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

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

Sponsors

Lead sponsor: Assembly Biosciences

Collaborator: Allergan

Source 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.

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.

Overall Status Recruiting
Start Date June 24, 2019
Completion Date December 2021
Primary Completion Date June 2021
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Incidence of Treatment-Emergent Adverse Events 8-weeks
Incidence of Treatment-Emergent Laboratory Abnormalities 8-weeks
Secondary Outcome
Measure Time Frame
Clinical Remission 8-weeks
Endoscopic Improvement 8-weeks
Enrollment 44
Condition
Intervention

Intervention type: Drug

Intervention name: ABI-M201

Description: Active Treatment

Arm group label: ABI-M201

Intervention type: Drug

Intervention name: Placebo

Description: Control Treatment

Arm group label: Placebo

Eligibility

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

Gender: All

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Overall Contact

Last name: Tami Warren

Phone: 1-843-614-9208

Email: [email protected]

Location
facility status contact
(Investigator site) | Oakland, California, 94612, United States Recruiting 510-444-3297
(Investigator Site) | San Carlos, California, 94070, United States Recruiting 650-596-8800 19
(Investigator Site) | Decatur, Georgia, 30033, United States Recruiting 404-296-1896
(Investigator Site) | Shreveport, Louisiana, 71105, United States Recruiting 318-631-9121 3454
(Investigator Site) | Rockville, Maryland, 20850, United States Withdrawn
(Investigator Site) | Chesterfield, Michigan, 48047, United States Recruiting 586-598-3329
(Investigator Site) | Ypsilanti, Michigan, 48197, United States Recruiting 734-714-0523
(Investigator site) | Minneapolis, Minnesota, 55455, United States Recruiting 612-626-1776
(Investigator Site) | Plymouth, Minnesota, 55446, United States Recruiting 612-870-5599
(Investigator Site) | Rochester, Minnesota, 55905, United States Recruiting 507-284-9709
(Investigator Site) | Beavercreek, Ohio, 45440, United States Recruiting 937-320-5050 3070
(Investigator Site) | Jackson, Tennessee, 38305, United States Recruiting 713-414-5027
(Investigator Site) | Houston, Texas, 77079, United States Recruiting 713-932-6446
(Investigator Site) | Ogden, Utah, 84405, United States Recruiting 801-409-2040
(Investigator Site) | Bellevue, Washington, 98004, United States Recruiting 425-452-0569
(Investigator Site) | Milwaukee, Wisconsin, 53226, United States Recruiting 414-805-7181
(Investigator site) | Calgary, Alberta, T2N 4N1, Canada Recruiting 403-210-7013
(Investigator Site) | Winnipeg, Manitoba, R3A1R9, Canada Recruiting 204-787-2060
(Investigator Site) | Hamilton, Ontario, L854K1, Canada Recruiting 905-521-2100 73601
(Investigator site) | Sudbury, Ontario, P3C 5K6, Canada Recruiting 705-566-0005
Location Countries

Canada

United States

Verification Date

August 2019

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: ABI-M201

Arm group type: Experimental

Description: Cohort A: 1 capsule one time a day Cohort B: 1- 5 capsules one time a day

Arm group label: Placebo

Arm group type: Placebo Comparator

Description: Cohort A: 1 capsule one time a day Cohort B: 1-5 capsules one time a day

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Double blind, placebo-controlled trial involving two sequential non-overlapping cohorts, with intervening interim analysis

Primary purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov