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

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ClinicalTrials.gov Identifier: NCT03923478
Recruitment Status : Recruiting
First Posted : April 22, 2019
Last Update Posted : April 30, 2019
Sponsor:
Collaborator:
Allergan
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 1-5 capsules per 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
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2021

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 ]
    [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]



Information from the National Library of Medicine

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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
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

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 ClinicalTrials.gov identifier (NCT number): NCT03923478


Contacts
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Contact: Tami Warren 1-843-614-9208 TamiWarren@inclin.com

Locations
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United States, California
(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) Recruiting
Rockville, Maryland, United States, 20850
Contact    301-417-8080      
United States, Michigan
(Investigator Site) Recruiting
Chesterfield, Michigan, United States, 48047
Contact    586-598-3329      
United States, Texas
(Investigator Site) Recruiting
Houston, Texas, United States, 77079
Contact    713-932-6446      
Sponsors and Collaborators
Assembly Biosciences
Allergan

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Responsible Party: Assembly Biosciences
ClinicalTrials.gov Identifier: NCT03923478     History of Changes
Other Study ID Numbers: ABI-M201-101
First Posted: April 22, 2019    Key Record Dates
Last Update Posted: April 30, 2019
Last Verified: April 2019

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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
Randomized
Placebo Controlled

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