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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03923478
Recruitment Status : Recruiting
First Posted : April 22, 2019
Last Update Posted : October 8, 2020
Information provided by (Responsible Party):
Assembly Biosciences

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 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
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [ Time Frame: 8-weeks ]

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

Secondary Outcome Measures :
  1. Clinical Remission [ Time Frame: 8-weeks ]
    [UC Disease Activity]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03923478

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Contact: Reeshav Mittal 1 (416) 270-8481

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United States, California
(Investigator site) Recruiting
Oakland, California, United States, 94612
Contact    510-444-3297      
(Investigator Site) Recruiting
San Carlos, California, United States, 94070
Contact    650-596-8800 ext 19      
United States, Georgia
(Investigator Site) Recruiting
Decatur, Georgia, United States, 30033
Contact    404-296-1896      
United States, Louisiana
(Investigator Site) Recruiting
Shreveport, Louisiana, United States, 71105
Contact    318-631-9121 ext 3454      
United States, Maryland
(Investigator Site) Withdrawn
Rockville, Maryland, United States, 20850
United States, Michigan
(Investigator Site) Recruiting
Chesterfield, Michigan, United States, 48047
Contact    586-598-3329      
(Investigator Site) Recruiting
Ypsilanti, Michigan, United States, 48197
Contact    734-714-0523      
United States, Minnesota
(Investigator site) Recruiting
Minneapolis, Minnesota, United States, 55455
Contact    612-626-1776      
(Investigator Site) Recruiting
Plymouth, Minnesota, United States, 55446
Contact    612-870-5599      
(Investigator Site) Recruiting
Rochester, Minnesota, United States, 55905
Contact    507-284-9709      
United States, Ohio
(Investigator Site) Recruiting
Beavercreek, Ohio, United States, 45440
Contact    937-320-5050 ext 3070      
United States, Tennessee
(Investigator Site) Recruiting
Jackson, Tennessee, United States, 38305
Contact    713-414-5027      
United States, Texas
(Investigator Site) Recruiting
Houston, Texas, United States, 77079
Contact    713-932-6446      
United States, Utah
(Investigator Site) Recruiting
Ogden, Utah, United States, 84405
Contact    801-409-2040      
United States, Washington
(Investigator Site) Recruiting
Bellevue, Washington, United States, 98004
Contact    425-452-0569      
United States, Wisconsin
(Investigator Site) Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact    414-805-7181      
Canada, Alberta
(Investigator site) Recruiting
Calgary, Alberta, Canada, T2N 4N1
Contact    403-210-7013      
Contact    403-399-9790      
Canada, Manitoba
(Investigator Site) Recruiting
Winnipeg, Manitoba, Canada, R3A1R9
Contact    204-787-2060      
Canada, Ontario
(Investigator Site) Recruiting
Hamilton, Ontario, Canada, L854K1
Contact    905-521-2100 ext 73601      
(Investigator site) Recruiting
Sudbury, Ontario, Canada, P3C 5K6
Contact    705-566-0005      
Sponsors and Collaborators
Assembly Biosciences
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Responsible Party: Assembly Biosciences Identifier: NCT03923478    
Other Study ID Numbers: ABI-M201-101
First Posted: April 22, 2019    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020

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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
Placebo Controlled
Additional relevant MeSH terms:
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Colitis, Ulcerative
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases