<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/NCT04444752</url>
  </required_header>
  <id_info>
    <org_study_id>CBP-201-WW001</org_study_id>
    <nct_id>NCT04444752</nct_id>
  </id_info>
  <brief_title>A Study to Assess the Efficacy and Safety of CBP-201 in Adult Subjects With Moderate to Severe Atopic Dermatitis</brief_title>
  <official_title>A Randomized, Double-Blind, Placebo-Controlled Multi-Centered Study of the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of CBP-201 in Adult Subjects With Moderate to Severe Atopic Dermatitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Suzhou Connect Biopharmaceuticals, Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Suzhou Connect Biopharmaceuticals, Ltd.</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>
      This study will evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of&#xD;
      CBP-201 in adult subjects with moderate to severe atopic dermatitis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized, double-blind, placebo-controlled, dose regimen finding study to assess&#xD;
      the efficacy, safety, and steady-state PK profile of CBP-201 administered to eligible adult&#xD;
      subjects with moderate to severe atopic dermatitis compared to placebo. CBP-201 is&#xD;
      administered as a subcutaneous (SC) injection. The study is divided into a treatment period&#xD;
      of 16 weeks and a follow-up period of 8 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 17, 2020</start_date>
  <completion_date type="Actual">September 22, 2021</completion_date>
  <primary_completion_date type="Actual">July 28, 2021</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent Reduction in EASI Score From Baseline to Week 16</measure>
    <time_frame>Reduction from baseline to 16 weeks</time_frame>
    <description>EASI=Eczema Area Severity Index is a validated physician score for signs of atopic dermatitis. EASI can range from 0 to 72. An EASI score of 0 indicates clear/no eczema, 0.1 to 1.0 almost clear, 1.1 to 7 mild disease, 7.1 to 21 moderate disease, 21.1 to 50 severe disease, and 51-72 indicates very severe disease. EASI Sub-scale ranges are as follows: Head/neck can range from 0-7.2, Trunk 0-14.4, Upper Extremities 0-21.6, Lower Extremities can range from 0-28.8. To calculate EASI, % involvement is first assessed by body region with an Area involvement Score of 0-6 for each region: 0=0%, 1=1-9%, 2=10-29%, 3=30-39%, 4=50-69%, 5=70-89%, 6=90-100% involvement. Then 4 attributes (Erythema, Edema/Papulation, Excoriation, and Lichenification) are scored for severity (0= none, 1=mild, 2=moderate, 3=severe). A multiplier is applied head/neck=0.1, trunk=0.2, upper extremities= 0.3, lower extremities=0.4. The total EASI score is the sum of 4 regional sub-scores.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>vIGA of 0/1 at Week 16</measure>
    <time_frame>Response Rate at 16 weeks</time_frame>
    <description>Validated Investigator Global Assessment Score (vIGA) is assigned by the physician based on morphologic presentation of the disease in the clinic. The physician considers extent and severity of erythema, induration/papulation, lichenification, and oozing/crusting. A vIGA Score of 0=Clear, 1=Almost Clear, 2= Mild dermatitis, 3=Moderate dermatitis, and 4= Severe dermatitis. Patients are required to have a baseline IGA of 3 or 4. The response rate or percentage of patients achieving a vIGA of 0 or 1 (improved to clear or almost clear) at week 16 is the outcome.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">226</enrollment>
  <condition>Moderate-to-severe Atopic Dermatitis</condition>
  <arm_group>
    <arm_group_label>CBP-201 Dose 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CBP-201 Dose 1 subcutaneous (SC) injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CBP-201 Dose 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CBP-201 Dose 2 subcutaneous (SC) injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CBP-201 Dose 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CBP-201 Dose 3 subcutaneous (SC) injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>subcutaneous (SC) injection</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CBP-201</intervention_name>
    <description>CBP-201 subcutaneous(SC) injection.</description>
    <arm_group_label>CBP-201 Dose 1</arm_group_label>
    <arm_group_label>CBP-201 Dose 2</arm_group_label>
    <arm_group_label>CBP-201 Dose 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>subcutaneous(SC) injection</description>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Be an adult ≥18 and ≤ 75 years of age at the screening visit (Screening) with atopic&#xD;
             dermatitis according to American Academy of Dermatology Consensus Criteria,&#xD;
             (Eichenfield 2014)&#xD;
&#xD;
          2. Present for at least 1 year prior to the baseline visit (Baseline) with an inadequate&#xD;
             response, in the judgement of the Investigator, to AD treatment with a topical regimen&#xD;
             of corticosteroids, phosphodiesterase inhibitors or calcineurin inhibitors, or for&#xD;
             whom topical treatments are otherwise medically inadvisable (eg, because of important&#xD;
             side effect or safety risks)&#xD;
&#xD;
          3. Investigator Global Assessment (IGA) score ≥ 3 at Screening and Baseline.&#xD;
&#xD;
          4. Eczema Area and Severity Index (EASI) score ≥ 16 at Screening and Baseline&#xD;
&#xD;
          5. Body Surface Area (BSA) for total AD involvement ≥ 10% at Screening and Baseline&#xD;
&#xD;
          6. Able and willing to apply a stable dose of a bland emollient twice a day to affected&#xD;
             areas for at least 7 days before Baseline and to continue for the duration of the&#xD;
             study&#xD;
&#xD;
          7. Females of child-bearing potential (FCBP) and males who have not undergone a vasectomy&#xD;
             must abstain from heterosexual activities or agree to use effective contraception&#xD;
             throughout the entire study period.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Have any of the following laboratory abnormalities at Screening:&#xD;
&#xD;
               1. Hemoglobin ≤ 90% of the lower limit of normal range (LLN)&#xD;
&#xD;
               2. White blood cell (WBC) below the LLN&#xD;
&#xD;
