Prurigo NodularisPhase 3TRuE-PN2NCT05764161
A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Prurigo Nodularis (PN)
A Phase 3 study testing Ruxolitinib Cream in people with Prurigo Nodularis, run by Incyte Corporation at 76 sites in 13 countries.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of Ruxolitinib cream in participants with Prurigo Nodularis (PN). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Prurigo Nodularis
- What is being tested?
- Ruxolitinib Cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 190 participants
- Where
- 76 sitesin 13 countries
- Study dates
- 12 Jun 2023to 4 Nov 2025
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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% BSA.
- IGA-CPG-S score of ≥ 2 at screening and baseline.
- Baseline PN-related WI-NRS score ≥ 7.
- Willingness to avoid pregnancy or fathering children.
Who cannot join
- Chronic pruritus due to a condition other than PN
- Total estimated BSA treatment area (excluding the scalp) > 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.
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- 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.
Trial locations and contacts
76 sites in 13 countries.
76 sites in 13 countries
United States16 sites
Northwest Arkansas Clinical Trials Center
Arkansas City, Arkansas, 72758
Oakview Dermatology
Athens, Ohio, 45701
Dermresearch, Inc.
Austin, Texas, 78759
Axon Clinical Research
Baltimore, Maryland, 21237
Activmed Practices Research, Llc Beverly
Beverly, Massachusetts, 01915
University of Alabama At Birmingham
Birmingham, Alabama, 35233
Aventiv Research Inc-Dublin
Dublin, Ohio, 43016
Wright State Physicians, Inc.
Fairborn, Ohio, 45324
Dermatology Research Associates
Los Angeles, California, 90045
Marietta Dermatology the Skin Cancer Center Marietta
Marietta, Georgia, 30060-1047
Ars - Maitland Clinical Research Unit
Orlando, Florida, 32819
University of Pittsburgh Medical Center Upmc Dermatology Clinic Oakland Falk Medical Building
Pittsburgh, Pennsylvania, 15232
Clinical Science Institute Clinical Research Specialists Inc
Santa Monica, California, 90404
Cura Clinical Research
Sherman Oaks, California, 91403
The South Bend Clinic Main Campus
South Bend, Indiana, 46617
Dermdox Center For Dermatology
Sugarloaf, Pennsylvania, 18249
Australia7 sites
Premier Specialists Pty Ltd
Kogarah, New South Wales, 02217
Liverpool Hospital
Liverpool, New South Wales, 02170
The Alfred Hospital
Melbourne, Victoria, 03004
Paratus Clinical Research, Woden
Phillip, 02606
Holdsworth House Medical Practice
Sydney, New South Wales, 02010
Westmead Hospital
Sydney, New South Wales, 02145
Veracity Clinical Research
Woolloongabba, Queensland, 04102
Poland7 sites
Diamond Clinic Specjalistyczne Poradnie Lekarskie
Krakow, 31-559
Dermoklinika Centrum Medyczne S.C., M. Kierstan, J. Narbutt, A. Lesiak
Lodz, 90-436
Luxderm Specjalistyczny Gabinet Dermatologiczny
Lublin, 20-362
Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. Z O.O.
Malbork, 82-200
Solumed Centrum Medyczne
Poznan, 60-529
Dermaceum Centrum Badan Klinicznych
Wroclaw, 50-414
Dermmedica Sp. Z O.O.
Wroclaw, 51-318
Bulgaria6 sites
Medical Center Medconsult Pleven Ood
Pleven, 05800
Medical Center- Prolet Ltd
Rousse, 07000
Medical Center Unimed Eood
Sevlievo, 05400
Dcc 'Alexandrovska', Eood
Sofia, 01431
Medical Center Hera Eood
Sofia, 01510
Umhat Prof. Dr. Stoyan Kirkovich Ad
Stara Zagora, 06000
France6 sites
Bordeaux Chu Hopital Saint - Andre
Bordeaux, 33000
Chu Dijon-Bourgogne
Dijon, 21000
Hopital Edouard Herrio
Lyon, 69003
Chu de Nice - Hospital L Archet
Nice, 06200
Centre Hospitalier Universitaire de Poitiers
Poitiers, 86021
Chu Amiens - Hopital Sud
Salouël, 80480
South Korea6 sites
Korea University Anam Hospital
Seoul, 02841
Seoul National University Hospital
Seoul, 03080
Asan Medical Center
Seoul, 05505
The Catholic University of Korea Seoul St. Mary'S Hospital
Seoul, 06591
Korea University Guro Hospital
Seoul, 08308
Ajou University Hospital
Suwon, 16499
Canada5 sites
Kingsway Clinical Research
Etobicoke, Ontario, M8X 1Y9
Lynderm Research Inc
Markham, Ontario, L3P 1X3
North York Research Inc.
North YORK, Ontario, M2M 4J5
Skin Centre For Dermatology
Peterborough, Ontario, K9J 5K2
Diex Recherche Quebec Inc.
Québec, Quebec, G1V 4T3
Germany5 sites
Klinikum Bielefeld Rosenhohe Dermatologie
Bielefeld, 33647
Universitatsklinikum Frankfurt
Frankfurt am Main, 60590
Universitatsmedizin Goettingen
Göttingen, 37075
Dermatologische Gemeinschaftspraxis Mahlow
Mahlow, 15831
Universitatsklinikum Munster
Münster, 48149
Italy5 sites
Fondazione Irccs Ca Granda Ospedale Maggiore
Milan, 20122
Universita Degli Studi Della Campania Luigi Vanvitelli
Naples, 80131
Azienda Ospedaliera Di Perugia - Ospedale Santa Maria Della Misericordia
Perugia, 06132
Azienda Ospedaliero Universitaria Pisana - Ospedale S. Chiara
Pisa, 56126
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Rome, 00133
Spain5 sites
Ceim Hospital Universitari Germans Trias I Pujol
Badalona, 08916
Hospital Universitario de Gran Canaria Doctor Negrin
Las Palmas de Gran Canaria, 35010
Hospital Universitario Ramon Y Cajal
Madrid, 28034
Hospital Universitario 12 de Octubre
Madrid, 28041
Clinica Gaias Santiago
Santiago de Compostela, 15002
Austria3 sites
Landeskrankenhaus Universitatsklinikum Graz
Graz, 08036
Ordensklinikum Linz Gmbh Elisabethinen
Linz, 04020
Sozialmedizinisches Zentrum Ost-Donauspital
Vienna, 01220
Switzerland3 sites
Dermatology & Skin Care Clinic
Buochs, 06374
Centre Hospitalier Universitaire Vaudois (Chuv)
Lausanne, 01011
Universitatsspital Zurich
Zurich-flughafen, 08058
Denmark2 sites
Herlev Og Gentofte Hospital
Hellerup, 02900
Sjaellands Universitetshospital
Roskilde, 04000
About this study
Official title: A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream in Participants With Prurigo Nodularis
The purpose of this study is to evaluate the safety and tolerability of Ruxolitinib cream in participants with Prurigo Nodularis (PN).
Read the detailed description
The study comprises of a 12 week double-blind, vehicle-controlled (DBVC) treatment period, followed by a 40 week open label extension period, and 30 day safety follow-up period During the double blind period, all PN-affected areas identified at baseline will be treated, and during the open label period, only active PN-affected areas will be treated.
- Conditions
- Prurigo Nodularis
- Being tested
- Ruxolitinib Cream, Vehicle Cream
- Keywords
- PN, INCB18424-320, INCB18424, Prurigo, Prurigo Nodularis, Skin Diseases, Dermatitis, ruxolitinib
- Medical subject headings
- Prurigo, Skin Diseases, Dermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ruxolitinib CreamDrug
Also called Opzelura, INCB018424 phosphate cream
Ruxolitinib cream 1.5% twice daily (BID) during the continuous and open label treatment period.
Vehicle CreamDrug
Ruxolitinib matching vehicle cream 1.5% twice daily (BID) during the vehicle-controlled period.
| Study group | Role | What they receive |
|---|---|---|
| Ruxolitinib 1.5% Cream | Experimental | Participants apply ruxolitinib 1.5% cream topically to the affected areas as a thin film BID for 12 weeks during the DBVC period. Participants who have completed the treatment during DBVC period will enter the open label extension (OLE) period for up to 40 weeks. Receives: Drug: Ruxolitinib Cream |
| Vehicle Cream | Placebo comparator | Participants apply ruxolitinib matching vehicle cream topically to the affected areas as a thin film twice daily (BID) for 12 weeks during the DBVC period. Participants who have completed the treatment during DBVC period will enter the open label extension (OLE) period for up to 40 weeks. Receives: Drug: Vehicle Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
WI-NRS4 Response at 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). The by-visit WI-NRS score for post-baseline visits was determined by averaging the 7 daily WI-NRS scores before the visit day. Participants with missing Week 12 data for any reason, including treatment discontinuation (due to development of atopic dermatitis lesions or any other cause), were defined as nonresponders.
