Cure8 trial brief
This trial tests a new oral drug, SAR441566, as a potential treatment for moderate-to-severe ulcerative colitis. Results could affect future treatment options if the drug is effective and safe.
The study focuses on achieving clinical remission by 12 weeks and includes longer maintenance follow-up, which matters for people seeking both induction and maintenance therapies.
Adults with moderate-to-severe ulcerative colitis, patients who have failed or been intolerant to standard therapies or advanced therapies, clinicians treating UC, and researchers interested in new oral IBD treatments.
This is a registry record (Phase 2, randomized, double-blind, placebo-controlled) testing oral SAR441566 versus matching placebo in adults with moderate-to-severe ulcerative colitis.
The primary outcome is clinical remission at Week 12 by a modified Mayo Score; the double-blind treatment period includes a 12-week induction and 40-week maintenance, with an optional open-label period. Eligibility, dosing arms (three dose regimens plus placebo), planned enrollment (204), and key inclusion/exclusion criteria are listed on the trial record.
The entry describes trial design, timelines, outcomes measured, and common exclusions (prior colectomy/ostomy/pouch, active infections, recent malignancy, positive stool pathogens). It is a trial registry entry rather than a peer-reviewed report of results, so no efficacy or safety findings are presented here.
If you are considering participation or want detailed protocol elements (visit schedule, exact dosing regimens, study locations), consult the full ClinicalTrials.gov record and discuss with your treating clinician or the study contact listed on the registry.
This is a ClinicalTrials.gov trial registration (Phase 2) describing planned study design and outcomes; it does not report results. Participation eligibility is restricted by several criteria (eg, prior surgeries, infections, recent malignancy). Consult the official registry entry and study contacts for up-to-date recruitment status and protocol details.
Review the original publication for the complete reporting, methods, and context.
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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