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

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Ulcerative Colitis Chronic Mild, Ulcerative Colitis Chronic Moderate

In brief

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.

Key facts

Study ID

NCT03923478

Run by

Assembly Biosciences

People needed

15

Starts

2019-06-24

Expected to finish

2021-01-20

Last updated by the study team

2021-03-19

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• (Investigator site) — Oakland, California, United States
• (Investigator Site) — San Carlos, California, United States
• (Investigator Site) — Decatur, Georgia, United States
• (Investigator Site) — Shreveport, Louisiana, United States
• (Investigator Site) — Chesterfield, Michigan, United States
• (Investigator Site) — Ypsilanti, Michigan, United States
• (Investigator Site) — Rochester, Minnesota, United States
• (Investigator Site) — Jackson, Tennessee, United States
• (Investigator Site) — Bellevue, Washington, United States
• (Investigator Site) — Milwaukee, Wisconsin, United States
• (Investigator site) — Greater Sudbury, Ontario, Canada

Full record on ClinicalTrials.gov

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