ABTECT-1 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -1
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
- 2022-11-16
- Primary completion
- 2025-06-24
- Completion
- 2025-06-25
Outcome
Met primary endpoint
release “ABTECT-1 showed a placebo-adjusted clinical remission rate of 19.3% (p<0.0001)” abivax.com ↗
release “ABTECT-1 and ABTECT-2 trials demonstrated that obefazimod met its FDA primary endpoint of clinical remission at Week 8” abivax.com ↗
release “Individually, ABTECT-1 showed a placebo-adjusted clinical remission rate of 19.3% (p<0.0001)” abivax.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Obefazimod | Small molecule | 25 mg | Oral |
| Subject | Obefazimod | Small molecule | 50 mg | Oral |