Ruxolitinib Cream 1.5% Shows Promise for Prurigo Nodularis at AAD 2025

Use of twice-daily ruxolitinib cream 1.5% (Opzelura) was associated with significant improvement in itch just 7 days after starting therapy among adults with prurigo nodularis (PN), according to data from the phase 3 TRuE-PN program.

At the 2025 American Academy of Dermatology (AAD) Annual Meeting, results of the TRuE-PN1 trial were presented and, during this presentation, investigators also debuted topline results from the TRuE-PN2 trial.1,2

“This program includes the first clinical trials evaluating a topical JAK inhibitor for the treatment of patients with PN, a condition associated with the formation of cutaneous nodules across the body that cause persistent itch and discomfort,” said Shawn Kwatra, MD, Joseph W. Burnett Endowed Professor and Chair of Dermatology at University of Maryland School of Medicine and Chief of Service Dermatology at the University of Maryland Medical Center, who presented the data at AAD 2025.2 “In TRuE-PN1, ruxolitinib cream 1.5% demonstrated its ability to significantly improve itch and PN lesions, and I believe it has the potential to be a much-needed novel approach for PN patients.”

Initially approved as a treatment for atopic dermatitis in September 2021, ruxolitinib received an additional approval from the US Food and Drug Administration for the treatment of vitiligo in June 2022. In 2023, Incyte launched the both the TRuE-PN1 and TRuE-PN 2 trials to examine the safety and efficacy of ruxolitinib cream relative to vehicle cream for management of PN in adult patients.3,4,5

Both the TRuE-PN1 and TRuE-PN2 trials were designed with 12-week double-blind, vehicle-controlled treatment periods, which were followed by a 40-week open-label extension and 30-day safety follow-up. The primary endpoint for both studies was the achievement of WI-NRS4 response at week 12.1,2,4,5

TRuE-PN1 data presented at AAD 2025 revealed a significantly greater proportion of patients receiving ruxolitinib cream 1.5% achieved a 4-point or greater improvement in WI-NRS at week 12 relative to the vehicle control group (44.6% vs 20.6%; P = .0003). Investigators highlighted significant itch improvements were observed with ruxolitinib cream 1.5% relative to vehicle cream at day 7 (22.4% vs 8.0%; P = .0064).1,2

Secondary analysis of TRuE-PN1 indicated ruxolitinib cream 1.5% was associated with greater rates of achieving WI-NRS4 at week 4 (29.7%vs 12.7%; P = .0034), an Investigator's Global Assessment for Stage of Chronic Prurigo Treatment Success at week 12 (15.8% vs 3.9%; P = .0048), and overall treatment success (11.9% vs 2.9%; P = .0164) at week 12 relative to vehicle cream.1,2

According to a release from Incyte, a strong positive trend across all key secondary endpoints, particularly for IGA-CPG-S-TS at Week 12 and WI-NRS4 at Day 7 (nominal P-value <0.05 for both) was observed in TRuE-PN2. The release noted the trial did not reach statistical significance for the primary endpoint, which was attributed to a high placebo response rate.2

"PN is a challenging condition characterized by intensely itchy nodules that significantly impact patients' quality of life,” said Jim Lee, MD, PhD, group vice president of Inflammation and Autoimmunity at Incyte.2 “These positive results display improvement in itch reduction and skin clearance, reinforcing the potential of ruxolitinib cream to become an effective topical treatment option that will help people living with PN."

References:

1. Kwatra S. Efficacy and Safety of Ruxolitinib Cream in Patients With Prurigo Nodularis: Results From a Phase 3, Randomized, Vehicle-Controlled Study (TRuE-PN1).Presented at the 2025 American Academy of Dermatology (ADA) Annual Meeting. Orlando, FL. March 07-11, 2025.

2. Incyte. Incyte announces results of phase 3 clinical trials evaluating ruxolitinib cream 1.5% (opzelura®) in patients with prurigo nodularis (PN) at 2025 American Academy of Dermatology Annual Meeting. Business Wire. March 8, 2025. Accessed March 8, 2025. https://www.businesswire.com/news/home/20250308179919/en/Incyte-Announces-Results-of-Phase-3-Clinical-Trials-Evaluating-Ruxolitinib-Cream-1.5-Opzelura%C2%AE-in-Patients-with-Prurigo-Nodularis-PN-at-2025-American-Academy-of-Dermatology-Annual-Meeting.

3. Incyte. Incyte announces U.S. FDA approval of OpzeluraTM (ruxolitinib) cream for the treatment of Vitiligo. Incyte. July 18, 2022. Accessed March 8, 2025. https://investor.incyte.com/news-releases/news-release-details/incyte-announces-us-fda-approval-opzeluratm-ruxolitinib-cream-0.

4. ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Prurigo Nodularis (PN) (TRuE-PN2). Clinicaltrials.gov. January 8, 2025. Accessed March 8, 2025. https://clinicaltrials.gov/study/NCT05764161.

5. ClinicalTrials.gov. A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream in Participants With Prurigo Nodularis (PN) (TRuE-PN1). Clinicaltrials.gov. November 7, 2024. Accessed March 8, 2025. https://clinicaltrials.gov/study/NCT05755438.