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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-24

Study Completion Date

2021-01-20

Brief Summary

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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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Detailed Description

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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.

Conditions

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Ulcerative Colitis Chronic Mild Ulcerative Colitis Chronic Moderate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double blind, placebo-controlled trial involving two sequential non-overlapping cohorts, with intervening interim analysis

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ABI-M201

Cohort A: 1 capsule one time a day

Cohort B: 1- 5 capsules one time a day

Group Type EXPERIMENTAL

ABI-M201

Intervention Type DRUG

Active Treatment

Placebo

Cohort A: 1 capsule one time a day

Cohort B: 1-5 capsules one time a day

Group Type PLACEBO_COMPARATOR

Placebo

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No