               3. Neutrophil count below the LLN&#xD;
&#xD;
               4. Platelet count below the LLN&#xD;
&#xD;
          2. Have undergone treatment with any of the following:&#xD;
&#xD;
               1. Topical agents such as corticosteroids, phosphodiesterase (PDE) inhibitors, Janus&#xD;
                  kinase (JAK) inhibitors, tacrolimus or pimecrolimus within 1 week prior to&#xD;
                  Baseline. Note that low to medium potency topical corticosteroids (TCS) are&#xD;
                  permitted after randomization to treat AD flares&#xD;
&#xD;
               2. Prior treatment with dupilumab or any antibody against IL-4Rα or IL-13&#xD;
&#xD;
               3. Systemic treatment for AD or other condition with steroids or other&#xD;
                  immunosuppressive/immunomodulating substances, e.g., cyclosporine,&#xD;
                  mycophenolate-mofetil, azathioprine, methotrexate or oral Janus kinase (JAK)&#xD;
                  inhibitors within 4 weeks prior to Baseline. Use of steroid inhalers and nasal&#xD;
                  corticosteroids is allowed.&#xD;
&#xD;
               4. Cell depleting agents, e.g. rituximab, within 6 months of Baseline or treatment&#xD;
                  with other biologics within 5 half-lives (if known) or 3 months prior to baseline&#xD;
                  visit, whichever is longer&#xD;
&#xD;
               5. Phototherapy (narrow band ultraviolet B [NBUVB], ultraviolet B [UVB], ultraviolet&#xD;
                  A1 [UVA1], psoralen + ultraviolet A [PUVA]), tanning beds, or any other light&#xD;
                  emitting device (LED), within 4 weeks of Baseline&#xD;
&#xD;
               6. ≥ 2 bleach baths within 2 weeks of Baseline&#xD;
&#xD;
               7. Prescription emollient to treat AD (e.g. Atopiclair®, MimyX®, Epicerum®, etc.)&#xD;
                  within 2 weeks of Baseline&#xD;
&#xD;
               8. Any investigational drug within 30 days or within 5 half-lives, whichever is&#xD;
                  longer, before Baseline.&#xD;
&#xD;
               9. Live (attenuated) vaccine within 8 weeks of Baseline.&#xD;
&#xD;
              10. Treatment with systemic traditional Chinese medicine (TCM) or herbal medications&#xD;
                  within 4 weeks before Baseline or treatment with topical TCM or herbal&#xD;
                  medications within 1 week before Baseline visit&#xD;
&#xD;
          3. Have any of the following:&#xD;
&#xD;
               1. Infection requiring treatment with systemic antibiotics, antivirals,&#xD;
                  antiparasitics, antiprotozoals, or antifungals within 4 weeks before Baseline, or&#xD;
                  superficial skin infection, such as impetigo, within 2 weeks before the Baseline&#xD;
                  (subjects may be rescreened after the infection has resolved)&#xD;
&#xD;
               2. A history of parasitic infection (e.g. helminth), within 6 months of Baseline&#xD;
&#xD;
               3. Per investigator judgement, known or suspected history of immunosuppression&#xD;
                  within 6 months of Baseline, including a history of invasive opportunistic&#xD;
                  infections, such as aspergillosis, coccidioidomycosis, histoplasmosis, human&#xD;
                  immunodeficiency virus (HIV), listeriosis, pneumocystosis, or tuberculosis,&#xD;
                  despite infection resolution; or unusually frequent, recurrent or prolonged&#xD;
                  infections.&#xD;
&#xD;
               4. Any history of vernal keratoconjunctivitis (VKC) and atopic keratoconjunctivitis&#xD;
                  (AKC)&#xD;
&#xD;
               5. A history of malignancy with the following exceptions: completely treated&#xD;
                  carcinoma in situ of cervix or non-metastatic squamous or basal cell carcinoma of&#xD;
                  the skin&#xD;
&#xD;
               6. Positive results at Screening for hepatitis B surface antigen (HBsAg), hepatitis&#xD;
                  B core antibody (HBcAb) or hepatitis C antibody with positive HCV RNA polymerase&#xD;
                  chain reaction; positive HIV serology at screening&#xD;
&#xD;
               7. An allergy to L-histidine, trehalose or Tween (polysorbate) 80&#xD;
&#xD;
          4. Women must not be pregnant, planning to become pregnant or breast-feed during the&#xD;
             study&#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>Suzhou Connect</last_name>
    <role>Study Director</role>
    <affiliation>Suzhou Connect Biopharmaceuticals, Ltd.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Connect Investigative Site 310</name>
      <address>
        <city>Glendale</city>
        <state>Arizona</state>
        <zip>85308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Connect Investigative Site 338</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85001</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Connect Investigative Site 316</name>
      <address>
        <city>Tempe</city>
        <state>Arizona</state>
        <zip>85284</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Connect Investigative Site 305</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Connect Investigative Site 327</name>
      <address>
        <city>Canoga Park</city>
        <state>California</state>
        <zip>91303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Connect Investigative Site 324</name>
      <address>
        <city>Encinitas</city>
        <state>California</state>
        <zip>92024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Connect Investigative Site 301</name>
      <address>
        <city>Fremont</city>
        <state>California</state>
        <zip>94538</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Connect Investigative Site 312</name>
      <address>
        <city>Huntington Beach</city>
        <state>California</state>
        <zip>92647</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Connect Investigative Site 329</name>
      <address>
        <city>Mission Viejo</city>
        <state>California</state>
        <zip>92691</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Connect Investigative Site 322</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Connect Investigative Site 323</name>
      <address>
        <city>San Luis Obispo</city>
        <state>California</state>
