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ABI-M201 in Adult Subjects With Mildly-to-Moderately Active Ulcerative Colitis | Clinical Trials | Clareo Health

TERMINATEDPHASE1

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

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

NCT03923478•Assembly Biosciences

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 70 years

Sex

ALL

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

Locations (11)

(Investigator site)

Oakland, California, United States

(Investigator Site)

San Carlos, California, United States

(Investigator Site)

Decatur, Georgia, United States

(Investigator Site)

Shreveport, Louisiana, United States

(Investigator Site)

Chesterfield, Michigan, United States

(Investigator Site)

Ypsilanti, Michigan, United States

(Investigator Site)

Rochester, Minnesota, United States

(Investigator Site)

Jackson, Tennessee, United States

(Investigator Site)

Bellevue, Washington, United States

(Investigator Site)

Milwaukee, Wisconsin, United States

Key Dates

Start Date

June 24, 2019

Primary Completion Date

January 20, 2021

Completion Date

January 20, 2021

Last Updated

March 19, 2021

Enrollment

ACTUAL participants

Conditions

Ulcerative Colitis Chronic MildUlcerative Colitis Chronic Moderate

Interventions

ABI-M201

DRUG

Placebo

DRUG

R-3750 in Patients With Mild to Moderate Ulcerative Colitis

NCT05666960

Ulcerative Colitis Chronic MildUlcerative Colitis Chronic Moderate+2 more

View study

UNKNOWNNA

Preliminary Clinical Study of NMN Intervention in Mild Ulcerative Colitis

NCT06214078

Ulcerative Colitis Chronic Mild

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 19, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

R-3750 in Patients With Mild to Moderate Ulcerative Colitis

Preliminary Clinical Study of NMN Intervention in Mild Ulcerative Colitis

Study of OST-122 in Patients With Moderate to Severe Ulcerative Colitis

Lactobacillus Rhamnosus GG (ATCC 53103) in Mild-moderately Active UC Patients

Effectiveness of Fecal Microbiota Transplantation as add-on Therapy in Mild-to-moderate Ulcerative Colitis