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

Phase 3

Active, not recruiting

• Conditions: Prurigo Nodularis
• Interventions: Drug: Vehicle Cream; Drug: Ruxolitinib Cream

• Registration Number: NCT05764161
• Lead Sponsor: Incyte Corporation

Brief Summary

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 Timeline

• Study First Submitted: 2023-03-01
• Study First Submitted QC: 2023-03-01
• Study First Posted: 2023-03-10
• Study Start: 2023-06-12
• Primary Completion: 2024-12-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-06
• Last Update Posted: 2025-01-08
• Study Completion: 2025-10-25

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 190

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% 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.

Exclusion Criteria

• 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.

• 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:

  1. Vulnerable populations according to article L.1121-6 of the French Public Health Code.
  2. Adults under legal protection or who are unable to express their consent per article L.1121-8 of the French Public Health Code.
  3. Individuals not affiliated with the social security system.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle Cream	Vehicle Cream	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.
Ruxolitinib 1.5% Cream	Ruxolitinib Cream	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.

Primary Outcome Measures

Name	Time	Method
Worst-Itch Numeric Rating Scale (WI-NRS) ≥ 4-point improvement in WI-NRS score Response	Week 12	Defined as achieving a ≥ 4-point improvement (reduction) in Worst Itch Numeric Rating Scale (WI-NRS) score from baseline.

Secondary Outcome Measures

Name	Time	Method
Overall Treatment Success (TS)	Week 12	Defined as achieving both a WI-NRS4 response and an Investigator's Global Assessment for Stage of Chronic Prurigo Treatment Success (IGA-CPG-S-TS).
WI-NRS4 Response	Day 7	Defined as achieving a ≥ 4-point improvement (reduction) in WI-NRS score from baseline.
Skin pain response, defined as a ≥ 2-point improvement in Skin Pain NRS score	Skin pain response, defined as a ≥ 2-point improvement in Skin Pain NRS score	Itch NRS is an 11-point scale (0 to 10) where 0 is "no itch" and 10 is the "worst itch imaginable".
> 75% healed lesions from baseline in PAS at each postbaseline visit.	Up to 56 weeks	PAS includes 5 items; descriptive of the type, predominant type, distribution, and quantity of pruriginous lesions, and disease activity in terms of percentage of pruriginous lesions with excoriations/crusts on top.
Time to ≥ 2-point improvement from baseline in WI-NRS score	Up to 52 weeks	Participants rate pruritus daily on Worst Itch \[pruritis\] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus)
Number of Treatment-emergent adverse events (TEAEs)	Up to 56 weeks	TEAE defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.
Proportion of participants with WI-NRS4 at each postbaseline visit.	Up to 52 weeks	Defined as percentage of participants that achieve a ≥ 4-point improvement in WI-NRS score
IGA-CPG-A 0 or 1 response, defined as achieving an IGA score of 0 or 1 at each postbaseline visit.	Up to 56 weeks	The IGA-CPG-A is an overall PN severity rating on a 5-point scale ranging from 0 (clear skin) to 4 (severe disease). The IGA-CPG-A score is based on disease activity based on % of PN lesions with excoriations or crusts.
Change from baseline in Dermatology Life Quality Index (DLQI) score at each postbaseline visit.	Up to 56 weeks	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
IGA-CPG-S-TS	Week 12	Defined as an IGA-CPG-S score of 0 or 1 with a ≥ 2 grade improvement from baseline
Time to ≥ 4-point improvement from baseline in WI-NRS score	Up to 52 weeks	Defined as time taken for the participant to achieve a ≥4 improvement in NRS scale compared to baseline
IGA-TS response, defined as achieving IGA TS at each postbaseline visit.	Up to 56 weeks	The IGA-CPG-s for chronic prurigo nodularis considers the number of nodules, also referred to as lesions, and uses them to determine an overall severity rating on a 5-point scale ranging from 0 (clear skin) to 4 (severe).
Change from baseline in WI-NRS score	Up to 52 weeks	Defined as change in Intensity of itch. Itch will be measured using an NRS used to indicate the intensity of the worst itching over the past 24 hours using a 0 to 10 numeric rating scale, where "0" represents "no itching" and "10" represents "worst itching imaginable".
Change from baseline in Skin Pain NRS score	Up to 52 weeks	Itch NRS is an 11-point scale (0 to 10) where 0 is "no itch" and 10 is the "worst itch imaginable".
Change from baseline in EQ-5D-5L score at each postbaseline visit.	Up to 56 weeks	The EQ-5D-5L questionnaire is a standardized, validated instrument for use as a measure of health outcome

Trial Locations

Locations (76)

Azienda Ospedaliero Universitaria Pisana - Ospedale S. Chiara; 🇮🇹 Pisa, Italy

Azienda Ospedaliera Universitaria Policlinico Tor Vergata; 🇮🇹 Rome, Italy

Korea University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

The Catholic University of Korea Seoul St. Mary'S Hospital; 🇰🇷 Seoul, Korea, Republic of

Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of

Ajou University Hospital; 🇰🇷 Suwon, Korea, Republic of

Diamond Clinic Specjalistyczne Poradnie Lekarskie; 🇵🇱 Krakow, Poland

Dermoklinika Centrum Medyczne S.C., M. Kierstan, J. Narbutt, A. Lesiak; 🇵🇱 Lodz, Poland

Luxderm Specjalistyczny Gabinet Dermatologiczny; 🇵🇱 Lublin, Poland

Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. Z O.O.; 🇵🇱 Malbork, Poland

