A Dose Ranging Study of the Effect of Ruxolitinib Phosphate Cream When Applied to Participants With Plaque Psoriasis
Summary
The study was double-blind, randomized, vehicle-controlled study with application of Ruxolitinib phosphate cream or vehicle cream in participants with stable plaque psoriasis applied once daily for 12 weeks without occlusive dressings. There were 4 treatment groups anticipated to have 50 participants in each.
Timeline
- Start
- 2008-10-28
- Primary completion
- 2009-06-26
- Completion
- 2009-06-26
Outcome
Met primary endpoint
registry analysis (superiority test); Vehicle Cream vs Ruxolitinib Phosphate 0.5% Cream; p = 0.0041; Least Squares (LS) Mean Difference -1.18 (90% CI -1.85 to -0.51); ANCOVA NCT00778700 ↗
registry analysis (superiority test); Vehicle Cream vs Ruxolitinib Phosphate 1.0% Cream; p = 0.0007; LS Mean Difference -1.40 (90% CI -2.08 to -0.73); ANCOVA NCT00778700 ↗
registry analysis (superiority test); Vehicle Cream vs Ruxolitinib Phosphate 1.5% Cream; p = 0.0035; LS Mean Difference -1.21 (90% CI -1.88 to -0.53); ANCOVA NCT00778700 ↗
release “a Phase IIa dose-escalation trial involving 28 patients, demonstrated that INCB18424 was well tolerated at all doses and significantly improved overall total lesion score” incyte.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ruxolitinib | Small molecule | 0.5 % | Topical |
| Subject | Ruxolitinib | Small molecule | 1 % | Topical |
| Subject | Ruxolitinib | Small molecule | 1.5 % | Topical |