drugset / Trial / NCT05507216

ABTECT-2 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -2

NCT05507216

Phase 3 Completed 636 enrolled Abivax S.A.
RandomizedParallel-groupTriple-blindTreatment

Summary

This is a multicenter, randomized, placebo controlled study to evaluate the efficacy and safety of ABX464 given at 25 or 50 mg QD in inducing clinical remission in subjects with moderately to severely active ulcerative colitis who have inadequate response, no response, a loss of response, or an intolerance to either conventional therapies \[corticosteroids, immunosuppressant (i.e. azathioprine, 6-mercaptopurine, methotrexate)\] and/or advanced therapies \[biologics (TNF inhibitors, anti-integrins, anti-IL-23), and/or S1P receptor modulators, and/or JAK inhibitors\].

Timeline

Start
2022-12-21
Primary completion
2025-06-24
Completion
2025-07-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Obefazimod Small molecule 25 mg Oral
Subject Obefazimod Small molecule 50 mg Oral

Indications