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

Prurigo Clinical Trial

— TRuE-PN1  

Official title:

A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream in Participants With Prurigo Nodularis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05755438
• Other study ID #: INCB 18424-319
• Status: Recruiting
• Phase: Phase 3
• Start date: March 10, 2023
• Est. completion date: December 3, 2025

Study information

• Verified date: April 2024
• Source: Incyte Corporation
• Contact: Incyte Corporation Call Center (US)
• Phone: 1.855.463.3463
• Email: medinfo[@]incyte.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 3, 2025
• Est. primary completion date: August 7, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prurigo

Intervention

Drug:
• Ruxolitinib Cream
Ruxolitinib cream 1.5% twice daily (BID) during the vehicle controlled (DBVC)and open label treatment period (OLE).
• Vehicle Cream
Ruxolitinib matching vehicle cream 1.5% twice daily (BID) during the vehicle controlled period (DBVC).

Locations

Country	Name	City	State
Argentina	Conexa Investigacion Clinica S.A.	Buenos Aires
Argentina	Buenos Aires Skin	Ciudad Autonoma Buenos Aires
Argentina	Cedic Centro de Investigaciones Clinicas	Ciudad Autonoma Buenos Aires
Argentina	Psoriahue-Medicina Interdisciplinar	Ciudad Autonoma Buenos Aires
Argentina	Centro de Investigaciones Medicas Mar Del Plata	Mar Del Plata
Argentina	Fundacion Scherbovsky	Mendoza
Argentina	Instituto de Especialidades de La Salud Rosario	Rosario
Argentina	Centro de Investigaciones Medicas Tucuman	San Miguel de Tucuman
Belgium	Cliniques Universitaires Ucl Saint-Luc	Brussels
Belgium	Ulb Hospital Erasme	Bruxelles
Belgium	Az Sint-Lucas	Gent
Belgium	Universitair Ziekenhuis Gent	Ghent
Belgium	Universitair Ziekenhuis (Uz) Leuven	Leuven
Belgium	Centre Hospitalier Universitaire de Liege - Sart Tilman	Liege
Belgium	Chu Ucl Namur de Saint Elisabeth	Namur
Brazil	Pesquisare Saude	Santo André
Canada	Simcomed Health Ltd	Barrie	Ontario
Canada	Beacon Dermatology	Calgary	Alberta
Canada	Dermeffects	London	Ontario
Canada	Centre de Recherche Saint-Louis	Quebec
Canada	Research Toronto	Toronto	Ontario
Chile	Centro Medico Skinmed	Las Condes
Chile	Ciec - Centro Internacional de Estudios Cli-Nicos	Santiago
Chile	Clinical Research Chile Spa.	Valdivia
France	Hospital Prive D'Antony	Antony
France	Hospital Morvan	Brest Cedex 2
France	Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu	Nantes
France	University Hospital of Saint Etienne	Saint-etienne Cedex 2
Germany	University Medical Center Rwth Aachen	Aachen
Germany	Fachklinik Bad Bentheim Dermatologie	Bad Bentheim
Germany	Universitaetsklinikum Carl Gustav Carus Tu Dresden	Dresden
Germany	Universitatsklinikum Schleswig Holstein	Kiel
Germany	Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii	Mainz
Germany	Universitats-Hautklink Tubingen	Tuebingen
Germany	Hautarztpraxis Dr. Med. Matthias Hoffmann	Witten
Italy	Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia (Presidio Spedali Civili)	Brescia
Italy	Azienda Ospedaliero Universitaria Policlinico G.Rodolico San Marco	Catania
Italy	Asl 1 Avezzano L'Aquila Sulmona- Ospedale Regionale San Salvatore	Coppito
Italy	Azienda Ospedaliera Universitaria Policlinico 'Federico Ii'	Napoli
Italy	Fondazione Policlinico Universitario Agostino Gemelli Irccs	Roma
Italy	Irccs Istituto Clinico Humanitas	Rozzano
Italy	Ospedali Riuniti Di Ancona	Torrette
Netherlands	Amsterdam University Medical Centre	Amsterdam
Netherlands	Bravis Ziekenhuis	Bergen Op Zoom
Poland	Pratia McM Krakow	Krakow
Poland	ETG LODZ	Lodz
Poland	Kliniczny Szpital Wojewodzki Nr 1	Rzeszow
Poland	Centralny Szpital Kliniczny Mswia	Warszawa
Poland	Clinical Research Group Sp. Z.O.O	Warszawa
Poland	High-Med Przychodnia Specjalistycza	Warszawa
Spain	Hospital General Unviersitario de Alicante	Alicante
Spain	Hospital Universitario Reina Sofia	Cordoba
Spain	Hospital de Manises	Manises
Spain	Hospital Universitario Quironsalud Madrid	Pozuelo de Alarcon
Spain	Complejo Hospitalario Universitario de Santiago	Santiago de Compostela
United States	Medical University of South Carolina	Charleston	South Carolina
