A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis (STOP-PN2)

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis

The purpose of this study is to evaluate effect of povorcitinib on itch and skin lesions in participants with prurigo nodularis.

Study Overview

• Status: Active, not recruiting
• Conditions: Prurigo Nodularis
• Intervention / Treatment: Drug: Placebo; Drug: Povorcitinib

• Study Type: Interventional
• Enrollment (Actual): 346
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Fremantle, Australia, 06160
    • Fremantle Dermatology
  • New South Wales
    • Charlestown, New South Wales, Australia, 02290
      • Novatrials
    • Kogarah, New South Wales, Australia, 02217
      • Premier Specialists Pty Ltd
    • Sydney, New South Wales, Australia, 02010
      • Skin & Cancer Foundation Australia
    • Westmead, New South Wales, Australia, 02145
      • Westmead Hospital
  • Queensland
    • Woolloongabba, Queensland, Australia, 04102
      • Veracity Clinical Research Pty Ltd
  • Victoria
    • Melbourne, Victoria, Australia, 03004
      • The Alfred Hospital
• Belgium
  • Bruges, Belgium, 08000
    • AZ Sint-Jan Brugge AV
  • Ghent, Belgium, 09000
    • Universitair Ziekenhuis Gent (Uz Gent)
  • Gilly, Belgium, 06060
    • Grand Hopital de Charleroi - Site Imtr
  • Liège, Belgium, 04000
    • Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman
  • Woluwe-Saint-Lambert, Belgium, 01200
    • Universite Catholique de Louvain (Ucl) - Cliniques Universitaires Saint-Luc
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6W 4V4
      • Skin Physicians
    • Edmonton, Alberta, Canada, T6X 0N9
      • Alpha Research-Lucere Dermatology and Laser Clinic
  • Ontario
    • Barrie, Ontario, Canada, L4M 7G1
      • SimcoDerm Medical and Surgical Dermatology Centre
    • London, Ontario, Canada, N6H 5L5
      • DermEffects
    • Toronto, Ontario, Canada, M3H 5Y8
      • Toronto Research Centre
    • Toronto, Ontario, Canada, M2N 3A6
      • North York Research Inc.
  • Quebec
    • Québec, Quebec, Canada, G1W 4R4
      • Centre de Recherche Saint-Louis
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7K 2C1
      • Skinsense Medical Research
• Chile
  • Santiago, Chile, 8420383
    • Centro Internacional de Estudios Clinicos
  • Santiago, Chile, 7580206
    • Centro Medico Skinmed Limitada
  • Valdivia, Chile, 5090000
    • Clinical Research Chile SpA.
• Czechia
  • Prague, Czechia, 100 00
    • CLINTRIAL s.r.o.
  • Prague, Czechia, 110 00
    • Sanatorium Profesora Arenbergera
  • Prague, Czechia, 158 00
    • Sanixtra Prague
• Germany
  • Aachen, Germany, 52074
    • University Hospital RWTH Aachen
  • Buxtehude, Germany, 21614
    • Elbe Kliniken Buxtehude
  • Chemnitz, Germany, 09117
    • Drk Krankenhaus Chemnitz-Rabenstein
  • Darmstadt, Germany, 64283
    • Klinikum Darmstadt
  • Darmstadt, Germany, 64283
    • Rosenpark Research GmbH
  • Dresden, Germany, 01307
    • University Hospital Carl Gustav Carus
  • Frankfurt am Main, Germany, 60590
    • Klinikum der Johann Wolfgang Goethe-Universitaet
  • Göttingen, Germany, 37075
    • Universitaetsmedizin Goettingen
  • Magdeburg, Germany, 39104
    • Magdeburger Company For Medical Studies and Services Gmbh
  • Mainz, Germany, 55128
    • Dermatologische Gemeinschaftspraxis Dres. Quist
  • München, Germany, 80802
    • Technischen Universitaet Muenchen
  • Münster, Germany, 48149
    • University Hospital Muenster
