Late-Breaking Data: Phase 3 Updates on Ruxolitinib Cream for Prurigo Nodularis

“This is the first study ever conducted for a topical agent for the treatment of prurigo nodularis. So really opening up avenues for the development and treatment. We're very excited about this for our patients,” said Shawn Kwatra, MD, FAAD, in an interview at the 2025 American Academy of Dermatology (AAD) Annual Meeting in Orlando, Florida.

Kwatra, a board-certified dermatologist, professor and chair of dermatology at the University of Maryland School of Medicine, chief of service dermatology at the University of Maryland Medical Center, and a Dermatology Times Editorial Advisory Board member, presented late-breaking data at AAD from the TRuE-PN1 and TRuE-PN2 studies on ruxolitinib cream 1.5% (Opzelura; Incyte) for the treatment of patients with prurigo nodularis.¹

The pivotal phase 3 TRuE-PN clinical trial program –TRuE-PN1 and TRuE-PN2 studies – evaluated twice-daily ruxolitinib cream in patients aged 18 years and older.²

In TRuE-PN1, results at week 12 showed that over 44% of patients achieved a ≥4-point reduction in itch (Worst-Itch Numeric Rating Scale), compared to approximately 20% in the placebo group. Additionally, all secondary end points demonstrated statistical significance, including improvements in skin lesions, quality-of-life scores, and pruritus relief as early as day 4. Significantly more patients who applied ruxolitinib cream vs vehicle control achieved an Investigator's Global Assessment for Stage of Chronic Prurigo Treatment Success at week 12 (15.8% vs 3.9%).

Shawn Kwatra, MD, FAAD, presenting his late-breaking session at AAD.

Photo provided by Kwatra

The TRuE-PN2 study yielded similar findings, with approximately 40% of patients achieving a 4-point itch reduction, despite a slightly higher placebo response. According to the announcement, although the primary end point was in favor of ruxolitinib cream vs vehicle, it did not reach statistical significance due to high placebo response. The overall safety profile of ruxolitinib in the TRuE-PN clinical trial program was consistent with previous data and no new safety signals were found.

According to Kwatra, these phase 3 trials mark the first-ever study of a topical therapy for prurigo nodularis. Given the significant early and sustained improvements observed, ruxolitinib cream represents a promising non-systemic option for patients with prurigo nodularis, addressing both pruritus and lesion resolution.

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). Poster presented at: 2025 American Academy of Dermatology Annual Meeting. March 8, 2024; Orlando, FL.
2. 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. News release. Incyte. March 8, 2025. Accessed March 8, 2025. https://investor.incyte.com/news-releases/news-release-details/incyte-announces-results-phase-3-clinical-trials-evaluating