Clinical trial NCT06516952: A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis (STOP-PN1)
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Prurigo Nodularis
Keywords: Prurigo nodularis
PN
INCB054707
chronic pruritus
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2024-07-24
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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 effect of povorcitinib on itch and skin lesions in participants with prurigo nodularis.


Eligibility criteria: Inclusion Criteria:

* Male and female participants 18 to 75 years of age.
* Clinical diagnosis of PN for at least 3 months prior to Screening visit.
* Pruritus, defined as an average Itch NRS score ≥ 7 during the 7 days prior to Day 1/Baseline.
* Total of ≥ 20 pruriginous lesions on ≥ 2 different body regions (both legs, and/or both arms, and/or trunk) at Screening and Day 1/Baseline.
* Documented history of treatment failure, demonstrated intolerance, or contraindication to a previous PN treatment.
* Willingness to avoid pregnancy or fathering children.

Exclusion Criteria:

* Chronic pruritus due to a condition other than PN or neuropathic and psychogenic pruritus.
* Diagnosis of PN secondary to medications.
* Active AD lesions (signs and symptoms other than dry skin) within 3 months prior to Screening visit.
* Women who are pregnant (or are considering pregnancy) or breastfeeding.
* Medical history including thrombocytopenia, coagulopathy or platelet dysfunction; venous and arterial thrombosis, deep vein thrombosis, pulmonary embolism, stroke, moderate to severe heart failure, cerebrovascular accident, myocardial infarction, or other significant cardiovascular diseases; Q-wave interval abnormalities; disseminated herpes zoster or dermatomal herpes zoster; disseminated herpes simplex; chronic/recurrent infections; malignancies.
* Evidence of infection with TB, HBV, HCV or HIV.
* History of failure to any topical or systemic JAK or TYK2 inhibitor as treatment of PN or any inflammatory disease.
* Laboratory values outside of the protocol-defined ranges.

Other protocol-defined Inclusion/Exclusion Criteria apply.

Primary outcomes:
measure: Proportion of participants achieving Itch NRS4 and IGA-CPG-S-TS at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: Proportion of participants achieving Itch NRS4 at Week 24
timeFrame: Week 24
measure: Proportion of participants achieving IGA-CPG-S-TS at Week 24
timeFrame: Week 24
measure: Proportion of participants achieving Itch NRS4 at Week 4
timeFrame: Week 4
measure: Time to Itch NRS4
timeFrame: Up to 52 weeks
measure: Change from baseline in Itch NRS score at each postbaseline visit
timeFrame: Up to 52 weeks
measure: Percent change from baseline in NRS score at each postbaseline visit
timeFrame: Up to 52 weeks
measure: Proportion of participants achieving Itch NRS4 at each postbaseline visit
timeFrame: Up to 52 weeks
measure: Proportion of participants achieving IGA-CPG-S-TS at each postbaseline visit
timeFrame: Up to 52 weeks
measure: Proportion of participants achieving Investigator's Global Assessment - Chronic Prurigo Activity (IGA-CPG-A) at each postbaseline visit
timeFrame: Up to 52 weeks
measure: Proportion of participants achieving ≥ 75% healed lesions in Prurigo Activity Score (PAS) at each postbaseline visit
timeFrame: Up to 52 weeks
measure: Proportion of participants achieving Itch NRS4 and IGA-CPG-S-TS at each postbaseline visit
timeFrame: Up to 52 weeks
measure: Change from baseline in Dermatology Life Quality Index (DLQI) score at each postbaseline visit.
timeFrame: Up to 52 weeks
measure: Percent change from baseline in Dermatology Life Quality Index (DLQI) score at each postbaseline visit.
