A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis (STOP-PN1)
- Registration Number
- NCT06516952
- Lead Sponsor
- Incyte Corporation
- Brief Summary
The purpose of this study is to evaluate effect of povorcitinib on itch and skin lesions in participants with prurigo nodularis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 330
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo at the protocol-defined dose. Povorcitinib Dose 1 Povorcitinib Povorcitinib at the protocol-defined dose. Povorcitinib Dose 2 Povorcitinib Povorcitinib at the protocol-defined dose.
- Primary Outcome Measures
Name Time Method Proportion of participants achieving Itch NRS4 and IGA-CPG-S-TS at Week 24 Week 24 Defined as proportion of participants achieving a ≥ 4-point improvement \[reduction\] in Itch NRS score from baseline (Itch NRS4) and an IGA CPG-S score of 0 or 1 with a ≥ 2-grade improvement from baseline (IGA-CPG-S-TS).
- Secondary Outcome Measures
Name Time Method Change from baseline in Skin Pain NRS score at each postbaseline visit Up to 52 weeks Skin Pain NRS is an 11-point scale (0 to10) where 0 is "no pain" and 10 is the "worst pain imaginable".
Change from baseline in EQ-5D-5L score at each postbaseline visit Up to 52 weeks The EQ-5D-5L questionnaire is a standardized, validated instrument for use as a measure of health outcome.
Time to Itch NRS4 Up to 52 weeks Defined as time taken for the participant to achieve a ≥4 improvement in Itch NRS score from baseline.
Proportion of participants achieving Itch NRS4 at Week 24 Week 24 Defined as percentage of participants that achieve a ≥ 4-point improvement (reduction) in Itch NRS score from baseline.
Proportion of participants achieving IGA-CPG-S-TS at Week 24 Week 24 Defined as percentage of participants that achieve IGA-CPG-S score of 0 or 1 with a ≥ 2 grade improvement from baseline.
Proportion of participants achieving Itch NRS4 at Week 4 Week 4 Defined as percentage of participants that achieve a ≥ 4-point improvement (reduction) in Itch NRS score from baseline.
Change from baseline in Itch NRS score at each postbaseline visit Up to 52 weeks 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".
Proportion of participants achieving IGA-CPG-S-TS at each postbaseline visit Up to 52 weeks Defined as percentage of participants that achieve an IGA-CPG-S score of 0 or 1 with a ≥ 2 grade improvement from baseline.
Proportion of participants achieving Itch NRS4 and IGA-CPG-S-TS at each postbaseline visit Up to 52 weeks Defined as percentage of participants that achieve a ≥ 4-point improvement (reduction) in Itch NRS score and IGA-CPG-S score of 0 or 1 with a ≥ 2-grade improvement from baseline.
Change from baseline in Dermatology Life Quality Index (DLQI) score at each postbaseline visit. Up to 52 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.
Percent change from baseline in the HADS score at each postbaseline visit Up to 52 weeks HADS is a 14-item questionnaire that assesses the levels of anxiety and depression that a participant is currently experiencing. There are 7 questions each for measuring anxiety and for measuring depression, with 4 possible responses to each question (responses are scored as 0, 1, 2, or 3).
Percent change from baseline in EQ-5D-5L score at each postbaseline visit Up to 52 weeks The EQ-5D-5L questionnaire is a standardized, validated instrument for use as a measure of health outcome.
Percent change in FACIT-F score at each postbaseline visit Up to 52 weeks The FACIT-F is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function over the past 7 days.
Percent change from baseline in NRS score at each postbaseline visit Up to 52 weeks 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".
Proportion of participants achieving Itch NRS4 at each postbaseline visit Up to 52 weeks Defined as percentage of participants that achieve a ≥ 4-point improvement in Itch NRS score from baseline.
Proportion of participants achieving Investigator's Global Assessment - Chronic Prurigo Activity (IGA-CPG-A) at each postbaseline visit Up to 52 weeks Defined as percentage of participants that achieve an IGA-CPG-A score of 0 or 1 with a ≥ 2 grade improvement (reduction) from baseline.
Proportion of participants achieving ≥ 75% healed lesions in Prurigo Activity Score (PAS) at each postbaseline visit Up to 52 weeks The modified PAS will be used in this study as defined by the protocol.
Percent change from baseline in Dermatology Life Quality Index (DLQI) score at each postbaseline visit. Up to 52 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.
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 Up to 52 weeks Defined as percentage 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.