  • Oldenburg, Germany, 26133
    • Klinikum Oldenburg AöR
  • Witten, Germany, 58453
    • Hautarztpraxis Dr. Hoffmann
• Japan
  • Bunkyō City, Japan, 113-8519
    • Tokyo Medical and Dental University Hospital, Faculty of Medicine
  • Inashiki-gun, Japan
    • Tokyo Medical University Ibaraki Medical Center - Kasumigaura Campus (Tokyo Medical University Kasum
  • Kamimashiki-gun, Japan, 861-3101
    • Noguchi Dermatology Clinic
  • Kawasaki-shi, Japan, 211-8533
    • Nippon Medical School Musashikosugi Hospital
  • Kitakyushu, Japan, 807-8555
    • University of Occupational and Environmental Health, Japan
  • Kobe, Japan, 657-0846
    • Shimizu Dermatology Clinic
  • Kumamoto, Japan, 861-2236
    • Aoi Dermatology Clinic
  • Minamikoshigaya, Japan, 343-8555
    • Dokkyo Medical University Saitama Medical Center
  • Minokamo, Japan, 505-8510
    • Central Japan International Medical Center
  • Niigata, Japan, 951-8520
    • Niigata University Medical & Dental Hospital
  • Osaka, Japan, 558-0003
    • Medical Corporation Jun Dermatology Clinic
  • Sakai, Japan, 593-8324
    • Kume Derma Clinic
  • Sapporo, Japan, 600063
    • Sapporo Skin Clinic
  • Sendai, Japan, 980-8574
    • Tohoku University Hospital
  • Shinjuku-ku, Japan, 160-0023
    • Tokyo Medical University Hospital
  • Tokorozawa, Japan, 359-0042
    • National Defense Medical College Hospital
  • Yokohama, Japan, 221-0825
    • Nomura Dermatology Clinic
  • Yokohama, Japan, 220-6208
    • Queen's Square Medical Facilities
  • Ōta-ku, Japan, 143-0023
    • Tanpopo Dermatology Clinic
• Poland
  • Gdansk, Poland, 80-280
    • Akk Medical Sp. Z O.O. - Centrum Medyczne Tu Sie Leczy
  • Katowice, Poland, 40-568
    • Care Clinic Sp. Z O.O.
  • Lodz, Poland, 90-436
    • Dermoklinika Centrum Medyczne S.C., M. Kierstan, J. Narbutt, A. Lesiak
  • Lodz, Poland, 90-302
    • Santa Familia PTG Lodz
  • Lublin, Poland, 20-573
    • Luxderm Specjalistyczny Gabinet Dermatologiczny Prof. Dr. Hab. N. Med. Dorota Krasowska
  • Poznan, Poland, 61-731
    • Clinical Research Center Spolka Z Ograniczona Odpowiedzialnoscia Medic-R Spolka Komandytowa
  • Rzeszów, Poland, 35-055
    • Uniwersytecki Szpital Kliniczny Im. Fryderyka Chopina W Rzeszowie
  • Torun, Poland, 87-100
    • MICS Centrum Medyczne Toruń
  • Warsaw, Poland, 02-692
    • Royalderm Agnieszka Nawrocka
  • Warsaw, Poland, 02-507
    • PANSTWOWY INSTYTUT MEDYCZNY MSWiA
  • Warsaw, Poland, 01-817
    • High-Med. Przychodnia Specjalistyczna
  • Wroclaw, Poland, 50566
    • Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spolka Partnerska
• Spain
  • Alicante, Spain, 03010
    • Hospital General Universitario Dr Balmis
  • Badalona, Spain, 08916
    • Hospital Universitari Germans Trias i Pujol (HUGTP)
  • Barcelona, Spain, 08041
    • Hospital de la Santa Creu i Sant Pau
  • Córdoba, Spain, 14004
    • Hospital Universitario Reina Sofia
  • Granada, Spain, 18016
    • Hospital Clinico Universitario San Cecilio
  • Madrid, Spain, 28034
    • Hospital Universitario Ramón y Cajal
  • Madrid, Spain, 28041
    • Hospital Universitario 12 De Octubre
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Majadahonda, Spain, 28222
    • Hospital Universitario Puerta de Hierro de Majadahonda
  • Manises, Spain, 46940
    • Hospital de Manises
  • Santiago de Compostela, Spain, 15706
    • Area Sanitaria de Santiago de Compostela Y Barbanza - Complejo Hospitalario Universitario de Santiag