        <zip>93405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Connect Investigative Site 317</name>
      <address>
        <city>Santa Ana</city>
        <state>California</state>
        <zip>92703</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Connect Investigative Site 318</name>
      <address>
        <city>Sherman Oaks</city>
        <state>California</state>
        <zip>91403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Connect Investigative Site 325</name>
      <address>
        <city>Thousand Oaks</city>
        <state>California</state>
        <zip>91320</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Connect Investigative Site 332</name>
      <address>
        <city>Coral Gables</city>
        <state>Florida</state>
        <zip>33144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Connect Investigative Site 320</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Connect Investigative Site 306</name>
      <address>
        <city>Hollywood</city>
        <state>Florida</state>
        <zip>33021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Connect Investigative Site 308</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32256</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Connect Investigative Site 314</name>
      <address>
        <city>Maitland</city>
        <state>Florida</state>
        <zip>32751</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Connect Investigative Site 331</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33155</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Connect Investigative Site 337</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33155</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Connect Investigative Site 321</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33173</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Connect Investigative Site 304</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Connect Investigative Site 340</name>
      <address>
        <city>Weston</city>
        <state>Florida</state>
        <zip>33331</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Connect Investigative Site 333</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60640</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Connect Investigative Site 303</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60660</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Connect Investigative Site 307</name>
      <address>
        <city>New Albany</city>
        <state>Indiana</state>
        <zip>47150</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Connect Investigative Site 313</name>
      <address>
        <city>West Lafayette</city>
        <state>Indiana</state>
        <zip>47906</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Connect Investigative Site 311</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40241</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Connect Investigative Site 319</name>
      <address>
        <city>Hunt Valley</city>
        <state>Maryland</state>
        <zip>21030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Connect Investigative Site 335</name>
      <address>
        <city>Saint Joseph</city>
        <state>Missouri</state>
        <zip>64506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Connect Investigative Site 315</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Connect Investigative Site 336</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Connect Investigative Site 326</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Connect Investigative Site 330</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Connect Investigative Site 328</name>
      <address>
        <city>Rapid City</city>
        <state>South Dakota</state>
        <zip>57702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Connect Investigative Site 309</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Connect Investigative Site 334</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Connect Investigative Site 111</name>
      <address>
        <city>Canberra</city>
        <state>Australian Capital Territory</state>
        <zip>2606</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Connect Investigative Site 104</name>
      <address>
        <city>Darlinghurst</city>
        <state>New South Wales</state>
        <zip>2010</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Connect Investigative Site 108</name>
      <address>
        <city>Kanwal</city>
        <state>New South Wales</state>
        <zip>2259</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Connect Investigative Site 105</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <zip>2289</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Connect Investigative Site 101</name>
      <address>
        <city>Brisbane</city>
        <state>Queensland</state>
        <zip>4102</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Connect Investigative Site 102</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3002</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Connect Investigative Site 106</name>
      <address>
        <city>Fremantle</city>
        <state>Western Australia</state>
        <zip>6160</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Connect Investigative Site 103</name>
      <address>
        <city>Perth</city>
        <state>Western Australia</state>
        <zip>6009</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Connect Investigative Site 408</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100020</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Connect Investigative Site 404</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100050</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Connect Investigative Site 405</name>
      <address>
        <city>Wuxi</city>
        <state>Jiangsu</state>
        <zip>214002</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Connect Investigative Site 409</name>
      <address>
        <city>Zhenjiang</city>
        <state>Jiangsu</state>