timeFrame: Up to 52 weeks
measure: Proportion of participants with at least a 4-point decrease in DLQI score from baseline at each postbaseline visit for participants with DLQI score ≥ 4 at baseline
timeFrame: Up to 52 weeks
measure: Change from baseline in Skin Pain NRS score at each postbaseline visit
timeFrame: Up to 52 weeks
measure: Percent change from baseline in Skin Pain NRS score at each postbaseline visit
timeFrame: Up to 52 weeks
measure: Change from baseline in the Hospital Anxiety and Depression Scale (HADS) score at each postbasline visit
timeFrame: Up to 52 weeks
measure: Percent change from baseline in the HADS score at each postbaseline visit
timeFrame: Up to 52 weeks
measure: Change from baseline in EQ-5D-5L score at each postbaseline visit
timeFrame: Up to 52 weeks
measure: Percent change from baseline in EQ-5D-5L score at each postbaseline visit
timeFrame: Up to 52 weeks
measure: Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) score at each postbaseline visit
timeFrame: Up to 52 weeks
measure: Percent change in FACIT-F score at each postbaseline visit
timeFrame: Up to 52 weeks
measure: Proportion of participants with at least a ≥ 4-point increase in FACIT-F score at each postbaseline visit for participants with FACIT-F score ≤ 48 at baseline
timeFrame: Up to 52 weeks
measure: Number of Participants with Treatment Emergent Adverse Events (TEAE)
timeFrame: Up to 52 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cahaba Dermatology
state: Alabama
city: Tucson
country: United States
facility: Banner - University Medicine Multispecialty Services Clinic
state: Arizona
city: Fayetteville
country: United States
facility: Premier Dermatology Clinical Trials Institute At Northwest Arkansas
state: Arkansas
city: Hot Springs
country: United States
facility: Burke Pharmaceutical Research
state: Arkansas
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Northridge
country: United States
facility: Northridge
state: California
city: Boca Raton
country: United States
facility: Rendon Center the Dermatology and Aesthetic Center
state: Florida
city: Coral Gables
country: United States
facility: Driven Research Llc
state: Florida
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
city: Tampa
country: United States
facility: Alliance Clinical Research Tampa
state: Florida
city: West Palm Beach
country: United States
facility: Research Institute of the Southeast, Llc
state: Florida
city: Chicago
country: United States
facility: Illinois Dermatology Institute the Chicago Loop
state: Illinois
city: Chicago
country: United States
facility: Chicago Cosmetic Surgery and Dermatology
state: Illinois
city: Chicago
country: United States
facility: Center For Medical Dermatology and Immunology Research
state: Illinois
city: Skokie
country: United States
facility: Northshore University Healthsystem
state: Illinois
city: Clarksville
country: United States
facility: Dermatology Specialists Research Ds Research Indiana Location
state: Indiana
city: Baton Rouge
country: United States
facility: Velocity Clinical Research At the Dermatology Clinic
state: Louisiana
city: Auburn Hills
country: United States
facility: Oakland Hills Dermatology
state: Michigan
city: Fort Gratiot
country: United States
facility: Hamzavi Dermatology
state: Michigan
city: Troy
country: United States
facility: Somerset Skin Centre
state: Michigan
city: Saint Joseph
country: United States
facility: Medisearch Clinical Trials
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Albuquerque
country: United States
facility: The University of New Mexico Unm Health Sciences Center Hsc
state: New Mexico
city: East Syracuse
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: Skin Center Dermatology Group
state: New York
city: Stony Brook
country: United States
facility: Stony Brook Dermatology Associates
state: New York
city: Dayton
country: United States
facility: Wright State Physicians Health Center
state: Ohio
city: Dublin
country: United States
facility: Centricity Research Aventiv Research Dublin
state: Ohio
city: Camp Hill
country: United States
facility: Dermdox Dermatology Centers, Pc
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center Upmc Dermatology Clinic Oakland Falk Medical Building
state: Pennsylvania
city: Anderson
country: United States
facility: Palmetto Clinical Trial Services
state: South Carolina
city: Murfreesboro
country: United States
facility: International Clinical Research Tennessee Llc
state: Tennessee
city: Dallas
country: United States
facility: Dermatology Treatment and Research Center
state: Texas
city: Sugar Land
country: United States
facility: Sweetwater Dermatology
state: Texas
city: Webster
country: United States
facility: Center For Clinical Studies
state: Texas
city: Mill Creek
country: United States
facility: Frontier Dermatology
state: Washington
city: Buenos Aires
country: Argentina
facility: Instituto de Neumonologia Y Dermatologia
city: Buenos Aires
country: Argentina
facility: Instituto de Investigaciones En Alergia Y Enfermedades Respiratorias (Inaer)
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Conexa Investigacion Clinica S.A.
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Buenos Aires Skin (Bas)
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Cedic - Consultorios Medicos
city: Mar Del Plata
country: Argentina
facility: Centro de Investigaciones Medicas Mar Del Plata
city: Rosario
country: Argentina
facility: Instituto Especialidades de La Salud Rosario - Clinica Del Torax
city: San Miguel de Tucuman
country: Argentina
facility: Investigaciones Reumatologicas Tucuman S.R.L.
city: Graz
country: Austria
facility: Medical University Graz University Clinic For Dermatology and Venerology
city: Wien
country: Austria
facility: Wiener Krankenanstaltenverbund, Krankenhaus Hietzing Mit Neurologischem Zentrum Rosenhugel
city: Gent
country: Belgium
facility: Az Sint-Lucas
city: Gent
country: Belgium
facility: UZ GENT
city: Liege
country: Belgium
facility: Centre Hospitalier Universitaire de Liege - Sart Tilman
city: Woluwe-saint-lambert
country: Belgium
facility: Cliniques Universitaires Ucl Saint-Luc
city: Lovech
country: Bulgaria
facility: Medical Center Medconsult Pleven
city: Pleven
country: Bulgaria
facility: Medconsult Pleven
city: Plovdiv
country: Bulgaria
facility: Diagnostic-Consultative Centre Pulmed Eood
city: Ruse
country: Bulgaria
facility: Medical Center Prolet Eood
city: Sevlievo
country: Bulgaria
facility: Medical Center Unimed Eood
city: Sofia
country: Bulgaria
facility: Diagnostic-Consultative Center Ascendent Eood
city: Sofia
country: Bulgaria
facility: Diagnostic-Consultative Center Aleksandrovska Eood
city: Edmonton
country: Canada
facility: Rao Dermatology
state: Alberta
city: Cobourg
country: Canada
facility: Skin Health
state: Ontario
city: London
country: Canada
facility: Centricity Research London Victoria Multispecialty
state: Ontario
city: London
country: Canada
facility: Dermeffects
state: Ontario
city: Toronto
country: Canada
facility: North York Research Inc.
state: Ontario
city: Quebec City
country: Canada
facility: Centre de Recherche Dermatologique de Quebec
state: Quebec
city: Verdun
country: Canada
facility: Sima Recherche
state: Quebec
city: Antony
country: France
facility: Hopital Prive D Antony
city: Brest
country: France
facility: Hospital Morvan
city: Martigues
country: France
facility: Cabinet Medical- Chemin de Paradis
city: Mulhouse
country: France
facility: Ghrmsa Hopital Emile Muller
city: Nantes
country: France
facility: Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hopital Hotel Dieu
city: Paris
country: France
facility: Chu Paris-Gh St-Louis Lariboisiere F.Widal Hopital Saint-Louis
city: Romans Sur Isere
country: France
facility: Hopitaux Drome Nord - Site de Romans Sur Isere
city: Toulouse
country: France
facility: Hopital Larrey
city: Aachen
country: Germany
facility: Aachen University Hospital
city: Bad Bentheim
country: Germany
facility: Fachklinik Bad Bentheim
city: Berlin
country: Germany
facility: Hautzentrum Friedrichshain Studien
city: Berlin
country: Germany
facility: Charite Universitatsmedizin Berlin
city: Dortmund
country: Germany
facility: Klinikum Dortmund Ggmbh
city: Gottingen
country: Germany
facility: Universitaetsmedizin Goettingen
city: Halle
country: Germany
facility: Universitaetsklinik Und Poliklinik Fuer Dermatologie Und Venerologie
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf
city: Heidelberg
country: Germany
facility: Universitatsklinik Heidelberg
city: Leipzig
country: Germany
facility: Universitaetsklinikum Leipzig
city: Luebeck
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein (Uksh) - Campus Luebeck
city: Mainz
country: Germany
facility: Universitaetsmedizin Der Johannes - Gutenberg Universitaet Mainz
city: Marburg
country: Germany
facility: Universitaetsklinikum Giessen Und Marburg Gmbh
city: Tuebingen
country: Germany
facility: Universitaets-Hautklinik Eberhard-Karls-Universitaet Tuebingen
city: Bari
country: Italy
facility: University of Bari Policlinico
city: Catania
country: Italy
