drugset / Trial / NCT03394924
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary Cholangitis
Phase 2
Completed
68 enrolled
Enanta Pharmaceuticals, Inc
Pharmaceutical Research Associates · collabTriangle Biostatistics, LLC · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
A randomized, double-blind study to assess the safety, tolerability, PK and efficacy of EDP-305 in subjects with primary biliary cholangitis
Timeline
- Start
- 2017-12-27
- Primary completion
- 2019-12-19
- Completion
- 2020-01-16
Outcome
Missed primary endpoint
registry analysis (superiority test); EDP-305 1 mg vs Placebo; p = 0.106; Odds Ratio (OR) 5.6 (95% CI 0.6 to 52); Cochran-Mantel-Haenszel NCT03394924 ↗
registry analysis (superiority test); EDP-305 2.5 mg vs Placebo; p = 0.063; Odds Ratio (OR) 7 (95% CI 0.75 to 65.22); Cochran-Mantel-Haenszel NCT03394924 ↗
release “While INTREPID did not meet the primary endpoint in subjects with PBC” enanta.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | EDP-305 | Unknown | 1 mg | Oral |
| Subject | EDP-305 | Unknown | 2.5 mg | Oral |