To Assess the Efficacy and Safety of INCB054707 in Participants With Hidradenitis Suppurativa
Summary
To evaluate the efficacy and safety of INCB054707 in participants with hidradenitis suppurativa over a 16-week placebo-controlled treatment period followed by a 36-week open-label extension period. All eligible participants will be invited to continue treatment for an additional 48-week Long-term extension period (also open label).
Timeline
- Start
- 2020-08-25
- Primary completion
- 2021-12-15
- Completion
- 2023-08-16
Outcome
Met primary endpoint
registry analysis (superiority test); Placebo vs INCB054707 15 mg; p = 0.0277; Least squares mean (LSM) difference -2.7 (95% CI -5.2 to -0.3); MMRM NCT04476043 ↗
registry analysis (superiority test); Placebo vs INCB054707 45 mg; p = 0.0006; LSM difference -4.4 (95% CI -6.8 to -1.9); MMRM NCT04476043 ↗
registry analysis (superiority test); Placebo vs INCB054707 75 mg; p = 0.0021; LSM difference -3.8 (95% CI -6.2 to -1.4); MMRM NCT04476043 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Povorcitinib | Small molecule | 15 mg | Oral |
| Subject | Povorcitinib | Small molecule | 45 mg | Oral |
| Subject | Povorcitinib | Small molecule | 75 mg | Oral |