Cure8 trial brief
Phase 3 trials test whether a new oral therapy can induce remission in people with moderate-to-severe ulcerative colitis who have not responded to or cannot tolerate existing treatments. If positive, results could add another treatment option for difficult-to-treat UC.
Researchers and clinicians involved in IBD clinical trials or UC treatment; adult patients and adolescents (where eligible) with moderate-to-severe UC who have failed conventional or advanced therapies; patient advocates following emerging UC therapies.
This is the phase 3 clinical trial record (ABTECT-2, NCT05507216) of ABX464 for moderately to severely active ulcerative colitis in patients with inadequate response, loss of response, or intolerance to conventional or advanced therapies.
The randomized, placebo-controlled study evaluated two oral doses (25 mg and 50 mg once daily) over an 8-week induction period with a primary outcome of clinical remission per a modified Mayo score (stool frequency, rectal bleeding, and endoscopic subscores).
The trial enrolled adolescents (with regulatory approval) and adults meeting defined disease activity and prior-treatment failure criteria. Key eligibility, exclusion criteria, dosing schedule, and the principal efficacy endpoint (proportion achieving clinical remission at Week 8) are provided in the registry entry.
Safety-related lab thresholds, infection exclusions, and washout requirements are also detailed in the record. This summary is grounded in the ClinicalTrials.gov record for NCT05507216 and does not represent a review of full study results or publications.
This entry is a ClinicalTrials.gov trial record (phase 3, completed). The registry lists trial design, eligibility, and primary endpoint but does not provide peer-reviewed results here. Treat any efficacy or safety claims as pending confirmation from trial publications or regulatory filings.
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.
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...
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