Clinical trial NCT03923478: ABI-M201 in Adult Subjects With Mildly-to-Moderately Active Ulcerative Colitis
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Ulcerative Colitis Chronic Mild
Ulcerative Colitis Chronic Moderate
Keywords: Phase 1B
Randomized
Placebo Controlled
Lead sponsor: Assembly Biosciences
Sponsor class: INDUSTRY
First posted: 2019-04-22
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blind, placebo-controlled trial involving two sequential non-overlapping cohorts, with intervening interim analysis
Primary purpose: 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.

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

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: 8-weeks
measure: Incidence of Treatment-Emergent Laboratory Abnormalities
timeFrame: 8-weeks
Secondary outcomes:
measure: Clinical Remission
timeFrame: 8-weeks
measure: Endoscopic Improvement
timeFrame: 8-weeks
Other outcomes:
Locations:
city: Oakland
country: United States
facility: (Investigator site)
state: California
city: San Carlos
country: United States
facility: (Investigator Site)
state: California
city: Decatur
country: United States
facility: (Investigator Site)
state: Georgia
city: Shreveport
country: United States
facility: (Investigator Site)
state: Louisiana
city: Chesterfield
country: United States
facility: (Investigator Site)
state: Michigan
city: Ypsilanti
country: United States
facility: (Investigator Site)
state: Michigan
city: Rochester
country: United States
facility: (Investigator Site)
state: Minnesota
city: Jackson
country: United States
facility: (Investigator Site)
state: Tennessee
city: Bellevue
country: United States
facility: (Investigator Site)
state: Washington
city: Milwaukee
country: United States
facility: (Investigator Site)
state: Wisconsin
city: Sudbury
country: Canada
facility: (Investigator site)
state: Ontario
Study officials:
References: