Phase 3
N=190
A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Prurigo Nodularis (PN)
Prurigo Nodularis
Bottom Line
View on ClinicalTrials.gov: NCT05764161 ↗Enrolled (actual)
190
Serious AEs
1.5%
Results posted
Nov 2025
Primary outcome: Primary: WI-NRS4 Response at Week 12 — 36.2; 40.0 percentage of participants — p=0.5859
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ruxolitinib Cream (Drug); Vehicle Cream (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Incyte Corporation
- Primary completion
- Dec 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY WI-NRS4 Response at Week 12 |
36.2; 40.0 | 0.5859 |
| SECONDARY WI-NRS4 Response at Week 4 |
19.1; 30.5 | 0.0741 |
| SECONDARY Percentage of Participants With Overall-Treatment Success at Week 12 |
6.4; 12.5 | 0.1493 |
| SECONDARY Percentage of Participants With IGA-CPG-S-TS at Week 12 |
10.6; 24.0 | 0.0142 sig |
| SECONDARY WI-NRS4 Response at Day 7 |
5.5; 15.6 | 0.0387 sig |
| SECONDARY WI-NRS4 Response at Each Post-baseline Visit |
4.5; 15.9; 21.2; 32.2; 31.7; 45.1 | — |
| SECONDARY DBVC Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit |
-1.14; -2.01; -1.86; -2.90; -2.60; -3.68 | 0.0005 sig |
| SECONDARY OLE Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit |
-4.07; -4.20; -4.82; -4.40; -5.30; -4.67 | — |
| SECONDARY Time to ≥2-point Improvement From Baseline in WI-NRS Score |
15.0; 5.0 | 0.0005 sig |
| SECONDARY Time to ≥4-point Improvement From Baseline in WI-NRS Score |
63.0; 21.0 | 0.0399 sig |
| SECONDARY DBVC Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline |
22.4; 40.0; 34.9; 58.6; 48.1; 65.8 | — |
| SECONDARY OLE Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline |
72.2; 79.7; 77.5; 88.5; 85.5; 84.2 | — |
| SECONDARY DBVC Period: Change From Baseline in Skin Pain NRS Score at Each Post-baseline Visit |
-1.06; -1.86; -1.80; -2.68; -2.39; -3.26 | 0.0016 sig |
| SECONDARY OLE Period: Change From Baseline in Skin Pain NRS Score at Each Post-baseline Visit |
-3.81; -3.93; -4.57; -4.17; -4.95; -4.38 | — |
| SECONDARY Percentage of Participants With IGA-CPG-S-TS at Each Postbaseline Visit |
4.5; 3.3; 5.6; 11.8; 10.5; 23.0 | — |
| SECONDARY Percentage of Participants With a IGA-CPG-A Score of 0 or 1 With ≥2-grade Improvement (Reduction) at Each Post-baseline Visit |
4.5; 9.8; 9.0; 16.1; 17.4; 26.4 | — |
| SECONDARY DBVC Period: Percentage of Participants With >75% Healed Lesions From Prurigo Activity Score (PAS) at Each Postbaseline Visit |
9.0; 12.0; 16.9; 21.5; 20.9; 39.1 | — |
| SECONDARY OLE Period: Percentage of Participants With >75% Healed Lesions From PAS at Each Postbaseline Visit |
36.8; 47.9; 41.9; 48.4; 44.3; 52.5 | — |
| SECONDARY DBVC Period: Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Each Post-baseline Visit |
-3.81; -5.14; -4.75; -5.93; -5.43; -6.29 | 0.0759 |
| SECONDARY OLE Period: Change From Baseline in the DLQI Total Score at Each Post-baseline Visit |
-6.88; -7.14; -7.07; -7.22; -7.63; -7.09 | — |
| SECONDARY DBVC Period: Change From Baseline in European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) Visual Analog Scale (VAS) Score at Each Postbaseline Visit |
4.43; 7.02; 6.52; 8.64; 6.02; 8.84 | 0.3053 |
| SECONDARY OLE Period: Change From Baseline in EQ-5D-5L VAS Score at Each Postbaseline Visit |
10.51; 10.15; 10.11; 11.25; 12.33; 6.60 | — |
| SECONDARY DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit |
-0.15; -0.02; -0.24; -0.02; -0.16; -0.07 | — |
| SECONDARY OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit |
-0.17; -0.01; -0.12; -0.03; -0.17; -0.07 | — |
| SECONDARY DBVC Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) |
22; 27 | — |
| SECONDARY DBVC Period: Number of Participants With Any ≥Grade 3 TEAE |
1; 1 | — |
| SECONDARY OLE Period: Number of Participants With Any TEAE |
36; 36 | — |
| SECONDARY OLE Period: Number of Participants With Any ≥Grade 3 TEAE |
2; 4 | — |
Summary
The purpose of this study is to evaluate the safety and tolerability of Ruxolitinib cream in participants with Prurigo Nodularis (PN).
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of PN ≥ 3 months before screening.
- ≥ 6 pruriginous lesions on ≥ 2 different body areas (such as right and left leg) at screening and baseline having a treatment area 20%.
- Neuropathic and psychogenic pruritus
- Active atopic dermatitis lesions within 3 months of screening and baseline.
- Uncontrolled thyroid function
- Concurrent skin or other serious or unstable medical conditions which may interfere with the evaluation of PN such as immunocompromised status, acute/chronic infections, active malignancy, history of TB, history of DVT/VTE, etc Protocol defined abnormal laboratory results.
- Use of any protocol-defined prohibited medication unless a washout is completed or use of medication known to cause itching.
- Psoralen and ultraviolet A or ultraviolet B therapy within 4 weeks before baseline or Ultraviolet light therapy or prolonged exposure to natural or artificial sources of ultraviolet radiation (within 2 weeks before baseline
- Pregnant or lactating, or considering pregnancy.
- History of alcoholism or drug addiction within 1 year
- Known allergy or reaction to any of the components of the study drug.
- Committed to a mental health institution by virtue of an order issued either by the judicial or the administrative authorities.
- Employees of the sponsor or investigator or otherwise dependents of them.
- The following participants are excluded in France:
- Vulnerable populations according to article L.1121-6 of the French Public Health Code.
- Adults under legal protection or who are unable to express their consent per article L.1121-8 of the French Public Health Code.
- Individuals not affiliated with the social security system.
Data sourced from ClinicalTrials.gov (NCT05764161). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.