ABI-M201 in Adult Subjects With Mildly-to-Moderately Active Ulcerative Colitis (NCT03923478) | Clinical Trial Compass
TerminatedPhase 1
ABI-M201 in Adult Subjects With Mildly-to-Moderately Active Ulcerative Colitis
Stopped: Sponsor Decision
United States15 participantsStarted 2019-06-24
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 wi…
What they're measuring
1
Incidence of Treatment-Emergent Adverse Events
Timeframe: 8-weeks
2
Incidence of Treatment-Emergent Laboratory Abnormalities