Measured: Baseline; Week 12
Secondary outcomes (27)
WI-NRS4 Response at 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). The by-visit WI-NRS score for post-baseline visits was determined by averaging the 7 daily WI-NRS scores before the visit day.
Measured: Baseline; Week 4
Percentage of Participants With Overall-Treatment Success at 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 [approximately 20-100 lesions]); 4, severe (abundant palpable pruriginous lesions [over 100 lesions]).
Measured: Baseline; Week 12
Percentage of Participants With IGA-CPG-S-TS at 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]).
Measured: Baseline; Week 12
WI-NRS4 Response at 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). The by-visit WI-NRS score for post-baseline visits was determined by averaging the 7 daily WI-NRS scores before the visit day.
Measured: Baseline; Day 7
WI-NRS4 Response at Each Post-baseline Visit
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). The by-visit WI-NRS score for post-baseline visits was determined by averaging the 7 daily WI-NRS scores before the visit day.
Measured: Baseline; up to Week 52
DBVC Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit
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). The by-visit WI-NRS score for post-baseline visits was determined by averaging the 7 daily WI-NRS scores before the visit day.
Measured: Baseline; up to Week 12
OLE Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit
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). The by-visit WI-NRS score for post-baseline visits was determined by averaging the 7 daily WI-NRS scores before the visit day.
Measured: Baseline; up to Week 52
Time to ≥2-point Improvement From Baseline in WI-NRS Score
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). The by-visit WI-NRS score for post-baseline visits was determined by averaging the 7 daily WI-NRS scores before the visit day.
Measured: Baseline; up to Week 12
Time to ≥4-point Improvement From Baseline in WI-NRS Score
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). The by-visit WI-NRS score for post-baseline visits was determined by averaging the 7 daily WI-NRS scores before the visit day.
Measured: Baseline; up to Week 12
DBVC Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline
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). The by-visit Skin Pain NRS score for post-baseline visits was determined by averaging the 7 daily NRS scores before the visit day.
Measured: Baseline; up to Week 12
OLE Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline
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). The by-visit Skin Pain NRS score for post-baseline visits was determined by averaging the 7 daily NRS scores before the visit day.
Measured: Baseline; up to Week 52
DBVC Period: Change From Baseline in Skin Pain NRS Score at Each Post-baseline Visit
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). The by-visit Skin Pain NRS score for post-baseline visits was determined by averaging the 7 daily NRS scores before the visit day. Change from baseline was calculated as the post-baseline value minus the baseline value.
Measured: Baseline; up to Week 12
OLE Period: Change From Baseline in Skin Pain NRS Score at Each Post-baseline Visit
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). The by-visit Skin Pain NRS score for post-baseline visits was determined by averaging the 7 daily NRS scores before the visit day. Change from baseline was calculated as the post-baseline value minus the baseline value.
Measured: Baseline; up to Week 52
Percentage of Participants With IGA-CPG-S-TS at Each Postbaseline Visit
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 nodularis 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]).
Measured: Baseline; up to Week 52
Percentage of Participants With a IGA-CPG-A Score of 0 or 1 With ≥2-grade Improvement (Reduction) at Each Post-baseline Visit
The Investigator Global Assessment for Activity of Chronic Prurigo (IGA-CPG-A) is an overall severity rating of chronic prurigo nodularis on a scale of 0 to 4: 0, clear (no pruriginous lesions have excoriations or crusts); 1, almost clear (very small proportion of pruriginous lesions have excoriations or crusts [up to approximately 10% of all pruriginous lesions]); 2, mild (minority of pruriginous lesions have excoriations or crusts [approximately 11%-25% of all pruriginous lesions]); 3, moderate (many pruriginous lesions have excoriations or crusts [approximately 26%-75% of all pruriginous lesions]); 4, severe (majority of pruriginous lesions have excoriations or crusts [approximately 76%-100% of all pruriginous lesions]).
