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

• ClinicalTrials.gov Identifier: NCT03923478
• Recruitment Status: Terminated
• First Posted: April 22, 2019
• Last Update Posted: March 19, 2021
• Sponsor: Assembly Biosciences
• Information provided by (Responsible Party): Assembly Biosciences

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Ulcerative Colitis Chronic Mild; Ulcerative Colitis Chronic Moderate	Drug: ABI-M201; Drug: Placebo	Phase 1

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 15 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Double blind, placebo-controlled trial involving two sequential non-overlapping cohorts, with intervening interim analysis
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: June 24, 2019
• Actual Primary Completion Date: January 20, 2021
• Actual Study Completion Date: January 20, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: ABI-M201; Cohort A: 1 capsule one time a day Cohort B: 1- 5 capsules one time a day	Drug: ABI-M201; Active Treatment
Placebo Comparator: Placebo; Cohort A: 1 capsule one time a day Cohort B: 1-5 capsules one time a day	Drug: Placebo; Control Treatment

Outcome Measures

Primary Outcome Measures :

1. Incidence of Treatment-Emergent Adverse Events [ Time Frame: 8-weeks ]
   [Safety]
2. Incidence of Treatment-Emergent Laboratory Abnormalities [ Time Frame: 8-weeks ]
   [Safety]

Secondary Outcome Measures :

1. Clinical Remission [ Time Frame: 8-weeks ]
   [UC Disease Activity]
2. Endoscopic Improvement [ Time Frame: 8-weeks ]
   [UC Disease Activity]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, California

(Investigator site)

Oakland, California, United States, 94612

(Investigator Site)

San Carlos, California, United States, 94070

United States, Georgia

(Investigator Site)

Decatur, Georgia, United States, 30033

United States, Louisiana

(Investigator Site)

Shreveport, Louisiana, United States, 71105

United States, Michigan

(Investigator Site)

Chesterfield, Michigan, United States, 48047

(Investigator Site)

Ypsilanti, Michigan, United States, 48197

United States, Minnesota

(Investigator Site)

Rochester, Minnesota, United States, 55905

United States, Tennessee

(Investigator Site)

Jackson, Tennessee, United States, 38305

United States, Washington

(Investigator Site)

Bellevue, Washington, United States, 98004

United States, Wisconsin

(Investigator Site)

Milwaukee, Wisconsin, United States, 53226

Canada, Ontario

(Investigator site)

Sudbury, Ontario, Canada, P3C 5K6

Sponsors and Collaborators

Assembly Biosciences

More Information

• Responsible Party: Assembly Biosciences
• ClinicalTrials.gov Identifier: NCT03923478
• Other Study ID Numbers: ABI-M201-101
• First Posted: April 22, 2019
• Last Update Posted: March 19, 2021
• Last Verified: March 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assembly Biosciences:

Phase 1B; Randomized; Placebo Controlled

Additional relevant MeSH terms:

Colitis; Colitis, Ulcerative; Ulcer; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases; Pathologic Processes; Inflammatory Bowel Diseases