Cure8 trial brief
Phase 3 trials test whether a new drug is effective and safe enough to be considered for clinical use. ABX464 is being evaluated as a potential new oral treatment for people with moderate-to-severe ulcerative colitis who have not responded to other therapies.
Adults and eligible adolescents with moderate-to-severe ulcerative colitis, patients who have failed or are intolerant to biologics/JAK/S1P therapies, gastroenterologists, clinical researchers, and patient advocates following new IBD therapies.
This is a ClinicalTrials.gov record (ABTECT-1, NCT05507203) for a completed Phase 3 randomized placebo-controlled trial testing ABX464 (25 mg or 50 mg once daily) versus placebo for induction of clinical remission in moderately to severely active ulcerative colitis in patients who failed or were intolerant to conventional or advanced therapies.
The primary outcome is clinical remission by modified Mayo score at Week 8. Planned enrollment was 639. Key eligibility includes age ≥16 (with adolescent conditions), modified Mayo score ≥5 with endoscopic confirmation (MES 2–3), and prior inadequate response to corticosteroids, immunosuppressants, biologics, S1P modulators, or JAK inhibitors.
The record lists common screening procedures (endoscopy with biopsy, central reader confirmation) and many exclusion criteria including recent serious infections, prior major colon surgery, primary sclerosing cholangitis, and positive infectious stool testing. Safety labs and washout requirements are specified in the protocol.
This brief summarizes the trial registry entry and does not report results; it describes the study design, interventions, eligibility, and registered primary outcome as provided on ClinicalTrials.gov.
This entry is a trial registry record (structured trial information) and does not contain trial results. Any safety or efficacy findings would need to come from the posted results on ClinicalTrials.gov or peer-reviewed publications. The trial targeted induction of remission over an 8-week period and used central endoscopy reading for eligibility.
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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