Dose-Ranging Phase 2b Study of ABX464 in Moderate to Severe Ulcerative Colitis
Summary
Phase 2b study to evaluate the efficacy and the safety of 3 dose-levels of ABX464, administered daily in patients with moderate to severe Ulcerative Colitis.
Timeline
- Start
- 2019-08-13
- Primary completion
- 2021-04-01
- Completion
- 2021-04-16
Outcome
Met primary endpoint
release “ABX464 phase 2b induction study confirmed short-term efficacy in patients refractory to conventional treatments” abivax.com ↗
release “Primary endpoint (statistically significant reduction of Modified Mayo Score[1]) was met with once-daily ABX464 (25mg, 50mg, 100mg) at week 8” abivax.com ↗
release “phase 2b induction study in ulcerative colitis (UC) after 8 and 16 weeks of treatment, primary and key secondary endpoints were met” abivax.com ↗
release “At week 8 of the induction study, the primary endpoint (statistically significant reduction of Modified Mayo Score) was met with once-daily administration of obefazimod” abivax.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Obefazimod | Small molecule | 25 mg | Oral |
| Subject | Obefazimod | Small molecule | 50 mg | Oral |
| Subject | Obefazimod | Small molecule | 100 mg | Oral |