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NCT05755438: TRuE-PN1

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

Completed Phase 3 Results posted Last updated 14 November 2025
What this trial tests

Phase 3 trial testing Ruxolitinib Cream in Prurigo in 204 participants. Completed in 13 August 2025.

Timeline
10 March 2023
Primary endpoint
7 October 2024
13 August 2025

Quick facts

Lead sponsorIncyte Corporation
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment204
Start date10 March 2023
Primary completion7 October 2024
Estimated completion13 August 2025
Sites71 locations across France, Italy, Netherlands, Belgium, Chile, Germany, Poland, Argentina

Drugs / interventions tested

Conditions studied

Sponsor

Incyte Corporation — full company profile →

Who can join

Adults 18 to 99, any sex, with Prurigo. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

WI-NRS4 Response at Week 12 Primary · Baseline; Week 12

WI-NRS4 was defined as the percentage of participants achieving a ≥4-point improvement (reduction) in Worst-Itch Numeric Rating Scale (WI-NRS) score from baseline. The WI-NRS is a patient-reported outcome comprised of a single item rated on a scale from 0 ("no itch") to 10 ("worst imaginable itch"). Participants assessed their worst level of prurigo nodularis-related itch during the past 24 hours on a scale of 0 to 10. The WI-NRS score for baseline was determined by averaging the 7 daily WI-NRS scores before Day 1 (i.e., Days -7 to -1) for all by-visit summaries. The by-visit WI-NRS score for

GroupValue95% CI
Vehicle Cream BID to Ruxolitinib 1.5% Cream BID20.613.2 – 29.7
Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID44.634.7 – 54.8
WI-NRS4 Response at Week 4 Secondary · Baseline; Week 4

WI-NRS4 was defined as the percentage of participants achieving a ≥4-point improvement (reduction) in WI-NRS score from baseline. The WI-NRS is a patient-reported outcome comprised of a single item rated on a scale from 0 ("no itch") to 10 ("worst imaginable itch"). Participants assessed their worst level of prurigo nodularis-related itch during the past 24 hours on a scale of 0 to 10. The WI-NRS score for baseline was determined by averaging the 7 daily WI-NRS scores before Day 1 (i.e., Days -7 to -1) for all by-visit summaries. The by-visit WI-NRS score for post-baseline visits was determine

GroupValue95% CI
Vehicle Cream BID to Ruxolitinib 1.5% Cream BID12.77.0 – 20.8
Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID29.721.0 – 39.6
Percentage of Participants With Overall-Treatment Success at Week 12 Secondary · Baseline; Week 12

Overall-Treatment Success was defined as both a WI-NRS4 response and Investigator's Global Assessment for Stage of Chronic Prurigo Treatment Success (IGA-CPG-S-TS). IGA-CPG-S-TS was defined as an IGA-CPG-S score of 0 or 1 with a ≥2 grade improvement from baseline. The IGA-CPG-S is an overall severity rating of chronic prurigo on a scale of 0 to 4: 0, clear (no pruriginous lesions); 1, almost clear (rare palpable pruriginous lesions \[approximately 1-5 lesions\]); 2, mild (few palpable pruriginous lesions \[approximately 6-19 lesions\]); 3, moderate (many palpable pruriginous lesions \[approxim

GroupValue95% CI
Vehicle Cream BID to Ruxolitinib 1.5% Cream BID2.90.6 – 8.3
Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID11.96.3 – 19.8
Percentage of Participants With IGA-CPG-S-TS at Week 12 Secondary · Baseline; Week 12

IGA-CPG-S-TS was defined as an IGA-CPG-S score of 0 or 1 with a ≥2 grade improvement from baseline. The IGA-CPG-S is an overall severity rating of chronic prurigo on a scale of 0 to 4: 0, clear (no lesions); 1, almost clear (rare palpable pruriginous lesions \[approximately 1-5 lesions\]); 2, mild (few palpable pruriginous lesions \[approximately 6-19 lesions\]); 3, moderate (many palpable pruriginous lesions \[approximately 20-100 lesions\]); 4, severe (abundant palpable pruriginous lesions \[over 100 lesions\]).

GroupValue95% CI
Vehicle Cream BID to Ruxolitinib 1.5% Cream BID3.91.1 – 9.6
Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID15.89.3 – 24.4
WI-NRS4 Response on Day 7 Secondary · Baseline; Day 7

WI-NRS4 was defined as the percentage of participants achieving a ≥4-point improvement (reduction) in WI-NRS score from baseline. The WI-NRS is a patient-reported outcome comprised of a single item rated on a scale from 0 ("no itch") to 10 ("worst imaginable itch"). Participants assessed their worst level of prurigo nodularis-related itch during the past 24 hours on a scale of 0 to 10. The WI-NRS score for baseline was determined by averaging the 7 daily WI-NRS scores before Day 1 (i.e., Days -7 to -1) for all by-visit summaries. The by-visit WI-NRS score for post-baseline visits was determine

GroupValue95% CI
Vehicle Cream BID to Ruxolitinib 1.5% Cream BID8.93.9 – 16.8
Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID23.315.1 – 33.4
DBVC Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit Secondary · Baseline; up to Week 12

The WI-NRS is a patient-reported outcome comprised of a single item rated on a scale from 0 ("no itch") to 10 ("worst imaginable itch"). Participants assessed their worst level of prurigo nodularis-related itch during the past 24 hours on a scale of 0 to 10. The WI-NRS score for baseline was determined by averaging the 7 daily WI-NRS scores before Day 1 (i.e., Days -7 to -1) for all by-visit summaries. The by-visit WI-NRS score for post-baseline visits was determined by averaging the 7 daily WI-NRS scores before the visit day.

Change from Baseline at Week 2
GroupValue95% CI
Vehicle Cream BID to Ruxolitinib 1.5% Cream BID-1.08± 0.196
Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID-2.07± 0.199
Change from Baseline at Week 4
GroupValue95% CI
Vehicle Cream BID to Ruxolitinib 1.5% Cream BID-1.52± 0.247
Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID-2.94± 0.250
Change from Baseline at Week 8
GroupValue95% CI
Vehicle Cream BID to Ruxolitinib 1.5% Cream BID-1.89± 0.267
Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID-3.58± 0.267
Change from Baseline at Week 12
GroupValue95% CI
Vehicle Cream BID to Ruxolitinib 1.5% Cream BID-2.13± 0.273
Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID-3.80± 0.272
OLE Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit Secondary · Baseline; up to Week 52

The WI-NRS is a patient-reported outcome comprised of a single item rated on a scale from 0 ("no itch") to 10 ("worst imaginable itch"). Participants assessed their worst level of prurigo nodularis-related itch during the past 24 hours on a scale of 0 to 10. The WI-NRS score for baseline was determined by averaging the 7 daily WI-NRS scores before Day 1 (i.e., Days -7 to -1) for all by-visit summaries. The by-visit WI-NRS score for post-baseline visits was determined by averaging the 7 daily WI-NRS scores before the visit day.

Change from Baseline at Week 14
GroupValue95% CI
Vehicle Cream BID to Ruxolitinib 1.5% Cream BID-3.11± 2.526
Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID-4.45± 2.679
Change from Baseline at Week 16
GroupValue95% CI
Vehicle Cream BID to Ruxolitinib 1.5% Cream BID-3.53± 2.640
Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID-4.41± 2.742
Change from Baseline at Week 20
GroupValue95% CI
Vehicle Cream BID to Ruxolitinib 1.5% Cream BID-4.14± 2.521
Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID-4.58± 2.701
Change from Baseline at Week 24
GroupValue95% CI
Vehicle Cream BID to Ruxolitinib 1.5% Cream BID-4.12± 2.650
Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID-4.64± 2.543
Change from Baseline at Week 28
GroupValue95% CI
Vehicle Cream BID to Ruxolitinib 1.5% Cream BID-4.03± 2.643
Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID-4.66± 2.614
Change from Baseline at Week 32
GroupValue95% CI
Vehicle Cream BID to Ruxolitinib 1.5% Cream BID-4.37± 2.735
Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID-5.40± 2.538
Change from Baseline at Week 36
GroupValue95% CI
Vehicle Cream BID to Ruxolitinib 1.5% Cream BID-4.70± 2.808
Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID-4.86± 2.784
Change from Baseline at Week 40
GroupValue95% CI
Vehicle Cream BID to Ruxolitinib 1.5% Cream BID-4.78± 2.777
Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID-4.43± 2.794
WI-NRS4 Response at Each Post-baseline Visit Secondary · Baseline; up to Week 52

WI-NRS4 was defined as the percentage of participants achieving a ≥4-point improvement (reduction) in WI-NRS score from baseline. The WI-NRS is a patient-reported outcome comprised of a single item rated on a scale from 0 ("no itch") to 10 ("worst imaginable itch"). Participants assessed their worst level of prurigo nodularis-related itch during the past 24 hours on a scale of 0 to 10. The WI-NRS score for baseline was determined by averaging the 7 daily WI-NRS scores before Day 1 (i.e., Days -7 to -1) for all by-visit summaries. The by-visit WI-NRS score for post-baseline visits was determine

Week 2
GroupValue95% CI
Vehicle Cream BID to Ruxolitinib 1.5% Cream BID5.21.7 – 11.7
Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID22.214.1 – 32.2
Week 4
GroupValue95% CI
Vehicle Cream BID to Ruxolitinib 1.5% Cream BID13.87.6 – 22.5
Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID34.524.6 – 45.4
Week 8
GroupValue95% CI
Vehicle Cream BID to Ruxolitinib 1.5% Cream BID22.113.4 – 33.0
Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID48.837.7 – 60.0
Week 12
GroupValue95% CI
Vehicle Cream BID to Ruxolitinib 1.5% Cream BID25.916.8 – 36.9
Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID52.341.3 – 63.2
Week 14
GroupValue95% CI
Vehicle Cream BID to Ruxolitinib 1.5% Cream BID33.823.2 – 45.7
Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID56.845.3 – 67.8
Week 16
GroupValue95% CI
Vehicle Cream BID to Ruxolitinib 1.5% Cream BID42.731.3 – 54.6
Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID56.844.7 – 68.2
Week 20
GroupValue95% CI
Vehicle Cream BID to Ruxolitinib 1.5% Cream BID54.242.0 – 66.0
Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID58.646.2 – 70.2
Week 24
GroupValue95% CI
Vehicle Cream BID to Ruxolitinib 1.5% Cream BID55.743.3 – 67.6
Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID60.848.8 – 72.0
Time to ≥2-point Improvement From Baseline in WI-NRS Score Secondary · Baseline; up to Week 52

The WI-NRS is a patient-reported outcome comprised of a single item rated on a scale from 0 ("no itch") to 10 ("worst imaginable itch"). Participants assessed their worst level of prurigo nodularis-related itch during the past 24 hours on a scale of 0 to 10. The WI-NRS score for baseline was determined by averaging the 7 daily WI-NRS scores before Day 1 (i.e., Days -7 to -1) for all by-visit summaries. The by-visit WI-NRS score for post-baseline visits was determined by averaging the 7 daily WI-NRS scores before the visit day.

GroupValue95% CI
Vehicle Cream BID to Ruxolitinib 1.5% Cream BID13.07.0 – 24.0
Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID5.04.0 – 8.0
Time to ≥4-point Improvement From Baseline in WI-NRS Score Secondary · Baseline; up to Week 52

The WI-NRS is a patient-reported outcome comprised of a single item rated on a scale from 0 ("no itch") to 10 ("worst imaginable itch"). Participants assessed their worst level of prurigo nodularis-related itch during the past 24 hours on a scale of 0 to 10. The WI-NRS score for baseline was determined by averaging the 7 daily WI-NRS scores before Day 1 (i.e., Days -7 to -1) for all by-visit summaries. The by-visit WI-NRS score for post-baseline visits was determined by averaging the 7 daily WI-NRS scores before the visit day.

GroupValue95% CI
Vehicle Cream BID to Ruxolitinib 1.5% Cream BIDNA60.0 – NA
Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID26.018.0 – 39.0
DBVC Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline Secondary · Baseline; up to Week 12

Participants assessed their worst level of prurigo nodularis-related skin pain during the past 24 hours on a scale of 0 ("no pain") to 10 ("worse imaginable pain"). The Skin Pain NRS score for baseline was determined by averaging the 7 daily NRS scores before Day 1 (i.e., Days -7 to -1) for all by-visit summaries. The by-visit Skin Pain NRS score for post-baseline visits was determined by averaging the 7 daily NRS scores before the visit day.

Week 2
GroupValue95% CI
Vehicle Cream BID to Ruxolitinib 1.5% Cream BID20.212.4 – 30.1
Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID36.125.9 – 47.4
Week 4
GroupValue95% CI
Vehicle Cream BID to Ruxolitinib 1.5% Cream BID30.721.3 – 41.4
Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID56.344.7 – 67.3
Week 8
GroupValue95% CI
Vehicle Cream BID to Ruxolitinib 1.5% Cream BID33.823.0 – 46.0
Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID64.953.2 – 75.5
Week 12
GroupValue95% CI
Vehicle Cream BID to Ruxolitinib 1.5% Cream BID45.333.8 – 57.3
Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID65.854.3 – 76.1
OLE Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline Secondary · Baseline; up to Week 52

Participants assessed their worst level of prurigo nodularis-related skin pain during the past 24 hours on a scale of 0 ("no pain") to 10 ("worse imaginable pain"). The Skin Pain NRS score for baseline was determined by averaging the 7 daily NRS scores before Day 1 (i.e., Days -7 to -1) for all by-visit summaries. The by-visit Skin Pain NRS score for post-baseline visits was determined by averaging the 7 daily NRS scores before the visit day.

