Clinical trial NCT05755438: A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream in Participants With Prurigo Nodularis (PN)
Official title: A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream in Participants With Prurigo Nodularis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Prurigo
Keywords: Prurigo
Prurigo Nodularis
PN
Skin Diseases
Dermatitis
Eczematous
ruxolitinib
INCB 18424
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2023-03-06
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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% 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.

Primary outcomes:
measure: Worst-Itch Numeric Rating Scale (WI-NRS) ≥ 4-point improvement in WI-NRS score Response
timeFrame: Week 12
Secondary outcomes:
measure: WI-NRS4 Response
timeFrame: Week 4
measure: Overall Treatment Success (TS)
timeFrame: Week 12
measure: IGA-CPG-S-TS
timeFrame: Week 12
measure: WI-NRS4 Response
timeFrame: Day 7
measure: Proportion of participants with WI-NRS4 at each postbaseline visit.
timeFrame: Up to 52 weeks
measure: Change from baseline in WI-NRS score
timeFrame: Up to 52 weeks
measure: Time to ≥ 2-point improvement from baseline in WI-NRS score
timeFrame: Up to 52 weeks
measure: Time to ≥ 4-point improvement from baseline in WI-NRS score
timeFrame: Up to 52 weeks
measure: Skin pain response, defined as a ≥ 2-point improvement in Skin Pain NRS score
timeFrame: Up to 52 weeks
measure: Change from baseline in Skin Pain NRS score
timeFrame: Up to 52 weeks
measure: IGA-TS response, defined as achieving IGA TS at each postbaseline visit.
timeFrame: Up to 56 weeks
measure: IGA-CPG-A 0 or 1 response, defined as achieving an IGA score of 0 or 1 at each postbaseline visit.
timeFrame: Up to 56 weeks
measure: > 75% healed lesions from baseline in PAS at each postbaseline visit.
timeFrame: Up to 56 weeks
measure: Number of Treatment-emergent adverse events (TEAEs)
timeFrame: Up to 56 weeks
measure: Change from baseline in Dermatology Life Quality Index (DLQI) score at each postbaseline visit.
timeFrame: Up to 56 weeks
measure: Change from baseline in EQ-5D-5L score at each postbaseline visit.
timeFrame: Up to 56 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Medical Dermatology Specialists Phoenix
state: Arizona
city: Fort Smith
country: United States
facility: Johnson Dermatology
state: Arkansas
city: Fountain Valley
country: United States
facility: First Oc Dermatology
state: California
city: Rockville
country: United States
facility: Dermatology Associates Pc
state: Maryland
city: Clarkston
country: United States
facility: Clarkston Medical Group
state: Michigan
city: Troy
country: United States
facility: Revival Research Institute, Llc Troy
state: Michigan
city: Saint Joseph
country: United States
facility: Medisearch Clinical Trials
state: Missouri
city: Winston-Salem
country: United States
facility: Wake Forest University
state: North Carolina
city: Cincinnati
country: United States
facility: UC Health, Llc
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Norman
country: United States
facility: Central Sooner Research
state: Oklahoma
city: Plymouth Meeting
country: United States
facility: Dermatology Associates of Plymouth Meeting
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Murfreesboro
country: United States
facility: International Clinical Research Tennessee Llc
state: Tennessee
city: Frisco
country: United States
facility: North Texas Center For Clinical Research Ntccr
state: Texas
city: Pflugerville
country: United States
facility: Austin Institute For Clinical Research Aicr Pflugerville
state: Texas
city: Webster
country: United States
facility: Center For Clinical Studies
state: Texas
city: Spokane
country: United States
facility: Premier Clinical Research
state: Washington
city: Buenos Aires
country: Argentina
facility: Conexa Investigacion Clinica S.A.