Measured: Baseline; up to Week 52
DBVC Period: Percentage of Participants With >75% Healed Lesions From Prurigo Activity Score (PAS) at Each Postbaseline Visit
The extent and severity of prurigo nodularis was assessed via the PAS (version 1.2). The first 3 items are descriptive of the type, predominant type, distribution, and quantity of pruriginous lesions. The remaining 2 items of the PAS assess disease activity in terms of percentage (i.e., 0%, 1%-25%, 26%-50%, 51%-75%, and 76%-100%) of pruriginous lesions with excoriations/crusts on top (to reflect active scratching) and the percentage (i.e., 100%, 76%-99%, 51%-75%, 26%-50%, and 0%-25%) of healed pruriginous lesions in order to quantify change of prurigo nodularis skin lesions.
Measured: Baseline; up to Week 12
OLE Period: Percentage of Participants With >75% Healed Lesions From PAS at Each Postbaseline Visit
The extent and severity of prurigo nodularis was assessed via the PAS (version 1.2). The first 3 items are descriptive of the type, predominant type, distribution, and quantity of pruriginous lesions. The remaining 2 items of the PAS assess disease activity in terms of percentage (i.e., 0%, 1%-25%, 26%-50%, 51%-75%, and 76%-100%) of pruriginous lesions with excoriations/crusts on top (to reflect active scratching) and the percentage (i.e., 100%, 76%-99%, 51%-75%, 26%-50%, and 0%-25%) of healed pruriginous lesions in order to quantify change of prurigo nodularis skin lesions.
Measured: Baseline; up to Week 52
DBVC Period: Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Each Post-baseline Visit
The DLQI is a simple, 10-question, validated questionnaire to measure how much the skin problem has affected the participant over the previous 7 days. Each question was scored as: 3 (very much), 2 (a lot), 1 (a little), 0 (not at all or not relevant). The DLQI total score was calculated by summing the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more the quality of life was impaired. Total DLQI scores were categorized as follows: 0 to 1 (no effect), 2 to 5 (small effect), 6 to 10 (moderate effect), 11 to 20 (very large effect), and 21 to 30 (extremely large effect). Change from Baseline was calculated as the post-baseline visit minus the baseline visit.
Measured: Baseline; up to Week 12
OLE Period: Change From Baseline in the DLQI Total Score at Each Post-baseline Visit
The DLQI is a simple, 10-question, validated questionnaire to measure how much the skin problem has affected the participant over the previous 7 days. Each question was scored as: 3 (very much), 2 (a lot), 1 (a little), 0 (not at all or not relevant). The DLQI total score was calculated by summing the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more the quality of life was impaired. Total DLQI scores were categorized as follows: 0 to 1 (no effect), 2 to 5 (small effect), 6 to 10 (moderate effect), 11 to 20 (very large effect), and 21 to 30 (extremely large effect). Change from Baseline was calculated as the post-baseline visit minus the baseline visit.
Measured: Baseline; up to Week 52
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
The EQ-5D-5L is a standardized instrument for use as a measure of health outcome. The EQ-5D-5L consists of 2 sections: the EQ-5D descriptive system and the EQ VAS. The descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 response levels, which are coded by single-digit numbers: 1 = no problems, 2 = slight problems, 3 = moderate problems, 4 = severe problems, 5 = unable to/extreme problems. The EQ VAS records the participant's self-rated health on a vertical VAS (0-100), on which the endpoints are labeled "the best health you can imagine" (100 score) and "the worst health you can imagine" (0 score). Change from Baseline was calculated as the post-baseline value minus the baseline value.
Measured: Baseline; up to Week 12
OLE Period: Change From Baseline in EQ-5D-5L VAS Score at Each Postbaseline Visit
The EQ-5D-5L is a standardized instrument for use as a measure of health outcome. The EQ-5D-5L consists of 2 sections: the EQ-5D descriptive system and the EQ VAS. The descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 response levels, which are coded by single-digit numbers: 1 = no problems, 2 = slight problems, 3 = moderate problems, 4 = severe problems, 5 = unable to/extreme problems. The EQ VAS records the participant's self-rated health on a vertical VAS (0-100), on which the endpoints are labeled "the best health you can imagine" (100 score) and "the worst health you can imagine" (0 score). Change from Baseline was calculated as the post-baseline value minus the baseline value.
