Phase 3
N=204
A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream in Participants With Prurigo Nodularis (PN)
Prurigo
Bottom Line
View on ClinicalTrials.gov: NCT05755438 ↗Enrolled (actual)
204
Serious AEs
6.3%
Results posted
Nov 2025
Primary outcome: Primary: WI-NRS4 Response at Week 12 — 20.6; 44.6 percentage of participants — p=0.0003
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
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY WI-NRS4 Response at Week 12 |
20.6; 44.6 | 0.0003 sig |
| SECONDARY WI-NRS4 Response at Week 4 |
12.7; 29.7 | 0.0034 sig |
| SECONDARY Percentage of Participants With Overall-Treatment Success at Week 12 |
2.9; 11.9 | 0.0164 sig |
| SECONDARY Percentage of Participants With IGA-CPG-S-TS at Week 12 |
3.9; 15.8 | 0.0048 sig |
| SECONDARY WI-NRS4 Response on Day 7 |
8.9; 23.3 | 0.0064 sig |
| SECONDARY DBVC Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit |
-1.08; -2.07; -1.52; -2.94; -1.89; -3.58 | 0.0005 sig |
| SECONDARY OLE Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit |
-3.11; -4.45; -3.53; -4.41; -4.14; -4.58 | — |
| SECONDARY WI-NRS4 Response at Each Post-baseline Visit |
5.2; 22.2; 13.8; 34.5; 22.1; 48.8 | — |
| SECONDARY Time to ≥2-point Improvement From Baseline in WI-NRS Score |
13.0; 5.0 | <0.0001 sig |
| SECONDARY Time to ≥4-point Improvement From Baseline in WI-NRS Score |
NA; 26.0 | 0.0002 sig |
| SECONDARY DBVC Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline |
20.2; 36.1; 30.7; 56.3; 33.8; 64.9 | — |
| SECONDARY OLE Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline |
57.1; 77.3; 68.6; 79.1; 78.8; 78.1 | — |
| SECONDARY DBVC Period: Change From Baseline in Skin Pain NRS Score at Each Post-baseline Visit |
-1.02; -1.70; -1.44; -2.58; -1.84; -2.94 | 0.0111 sig |
| SECONDARY OLE Period: Change From Baseline in Skin Pain NRS Score at Each Post-baseline Visit |
-2.88; -3.77; -3.20; -3.71; -3.71; -3.93 | — |
| SECONDARY Percentage of Participants With IGA-CPG-S-TS at Each Postbaseline Visit |
1.0; 2.1; 3.2; 8.4; 5.8; 15.6 | — |
| SECONDARY Percentage of Participants With a IGA-CPG-A Score of 0 or 1 With ≥2-grade Improvement (Reduction) at Each Post-baseline Visit |
1.0; 5.2; 5.3; 11.6; 14.0; 24.4 | — |
| SECONDARY DBVC Period: Percentage of Participants With >75% Healed Lesions From Prurigo Activity Score (PAS) at Each Postbaseline Visit |
10.3; 14.4; 21.3; 26.3; 23.3; 32.2 | — |
| SECONDARY OLE Period: Percentage of Participants With >75% Healed Lesions From PAS at Each Postbaseline Visit |
36.7; 37.9; 40.0; 45.2; 45.5; 45.1 | — |
| SECONDARY DBVC Period: Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Each Post-baseline Visit |
-4.47; -4.67; -5.37; -5.71; -5.17; -6.25 | 0.8028 |
| SECONDARY OLE Period: Change From Baseline in the DLQI Total Score at Each Post-baseline Visit |
-7.22; -6.90; -7.27; -7.60; -6.97; -6.98 | — |
| 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 |
3.00; 7.90; 5.59; 8.90; 2.52; 9.83 | 0.0736 |
| SECONDARY OLE Period: Change From Baseline in EQ-5D-5L VAS Score at Each Postbaseline Visit |
7.54; 10.49; 6.06; 12.06; 8.51; 12.34 | — |
| SECONDARY DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit |
-0.18; -0.07; -0.21; -0.08; -0.19; -0.08 | — |
| SECONDARY OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit |
-0.05; -0.10; -0.17; -0.11; -0.22; -0.19 | — |
| SECONDARY DBVC Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) |
37; 31 | — |
| SECONDARY DBVC Period: Number of Participants With Any ≥Grade 3 TEAE |
5; 4 | — |
| SECONDARY OLE Period: Number of Participants With Any TEAE |
37; 46 | — |
| SECONDARY OLE Period: Number of Participants With Any ≥Grade 3 TEAE |
5; 6 | — |
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 (NCT05755438). 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.