MEDI7183 Phase 2 Study in Japanese Ulcerative Colitis Patients

Study Overview
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Brief Summary
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This is a multi-centre, randomised, double-blind, placebo controlled, parallel group, Phase II study to evaluate efficacy and safety of 3 doses of MEDI7183, in Japanese subjects with moderate to severe UC

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Drug: MEDI7183 low dose
* Drug: MEDI7183 medium dose
* Drug: MEDI7183 high dose
* Drug: Matching Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of informed consent prior to any study specific procedures Diagnosis of UC established by clinical and endoscopic evidence and corroborated by a histopathology report Moderate to severe active UC as defined by a total Mayo score of 6 to 12 with rectosigmoidoscopy score ≥ 2 during screening period Demonstrated an inadequate response to, loss of response to, or intolerance to at least one of immunomodulators or Anti- TNF-α agents. etc. Exclusion Criteria: Disease limited to the rectum Toxic megacolon Crohn's Disease History of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Koch pouch, or ileostomy for UC Planned bowel surgery within 12 weeks from Visit 2 Stool positive for C. difficile toxin at screening Primary Sclerosing Cholangitis History of gastrointestinal surgery within 8 weeks of Visit 2 Any uncontrolled or clinically significant systemic disease Condition or disease that, in the opinion of the investigator would pose a risk to subject safety or interfere with study evaluation, procedures or completion Subjects with positive HBsAg, HBsAb, HBcAb or HCVAb serology at screening etc

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MEDI7183 dose 1<br>Double blinded | Drug: MEDI7183 low dose<br>* MEDI7183 will be administered by SC on Day 1, Week 2, 4, and 8<br>|
| Experimental: MEDI7183 dose 2<br>Double blinded | Drug: MEDI7183 medium dose<br>* MEDI7183 will be administered by SC on Day 1, Week 2, 4, and 8<br>|
| Experimental: MEDI7183 dose 3<br>Double blinded | Drug: MEDI7183 high dose<br>* MEDI7183 will be administered by SC on Day 1, and placebo for MEDI7183 at Week 2, 4, and 8<br>|
| Placebo Comparator: Placebo<br>Double blinded | Drug: Matching Placebo<br>* Placebo will be administered by SC on Day 1, Week 2,4, and 8<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Remission at Week 8 | Remission at Week 8 was defined as a total Mayo score 2 points or smaller, and with no individual subscore more than 1 point. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Response at Week 8 | Response at Week 8 was assessed by total Mayo score. Response was defined as decrease 3 points or more and 30 percents in total Mayo score compared to baseline, and with an accompanying decrease in the subscore for rectal bleeding of 1 point or more, or with an absolute subscore for rectal bleeding of 0 or 1. | 8 weeks | 
| Number of Participants With Mucosal Healing at Week 8 | Mucosal healing was defined as an absolute Mayo subscore for rectosigmoidoscopy of 0 or 1. | 8 weeks | 
| Number of Participants With Response at Week 12 | Response at Week 12 was assessed by Partial Mayo Score. Response was defined as reduction by 2 or more points and 25% in Partial Mayo Score compared to baseline. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ulcerative Colitis, Japanese, subcutaneously