Clinical Trial: A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Prurigo Nodularis (PN)
Study Status: RECRUITING
Recruit Status: RECRUITING
Study Type: INTERVENTIONAL
Official Title: A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream in Participants With Prurigo Nodularis
Brief Summary: The purpose of this study is to evaluate the safety and tolerability of Ruxolitinib cream in participants with Prurigo Nodularis (PN).
Detailed Summary: 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.
Sponsor: Incyte Corporation
Current Primary Outcome: Defined as achieving a ? 4-point improvement (reduction) in Worst Itch Numeric Rating Scale (WI-NRS) score from baseline.
Original Primary Outcome: Defined as achieving a ? 4-point improvement (reduction) in Worst Itch Numeric Rating Scale (WI-NRS) score from baseline.
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Incyte Corporation
Dates:
Date Received: March 01, 2023
Date Started: June 12, 2023
Date Completion: June 12, 2023
Last Updated: December 26, 2023
Last Verified: December 01, 2023