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Phase 3 N=190 Randomized Quadruple-blind Treatment

A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Prurigo Nodularis (PN)

Prurigo Nodularis

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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