NCT05755438

A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream in Participants With Prurigo Nodularis (PN)

A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream in Participants With Prurigo Nodularis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 204 (actual)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and tolerability of Ruxolitinib cream in participants with Prurigo Nodularis (PN).

Detailed description

The study comprises of a 12 week double-blind, vehicle-controlled (DBVC) treatment period, followed by a 40 week open label extension period, and 30 day safety follow-up period During the double blind period, all PN-affected areas identified at baseline will be treated, and during the open label period, only active PN-affected areas will be treated.

Conditions

• Prurigo

Interventions

Type	Name	Description
DRUG	Ruxolitinib Cream	Ruxolitinib cream 1.5% twice daily (BID) during the vehicle controlled (DBVC)and open label treatment period (OLE).
DRUG	Vehicle Cream	Ruxolitinib matching vehicle cream 1.5% twice daily (BID) during the vehicle controlled period (DBVC).

Timeline

• Start date: 2023-03-10
• Primary completion: 2024-10-07
• Completion: 2025-08-13
• First posted: 2023-03-06
• Last updated: 2025-11-14
• Results posted: 2025-11-14

Locations

71 sites across 11 countries: United States, Argentina, Belgium, Canada, Chile, France, Germany, Italy, Netherlands, Poland, Spain

Regulatory

• FDA-regulated drug study