  • Seville, Spain, 41013
    • Hospital Universitario Virgen del Rocio
  • Valencia, Spain, 46026
    • Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulev
• United Kingdom
  • Dudley, United Kingdom, DY1 2HQ
    • The Dudley Group NHS Foundation Trust
  • Ipswich, United Kingdom, IP4 5PD
    • Ipswich Hospital, East Suffolk and North Essex Nhs Foundation Trust
  • Liverpool, United Kingdom, L14 3LB
    • Broadgreen Hospital - Liverpool University Hospitals Nhs Foundation Trust
  • London, United Kingdom, SE1 9RT
    • Guy'S Hospital - Guy'S & St Thomas' Nhs Foundation Trust
  • London, United Kingdom, E1 1FR
    • The Royal London Hospital - Barts Health Nhs Trust
  • Poole, United Kingdom, BH15 2JB
    • Poole Hospital - University Hospitals Dorset Nhs Foundation Trust
  • Redhill, United Kingdom
    • Surrey and Sussex Healthcare Nhs Trust - East Surrey Hospital
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Medical Dermatology Specialists Phoenix
    • Scottsdale, Arizona, United States, 85255
      • Investigate MD
  • California
    • Fountain Valley, California, United States, 92708-3701
      • First OC Dermatology Research Inc
    • Santa Monica, California, United States, 90404
      • Clinical Science Institute Clinical Research Specialists Inc
  • Florida
    • Aventura, Florida, United States, 33180
      • Center for Clinical and Cosmetic Research
    • Boca Raton, Florida, United States, 33428
      • Schweiger Dermatology
    • Hialeah, Florida, United States, 33012
      • Direct Helpers Research Center
    • Hollywood, Florida, United States, 33201
      • Skin Care Research, Llc
    • Miami, Florida, United States, 33162
      • Ziaderm Research, Llc
    • Tampa, Florida, United States, 33607
      • Nodal Medical Center, LLC
    • Tampa, Florida, United States, 33609
      • Trueblue Clinical Research Moore Clinical Research, Inc McR Tampa Clinic Location
  • Kentucky
    • Louisville, Kentucky, United States, 40241
      • Dermatology Specialists Research
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland School of Medicine
    • Rockville, Maryland, United States, 20850
      • Dermatology Associates Pc
  • Massachusetts
    • Brighton, Massachusetts, United States, 02135-3511
      • Metro Boston Clinical Partners
  • Michigan
    • Ann Arbor, Michigan, United States, 48103
      • Fivenson Dermatology
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
    • Waterford, Michigan, United States, 48328
      • Michigan Dermatology Institute
  • New Hampshire
    • Portsmouth, New Hampshire, United States, 03801
      • Allcutis Research, Llc
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Schweiger Dermatology
  • New York
    • New York, New York, United States, 10128
      • OPTISKIN
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • University of Cincinnati Cancer Institute
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73118
      • Central Sooner Research
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19103
      • Paddington Testing Co Inc
    • Yardley, Pennsylvania, United States, 19067
      • Yardley Dermatology Associates
  • Texas
    • Dallas, Texas, United States, 75231
      • Modern Research Associates PLLC
  • Utah
    • Murray, Utah, United States, 84107
      • University of Utah MidValley Dermatology
  • Washington
    • Burien, Washington, United States, 98168
      • Aesthetic General Dermatology of Seattle

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Povorcitinib Dose 1; Povorcitinib at the protocol-defined dose.	Drug: Povorcitinib; Oral Tablet; Other Names: INCB054707
Experimental: Povorcitinib Dose 2; Povorcitinib at the protocol-defined dose.	Drug: Povorcitinib; Oral Tablet; Other Names: INCB054707
Placebo Comparator: Placebo; Placebo at the protocol-defined dose.	Drug: Placebo; Oral Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants achieving Itch NRS4 and IGA-CPG-S-TS at 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).	Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants achieving Itch NRS4 at Week 24	Defined as percentage of participants that achieve a ≥ 4-point improvement (reduction) in Itch NRS score from baseline.	Week 24
Proportion of participants achieving IGA-CPG-S-TS at Week 24	Defined as percentage of participants that achieve IGA-CPG-S score of 0 or 1 with a ≥ 2 grade improvement from baseline.	Week 24
Proportion of participants achieving Itch NRS4 at Week 4	Defined as percentage of participants that achieve a ≥ 4-point improvement (reduction) in Itch NRS score from baseline.	Week 4
Time to Itch NRS4	Defined as time taken for the participant to achieve a ≥4 improvement in Itch NRS score from baseline.	Up to 52 Weeks
Change from baseline in Itch NRS score at each postbaseline visit	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
Percent change from baseline in NRS score at each postbaseline visit	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
Proportion of participants achieving Itch NRS4 at each postbaseline visit	Defined as percentage of participants that achieve a ≥ 4-point improvement in Itch NRS score from baseline.	Up to 52 weeks
Proportion of participants achieving IGA-CPG-S-TS at each postbaseline visit	Defined as percentage of participants that achieve an IGA-CPG-S score of 0 or 1 with a ≥ 2 grade improvement from baseline.	Up to 52 weeks
Proportion of participants achieving Investigator's Global Assessment - Chronic Prurigo Activity (IGA-CPG-A) at each postbaseline visit	Defined as percentage of participants that achieve an IGA-CPG-A score of 0 or 1 with a ≥ 2 grade improvement (reduction) from baseline.	Up to 52 weeks
Proportion of participants achieving ≥ 75% healed lesions in Prurigo Activity Score (PAS) at each postbaseline visit	The modified PAS will be used in this study as defined by the protocol.	Up to 52 weeks
Proportion of participants achieving Itch NRS4 and IGA-CPG-S-TS at each postbaseline visit	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.	Up to 52 weeks
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 52 weeks
Percent 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 52 weeks
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	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.	Up to 52 weeks
Change from baseline in Skin Pain NRS score at each postbaseline visit	Skin Pain NRS is an 11-point scale (0 to10) where 0 is "no pain" and 10 is the "worst pain imaginable".	Up to 52 weeks
Percent change from baseline in Skin Pain NRS score at each postbaseline visit	Skin Pain NRS is an 11-point scale (0 to10) where 0 is "no pain" and 10 is the "worst pain imaginable".	Up to 52 weeks
Change from baseline in the Hospital Anxiety and Depression Scale (HADS) score at each postbasline visit	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).	Up to 52 weeks
Percent change from baseline in the HADS score at each postbaseline visit	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).	Up to 52 weeks
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 52 weeks
Percent 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 52 weeks
Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) score at each postbaseline visit	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.	Up to 52 weeks
Percent change in FACIT-F score at each postbaseline visit	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.	Up to 52 weeks
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	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.	Up to 52 weeks
Number of Participants with Treatment Emergent Adverse Events (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 52 weeks

Collaborators and Investigators

• Sponsor: Incyte Corporation
• Investigators: Study Director: Incyte Medical Monitor, Incyte Corporation

Publications and helpful links

Helpful Links

• A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis (STOP-PN2)

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2024
• Primary Completion (Estimated): October 19, 2026
• Study Completion (Estimated): May 3, 2027

Study Registration Dates

• First Submitted: July 18, 2024
• First Submitted That Met QC Criteria: July 18, 2024
• First Posted (Actual): July 24, 2024

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Prurigo nodularis; PN; INCB054707; chronic pruritus
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Eczematous; Dermatitis; Prurigo; Neurodermatitis; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: INCB54707-306; 2024-511881-35-00 (Registry Identifier: EU CT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
• IPD Sharing Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
• IPD Sharing Access Criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No