A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis (STOP-PN2)
- Registration Number
- NCT06516965
- 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 Povorcitinib Dose 1 Povorcitinib Povorcitinib at the protocol-defined dose. Placebo Placebo Placebo 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 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.
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.
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.
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 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 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.
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.
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.
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.
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 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.
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".
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".
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 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.
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).
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.
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.
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.
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.
Trial Locations
- Locations (135)
Medical Dermatology Specialists Phoenix
🇺🇸Phoenix, Arizona, United States
Investigate Md
🇺🇸Scottsdale, Arizona, United States
Premier Dermatology Clinical Trials Institute At Northwest Arkansas
🇺🇸Fayetteville, Arkansas, United States
First Oc Dermatology Research Inc
🇺🇸Fountain Valley, California, United States
Dermatology Research Associates
🇺🇸Los Angeles, California, United States
Integrative Skin Science and Research
🇺🇸Sacramento, California, United States
Clinical Science Institute Clinical Research Specialists Inc
🇺🇸Santa Monica, California, United States
Center For Clinical and Cosmetic Research
🇺🇸Aventura, Florida, United States
Clearlyderm Dermatology
🇺🇸Boca Raton, Florida, United States
Driven Research Llc
🇺🇸Coral Gables, Florida, United States
Boynton Beach Facility
🇺🇸Hollywood, Florida, United States
Direct Helpers Research Center
🇺🇸Hialeah, Florida, United States
Skin Care Research, Llc Scr Hollywood
🇺🇸Hollywood, Florida, United States
Trueblue Clinical Research Moore Clinical Research, Inc McR Tampa Clinic Location
🇺🇸Tampa, Florida, United States
Chicago Cosmetic Surgery and Dermatology
🇺🇸Chicago, Illinois, United States
University of Miami Miller School of Medicine
🇺🇸Miami, Florida, United States
Ziaderm Research, Llc
🇺🇸Miami, Florida, United States
Dh Tamarac Research Center Etna Medical Center Emc
🇺🇸Tamarac, Florida, United States
Nodal Medical Center, Llc
🇺🇸Tampa, Florida, United States
Dermatology Specialists Research Indiana
🇺🇸Clarksville, Indiana, United States
Southern Indiana Clinical Trials
🇺🇸New Albany, Indiana, United States
Hamzavi Dermatology
🇺🇸Fort Gratiot, Michigan, United States
Michigan Dermatology Institute
🇺🇸Waterford, Michigan, United States
Medisearch Clinical Trials
🇺🇸Saint Joseph, Missouri, United States
Allcutis Research, Llc
🇺🇸Portsmouth, New Hampshire, United States
Dermatology Specialists Research
🇺🇸Louisville, Kentucky, United States
Dermatology Associates Pc
🇺🇸Rockville, Maryland, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
University of Maryland School of Medicine
🇺🇸Baltimore, Maryland, United States
Metro Boston Clinical Partners
🇺🇸Brighton, Massachusetts, United States
Fivenson Dermatology
🇺🇸Ann Arbor, Michigan, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Schweiger Dermatology
🇺🇸Hackensack, New Jersey, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
Suny Downstate Medical Center
🇺🇸Brooklyn, New York, United States
Equity Medical, Llc
🇺🇸New York, New York, United States
Paddington Testing Co Inc
🇺🇸Philadelphia, Pennsylvania, United States
OPTISKIN
🇺🇸New York, New York, United States
Oakview Dermatology
🇺🇸Athens, Ohio, United States
University of Cincinnati Cancer Institute
🇺🇸Cincinnati, Ohio, United States
Centricity Research Aventiv Research Dublin
🇺🇸Dublin, Ohio, United States
Central Sooner Research
🇺🇸Oklahoma City, Oklahoma, United States
Yardley Dermatology Associates
🇺🇸Yardley, Pennsylvania, United States
International Clinical Research Tennessee Llc
🇺🇸Murfreesboro, Tennessee, United States
University of Utah Midvalley Dermatology
🇺🇸Murray, Utah, United States
Skin & Cancer Foundation Australia
🇦🇺Sydney, New South Wales, Australia
The Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
Modern Research Associates Pllc
🇺🇸Dallas, Texas, United States
Aesthetic General Dermatology of Seattle
🇺🇸Burien, Washington, United States
West Virginia Research Institute
🇺🇸Morgantown, West Virginia, United States
Veracity Clinical Research Pty Ltd
🇦🇺Wolloongabba, Queensland, Australia
Alpha Research-Lucere Dermatology and Laser Clinic
🇨🇦Edmonton, Alberta, Canada
Premier Specialists Pty Ltd
🇦🇺Kogarah, New South Wales, Australia
Novatrials
🇦🇺Newcastle, New South Wales, Australia
Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
Fremantle Dermatology
🇦🇺Fremantle, Australia
Az Sint-Jan Brugge - Oostende Av - Campus Sint-Jan
🇧🇪Brugge, Belgium
Skin Physicians
🇨🇦Edmonton, Alberta, Canada
UZ GENT
🇧🇪Gent, Belgium
Centre Hospitalier Universitaire de Liege - Sart Tilman
🇧🇪Liege, Belgium
Grand Hopital de Charleroi
🇧🇪Loverval, Belgium
Cliniques Universitaires Ucl Saint-Luc
🇧🇪Woluwe-saint-lambert, Belgium
Simcoderm Medical and Surgical Dermatology Centre
🇨🇦Barrie, Ontario, Canada
Dermeffects
🇨🇦London, Ontario, Canada
North York Research Inc.
🇨🇦Toronto, Ontario, Canada
Toronto Research Centre
🇨🇦Toronto, Ontario, Canada
Centre de Recherche Saint-Louis
🇨🇦Quebec City, Quebec, Canada
Skinsense Medical Research
🇨🇦Saskatoon, Saskatchewan, Canada
Centro Medico Skinmed Limitada
🇨🇱LAS Condes Santiago, Chile
Centro Internacional de Estudios Clinicos
🇨🇱Santiago, Chile
Clinical Research Chile Spa.
🇨🇱Valdivia, Chile
Clintrial S.R.O.
🇨🇿Prague, Czechia
Sanatorium Profesora Arenbergera
🇨🇿Prague, Czechia
Magdeburger Company For Medical Studies and Services Gmbh
🇩🇪Magdeburg, Germany
Aachen University Hospital
🇩🇪Aachen, Germany
Rosenpark Research
🇩🇪Darmstadt, Germany
Klinikum Der Johann Wolfgang Goethe University
🇩🇪Frankfurt Am Main, Germany
Universitaetsmedizin Goettingen
🇩🇪Gottingen, Germany
Nippon Medical School Musashikosugi Hospital
🇯🇵Kawasaki-shi, Japan
Dokkyo Medical University Saitama Medical Center
🇯🇵Minamikoshigaya, Japan
Elbe Kliniken Buxtehude
🇩🇪Buxtehude, Germany
Drk Krankenhaus Chemnitz-Rabenstein
🇩🇪Chemnitz, Germany
Klinikum Darmstadt
🇩🇪Darmstadt, Germany
University Hospital Carl Gustav Carus
🇩🇪Dresden, Germany
Dermatologische Gemeinschaftspraxis Dres. Quist
🇩🇪Mainz, Germany
Technischen Universitaet Muenchen
🇩🇪Muenchen, Germany
University Hospital Muenster
🇩🇪Muenster, Germany
Klinikum Oldenburg Aor
🇩🇪Oldenburg, Germany
Hautarztpraxis Dr. Hoffmann
🇩🇪Witten, Germany
Tokyo Medical and Dental University Hospital, Faculty of Medicine
🇯🇵Bunkyo-ku, Japan
Tokyo Medical University Ibaraki Medical Center - Kasumigaura Campus (Tokyo Medical University Kasum
🇯🇵Inashiki-gun, Japan
University of Occupational and Environmental Health, Japan
🇯🇵Kitakyushu, Japan
Noguchi Dermatology Clinic
🇯🇵Kamimashiki-gun, Japan
Shimizu Dermatology Clinic
🇯🇵Kobe, Japan
Niigata University Medical & Dental Hospital
🇯🇵Niigata, Japan
Medical Corporation Jun Dermatology Clinic
🇯🇵Osaka, Japan
Tanpopo Dermatology Clinic
🇯🇵Ota-ku, Japan
Kume Derma Clinic
🇯🇵Sakai, Japan
Sapporo Skin Clinic
🇯🇵Sapporo, Japan
Tohoku University Hospital
🇯🇵Sendai, Japan
Tokyo Medical University Hospital
🇯🇵Shinjuku-ku, Japan
National Defence Medical College Hospital
🇯🇵Tokorozawa-shi, Japan
Akk Medical Sp. Z O.O. - Centrum Medyczne Tu Sie Leczy
🇵🇱Gdansk, Poland
Care Clinic Sp. Z O.O.
🇵🇱Katowice, Poland
Santa Familia Ptg Lodz
🇵🇱Lodz, Poland
Dermoklinika Centrum Medyczne S.C., M. Kierstan, J. Narbutt, A. Lesiak
🇵🇱Lodz, Poland
Luxderm Specjalistyczny Gabinet Dermatologiczny Prof. Dr. Hab. N. Med. Dorota Krasowska
🇵🇱Lublin, Poland
Dermedic Jacek Zdybski
🇵🇱Ostrowiec Swietokrzyski, Poland
Clinical Research Center Spolka Z Ograniczona Odpowiedzialnoscia Medic-R Spolka Komandytowa
🇵🇱Poznan, Poland
Uniwersytecki Szpital Kliniczny Im. Fryderyka Chopina W Rzeszowie
🇵🇱Rzeszow, Poland
Mics Centrum Medyczne Torun
🇵🇱Torun, Poland
High-Med. Przychodnia Specjalistyczna
🇵🇱Warszawa, Poland
Panstwowy Instytut Medyczny Mswia
🇵🇱Warszawa, Poland
Royalderm Agnieszka Nawrocka
🇵🇱Warszawa, Poland
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spolka Partnerska
🇵🇱Wroclaw, Poland
Hospital Universitari Germans Trias I Pujol
🇪🇸Badalona, Spain
Hospital de La Santa Creu I Sant Pau
🇪🇸Barcelona, Spain
Hospital Universitario Reina Sofia
🇪🇸Cordoba, Spain
Hospital Clinico Universitario San Cecilio
🇪🇸Granada, Spain
Hospital General Universitario de Alicante
🇪🇸Alicante, Spain
Hospital Universitario Ramon Y Cajal
🇪🇸Madrid, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital Universitario Puerta de Hierro
🇪🇸Majadahonda, Spain
Hospital de Manises
🇪🇸Manises, Spain
Hospital Universitario Virgen Del Rocio
🇪🇸Seville, Spain
Area Sanitaria de Santiago de Compostela Y Barbanza - Complejo Hospitalario Universitario de Santiag
🇪🇸Santiago de Compostela, Spain
Hospital Universitari I Politecnic La Fe de Valencia - Instituto de Investigacion Sanitaria La Fe (I
🇪🇸Valencia, Spain
Broadgreen Hospital - Liverpool University Hospitals Nhs Foundation Trust
🇬🇧Liverpool, United Kingdom
The Royal London Hospital - Barts Health Nhs Trust
🇬🇧London, United Kingdom
The Dudley Group Nhs Foundation Trust
🇬🇧Dudley, United Kingdom
Ipswich Hospital, East Suffolk and North Essex Nhs Foundation Trust
🇬🇧Ipswich, United Kingdom
Guy'S Hospital - Guy'S & St Thomas' Nhs Foundation Trust
🇬🇧London, United Kingdom
Poole Hospital - University Hospitals Dorset Nhs Foundation Trust
🇬🇧Poole, United Kingdom
Surrey and Sussex Healthcare Nhs Trust - East Surrey Hospital
🇬🇧Redhill, United Kingdom