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

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.

Study Overview

• Status: Terminated
• Conditions: Ulcerative Colitis Chronic Moderate; Ulcerative Colitis Chronic Mild
• Intervention / Treatment: Drug: ABI-M201; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Sudbury, Ontario, Canada, P3C 5K6
      • (Investigator site)
• United States
  • California
    • Oakland, California, United States, 94612
      • (Investigator site)
    • San Carlos, California, United States, 94070
      • (Investigator site)
  • Georgia
    • Decatur, Georgia, United States, 30033
      • (Investigator site)
  • Louisiana
    • Shreveport, Louisiana, United States, 71105
      • (Investigator site)
  • Michigan
    • Chesterfield, Michigan, United States, 48047
      • (Investigator site)
    • Ypsilanti, Michigan, United States, 48197
      • (Investigator site)
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • (Investigator site)
  • Tennessee
    • Jackson, Tennessee, United States, 38305
      • (Investigator site)
  • Washington
    • Bellevue, Washington, United States, 98004
      • (Investigator site)
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • (Investigator site)

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events	[Safety]	8-weeks
Incidence of Treatment-Emergent Laboratory Abnormalities	[Safety]	8-weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Remission	[UC Disease Activity]	8-weeks
Endoscopic Improvement	[UC Disease Activity]	8-weeks

Collaborators and Investigators

• Sponsor: Assembly Biosciences

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2019
• Primary Completion (Actual): January 20, 2021
• Study Completion (Actual): January 20, 2021

Study Registration Dates

• First Submitted: April 15, 2019
• First Submitted That Met QC Criteria: April 17, 2019
• First Posted (Actual): April 22, 2019

Study Record Updates

• Last Update Posted (Actual): March 19, 2021
• Last Update Submitted That Met QC Criteria: March 17, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Randomized; Phase 1B; Placebo Controlled
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: ABI-M201-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No