Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|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.
|Countries||Canada, United States|
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 up to 5 capsules one time a day of ABI-M201 versus Placebo.
Cohort A: 1 capsule one time a day Cohort B: 1- 5 capsules one time a day
Placebo Comparator: Placebo
Cohort A: 1 capsule one time a day Cohort B: 1-5 capsules one time a day
Drug: - ABI-M201
Drug: - Placebo
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.