United States	UC Health, Llc	Cincinnati	Ohio
United States	Clarkston Medical Group	Clarkston	Michigan
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Johnson Dermatology	Fort Smith	Arkansas
United States	First Oc Dermatology	Fountain Valley	California
United States	North Texas Center For Clinical Research Ntccr	Frisco	Texas
United States	International Clinical Research Tennessee Llc	Murfreesboro	Tennessee
United States	Central Sooner Research	Norman	Oklahoma
United States	Austin Institute For Clinical Research Aicr Pflugerville	Pflugerville	Texas
United States	Medical Dermatology Specialists Phoenix	Phoenix	Arizona
United States	Dermatology Associates of Plymouth Meeting	Plymouth Meeting	Pennsylvania
United States	Dermatology Associates Pc	Rockville	Maryland
United States	Medisearch Clinical Trials	Saint Joseph	Missouri
United States	Premier Clinical Research	Spokane	Washington
United States	Revival Research Institute, Llc Troy	Troy	Michigan
United States	Center For Clinical Studies	Webster	Texas
United States	Wake Forest University	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Brazil,  Canada,  Chile,  France,  Germany,  Italy,  Netherlands,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Worst-Itch Numeric Rating Scale (WI-NRS) = 4-point improvement in WI-NRS score Response	Defined as achieving a = 4-point improvement (reduction) in Worst Itch Numeric Rating Scale (WI-NRS) score from baseline.	Week 12
Secondary	WI-NRS4 Response	Defined as achieving a = 4-point improvement (reduction) in WI-NRS score from baseline.	Week 4
Secondary	Overall Treatment Success (TS)	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).	Week 12
Secondary	IGA-CPG-S-TS	Defined as an IGA-CPG-S score of 0 or 1 with a = 2 grade improvement from baseline	Week 12
Secondary	WI-NRS4 Response	Defined as achieving a = 4-point improvement (reduction) in WI-NRS score from baseline.	Day 7
Secondary	Proportion of participants with WI-NRS4 at each postbaseline visit.	Defined as percentage of participants that achieve a = 4-point improvement in WI-NRS score	Up to 52 weeks
Secondary	Change from baseline in WI-NRS score	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".	Up to 52 weeks
Secondary	Time to = 2-point improvement from baseline in WI-NRS score	Participants rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus)	Up to 52 weeks
Secondary	Time to = 4-point improvement from baseline in WI-NRS score	Defined as time taken for the participant to achieve a =4 improvement in NRS scale compared to baseline	Up to 52 weeks
Secondary	Skin pain response, defined as a = 2-point improvement in Skin Pain NRS score	Itch NRS is an 11-point scale (0 to10) where 0 is "no itch" and 10 is the "worst itch imaginable".	Up to 52 weeks
Secondary	Change from baseline in Skin Pain NRS score	Itch NRS is an 11-point scale (0 to10) where 0 is "no itch" and 10 is the "worst itch imaginable".	Up to 52 weeks
Secondary	IGA-TS response, defined as achieving IGA TS at each postbaseline visit.	The IGA for chronic prurigo nodularis considers the number of nodules, also referred to as lesions, and uses them to determine an overall severity rating on on a 5-point scale ranging from 0 (clear skin) to 4 (severe).	Up to 56 weeks
Secondary	IGA-CPG-A 0 or 1 response, defined as achieving an IGA score of 0 or 1 at each postbaseline visit.	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 score is based on an overall assessment of the degree of erythema, induration/papulation, and oozing/crusting.	Up to 56 weeks
Secondary	> 75% healed lesions from baseline in PAS at each postbaseline visit.	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.	Up to 56 weeks
Secondary	Number of Treatment-emergent adverse events (TEAEs)	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.	Up to 56 weeks
Secondary	Change from baseline in Dermatology Life Quality Index (DLQI) score at each postbaseline 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	Up to 56 weeks
Secondary	Change from baseline in EQ-5D-5L score at each postbaseline visit.	The EQ-5D-5L questionnaire is a standardized, validated instrument for use as a measure of health outcome	Up to 56 weeks