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

Ulcerative Colitis Chronic Moderate Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03923478
• Other study ID #: ABI-M201-101
• Status: Terminated
• Phase: Phase 1
• Start date: June 24, 2019
• Est. completion date: January 20, 2021

Study information

• Verified date: March 2021
• Source: Assembly Biosciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: January 20, 2021
• Est. primary completion date: January 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis Chronic Mild
• Ulcerative Colitis Chronic Moderate

Intervention

Drug:
• ABI-M201
Active Treatment
• Placebo
Control Treatment

Locations

Country	Name	City	State
Canada	(Investigator site)	Sudbury	Ontario
United States	(Investigator Site)	Bellevue	Washington
United States	(Investigator Site)	Chesterfield	Michigan
United States	(Investigator Site)	Decatur	Georgia
United States	(Investigator Site)	Jackson	Tennessee
United States	(Investigator Site)	Milwaukee	Wisconsin
United States	(Investigator site)	Oakland	California
United States	(Investigator Site)	Rochester	Minnesota
United States	(Investigator Site)	San Carlos	California
United States	(Investigator Site)	Shreveport	Louisiana
United States	(Investigator Site)	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Assembly Biosciences

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-Emergent Adverse Events	[Safety]	8-weeks
Primary	Incidence of Treatment-Emergent Laboratory Abnormalities	[Safety]	8-weeks
Secondary	Clinical Remission	[UC Disease Activity]	8-weeks
Secondary	Endoscopic Improvement	[UC Disease Activity]	8-weeks