        <zip>212001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Connect Investigative Site 402</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <zip>250013</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Connect Investigative Site 401</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200040</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Connect Investigative Site 406</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200071</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Connect Investigative Site 410</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300120</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Connect Investigative Site 403</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310003</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Connect Investigative Site 204</name>
      <address>
        <city>Tauranga</city>
        <state>Bay Of Plenty</state>
        <zip>3110</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Connect Investigative Site 202</name>
      <address>
        <city>Havelock North</city>
        <state>Hawke's Bay</state>
        <zip>4130</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Connect Investigative Site 205</name>
      <address>
        <city>Waikanae</city>
        <state>Kapiti Coast</state>
        <zip>5036</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Connect Investigative Site 203</name>
      <address>
        <city>Auckland</city>
        <zip>1010</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>China</country>
    <country>New Zealand</country>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <results_first_submitted>November 9, 2022</results_first_submitted>
  <results_first_submitted_qc>July 31, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">August 1, 2023</results_first_posted>
  <last_update_submitted>July 31, 2023</last_update_submitted>
  <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dermatitis, Atopic</mesh_term>
    <mesh_term>Dermatitis</mesh_term>
    <mesh_term>Eczema</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>May 28, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/52/NCT04444752/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 15, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/52/NCT04444752/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>August 7, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/52/NCT04444752/ICF_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Patients were recruited based on physician referrral at academic and non-academic clinical centers between Jun 2020 and Sep 2021; 394 patients were screened. The first participant was randomized to treatment on 30 Jun 2020 and the last patient was randomized in April 2021. The last patient last visit was 22 Sept 2021.</recruitment_details>
      <pre_assignment_details>After providing informed consent, patients were assessed for study eligibility within 45 days before the baseline visit. Of the 394 patients screeened, 226 patients met the eligibility criteria and were randomized to treatment.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>CBP-201 150 Q2W</title>
          <description>CBP-201 1800 mg, 600 mg Loading dose followed by 150 mg Q2W for 16 weeks</description>
        </group>
        <group group_id="P2">
          <title>CBP-201 300 Q2W</title>
          <description>CBP-201 3000 mg, 600 mg Loading dose followed by 300 mg Q2W for 16 weeks</description>
        </group>
        <group group_id="P3">
          <title>CBP-201 300 Q4W</title>
          <description>CBP-201 1800 mg, 600 mg Loading dose followed by 300 mg Q4W for 16 weeks alternating with 2 mLs matched volume placebo Q4W for 16 weeks</description>
        </group>
        <group group_id="P4">
          <title>Placebo</title>
          <description>Placebo, 4 mLs matched loading dose volume follwed by 2 mls matched volume Q2W for 16 weeks</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="57"/>
                <participants group_id="P2" count="57"/>
                <participants group_id="P3" count="56"/>
                <participants group_id="P4" count="56"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="46"/>
                <participants group_id="P2" count="45"/>
                <participants group_id="P3" count="50"/>
                <participants group_id="P4" count="40"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="16"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Patient moving out of town</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>CBP-201 150 Q2W</title>
          <description>CBP-201 1800 mg, 600 mg Loading dose followed by 150 mg Q2W for 16 weeks</description>
        </group>
        <group group_id="B2">
          <title>CBP-201 300 Q2W</title>
          <description>CBP-201 3000 mg, 600 mg Loading dose followed by 300 mg Q2W for 16 weeks</description>
        </group>
        <group group_id="B3">
          <title>CBP-201 300 Q4W</title>
          <description>CBP-201 1800 mg, 600 mg Loading dose followed by 300 mg Q4W for 16 weeks alternating with 2 mLs matched volume placebo Q4W for 16 weeks</description>
        </group>
        <group group_id="B4">
          <title>Placebo</title>
          <description>Placebo, 4 mLs matched loading dose volume follwed by 2 mls matched volume Q2W for 16 weeks</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="57"/>
            <count group_id="B2" value="57"/>
            <count group_id="B3" value="56"/>
            <count group_id="B4" value="56"/>
            <count group_id="B5" value="226"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="52"/>
                    <measurement group_id="B2" value="54"/>
                    <measurement group_id="B3" value="52"/>
                    <measurement group_id="B4" value="54"/>
                    <measurement group_id="B5" value="212"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39.5" spread="15.98"/>
                    <measurement group_id="B2" value="39.6" spread="14.79"/>
                    <measurement group_id="B3" value="41.7" spread="15.22"/>
                    <measurement group_id="B4" value="39.6" spread="14.79"/>
                    <measurement group_id="B5" value="40.1" spread="15.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="28"/>
                    <measurement group_id="B4" value="36"/>
                    <measurement group_id="B5" value="121"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="28"/>
                    <measurement group_id="B4" value="20"/>
