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

Assembly Biosciences

Status and phase

Terminated

Phase 1

Conditions

Ulcerative Colitis Chronic Mild

Ulcerative Colitis Chronic Moderate

Treatments

Drug: Placebo

Drug: ABI-M201

Study type

Interventional

Funder types

Industry

Identifiers

NCT03923478

ABI-M201-101

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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