Pooled Phase 3 Data on Ruxolitinib Highlights Benefit in Prurigo Nodularis

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Combined data from a pair of phase 3 trials could set the stage for ruxolitinib cream 1.5% (Opzelura) to become the next US Food and Drug Administration (FDA)-approved therapy for prurigo nodularis.

Presented at the European Academy of Dermatology and Venereology (EADV) 2025 Congress, pooled data from the TRuE-PN1 and TRuE-PN2 studies demonstrate use of ruxolitinib cream was associated with statistically significant early improvements in symptoms of prurigo nodularis, which were maintained through week 24 of the trials.1

“In total, I hope we could demonstrate today that ruxolitinib demonstrated significant improvement versus the vehicle treatment in signs and symptoms of prurigo nodularis, and that those patients who received ruxolitinib treatment after the vehicle treatment showed a similar trend and the improvement was getting better until the week 24,” explained Sonja Ständer, MD, professor of Dermatology and Neurodermatology at the University of Münster and head of the interdisciplinary Center for Chronic Pruritus at the University Hospital Münster, during her presentation at EADV 2025.

A selective JAK1/JAK2 inhibitor from Incyte, ruxolitinib cream boasts approvals in atopic dermatitis and vitiligo in 2021 and 2022, respectively. Incyte also owns an oral form of ruxolitinib (Jakafi), which received approval from the FDA for myelofibrosis, polycythemia vera, acute graft-versus-host disease, and chronic graft-versus-host disease in 2011, 2014, 2019, and 2021, respectively.1,2

In March 2025, Incyte announced topline results from their phase 3 TRuE-PN1 and TRuE-PN2 studies, with the former being presented as a late-breaking oral presentation at the 2025 American Academy of Dermatology Annual Meeting.3

The trials enrolled 394 adults with prurigo nodularis for at least 3 months’ duration, at least 6 pruriginous lesions across 2 or more body regions, and moderate-to-severe disease, which was defined as an Investigator’s Global Assessment for Stage of Chronic Prurigo (IGA-CPG-S) of 2 or more and a Worst Itch Numerical Rating Scale (WI-NRS) of 7 or more. Per trial design, patients were randomized 1:1 to receive ruxolitinib cream 1.5% or vehicle twice daily for 12 weeks in a double-blind, vehicle-controlled period, followed by a 40-week open-label extension.1

The primary endpoint was the proportion of patients achieving a ≥4-point WI-NRS improvement (WI-NRS4) at week 12. Key secondary endpoints included IGA-CPG-S treatment success, which was defined as a score of 0 or 1 with 2-grade improvement or more and combined overall treatment success, which was defined as WI-NRS4 and IGA-CPG-S treatment success.1

At week 12, significantly more patients treated with ruxolitinib cream achieved WI-NRS4 compared with vehicle (42.3% vs 28.1%; P = .0029). Improvements were also seen in IGA-CPG-S TS (19.8% vs 7.1%; P = .0002) and overall TS (12.2% vs 4.6%; P = .0066). In her presentation, Ständer noted patients initially randomized to ruxolitinib cream maintained responses through week 24. Ständer also highlighted those who switched from vehicle achieved comparable outcomes by this timepoint for WI-NRS4 (63.6% vs 62.8%) and IGA-CPG-S treatment success (32.9% vs 25.3%).1

Investigators found patient-reported outcomes mirrored these results. At week 12, 61.8% of patients treated with ruxolitinib cream reported “much” or “very much” improvement on the Patient Global Impression of Change (PGIC) compared with 41.8% for vehicle. By week 24, both groups showed high rates of PGIC response, with an observed rate of 76.8% with ruxolitinib cream and 75.9% with the vehicle to ruxolitinib group.1

Safety data from the trials indicated ruxolitinib cream was generally well tolerated, with low rates of application-site reactions (1.1%) and no grade 3 or greater treatment-related adverse events. Of note, a single fatal event occurred but was deemed unrelated to treatment.1

“The full data set needs to be reported later,” noted Ständer. “The safety is good, and all signs are positive for the development of ruxolitinib cream as a topical treatment in patients with prurigo nodularis.”

References:
  1. Ständer S. Efficacy and Safety of Ruxolitinib Cream in Patients With Prurigo Nodularis: Pooled Results From the Phase 3 TRuE-PN1 and TRuE-PN2 Randomized, Vehicle-Controlled Studies. Presented at the European Academy of Dermatology and Venereology (EADV) 2025 Congress. Paris, France. September 17-20, 2025.
  2. Drugs.com. Jakafi (ruxolitinib) FDA Approval History. Drugs.com. Published September 27, 2021. Accessed September 21, 2025. https://www.drugs.com/history/jakafi.html
  3. 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 | Incyte. Incyte. Published March 8, 2025. Accessed September 21, 2025. https://investor.incyte.com/news-releases/news-release-details/incyte-announces-results-phase-3-clinical-trials-evaluating

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