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
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- Assembly Biosciences
- Enrollment
- 15
- Locations
- 2
- Primary Endpoint
- Incidence of Treatment-Emergent Laboratory Abnormalities
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
ABI-M201
Cohort A: 1 capsule one time a day
Cohort B: 1- 5 capsules one time a day
Intervention: ABI-M201 (Drug)
Placebo
Cohort A: 1 capsule one time a day
Cohort B: 1-5 capsules one time a day
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Incidence of Treatment-Emergent Laboratory Abnormalities
Time Frame: 8-weeks
\[Safety\]
Incidence of Treatment-Emergent Adverse Events
Time Frame: 8-weeks
\[Safety\]
Secondary Outcomes
- Clinical Remission(8-weeks)
- Endoscopic Improvement(8-weeks)