ClinicalTrials.gov
Cure8 trial brief
Why This Matters
An oral biologic study could offer a new treatment approach for people with moderate–severe ulcerative colitis; the trial is evaluating safety and multiple measures of disease activity including endoscopy and histology.
The study is actively recruiting and targets patients who have had inadequate response or intolerance to established UC treatments.
Who Should Pay Attention
Adult patients with moderately to severely active ulcerative colitis, gastroenterologists and IBD clinicians, clinical researchers, and people tracking new oral biologic therapies.
Study Snapshot
Story typeClinical Reference
Trial phasePhase 1, Phase 2
Enrollment100 participants
Study statusRecruiting
Source depthTrial registry record
What To Know
This clinicaltrials.gov record describes an interventional, double-blind, placebo-controlled trial of MB-001 taken once daily for 12 weeks in adults (18–75) with moderately to severely active UC. Key objectives are safety and efficacy; secondary/exploratory measures include endoscopic response, histologic response, pharmacokinetics, and pharmacodynamics.
The trial allows certain stable background UC therapies and excludes people with prior extensive colonic resection, ileostomy/colostomy/pouch, or recent toxic megacolon. The listing indicates planned enrollment of about 100 participants and that participants may enter a 12-week open-label extension after the blinded period.
Eligibility requires prior inadequate response or intolerance to at least one standard therapy (5-ASA, corticosteroids, immunomodulators, approved biologics or S1PR modulators).
Keep In Mind
This is a clinicaltrials.gov trial record (Phase 1/2, recruiting) and does not present study results. The entry lists planned endpoints, inclusion/exclusion criteria, and safety monitoring; interested patients should contact the study site or sponsor for enrollment details.
Source Details
Review the original publication for the complete reporting, methods, and context.
Clinical trial
Evidence type derived from source or registry metadata.
PublicationClinicalTrials.gov
SponsorMage Biologics
Trial IDNCT07374471
Study typeInterventional
Trial phasePhase 1, Phase 2
Enrollment100 participants
Indexed viaClinicalTrials.gov
Source typeTrial registry record
PublishedOct 20, 2026, 12:00 AM
Content availableTrial registry record
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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