                    <measurement group_id="B5" value="105"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="27"/>
                    <measurement group_id="B4" value="24"/>
                    <measurement group_id="B5" value="92"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="29"/>
                    <measurement group_id="B4" value="32"/>
                    <measurement group_id="B5" value="134"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="14"/>
                    <measurement group_id="B5" value="52"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="32"/>
                    <measurement group_id="B4" value="32"/>
                    <measurement group_id="B5" value="132"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="4"/>
                  </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>New Zealand</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="41"/>
                    <measurement group_id="B4" value="44"/>
                    <measurement group_id="B5" value="172"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>China</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Australia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>EASI Score</title>
          <description>Eczema Area Severity Index Score</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24.61" spread="10.471"/>
                    <measurement group_id="B2" value="27.57" spread="11.776"/>
                    <measurement group_id="B3" value="23.08" spread="8.218"/>
                    <measurement group_id="B4" value="25.16" spread="9.021"/>
                    <measurement group_id="B5" value="25.11" spread="10.042"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>IGA Score</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>IGA 3 = Moderate disease</title>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="40"/>
                    <measurement group_id="B4" value="39"/>
                    <measurement group_id="B5" value="156"/>
                  </measurement_list>
                </category>
                <category>
                  <title>IGA 4 = Severe disease</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="16"/>
                    <measurement group_id="B4" value="17"/>
                    <measurement group_id="B5" value="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BSA</title>
          <description>Body Surface Area affected by AD in %</description>
          <units>percentage</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39.86" spread="19.145"/>
                    <measurement group_id="B2" value="43.11" spread="20.738"/>
                    <measurement group_id="B3" value="37.34" spread="19.479"/>
                    <measurement group_id="B4" value="37.71" spread="18.341"/>
                    <measurement group_id="B5" value="39.52" spread="19.456"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percent Reduction in EASI Score From Baseline to Week 16</title>
        <description>EASI=Eczema Area Severity Index is a validated physician score for signs of atopic dermatitis. EASI can range from 0 to 72. An EASI score of 0 indicates clear/no eczema, 0.1 to 1.0 almost clear, 1.1 to 7 mild disease, 7.1 to 21 moderate disease, 21.1 to 50 severe disease, and 51-72 indicates very severe disease. EASI Sub-scale ranges are as follows: Head/neck can range from 0-7.2, Trunk 0-14.4, Upper Extremities 0-21.6, Lower Extremities can range from 0-28.8. To calculate EASI, % involvement is first assessed by body region with an Area involvement Score of 0-6 for each region: 0=0%, 1=1-9%, 2=10-29%, 3=30-39%, 4=50-69%, 5=70-89%, 6=90-100% involvement. Then 4 attributes (Erythema, Edema/Papulation, Excoriation, and Lichenification) are scored for severity (0= none, 1=mild, 2=moderate, 3=severe). A multiplier is applied head/neck=0.1, trunk=0.2, upper extremities= 0.3, lower extremities=0.4. The total EASI score is the sum of 4 regional sub-scores.</description>
        <time_frame>Reduction from baseline to 16 weeks</time_frame>
        <population>All efficacy analyses were carried out using the FAS (all randomized subjects who received at least part of an SC dose of study drug based on planned treatment assignment (ie, &quot;as randomized&quot;).</population>
        <group_list>
          <group group_id="O1">
            <title>CBP-201 150 Q2W</title>
            <description>CBP-201 1800 mg, 600 mg Loading dose followed by 150 mg Q2W for 16 weeks</description>
          </group>
          <group group_id="O2">
            <title>CBP-201 300 Q2W</title>
            <description>CBP-201 3000 mg, 600 mg Loading dose followed by 300 mg Q2W for 16 weeks</description>
          </group>
          <group group_id="O3">
            <title>CBP-201 300 Q4W</title>
            <description>CBP-201 1800 mg, 600 mg Loading dose followed by 300 mg Q4W for 16 weeks alternating with 2 mLs matched volume placebo Q4W for 16 weeks</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo, 4 mLs matched loading dose volume follwed by 2 mls matched volume Q2W for 16 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Reduction in EASI Score From Baseline to Week 16</title>
          <description>EASI=Eczema Area Severity Index is a validated physician score for signs of atopic dermatitis. EASI can range from 0 to 72. An EASI score of 0 indicates clear/no eczema, 0.1 to 1.0 almost clear, 1.1 to 7 mild disease, 7.1 to 21 moderate disease, 21.1 to 50 severe disease, and 51-72 indicates very severe disease. EASI Sub-scale ranges are as follows: Head/neck can range from 0-7.2, Trunk 0-14.4, Upper Extremities 0-21.6, Lower Extremities can range from 0-28.8. To calculate EASI, % involvement is first assessed by body region with an Area involvement Score of 0-6 for each region: 0=0%, 1=1-9%, 2=10-29%, 3=30-39%, 4=50-69%, 5=70-89%, 6=90-100% involvement. Then 4 attributes (Erythema, Edema/Papulation, Excoriation, and Lichenification) are scored for severity (0= none, 1=mild, 2=moderate, 3=severe). A multiplier is applied head/neck=0.1, trunk=0.2, upper extremities= 0.3, lower extremities=0.4. The total EASI score is the sum of 4 regional sub-scores.</description>
          <population>All efficacy analyses were carried out using the FAS (all randomized subjects who received at least part of an SC dose of study drug based on planned treatment assignment (ie, &quot;as randomized&quot;).</population>
          <units>percent reduction from Baseline</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="57"/>
                <count group_id="O2" value="57"/>
                <count group_id="O3" value="56"/>
                <count group_id="O4" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.56" spread="4.610"/>
                    <measurement group_id="O2" value="63.03" spread="4.961"/>
                    <measurement group_id="O3" value="63.50" spread="4.661"/>
                    <measurement group_id="O4" value="39.67" spread="4.638"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The primary efficacy analysis includes comparison of percentage reduction in EASI from baseline to Week 16 for CBP-201 300 mg Q2W regimen vs placebo.&#xD;
The sample size of the study was determined based on power calculations for the primary endpoint in patients receiving CBP-201 300 mg Q2W.&#xD;
Null hypothesis: CBP-201 300 Q2W is not superior to placebo in terms of percent reduction in EASI Score from Baseline to Week 16.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Pairwise comparisons for each CBP-201 group vs placebo were performed and a serial gate-keeping procedure was used for multiplicity adjustment. Each CBP-201 group was compared to placebo group in order from highest dose (300 mg Q2W) to the lowest dose frequency (300 mg Q4W), until statistical signficance at p=0.05 level was not achieved.</non_inferiority_desc>
            <p_value>0.0007</p_value>
            <p_value_desc>Adjusted for multiplicity using a serial gatekeeping procedure at the 5% in descending order: 1. 300 mg dose Q2W 2. 150 mg dose Q2W 3. 300 mg dose Q4W vs placebo</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>The data were analyzed using an ANCOVA model adjusted for treatment, baseline vIGA (moderate, severe), and baseline EASI.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>23.36</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>6.794</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The sample size of the study was determined based on power calculations for the primary endpoint in patients receiving CBP-201 300 mg Q2W.&#xD;
Null hypothesis: CBP-201 150 Q2W is not superior to placebo in terms of percent reduction in EASI Score from Baseline to Week 16.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Pairwise comparisons for each CBP-201 group vs placebo were performed and a serial gatekeeping procedure was used for multiplicity adjustment. Each CBP-201 group was compared with the placebo group in order from the highest dose (300 mg Q2W) to the lowest dose frequency (300 mg Q4W), until statistical significance at 0.05 level was not achieved.</non_inferiority_desc>
            <p_value>0.0067</p_value>
            <p_value_desc>Adjusted for multiplicity using a serial gatekeeping procedure at the 5% in descending order: 1. 300 mg dose Q2W 2. 150 mg Q2W 3. 300 mg Q4W vs placebo.</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>The data were analyzed using an ANCOVA model with terms for treatment, baseline vIGA (moderate, severe), and baseline EASI.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>17.89</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>6.537</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The efficacy analysis includes comparing percentage reduction in EASI from baseline to Week 16 for CBP-201 300 mg Q4W regimen vs placebo.&#xD;
The sample size of the study was determined based on power calculations for the primary endpoint in patients receiving CBP-201 300 mg Q2W.&#xD;
Null hypothesis: CBP-201 300 Q4W is not superior to placebo in terms of percent reduction in EASI Score from Baseline to Week 16.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Pairwise comparisons for each CBP-201 group vs placebo were performed and a serial gatekeeping procedure was used for multiplicity adjustment. Each CBP-201 group was compared with placebo in order from highest dose (300 mg Q2W) to the lowest dose frequency (300 mg Q4W), until statistical significance at the 0.05 level was not achieved.</non_inferiority_desc>
            <p_value>0.0004</p_value>
            <p_value_desc>Adjusted for mulitplicity using a serial gatekeeping procedure at the 5% in descending order: 1. 300 mg dose Q2W 2. 150 mg Q2W 3. 300 mg Q4W vs placebo.</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>The data were anlayzed using an ANCOVA model with terms for treatment, baseline vIGA (moderate, severe), and baseline EASI</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>23.83</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>6.575</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>vIGA of 0/1 at Week 16</title>
        <description>Validated Investigator Global Assessment Score (vIGA) is assigned by the physician based on morphologic presentation of the disease in the clinic. The physician considers extent and severity of erythema, induration/papulation, lichenification, and oozing/crusting. A vIGA Score of 0=Clear, 1=Almost Clear, 2= Mild dermatitis, 3=Moderate dermatitis, and 4= Severe dermatitis. Patients are required to have a baseline IGA of 3 or 4. The response rate or percentage of patients achieving a vIGA of 0 or 1 (improved to clear or almost clear) at week 16 is the outcome.</description>
        <time_frame>Response Rate at 16 weeks</time_frame>
        <population>All efficacy analyses were carried out using the FAS (all randomized subjects who received at least part of an SC dose of study drug), based on planned treatment assignment (ie, &quot;as randomized&quot;).</population>
        <group_list>
          <group group_id="O1">
            <title>CBP-201 150 Q2W</title>
            <description>CBP-201 1800 mg, 600 mg Loading dose followed by 150 mg Q2W for 16 weeks</description>
          </group>
          <group group_id="O2">
            <title>CBP-201 300 Q2W</title>
            <description>CBP-201 3000 mg, 600 mg Loading dose followed by 300 mg Q2W for 16 weeks</description>
          </group>
          <group group_id="O3">
            <title>CBP-201 300 Q4W</title>
            <description>CBP-201 1800 mg, 600 mg Loading dose followed by 300 mg Q4W for 16 weeks alternating with 2 mLs matched volume placebo Q4W for 16 weeks</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo, 4 mLs matched loading dose volume follwed by 2 mls matched volume Q2W for 16 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>vIGA of 0/1 at Week 16</title>