facility: Azienda Ospedaliero-Universitaria Policlinico Vittorio Emanuele Ospedale Gaspare Rodolico Di Catania
city: Chieti
country: Italy
facility: Clinical Research Centre - Cast
city: Firenze
country: Italy
facility: Presidio Ospedaliero Firenze Centro Piero Palagi
city: L'aquila
country: Italy
facility: Azienda Sanitaria Locale 1 (Asl 1) - Ospedale Regionale San Salvatore
city: Milano
country: Italy
facility: Uoc Dermatologia Ospedale Maggiore Policlinico, Fondazione Irccs Ca' Granda
city: Napoli
country: Italy
facility: Aou Universita Della Campania Luigi Vanvitelli, Azienda Ospedaliero Universitaria Federico Ii Di Nap
city: Perugia
country: Italy
facility: Azienda Ospedaliera Di Perugia
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana - Ospedale S. Chiara
city: Rome
country: Italy
facility: Catholic University of the Sacred Heart
city: Rozzano
country: Italy
facility: Irccs Istituto Clinico Humanitas
city: Ansan-si
country: Korea, Republic of
facility: Korea University Ansan Hospital
city: Bucheon-si
country: Korea, Republic of
facility: Soon Chun Hyang University Bucheon Hospital
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital (Pnuh)
city: Incheon
country: Korea, Republic of
facility: The Catholic University of Korea, Incheon St. Mary'S Hospital
city: Jeonju-si
country: Korea, Republic of
facility: Jeonbuk National University Hospital
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital (Snubh)
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Hanyang University Seoul Hospital
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Seoul Hospital
city: Yangsan-si
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
city: Amsterdam
country: Netherlands
facility: Amsterdam Umc Research Bv
city: Veldhoven
country: Netherlands
facility: Maxima Medisch Centrum
city: Bialystok
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej Specjalistyczny Osrodek Dermatologiczny Dermal
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Grodzisk Mazowiecki
country: Poland
facility: Mazowieckie Centrum Badan Klinicznych
city: Katowice
country: Poland
facility: Gyncentrum Sp. Z O.O., Nzoz Holsamed- Oddzial Libero
city: Katowice
country: Poland
facility: Pro Familia Altera Sp. Z O.O.
city: Kraków
country: Poland
facility: Centrum Badan Klinicznych, Jagiellonskie Centrum Innowacji Sp.Z.O.O.
city: Lublin
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej Med-Laser
city: Lublin
country: Poland
facility: Luxderm Specjalistyczny Gabinet Dermatologiczny Prof. Dr. Hab. N. Med. Dorota Krasowska
city: Ostrowiec Swietokrzyski
country: Poland
facility: Dermedic Jacek Zdybski
city: Szczecin
country: Poland
facility: Laser Clinic
city: Torun
country: Poland
facility: Mics Centrum Medyczne Torun
city: Warsaw
country: Poland
facility: Centrum Medyczne Evimed
city: Warszawa
country: Poland
facility: Clinical Research Group Sp. Z.O.O
city: Warszawa
country: Poland
facility: High-Med. Przychodnia Specjalistyczna
city: Warszawa
country: Poland
facility: Panstwowy Instytut Medyczny Mswia
city: Warszawa
country: Poland
facility: Klinika Ambroziak Sp. Z O.O.
city: Wrocaw
country: Poland
facility: Emc Instytut Medyczny Spolka Akcyjna-Euromedicare Szpital Specjalistyczny Z Przychodnia
city: Wroclaw
country: Poland
facility: Dermaceum Centrum Badan Klinicznych
city: Wroclaw
country: Poland
facility: Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spolka Partnerska
city: Valencia
country: Spain
facility: Hospital Universitari I Politecnic La Fe de Valencia - Instituto de Investigacion Sanitaria La Fe (I
city: Basel
country: Switzerland
facility: Felix Platter Spital
city: Basel
country: Switzerland
facility: Felix Platter Spital
city: Bern
country: Switzerland
facility: Inselspital Bern
city: Buochs
country: Switzerland
facility: Dsc Clinic Buochs
city: Zurich
country: Switzerland
facility: Universitatsspital Zurich
Study officials:
affiliation: Incyte Corporation
name: Incyte Medical Monitor
role: STUDY_DIRECTOR
References: