ABI-M201 in Adult Subjects With Mildly-to-Moderately Active Ulcerative Colitis

Study Overview
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Brief Summary
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Phase 1B randomized, double-blind, placebo-controlled, two-cohort clinical trial of ABI-M201 in adult subjects with mildly-to-moderately active Ulcerative Colitis(UC) and ongoing treatment with mesalamine.

Detailed Description
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This multi-center randomized, double-blind, placebo-controlled study will evaluate the safety of ABI-M201 and its effects on disease activity measures in men and women with mildly-to-moderately active UC and ongoing treatment with mesalamine. The study will consist of 2 sequential, non-overlapping participant cohorts, separated by intervening interim analysis (IA). Both cohorts will involve 8-weeks of study drug treatment. Interim data from the initial treatment cohort (Cohort A) will inform decision to advance to the subsequent second cohort (Cohort B) and its dose selection. 20 subjects will be randomized to cohort A (1:1 allocation) and receive treatment with 1 capsule per day of ABI-M201 versus Placebo. 24 subjects will be randomized to cohort B (3:1 allocation) and receive treatment with up to 5 capsules one time a day of ABI-M201 versus Placebo.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase 1b Study to Evaluate the Safety, Efficacy and Mircobiological Response of Oral ABI-M201 in Subjects With Mildly-to-Moderately Active UC With Ongoing Mesalamine Treatment

Conditions
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Ulcerative Colitis Chronic Mild, Ulcerative Colitis Chronic Moderate

Intervention / Treatment
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* Drug: ABI-M201
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Established diagnosis of UC for at least 3 months prior to screening, with minimum disease extent of 15 cm from the anal verge Mildly to moderately active UC Inadequate response to ongoing treatment with oral mesalamine ≥2.4 g/day for ≥4 weeks from screening visit Exclusion Criteria: Possible or confirmed diagnosis of Crohn's Disease or other forms of inflammatory bowel disorders Ongoing or failed prior treatment for UC with methotrexate, azathioprine, 6-mercaptopurine, cyclosporine, tofacitinib, mycophenolate mofetil, sirolimus (rapamycin), thalidomide, tacrolimus (FK-506), or biologics (e.g., TNF-alpha-antagonists, anti-integrin therapies, or agents targeting IL-12 or IL-23, etc.) Any immunosuppressive condition or treatment with immunosuppressive medications History of prior surgical intervention in any region of the gastrointestinal tract (excluding minor surgery) Prior diagnosis of any cardiovascular, renal, hepatic, endocrine, infectious, hematological, oncologic, neuro-psychiatric or immune-mediated disorder, which in the opinion of the Principal Investigator might impact the subject's safety or compliance, or the interpretation of results Treatment with any other investigational drugs ≤12 weeks prior to baseline visit The participant has a condition or is in a situation which, in the Principal Investigator's opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant's participation in the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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
Interventional Model Description: Double blind, placebo-controlled trial involving two sequential non-overlapping cohorts, with intervening interim analysis
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ABI-M201<br>Cohort A: 1 capsule one time a day Cohort B: 1- 5 capsules one time a day | Drug: ABI-M201<br>* Active Treatment<br>|
| Placebo Comparator: Placebo<br>Cohort A: 1 capsule one time a day Cohort B: 1-5 capsules one time a day | Drug: Placebo<br>* Control Treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events | [Safety] | 8-weeks | 
| Incidence of Treatment-Emergent Laboratory Abnormalities | [Safety] | 8-weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Remission | [UC Disease Activity] | 8-weeks | 
| Endoscopic Improvement | [UC Disease Activity] | 8-weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase 1B, Randomized, Placebo Controlled