanzhou</city>
        <state>Guangzhou</state>
        <zip>510080</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hainan General Hospital</name>
      <address>
        <city>Hainan</city>
        <state>Hainan</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sir Run Run Shaw Hospital Zhejiang University, School of Medicine</name>
      <address>
        <city>Zhejiang</city>
        <state>Hangzhou</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Harbin Medical University</name>
      <address>
        <city>Harbin</city>
        <state>Harbin</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The first Bethune hospital of Jilin university</name>
      <address>
        <city>Jilin</city>
        <state>Jilin</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The first affiliated hospital of Nanchang Univesity</name>
      <address>
        <city>Nanchang</city>
        <state>Nanchang</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jiangsu Province Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Nanjing</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Affiliated Hospital of Nanjing University Medical School</name>
      <address>
        <city>Nanjing</city>
        <state>Nanjing</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zhongda Hospital Southeast University</name>
      <address>
        <city>Nanjing</city>
        <state>Nanjing</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Renji Hospital, Shanghai Jiaotong University School of Medicine</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ruijin Hospital, Shanghai Jiaotong University School of Medicine</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Xin Hua Hospital affiliated to Shanghai Jiaotong University School of Medicine</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shengjing hospital of China medical university</name>
      <address>
        <city>Shenyang</city>
        <state>Shenyang</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Second Hospital of Shanxi Medical University</name>
      <address>
        <city>Shanxi</city>
        <state>Taiyuan</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tianjin Medical University General Hospital</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yeungnam University Medical Center</name>
      <address>
        <city>Daegu</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHA Bundang Medical Center, CHA University</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Kaohsiung</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chang Gung Memorial Hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chang Gung Memorial Hospital</name>
      <address>
        <city>Taoyuan</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
    <country>Korea, Republic of</country>
    <country>Taiwan</country>
  </location_countries>
  <removed_countries>
    <country>Australia</country>
  </removed_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>July 28, 2017</study_first_submitted>
  <study_first_submitted_qc>July 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <last_update_submitted>January 3, 2021</last_update_submitted>
  <last_update_submitted_qc>January 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Randomized</keyword>
  <keyword>Double-blind</keyword>
  <keyword>Placebo-controlled</keyword>
  <keyword>Safety</keyword>
  <keyword>Efficacy</keyword>
  <keyword>Active 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>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03235752
org study id: CTJ301UC201
nct id: NCT03235752
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a multicenter, randomized, double-blind, placebo-controlled phase II study.
is a multicenter, randomized, double-blind, placebo-controlled phase II study. The trial
      includes a Run-in Period (if stable conventional treatment needed), a 4-week Screening
      Period, a 12-week Treatment Period, and a 3-week Safety Follow-up Period to Day 105.

      90 patients will be centrally, dynamically, randomly assigned to 3 groups (1:1:1) to receive
      600mg TJ301 Q2W, 300mg TJ301 Q2W or placebo Q2W.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized, Double-blind, Placebo-controlled
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Randomized, Double-blind, Placebo-controlled
measure: Clinical and endoscopy response
time frame: Week 12
description: Clinical and endoscopy response (decrease from Baseline in full Mayo score ≥3 and ≥30%, including decrease from Baseline in rectal bleeding subscore ≥1 or rectal bleeding subscore ≤1) at Week 12.
measure: Clinical and endoscopy remission at Week 12
time frame: Week 12.
description: Clinical and endoscopy remission at Week 12, defined as a full Mayo score ≤2, no individual subscore >1, rectal bleeding subscore = 0.
measure: Clinical remission at Weeks 4, 6, 8, 10, and 12
time frame: Weeks 4, 6, 8, 10, and 12
description: Clinical remission at Weeks 4, 6, 8, 10, and 12 defined as a stool frequency subscore=0, rectal bleeding subscore = 0, and 9-point partial Mayo score ≤1.
measure: Change from Baseline to Weeks 4, 8, and 12 in exploratory biomarkers
time frame: Baseline to Weeks 4, 8, and 12
description: Change from Baseline to Weeks 4, 8, and 12 in exploratory biomarkers (erythrocyte sedimentation rate [ESR], C-reactive protein (CRP), IL-6, IL-6/sIL-6R complex, neutrophil and platelet count, faecal calprotectin).
arm group label: TJ301 300mg
arm group type: Experimental
description: TJ301 300mg administrations will occur on Days 0, 14, 28, 42, 56, and 70.
arm group label: TJ301 600mg
arm group type: Experimental
description: TJ301 300mg administrations will occur on Days 0, 14, 28, 42, 56, and 70.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo administrations will occur on Days 0, 14, 28, 42, 56, and 70.
intervention type: Drug
intervention name: TJ301 300mg
description: TJ301 300mg IV infusion
arm group label: TJ301 300mg
intervention type: Drug
intervention name: TJ301 600mg
description: TJ301 600mg IV infusion
arm group label: TJ301 600mg
intervention type: Drug
intervention name: Placebo
description: Placebo IV infusion
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Minhu Chen, Doctor
role: Principal Investigator
affiliation: First Affiliated Hospital, Sun Yat-Sen University
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
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facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: China
country: Korea, Republic of
country: Taiwan
country: Australia
responsible party type: Sponsor
mesh term: Colitis
mesh term: Colitis, Ulcerative
mesh term: Ulcer
sharing ipd: No