Percent change from baseline in Skin Pain NRS score at each postbaseline visit Up to 52 weeks Skin Pain NRS is an 11-point scale (0 to10) where 0 is "no pain" and 10 is the "worst pain imaginable".
Change from baseline in the Hospital Anxiety and Depression Scale (HADS) score at each postbasline visit Up to 52 weeks HADS is a 14-item questionnaire that assesses the levels of anxiety and depression that a participant is currently experiencing. There are 7 questions each for measuring anxiety and for measuring depression, with 4 possible responses to each question (responses are scored as 0, 1, 2, or 3).
Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) score at each postbaseline visit Up to 52 weeks The FACIT-F is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function over the past 7 days.
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 Up to 52 weeks The FACIT-F is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function over the past 7 days.
Number of Participants with Treatment Emergent Adverse Events (TEAE) Up to 52 weeks Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.
Related Research Topics
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Trial Locations
- Locations (134)
Medconsult Pleven
🇧🇬Pleven, Bulgaria
Centrum Medyczne Evimed
🇵🇱Warsaw, Poland
Cahaba Dermatology
🇺🇸Birmingham, Alabama, United States
Banner - University Medicine Multispecialty Services Clinic
🇺🇸Tucson, Arizona, United States
Premier Dermatology Clinical Trials Institute At Northwest Arkansas
🇺🇸Fayetteville, Arkansas, United States
Burke Pharmaceutical Research
🇺🇸Hot Springs, Arkansas, United States
Dermatology Research Associates
🇺🇸Los Angeles, California, United States
Northridge
🇺🇸Northridge, California, United States
Rendon Center the Dermatology and Aesthetic Center
🇺🇸Boca Raton, Florida, United States
Driven Research Llc
🇺🇸Coral Gables, Florida, United States
University of Miami Miller School of Medicine
🇺🇸Miami, Florida, United States
Alliance Clinical Research Tampa
🇺🇸Tampa, Florida, United States
Research Institute of the Southeast, Llc
🇺🇸West Palm Beach, Florida, United States
Illinois Dermatology Institute the Chicago Loop
🇺🇸Chicago, Illinois, United States
Chicago Cosmetic Surgery and Dermatology
🇺🇸Chicago, Illinois, United States
Center For Medical Dermatology and Immunology Research
🇺🇸Chicago, Illinois, United States
Northshore University Healthsystem
🇺🇸Skokie, Illinois, United States
Dermatology Specialists Research Ds Research Indiana Location
🇺🇸Clarksville, Indiana, United States
Velocity Clinical Research At the Dermatology Clinic
🇺🇸Baton Rouge, Louisiana, United States
Oakland Hills Dermatology
🇺🇸Auburn Hills, Michigan, United States
Hamzavi Dermatology
🇺🇸Fort Gratiot, Michigan, United States
Somerset Skin Centre
🇺🇸Troy, Michigan, United States
Medisearch Clinical Trials
🇺🇸Saint Joseph, Missouri, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
The University of New Mexico Unm Health Sciences Center Hsc
🇺🇸Albuquerque, New Mexico, United States
Montefiore Medical Center
🇺🇸East Syracuse, New York, United States
Skin Center Dermatology Group
🇺🇸New York, New York, United States
Stony Brook Dermatology Associates
🇺🇸Stony Brook, New York, United States
Wright State Physicians Health Center
🇺🇸Dayton, Ohio, United States
Centricity Research Aventiv Research Dublin
🇺🇸Dublin, Ohio, United States
Dermdox Dermatology Centers, Pc
🇺🇸Camp Hill, Pennsylvania, United States
University of Pittsburgh Medical Center Upmc Dermatology Clinic Oakland Falk Medical Building
🇺🇸Pittsburgh, Pennsylvania, United States
Palmetto Clinical Trial Services
🇺🇸Anderson, South Carolina, United States
International Clinical Research Tennessee Llc
🇺🇸Murfreesboro, Tennessee, United States
Dermatology Treatment and Research Center
🇺🇸Dallas, Texas, United States
Sweetwater Dermatology
🇺🇸Sugar Land, Texas, United States
Center For Clinical Studies
🇺🇸Webster, Texas, United States
Frontier Dermatology
🇺🇸Mill Creek, Washington, United States
Instituto de Neumonologia Y Dermatologia
🇦🇷Buenos Aires, Argentina
Instituto de Investigaciones En Alergia Y Enfermedades Respiratorias (Inaer)
🇦🇷Buenos Aires, Argentina
Conexa Investigacion Clinica S.A.
🇦🇷Ciudad Autonoma de Buenos Aires, Argentina
Buenos Aires Skin (Bas)
🇦🇷Ciudad Autonoma de Buenos Aires, Argentina
Cedic - Consultorios Medicos
🇦🇷Ciudad Autonoma de Buenos Aires, Argentina
Centro de Investigaciones Medicas Mar Del Plata
🇦🇷Mar Del Plata, Argentina
Instituto Especialidades de La Salud Rosario - Clinica Del Torax
🇦🇷Rosario, Argentina
Investigaciones Reumatologicas Tucuman S.R.L.
🇦🇷San Miguel de Tucuman, Argentina
Medical University Graz University Clinic For Dermatology and Venerology
🇦🇹Graz, Austria
Wiener Krankenanstaltenverbund, Krankenhaus Hietzing Mit Neurologischem Zentrum Rosenhugel
🇦🇹Wien, Austria
Az Sint-Lucas
🇧🇪Gent, Belgium
UZ GENT
🇧🇪Gent, Belgium
Centre Hospitalier Universitaire de Liege - Sart Tilman
🇧🇪Liege, Belgium
Cliniques Universitaires Ucl Saint-Luc
🇧🇪Woluwe-saint-lambert, Belgium
Medical Center Medconsult Pleven Ood
🇧🇬Lovech, Bulgaria
Dcc (Diagnostic and Consultation Center) Pulmed
🇧🇬Plovdiv, Bulgaria
Medical Center- Prolet Ltd
🇧🇬Ruse, Bulgaria
Medical Center Unimed Eood
🇧🇬Sevlievo, Bulgaria
Diagnostic Consulting Center Dcc Ascendent
🇧🇬Sofia, Bulgaria
Diagnostic Consultative Center (Dcc) Aleksandrovska
🇧🇬Sofia, Bulgaria
Rao Dermatology
🇨🇦Edmonton, Alberta, Canada
Skin Health
🇨🇦Cobourg, Ontario, Canada
Centricity Research London Victoria Multispecialty
🇨🇦London, Ontario, Canada
Dermeffects
🇨🇦London, Ontario, Canada
North York Research Inc.
🇨🇦Toronto, Ontario, Canada
Centre de Recherche Dermatologique de Quebec
🇨🇦Quebec City, Quebec, Canada
Sima Recherche
🇨🇦Verdun, Quebec, Canada
Hopital Prive D Antony
🇫🇷Antony, France
Chru Morvan/Chu Brest Hopital Morvan
🇫🇷Brest, France
Cabinet Medical- Chemin de Paradis
🇫🇷Martigues, France
Ghrmsa Hopital Emile Muller
🇫🇷Mulhouse, France
Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hopital Hotel Dieu
🇫🇷Nantes, France
Chu Paris-Gh St-Louis Lariboisiere F.Widal Hopital Saint-Louis
🇫🇷Paris, France
Hopitaux Drome Nord - Site de Romans Sur Isere
🇫🇷Romans Sur Isere, France
Hopital Larrey
🇫🇷Toulouse, France
Aachen University Hospital
🇩🇪Aachen, Germany
Fachklinik Bad Bentheim
🇩🇪Bad Bentheim, Germany
Hautzentrum Friedrichshain Studien
🇩🇪Berlin, Germany
Charite Universitatsmedizin Berlin
🇩🇪Berlin, Germany
Klinikum Dortmund Ggmbh
🇩🇪Dortmund, Germany
Universitaetsmedizin Goettingen
🇩🇪Gottingen, Germany
Universitaetsklinik Und Poliklinik Fuer Dermatologie Und Venerologie
🇩🇪Halle, Germany
Universitaetsklinikum Hamburg-Eppendorf
🇩🇪Hamburg, Germany
Universitatsklinik Heidelberg
🇩🇪Heidelberg, Germany
Universitaetsklinikum Leipzig
🇩🇪Leipzig, Germany
Universitaetsklinikum Schleswig-Holstein (Uksh) - Campus Luebeck
🇩🇪Luebeck, Germany
Universitaetsmedizin Der Johannes - Gutenberg Universitaet Mainz
🇩🇪Mainz, Germany
Universitaetsklinikum Giessen Und Marburg Gmbh
🇩🇪Marburg, Germany
Universitaets-Hautklinik Eberhard-Karls-Universitaet Tuebingen
🇩🇪Tuebingen, Germany
Azienda Ospedaliero Universitaria Consorziale Policlinico Di Bari
🇮🇹Bari, Italy