Week 14
GroupValue95% CI
Vehicle Cream BID to Ruxolitinib 1.5% Cream BID57.144.7 – 68.9
Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID77.366.2 – 86.2
Week 16
GroupValue95% CI
Vehicle Cream BID to Ruxolitinib 1.5% Cream BID68.656.4 – 79.1
Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID79.167.4 – 88.1
Week 20
GroupValue95% CI
Vehicle Cream BID to Ruxolitinib 1.5% Cream BID78.867.0 – 87.9
Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID78.166.0 – 87.5
Week 24
GroupValue95% CI
Vehicle Cream BID to Ruxolitinib 1.5% Cream BID76.964.8 – 86.5
Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID80.969.5 – 89.4
Week 28
GroupValue95% CI
Vehicle Cream BID to Ruxolitinib 1.5% Cream BID72.959.7 – 83.6
Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID82.370.5 – 90.8
Week 32
GroupValue95% CI
Vehicle Cream BID to Ruxolitinib 1.5% Cream BID75.659.7 – 87.6
Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID86.472.6 – 94.8
Week 36
GroupValue95% CI
Vehicle Cream BID to Ruxolitinib 1.5% Cream BID77.561.5 – 89.2
Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID83.868.0 – 93.8
Week 40
GroupValue95% CI
Vehicle Cream BID to Ruxolitinib 1.5% Cream BID85.769.7 – 95.2
Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID80.860.6 – 93.4

Adverse events — posted to ClinicalTrials.gov

Time frame: up to Week 56. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Vehicle Cream BID
Serious: 5/103 (5%)
Deaths: 0/103
Ruxolitinib 1.5% Cream BID
Serious: 13/184 (7%)
Deaths: 0/184

Serious adverse events (21 terms)

ReactionSystemVehicle Cream BIDRuxolitinib 1.5% Cream BID
Abscess neckInfections and infestations——
Atrial flutterCardiac disorders——
Bowen's diseaseNeoplasms benign, malignant and unspecified (incl cysts and polyps)——
Burns second degreeInjury, poisoning and procedural complications——
COVID-19Infections and infestations——
Cardiac failure congestiveCardiac disorders——
Cerebrovascular accidentNervous system disorders——
Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders——
DepressionPsychiatric disorders——
HidradenitisSkin and subcutaneous tissue disorders——
Ischaemic strokeNervous system disorders——
LymphadenitisBlood and lymphatic system disorders——
NephrolithiasisRenal and urinary disorders——
NeurodermatitisSkin and subcutaneous tissue disorders——
OsteonecrosisMusculoskeletal and connective tissue disorders——
Panic attackPsychiatric disorders——
PneumoniaInfections and infestations——
Pulmonary embolismRespiratory, thoracic and mediastinal disorders——
Pulmonary sepsisInfections and infestations——
Urinary tract infectionInfections and infestations——
VertigoEar and labyrinth disorders——
Other adverse events (2 terms — click to expand)

ReactionSystemVehicle Cream BIDRuxolitinib 1.5% Cream BID
NasopharyngitisInfections and infestations——
COVID-19Infections and infestations——

Most-reported serious reactions: Abscess neck, Atrial flutter, Bowen's disease, Burns second degree, COVID-19, Cardiac failure congestive, Cerebrovascular accident, Chronic obstructive pulmonary disease.

Data from ClinicalTrials.gov NCT05755438 adverse events section.

Sponsor's own description

The purpose of this study is to evaluate the safety and tolerability of Ruxolitinib cream in participants with Prurigo Nodularis (PN).

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Prurigo nodularis: new insights into pathogenesis and novel therapeutics.
    Liao V, Cornman HL, Ma E, Kwatra SG. · · 2024 · cited 38× · PMID 38345154 · DOI 10.1093/bjd/ljae052
  2. Chronic Prurigo Including Prurigo Nodularis: New Insights and Treatments.
    Müller S, Zeidler C, Ständer S. · · 2024 · cited 38× · PMID 37717255 · DOI 10.1007/s40257-023-00818-z
  3. Molecular mechanisms of pruritus in prurigo nodularis.
    Shao Y, Wang D, Zhu Y, Xiao Z, et al · · 2023 · cited 29× · PMID 38077377 · DOI 10.3389/fimmu.2023.1301817
  4. Prurigo Nodularis: Pathogenesis and the Horizon of Potential Therapeutics.
    Yook HJ, Lee JH. · · 2024 · cited 18× · PMID 38791201 · DOI 10.3390/ijms25105164
  5. New and Emerging Biologics and Jak Inhibitors for the Treatment of Prurigo Nodularis: A Narrative Review.
    Bianco M, D'Oria F, Falcidia C, Foggi G, et al · · 2025 · cited 5× · PMID 40282922 · DOI 10.3390/medicina61040631

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