ABI-M201 in Adult Subjects With Mildly-to-Moderately Active Ulcerative Colitis
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.
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|Eligible Ages||18 Years - 70 Years|
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
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Ulcerative Colitis Chronic Mild, Ulcerative Colitis Chronic Moderate|
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 1-5 capsules per day of ABI-M201 versus Placebo.
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