Measured: Baseline; up to Week 52
DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit
The EQ-5D-5L is a standardized instrument for use as a measure of health outcome. The EQ-5D-5L consists of 2 sections: the EQ-5D descriptive system and the EQ VAS. The descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 response levels, which are coded by single-digit numbers: 1 = no problems, 2 = slight problems, 3 = moderate problems, 4 = severe problems, 5 = unable to/extreme problems. The EQ VAS records the participant's self-rated health on a vertical VAS (0-100), on which the endpoints are labeled "the best health you can imagine" (100 score) and "the worst health you can imagine" (0 score). Change from Baseline was calculated as the post-baseline value minus the baseline value.
Measured: Baseline; up to Week 12
OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit
The EQ-5D-5L is a standardized instrument for use as a measure of health outcome. The EQ-5D-5L consists of 2 sections: the EQ-5D descriptive system and the EQ VAS. The descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 response levels, which are coded by single-digit numbers: 1 = no problems, 2 = slight problems, 3 = moderate problems, 4 = severe problems, 5 = unable to/extreme problems. The EQ VAS records the participant's self-rated health on a vertical VAS (0-100), on which the endpoints are labeled "the best health you can imagine" (100 score) and "the worst health you can imagine" (0 score). Change from Baseline was calculated as the post-baseline value minus the baseline value.
Measured: Baseline; up to Week 52
DBVC Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE can therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study cream. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug.
Measured: up to Week 12
DBVC Period: Number of Participants With Any ≥Grade 3 TEAE
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE can therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study cream. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug. The severity of TEAEs was assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grades 1 through 5. The investigator made an assessment of intensity for each TEAE and assigned it to one of the following categories: Grade 1, mild; Grade 2, moderate; Grade 3, severe or medically significant but not immediately life threatening; Grade 4, life-threatening consequences; Grade 5, fatal.
Measured: up to Week 12
OLE Period: Number of Participants With Any TEAE
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE can therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study cream. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug.
Measured: from beginning of Week 13 up to Week 56
OLE Period: Number of Participants With Any ≥Grade 3 TEAE
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE can therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study cream. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug. The severity of TEAEs was assessed using CTCAE version 5.0 Grades 1 through 5. The investigator made an assessment of intensity for each TEAE and assigned it to one of the following categories: Grade 1, mild; Grade 2, moderate; Grade 3, severe or medically significant but not immediately life threatening; Grade 4, life-threatening consequences; Grade 5, fatal.
Measured: from beginning of Week 13 up to Week 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start12 Jun 2023
- Primary completion30 Dec 2024
- Study completion4 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prurigo NodularisStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05764161
- Sponsor's protocol ID
- INCB18424-320
- Other IDs
- 2022-502461-23-00
- Acronym
- TRuE-PN2
- Status last verified
- Oct 2026
- First submitted
- 1 Mar 2023
- Last updated
- 6 Nov 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream in Participants With Prurigo Nodularis
- ClinicalTrials.gov ID
- NCT05764161
- Acronym / sponsor ID
- TRuE-PN2 / INCB18424-320
- Conditions
- Prurigo Nodularis
- Keywords
- PN, INCB18424-320, INCB18424, Prurigo, Prurigo Nodularis, Skin Diseases, Dermatitis, ruxolitinib
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 12 Jun 2023 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 4 Nov 2025 (actual)
- First posted
- 10 Mar 2023 (actual)
- Results
- Posted 24 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and tolerability of Ruxolitinib cream in participants with Prurigo Nodularis (PN).
Detailed description
The study comprises of a 12 week double-blind, vehicle-controlled (DBVC) treatment period, followed by a 40 week open label extension period, and 30 day safety follow-up period During the double blind period, all PN-affected areas identified at baseline will be treated, and during the open label period, only active PN-affected areas will be treated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ruxolitinib 1.5% Cream | Experimental | Drug: Ruxolitinib CreamParticipants apply ruxolitinib 1.5% cream topically to the affected areas as a thin film BID for 12 weeks during the DBVC period. Participants who have completed the treatment during DBVC period will enter the open label extension (OLE) period for up to 40 weeks. |
| Vehicle Cream | Placebo comparator | Drug: Vehicle CreamParticipants apply ruxolitinib matching vehicle cream topically to the affected areas as a thin film twice daily (BID) for 12 weeks during the DBVC period. Participants who have completed the treatment during DBVC period will enter the open label extension (OLE) period for up to 40 weeks. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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% BSA.
- IGA-CPG-S score of ≥ 2 at screening and baseline.
- Baseline PN-related WI-NRS score ≥ 7.
- Willingness to avoid pregnancy or fathering children.
Key exclusion criteria (17 listed)
- Chronic pruritus due to a condition other than PN
- Total estimated BSA treatment area (excluding the scalp) > 20%.
- Neuropathic and psychogenic pruritus
- Active atopic dermatitis lesions within 3 months of screening and baseline.
- Uncontrolled thyroid function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ruxolitinib CreamAlso: Opzelura, INCB018424 phosphate creamRuxolitinib cream 1.5% twice daily (BID) during the continuous and open label treatment period. | Drug | Ruxolitinib 1.5% Cream |
| Vehicle CreamRuxolitinib matching vehicle cream 1.5% twice daily (BID) during the vehicle-controlled period. | Drug | Vehicle Cream |
Primary outcome
WI-NRS4 Response at Week 12
Time frame: 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). The by-visit WI-NRS score for post-baseline visits was determined by averaging the 7 daily WI-NRS scores before the visit day. Participants with missing Week 12 data for any reason, including treatment discontinuation (due to development of atopic dermatitis lesions or any other cause), were defined as nonresponders.
27 secondary outcomes
WI-NRS4 Response at Week 4
Time frame: Baseline; Week 4
Percentage of Participants With Overall-Treatment Success at Week 12
Time frame: Baseline; Week 12
Percentage of Participants With IGA-CPG-S-TS at Week 12
Time frame: Baseline; Week 12
WI-NRS4 Response at Day 7
Time frame: Baseline; Day 7
WI-NRS4 Response at Each Post-baseline Visit
Time frame: Baseline; up to Week 52
DBVC Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit
Time frame: Baseline; up to Week 12
OLE Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit
Time frame: Baseline; up to Week 52
Time to ≥2-point Improvement From Baseline in WI-NRS Score
Time frame: Baseline; up to Week 12
Time to ≥4-point Improvement From Baseline in WI-NRS Score
Time frame: Baseline; up to Week 12
DBVC Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline
Time frame: Baseline; up to Week 12
OLE Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline
Time frame: Baseline; up to Week 52
DBVC Period: Change From Baseline in Skin Pain NRS Score at Each Post-baseline Visit
Time frame: Baseline; up to Week 12
OLE Period: Change From Baseline in Skin Pain NRS Score at Each Post-baseline Visit
Time frame: Baseline; up to Week 52
Percentage of Participants With IGA-CPG-S-TS at Each Postbaseline Visit
Time frame: Baseline; up to Week 52
Percentage of Participants With a IGA-CPG-A Score of 0 or 1 With ≥2-grade Improvement (Reduction) at Each Post-baseline Visit
Time frame: Baseline; up to Week 52
DBVC Period: Percentage of Participants With >75% Healed Lesions From Prurigo Activity Score (PAS) at Each Postbaseline Visit
Time frame: Baseline; up to Week 12
OLE Period: Percentage of Participants With >75% Healed Lesions From PAS at Each Postbaseline Visit
Time frame: Baseline; up to Week 52
DBVC Period: Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Each Post-baseline Visit
Time frame: Baseline; up to Week 12
OLE Period: Change From Baseline in the DLQI Total Score at Each Post-baseline Visit
Time frame: Baseline; up to Week 52
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
Time frame: Baseline; up to Week 12
OLE Period: Change From Baseline in EQ-5D-5L VAS Score at Each Postbaseline Visit
Time frame: Baseline; up to Week 52
DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit
Time frame: Baseline; up to Week 12
OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit
Time frame: Baseline; up to Week 52
DBVC Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
Time frame: up to Week 12
DBVC Period: Number of Participants With Any ≥Grade 3 TEAE
Time frame: up to Week 12
OLE Period: Number of Participants With Any TEAE
Time frame: from beginning of Week 13 up to Week 56
OLE Period: Number of Participants With Any ≥Grade 3 TEAE
Time frame: from beginning of Week 13 up to Week 56
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
76 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ruxolitinib Cream in people with Prurigo Nodularis, run by Incyte Corporation at 76 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 76 sites in United States, Australia, Poland, Bulgaria, France and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WI-NRS4 Response at Week 12 (time frame: Baseline; Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.