          <description>Validated Investigator Global Assessment Score (vIGA) is assigned by the physician based on morphologic presentation of the disease in the clinic. The physician considers extent and severity of erythema, induration/papulation, lichenification, and oozing/crusting. A vIGA Score of 0=Clear, 1=Almost Clear, 2= Mild dermatitis, 3=Moderate dermatitis, and 4= Severe dermatitis. Patients are required to have a baseline IGA of 3 or 4. The response rate or percentage of patients achieving a vIGA of 0 or 1 (improved to clear or almost clear) at week 16 is the outcome.</description>
          <population>All efficacy analyses were carried out using the FAS (all randomized subjects who received at least part of an SC dose of study drug), based on planned treatment assignment (ie, &quot;as randomized&quot;).</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="57"/>
                <count group_id="O2" value="57"/>
                <count group_id="O3" value="56"/>
                <count group_id="O4" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="16"/>
                    <measurement group_id="O3" value="11"/>
                    <measurement group_id="O4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis: CBP-201 300 Q2W is not superior to placebo in terms of the number of patients achieving a vIGA score of 0/1 (clear/almost clear) at Week 16.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The secondary efficacy analysis includes comparison of the number of patients achieving a vIGA score of 0/1 (clear/almost clear) at Week 16 for each CBP-201 300 mg Q2W vs placebo.</non_inferiority_desc>
            <p_value>0.0089</p_value>
            <p_value_desc>There were no adjustments for multiple comparisons. For IGA response, counts, percentage, and 95% CIs obtained using the Clopper-Pearson method and were presented for pairwise comparisons for each CBP-201 group vs. placebo.</p_value_desc>
            <method>Chi-squared</method>
            <param_type>Difference in vIGA Response Rate</param_type>
            <param_value>28.1</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were reported from the time the subject signed the informed consent and continued through the scheduled last visit (32 weeks after baseline visit), or if unresolved, until clinical recovery was complete.</time_frame>
      <desc>An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. All AEs will be reported along with causality (related or not related) and Severity (CTCAE grading 1-5). In addition, AEs will be considered AEs of Special Interest (AESI) if they are involve ophthalmic complications (conjunctivitis or keratitis). Serious AEs will be reported within 24 hours to the Sponsor and CRO.</desc>
      <group_list>
        <group group_id="E1">
          <title>CBP-201 150 Q2W</title>
          <description>CBP-201 1800 mg, 600 mg Loading dose followed by 150 mg Q2W for 16 weeks</description>
        </group>
        <group group_id="E2">
          <title>CBP-201 300 Q2W</title>
          <description>CBP-201 3000 mg, 600 mg Loading dose followed by 300 mg Q2W for 16 weeks</description>
        </group>
        <group group_id="E3">
          <title>CBP-201 300 Q4W</title>
          <description>CBP-201 1800 mg, 600 mg Loading dose followed by 300 mg Q4W for 16 weeks alternating with 2 mLs matched volume placebo Q4W for 16 weeks</description>
        </group>
        <group group_id="E4">
          <title>Placebo</title>
          <description>Placebo, 4 mLs matched loading dose volume follwed by 2 mls matched volume Q2W for 16 weeks</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 24.0</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="57"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="56"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 24.0</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="26" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="34" subjects_at_risk="56"/>
                <counts group_id="E4" subjects_affected="31" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Eye pruritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="57"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="56"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Injection site reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E3" events="6" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="57"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="56"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="56"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="57"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="57"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="57"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="56"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="57"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="57"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="56"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis atopic</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="57"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="57"/>
                <counts group_id="E3" events="14" subjects_affected="14" subjects_at_risk="56"/>
                <counts group_id="E4" events="8" subjects_affected="8" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>COVID-19</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="57"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="57"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Pruritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="56"/>
              </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 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>Malinda Longphre</name_or_title>
      <organization>Head of Clinical Operations US</organization>
      <phone>+15105203361</phone>
      <email>Mlongphre@connectpharm.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/NCT04444752
org study id: CBP-201-WW001
nct id: NCT04444752
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This study will evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of
      CBP-201 in adult subjects with moderate to severe atopic dermatitis.