Azienda Policlinico Vittorio Emanuele
🇮🇹Catania, Italy
Clinical Research Centre - Cast
🇮🇹Chieti, Italy
Azienda Sanitaria Locale 1 (Asl 1) - Ospedale Regionale San Salvatore
🇮🇹L'aquila, Italy
Uoc Dermatologia Ospedale Maggiore Policlinico, Fondazione Irccs Ca' Granda
🇮🇹Milano, Italy
Universita Degli Studi Della Campania Luigi Vanvitelli
🇮🇹Napoli, Italy
Azienda Ospedaliera Di Perugia
🇮🇹Perugia, Italy
Azienda Ospedaliero Universitaria Pisana - Ospedale S. Chiara
🇮🇹Pisa, Italy
Catholic University of the Sacred Heart
🇮🇹Rome, Italy
Irccs Istituto Clinico Humanitas
🇮🇹Rozzano, Italy
Korea University Ansan Hospital
🇰🇷Ansan-si, Korea, Republic of
Soon Chun Hyang University Bucheon Hospital
🇰🇷Bucheon-si, Korea, Republic of
Pusan National University Hospital (Pnuh)
🇰🇷Busan, Korea, Republic of
The Catholic University of Korea, Incheon St. Mary'S Hospital
🇰🇷Incheon, Korea, Republic of
Jeonbuk National University Hospital
🇰🇷Jeonju-si, Korea, Republic of
Seoul National University Bundang Hospital (Snubh)
🇰🇷Seongnam-si, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Hanyang University Seoul Hospital
🇰🇷Seoul, Korea, Republic of
Konkuk University Medical Center
🇰🇷Seoul, Korea, Republic of
Chung-Ang University Hospital
🇰🇷Seoul, Korea, Republic of
Ewha Womans University Seoul Hospital
🇰🇷Seoul, Korea, Republic of
Pusan National University Yangsan Hospital
🇰🇷Yangsan-si, Korea, Republic of
Amsterdam University Medical Centre
🇳🇱Amsterdam, Netherlands
Maxima Medisch Centrum
🇳🇱Veldhoven, Netherlands
Niepubliczny Zaklad Opieki Zdrowotnej Specjalistyczny Osrodek Dermatologiczny Dermal
🇵🇱Bialystok, Poland
Uniwersyteckie Centrum Kliniczne
🇵🇱Gdansk, Poland
Mazowieckie Centrum Badan Klinicznych
🇵🇱Grodzisk Mazowiecki, Poland
Gyncentrum Sp. Z O.O., Nzoz Holsamed- Oddzial Libero
🇵🇱Katowice, Poland
Pro Familia Altera Sp. Z O.O.
🇵🇱Katowice, Poland
Centrum Badan Klinicznych, Jagiellonskie Centrum Innowacji Sp.Z.O.O.
🇵🇱Kraków, Poland
Niepubliczny Zaklad Opieki Zdrowotnej Med-Laser
🇵🇱Lublin, Poland
Luxderm Specjalistyczny Gabinet Dermatologiczny Prof. Dr. Hab. N. Med. Dorota Krasowska
🇵🇱Lublin, Poland
Dermedic Jacek Zdybski
🇵🇱Ostrowiec Swietokrzyski, Poland
Laser Clinic
🇵🇱Szczecin, Poland
Mics Centrum Medyczne Torun
🇵🇱Torun, Poland
Clinical Research Group Sp. Z.O.O
🇵🇱Warszawa, Poland
High-Med. Przychodnia Specjalistyczna
🇵🇱Warszawa, Poland
Panstwowy Instytut Medyczny Mswia
🇵🇱Warszawa, Poland
Klinika Ambroziak Sp. Z O.O.
🇵🇱Warszawa, Poland
Emc Instytut Medyczny Spolka Akcyjna-Euromedicare Szpital Specjalistyczny Z Przychodnia
🇵🇱Wrocaw, Poland
Dermaceum Centrum Badan Klinicznych
🇵🇱Wroclaw, Poland
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spolka Partnerska
🇵🇱Wroclaw, Poland
Hospital Universitari I Politecnic La Fe de Valencia - Instituto de Investigacion Sanitaria La Fe (I
🇪🇸Valencia, Spain
Felix Platter Spital
🇨🇭Basel, Switzerland
Inselspital Bern
🇨🇭Bern, Switzerland
Dsc Clinic Buochs
🇨🇭Buochs, Switzerland
Universitatsspital Zurich
🇨🇭Zurich, Switzerland