Incyte Presents Phase 3 Results of Ruxolitinib Cream for Prurigo Nodularis at AAD 2025
Incyte (Nasdaq: INCY) today announced the results of its pivotal Phase 3 TRuE-PN clinical trial program, which includes the TRuE-PN1 and TRuE-PN2 studies. These trials evaluated the safety and efficacy of twice-daily ruxolitinib cream 1.5% (Opzelura®), a topical JAK1/2 inhibitor, in adult patients (≥18 years) with prurigo nodularis (PN). The positive results from TRuE-PN1 were presented as a late-breaking oral presentation (Session: S028 – Late-Breaking Research: Session 1) at the 2025 American Academy of Dermatology (AAD) Annual Meeting, held March 7–11, 2025, in Orlando.
Incyte (Nasdaq: INCY) has announced positive results from its pivotal Phase 3 TRuE-PN clinical trial program, which includes two studies: TRuE-PN1 and TRuE-PN2. These trials evaluated the safety and efficacy of twice-daily ruxolitinib cream 1.5% (Opzelura®), a topical JAK1/2 inhibitor, in adult patients with prurigo nodularis (PN), a condition characterized by intensely itchy nodules that significantly affect patients’ quality of life. The results from TRuE-PN1 were presented as a late-breaking oral session at the 2025 American Academy of Dermatology (AAD) Annual Meeting in Orlando, Florida.
Positive Outcomes in the TRuE-PN1 Study
The TRuE-PN1 study met its primary endpoint, demonstrating that significantly more patients who applied ruxolitinib cream 1.5% achieved a ≥4-point improvement in Worst-Itch Numeric Rating Scale (WI-NRS4) from baseline compared to those who used a vehicle control. Specifically, 44.6% of ruxolitinib-treated patients achieved this improvement at Week 12, compared to only 20.6% of those in the vehicle control group (P=0.0003). Additionally, significant improvements in itch were observed as early as Day 7, with 22.4% of ruxolitinib-treated patients showing improvement, compared to 8.0% in the vehicle control group (P=0.0064). Numerical improvements were also seen at earlier timepoints.
The study also met all key secondary endpoints, including:
- A higher percentage of patients treated with ruxolitinib cream 1.5% achieved the Investigator’s Global Assessment for Stage of Chronic Prurigo Treatment Success (IGA-CPG-S-TS) at Week 12 (15.8% vs 3.9%; P=0.0048).
- A significantly higher number of ruxolitinib-treated patients achieved overall treatment success (defined by both a WI-NRS4 response and IGA-CPG-S-TS at Week 12) compared to those in the vehicle control group (11.9% vs 2.9%; P=0.0164).
- At Week 4, significantly more patients treated with ruxolitinib achieved a WI-NRS4 response compared to the vehicle control group (29.7% vs 12.7%; P=0.0034).
“PN is a challenging condition characterized by intensely itchy nodules that significantly impact patients’ quality of life,” said Jim Lee, M.D., Ph.D., Group Vice President, Inflammation and Autoimmunity at Incyte. “These positive results demonstrate improvement in both itch reduction and skin clearance, underscoring the potential of ruxolitinib cream to become an effective topical treatment option for those living with PN.”
Results from the TRuE-PN2 Study
Topline data from the Phase 3 TRuE-PN2 clinical trial also showed strong positive trends across key secondary endpoints, particularly for IGA-CPG-S-TS at Week 12 and WI-NRS4 at Day 7, with nominal P-values <0.05 for both. While the primary endpoint was in favor of ruxolitinib cream 1.5%, it did not reach statistical significance due to a high placebo response. The data from TRuE-PN2 will be submitted for presentation at an upcoming scientific meeting.
Safety Profile
The overall safety profile of ruxolitinib cream 1.5% in the TRuE-PN clinical trial program was consistent with previous data, and no new safety signals were observed. The safety profile was well-tolerated, reinforcing the viability of ruxolitinib as a treatment option for PN patients.
“This program represents the first clinical trials evaluating a topical JAK inhibitor for treating PN, a condition that leads to the formation of cutaneous nodules and causes persistent itching and discomfort,” said Dr. Shawn Kwatra, M.D., Joseph W. Burnett Endowed Professor and Chair of Dermatology at the University of Maryland School of Medicine. “In TRuE-PN1, ruxolitinib cream 1.5% demonstrated its ability to significantly improve both itch and PN lesions. I believe it holds the potential to be a novel and much-needed approach for PN patients.”
Regulatory Discussions and Future Steps
The findings from the TRuE-PN1 and TRuE-PN2 studies will guide discussions with regulatory authorities as Incyte determines the next steps for bringing ruxolitinib cream 1.5% to the market for the treatment of prurigo nodularis.
Ruxolitinib cream 1.5% (Opzelura®) was previously approved by the FDA for the topical treatment of nonsegmental vitiligo in patients aged 12 years and older and for the short-term, non-continuous treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients aged 12 years and older whose condition is not adequately controlled with other topical prescription therapies.
About TRuE-PN
The TRuE-PN clinical trial program consists of two Phase 3 studies, TRuE-PN1 (NCT05755438) and TRuE-PN2 (NCT05764161), which are evaluating the safety and efficacy of twice-daily ruxolitinib cream 1.5% in patients with prurigo nodularis. Each study includes a 12-week double-blind, vehicle-controlled treatment period, followed by a 40-week open-label extension and a 30-day safety follow-up.
Both trials enrolled approximately 180 patients aged 18 and older who had at least six pruriginous lesions and met other criteria. The primary endpoint for both studies was the reduction in WI-NRS4 at Week 12, with key secondary endpoints including overall treatment success, IGA-CPG-S-TS at Week 12, and WI-NRS4 response at Day 7 and Week 4.