This is a randomized, double-blind, placebo-controlled, dose regimen finding study to assess
      the efficacy, safety, and steady-state PK profile of CBP-201 administered to eligible adult
      subjects with moderate to severe atopic dermatitis compared to placebo. CBP-201 is
      administered as a subcutaneous (SC) injection. The study is divided into a treatment period
      of 16 weeks and a follow-up period of 8 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Percent Reduction in EASI Score From Baseline to Week 16
time frame: Reduction from baseline to 16 weeks
description: EASI=Eczema Area Severity Index is a validated physician score for signs of atopic dermatitis. EASI can range from 0 to 72. An EASI score of 0 indicates clear/no eczema, 0.1 to 1.0 almost clear, 1.1 to 7 mild disease, 7.1 to 21 moderate disease, 21.1 to 50 severe disease, and 51-72 indicates very severe disease. EASI Sub-scale ranges are as follows: Head/neck can range from 0-7.2, Trunk 0-14.4, Upper Extremities 0-21.6, Lower Extremities can range from 0-28.8. To calculate EASI, % involvement is first assessed by body region with an Area involvement Score of 0-6 for each region: 0=0%, 1=1-9%, 2=10-29%, 3=30-39%, 4=50-69%, 5=70-89%, 6=90-100% involvement. Then 4 attributes (Erythema, Edema/Papulation, Excoriation, and Lichenification) are scored for severity (0= none, 1=mild, 2=moderate, 3=severe). A multiplier is applied head/neck=0.1, trunk=0.2, upper extremities= 0.3, lower extremities=0.4. The total EASI score is the sum of 4 regional sub-scores.
measure: vIGA of 0/1 at Week 16
time frame: Response Rate at 16 weeks
description: Validated Investigator Global Assessment Score (vIGA) is assigned by the physician based on morphologic presentation of the disease in the clinic. The physician considers extent and severity of erythema, induration/papulation, lichenification, and oozing/crusting. A vIGA Score of 0=Clear, 1=Almost Clear, 2= Mild dermatitis, 3=Moderate dermatitis, and 4= Severe dermatitis. Patients are required to have a baseline IGA of 3 or 4. The response rate or percentage of patients achieving a vIGA of 0 or 1 (improved to clear or almost clear) at week 16 is the outcome.
arm group label: CBP-201 Dose 1
arm group type: Experimental
description: CBP-201 Dose 1 subcutaneous (SC) injection
arm group label: CBP-201 Dose 2
arm group type: Experimental
description: CBP-201 Dose 2 subcutaneous (SC) injection
arm group label: CBP-201 Dose 3
arm group type: Experimental
description: CBP-201 Dose 3 subcutaneous (SC) injection
arm group label: placebo
arm group type: Placebo Comparator
description: subcutaneous (SC) injection
intervention type: Drug
intervention name: CBP-201
description: CBP-201 subcutaneous(SC) injection.
arm group label: CBP-201 Dose 1
arm group label: CBP-201 Dose 2
arm group label: CBP-201 Dose 3
intervention type: Drug
intervention name: placebo
description: subcutaneous(SC) injection
arm group label: placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Suzhou Connect
role: Study Director
affiliation: Suzhou Connect Biopharmaceuticals, Ltd.
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country: Australia
country: China
country: New Zealand
country: United States
responsible party type: Sponsor
mesh term: Dermatitis, Atopic
mesh term: Dermatitis
mesh term: Eczema
sharing ipd: No
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