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Cedic Centro de Investigaciones Clinicas
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Buenos Aires Skin
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Psoriahue-Medicina Interdisciplinar
city: Mar Del Plata
country: Argentina
facility: Centro de Investigaciones Medicas Mar Del Plata
city: Mendoza
country: Argentina
facility: Fundacion Scherbovsky
city: Rosario
country: Argentina
facility: Instituto de Especialidades de La Salud Rosario
city: San Miguel de Tucuman
country: Argentina
facility: Centro de Investigaciones Medicas Tucuman
city: Brussels
country: Belgium
facility: Cliniques Universitaires Ucl Saint-Luc
city: Bruxelles
country: Belgium
facility: Ulb Hospital Erasme
city: Gent
country: Belgium
facility: Az Sint-Lucas
city: Ghent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis (Uz) Leuven
city: Liege
country: Belgium
facility: Centre Hospitalier Universitaire de Liege - Sart Tilman
city: Namur
country: Belgium
facility: Chu Ucl Namur de Saint Elisabeth
city: Calgary
country: Canada
facility: Beacon Dermatology
state: Alberta
city: Barrie
country: Canada
facility: Simcomed Health Ltd
state: Ontario
city: London
country: Canada
facility: Dermeffects
state: Ontario
city: Toronto
country: Canada
facility: Research Toronto
state: Ontario
city: Quebec
country: Canada
facility: Centre de Recherche Saint-Louis
city: Las Condes
country: Chile
facility: Centro Medico Skinmed
city: Santiago
country: Chile
facility: Ciec - Centro Internacional de Estudios Cli-Nicos
city: Valdivia
country: Chile
facility: Clinical Research Chile Spa.
city: Antony
country: France
facility: Hospital Prive D'Antony
city: Brest Cedex 2
country: France
facility: Hospital Morvan
city: Nantes
country: France
facility: Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu
city: Saint-etienne Cedex 2
country: France
facility: University Hospital of Saint Etienne
city: Aachen
country: Germany
facility: University Medical Center Rwth Aachen
city: Bad Bentheim
country: Germany
facility: Fachklinik Bad Bentheim Dermatologie
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus Tu Dresden
city: Kiel
country: Germany
facility: Universitatsklinikum Schleswig Holstein
city: Mainz
country: Germany
facility: Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
city: Tuebingen
country: Germany
facility: Universitats-Hautklink Tubingen
city: Witten
country: Germany
facility: Hautarztpraxis Dr. Med. Matthias Hoffmann
city: Brescia
country: Italy
facility: Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia (Presidio Spedali Civili)
city: Catania
country: Italy
facility: Azienda Ospedaliero Universitaria Policlinico G.Rodolico San Marco
city: Coppito
country: Italy
facility: Asl 1 Avezzano L'Aquila Sulmona- Ospedale Regionale San Salvatore
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico 'Federico Ii'
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli Irccs
city: Torrette
country: Italy
facility: Ospedali Riuniti Di Ancona
city: Amsterdam
country: Netherlands
facility: Amsterdam University Medical Centre
city: Bergen Op Zoom
country: Netherlands
facility: Bravis Ziekenhuis
city: Krakow
country: Poland
facility: Pratia McM Krakow
city: Lodz
country: Poland
facility: ETG LODZ
city: Rzeszow
country: Poland
facility: Kliniczny Szpital Wojewodzki Nr 1
city: Warszawa
country: Poland
facility: Clinical Research Group Sp. Z.O.O
city: Warszawa
country: Poland
facility: High-Med Przychodnia Specjalistycza
city: Warszawa
country: Poland
facility: Centralny Szpital Kliniczny Mswia
city: Alicante
country: Spain
facility: Hospital General Unviersitario de Alicante
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia
city: Manises
country: Spain
facility: Hospital de Manises
city: Pozuelo de Alarcon
country: Spain
facility: Hospital Universitario Quironsalud Madrid
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago
Study officials:
affiliation: Incyte Corporation
name: Haq Nawaz, md
role: STUDY_DIRECTOR
References: