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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

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.

Interventional
Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

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.

NCT03923478
Phase

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.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Assembly Biosciences
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

IndustryIndustry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Ulcerative Colitis Chronic Mild, Ulcerative Colitis Chronic Moderate
Additional Details

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.

Contact a Trial Team

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(Investigator Site), Milwaukee, Wisconsin

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Recruiting

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(Investigator Site)

Milwaukee, Wisconsin, 53226

(Investigator Site), Bellevue, Washington

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Recruiting

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(Investigator Site)

Bellevue, Washington, 98004

(Investigator Site), Ogden, Utah

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Recruiting

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(Investigator Site)

Ogden, Utah, 84405

(Investigator Site), Houston, Texas

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Recruiting

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(Investigator Site)

Houston, Texas, 77079

(Investigator Site), Jackson, Tennessee

Status

Recruiting

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(Investigator Site)

Jackson, Tennessee, 38305

(Investigator Site), Rochester, Minnesota

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Recruiting

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(Investigator Site)

Rochester, Minnesota, 55905

(Investigator Site), Plymouth, Minnesota

Status

Recruiting

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(Investigator Site)

Plymouth, Minnesota, 55446

(Investigator Site), Chesterfield, Michigan

Status

Recruiting

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(Investigator Site)

Chesterfield, Michigan, 48047

(Investigator Site), Rockville, Maryland

Status

Recruiting

Address

(Investigator Site)

Rockville, Maryland, 20850

(Investigator Site), Shreveport, Louisiana

Status

Recruiting

Address

(Investigator Site)

Shreveport, Louisiana, 71105

(Investigator Site), Decatur, Georgia

Status

Recruiting

Address

(Investigator Site)

Decatur, Georgia, 30033

(Investigator Site), San Carlos, California

Status

Recruiting

Address

(Investigator Site)

San Carlos, California, 94070

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