Solumed Centrum Medyczne; 🇵🇱 Poznan, Poland

Dermaceum Centrum Badan Klinicznych; 🇵🇱 Wroclaw, Poland

Dermmedica Sp. Z O.O.; 🇵🇱 Wroclaw, Poland

Ceim Hospital Universitari Germans Trias I Pujol; 🇪🇸 Badalona, Spain

Hospital Universitario de Gran Canaria Doctor Negrin; 🇪🇸 Las Palmas de Gran Canaria, Spain

Hospital Universitario Ramon Y Cajal; 🇪🇸 Madrid, Spain

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain

Clinica Gaias Santiago; 🇪🇸 Santiago de Compostela, Spain

Dermatology & Skin Care Clinic; 🇨🇭 Buochs, Switzerland

Centre Hospitalier Universitaire Vaudois (Chuv); 🇨🇭 Lausanne, Switzerland

Universitatsspital Zurich; 🇨🇭 Zurich-flughafen, Switzerland

University of Alabama At Birmingham; 🇺🇸 Birmingham, Alabama, United States

Northwest Arkansas Clinical Trials Center; 🇺🇸 Arkansas, Arkansas, United States

Dermatology Research Associates; 🇺🇸 Los Angeles, California, United States

Clinical Science Institute Clinical Research Specialists Inc; 🇺🇸 Santa Monica, California, United States

Cura Clinical Research; 🇺🇸 Sherman Oaks, California, United States

Ars - Maitland Clinical Research Unit; 🇺🇸 Orlando, Florida, United States

Marietta Dermatology the Skin Cancer Center Marietta; 🇺🇸 Marietta, Georgia, United States

The South Bend Clinic Main Campus; 🇺🇸 South Bend, Indiana, United States

Axon Clinical Research; 🇺🇸 Baltimore, Maryland, United States

Activmed Practices Research, Llc Beverly; 🇺🇸 Beverly, Massachusetts, United States

Oakview Dermatology; 🇺🇸 Athens, Ohio, United States

Aventiv Research Inc-Dublin; 🇺🇸 Dublin, Ohio, United States

Wright State Physicians, Inc.; 🇺🇸 Fairborn, Ohio, United States

University of Pittsburgh Medical Center Upmc Dermatology Clinic Oakland Falk Medical Building; 🇺🇸 Pittsburgh, Pennsylvania, United States

Dermdox Center For Dermatology; 🇺🇸 Sugarloaf, Pennsylvania, United States

Dermresearch, Inc.; 🇺🇸 Austin, Texas, United States

Premier Specialists Pty Ltd; 🇦🇺 Kogarah, New South Wales, Australia

Liverpool Hospital; 🇦🇺 Liverpool, New South Wales, Australia

Holdsworth House Medical Practice; 🇦🇺 Sydney, New South Wales, Australia

Westmead Hospital; 🇦🇺 Sydney, New South Wales, Australia

Veracity Clinical Research; 🇦🇺 Woolloongabba, Queensland, Australia

The Alfred Hospital; 🇦🇺 Melbourne, Victoria, Australia

Paratus Clinical Research, Woden; 🇦🇺 Phillip, Australia

Landeskrankenhaus Universitatsklinikum Graz; 🇦🇹 Graz, Austria

Ordensklinikum Linz Gmbh Elisabethinen; 🇦🇹 Linz, Austria

Sozialmedizinisches Zentrum Ost-Donauspital; 🇦🇹 Vienna, Austria

Medical Center Medconsult Pleven Ood; 🇧🇬 Pleven, Bulgaria

Medical Center- Prolet Ltd; 🇧🇬 Ruse, Bulgaria

Medical Center Unimed Eood; 🇧🇬 Sevlievo, Bulgaria

Dcc 'Alexandrovska', Eood; 🇧🇬 Sofia, Bulgaria

Medical Center Hera Eood; 🇧🇬 Sofia, Bulgaria

Umhat Prof. Dr. Stoyan Kirkovich Ad; 🇧🇬 Stara Zagora, Bulgaria

Kingsway Clinical Research; 🇨🇦 Etobicoke, Ontario, Canada

Lynderm Research Inc; 🇨🇦 Markham, Ontario, Canada

North York Research Inc.; 🇨🇦 North York, Ontario, Canada

Skin Centre For Dermatology; 🇨🇦 Peterborough, Ontario, Canada

Diex Recherche Quebec Inc.; 🇨🇦 Quebec, Canada

Herlev Og Gentofte Hospital; 🇩🇰 Hellerup, Denmark

Sjaellands Universitetshospital; 🇩🇰 Roskilde, Denmark

Bordeaux Chu Hopital Saint - Andre; 🇫🇷 Bordeaux, France

Chu Dijon-Bourgogne; 🇫🇷 Dijon, France

Hopital Edouard Herrio; 🇫🇷 Lyon, France

Chu de Nice - Hospital L Archet; 🇫🇷 Nice Cedex 3, France

Centre Hospitalier Universitaire de Poitiers; 🇫🇷 Poitiers Cedex, France

Chu Amiens - Hopital Sud; 🇫🇷 Salouel, France

Klinikum Bielefeld Rosenhohe Dermatologie; 🇩🇪 Bielefeld, Germany

Universitatsklinikum Frankfurt; 🇩🇪 Frankfurt Am Main, Germany

Universitatsmedizin Goettingen; 🇩🇪 Göttingen, Germany

Dermatologische Gemeinschaftspraxis Mahlow; 🇩🇪 Mahlow, Germany

Universitatsklinikum Munster; 🇩🇪 Muenster, Germany

Fondazione Irccs Ca Granda Ospedale Maggiore; 🇮🇹 Milano, Italy

Universita Degli Studi Della Campania Luigi Vanvitelli; 🇮🇹 Napoli, Italy

Azienda Ospedaliera Di Perugia - Ospedale Santa Maria Della Misericordia; 🇮🇹 Perugia, Italy