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

• Register: ClinicalTrials.gov
• Last refreshed on: 29 March 2021
• Main ID: NCT03923478
• Date of registration: 15/04/2019
• Prospective Registration: Yes
• Primary sponsor: Assembly Biosciences
• Public title: ABI-M201 in Adult Subjects With Mildly-to-Moderately Active Ulcerative Colitis
• Scientific 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
• Date of first enrolment: June 24, 2019
• Target sample size: 15
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03923478
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1

Countries of recruitment

Canada, United States

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Ulcerative Colitis Chronic Mild

Ulcerative Colitis Chronic Moderate

Intervention(s)

Drug: Placebo

Drug: ABI-M201

Primary Outcome(s)

Incidence of Treatment-Emergent Laboratory Abnormalities [Time Frame: 8-weeks]

Incidence of Treatment-Emergent Adverse Events [Time Frame: 8-weeks]

Secondary Outcome(s)

Endoscopic Improvement [Time Frame: 8-weeks]

Clinical Remission [Time Frame: 8-weeks]

Secondary ID(s)

ABI-M201-101

Source(s) of Monetary Support

Please refer to primary and secondary sponsors