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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.
 
ClinicalTrials.gov Identifier: NCT03923478
Recruitment Status : Recruiting
First Posted : April 22, 2019
Last Update Posted : April 1, 2020
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Assembly Biosciences

Tracking Information
First Submitted Date  ICMJE April 15, 2019
First Posted Date  ICMJE April 22, 2019
Last Update Posted Date April 1, 2020
Actual Study Start Date  ICMJE June 24, 2019
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2019)
  • Incidence of Treatment-Emergent Adverse Events [ Time Frame: 8-weeks ]
    [Safety]
  • Incidence of Treatment-Emergent Laboratory Abnormalities [ Time Frame: 8-weeks ]
    [Safety]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2019)
  • Clinical Remission [ Time Frame: 8-weeks ]
    [UC Disease Activity]
  • Endoscopic Improvement [ Time Frame: 8-weeks ]
    [UC Disease Activity]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ABI-M201 in Adult Subjects With Mildly-to-Moderately Active Ulcerative Colitis
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE 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
Condition  ICMJE
  • Ulcerative Colitis Chronic Mild
  • Ulcerative Colitis Chronic Moderate
Intervention  ICMJE
  • Drug: ABI-M201
    Active Treatment
  • Drug: Placebo
    Control Treatment
Study Arms  ICMJE
  • Experimental: ABI-M201

    Cohort A: 1 capsule one time a day

    Cohort B: 1- 5 capsules one time a day

    Intervention: Drug: ABI-M201
  • Placebo Comparator: Placebo

    Cohort A: 1 capsule one time a day

    Cohort B: 1-5 capsules one time a day

    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 17, 2019)
44
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Tami Warren 1-843-614-9208 TamiWarren@inclin.com
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03923478
Other Study ID Numbers  ICMJE ABI-M201-101
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assembly Biosciences
Study Sponsor  ICMJE Assembly Biosciences
Collaborators  ICMJE Allergan
Investigators  ICMJE Not Provided
PRS Account Assembly Biosciences
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP