A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis (STOP-PN1)

NCT06516952 | Active Not Recruiting Phase 3 FDA Drug

• 2 other identifiers: INCB54707-3052024-511879-16-00
• Study Type: interventional
• Target: 349
• Locations: 12 countries
• Sites: 120

Brief Summary

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

Conditions

Prurigo Nodularis

Keywords

Prurigo nodularis; PN; INCB054707; chronic pruritus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (24)

• Proportion of participants achieving Itch NRS4 at Week 24

  Week 24

• Proportion of participants achieving IGA-CPG-S-TS at Week 24

  Week 24

• Proportion of participants achieving Itch NRS4 at Week 4

  Week 4

• Time to Itch NRS4

  Up to 52 weeks

• Change from baseline in Itch NRS score at each postbaseline visit

  Up to 52 weeks

Study Arms (3)

Povorcitinib Dose 1

EXPERIMENTAL

Povorcitinib at the protocol-defined dose.

Drug: Povorcitinib

Povorcitinib Dose 2

EXPERIMENTAL

Povorcitinib at the protocol-defined dose.

Drug: Povorcitinib

Placebo

PLACEBO COMPARATOR

Placebo at the protocol-defined dose.

Drug: Placebo

Interventions

Povorcitinib DRUG

Oral Tablet

Also known as: INCB054707

Povorcitinib Dose 1; Povorcitinib Dose 2

Placebo DRUG

Oral Tablet

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (120)

Cahaba Dermatology

Birmingham, Alabama, 35244, United States

Location

Banner - University Medicine Multispecialty Services Clinic

Tucson, Arizona, 85718, United States

Location

Premier Dermatology Clinical Trials Institute At Northwest Arkansas

Fayetteville, Arkansas, 72703, United States

Location

Burke Pharmaceutical Research

Hot Springs, Arkansas, 71913, United States

Location

Dermatology Research Associates

Los Angeles, California, 90045, United States

Location

Northridge

Northridge, California, 91325, United States

Location

Rendon Center the Dermatology and Aesthetic Center

Boca Raton, Florida, 33486, United States

Location

Driven Research Llc

Coral Gables, Florida, 33134, United States

Location

University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Location

Research Institute of the Southeast, Llc

West Palm Beach, Florida, 33401, United States

Location

Illinois Dermatology Institute the Chicago Loop

Chicago, Illinois, 60602, United States

Location

Chicago Cosmetic Surgery and Dermatology

Chicago, Illinois, 60654, United States

Location

Center For Medical Dermatology and Immunology Research

Chicago, Illinois, 60657, United States

Location

Northshore University Healthsystem

Skokie, Illinois, 60077, United States

Location

Dermatology Specialists Research Indiana

Clarksville, Indiana, 47129, United States

Location

Oakland Hills Dermatology

Auburn Hills, Michigan, 48326, United States

Location

Hamzavi Dermatology

Fort Gratiot, Michigan, 48059, United States

Location

Somerset Skin Centre

Troy, Michigan, 48084, United States

Location

Medisearch Clinical Trials

Saint Joseph, Missouri, 64506, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

The University of New Mexico Unm Health Sciences Center Hsc

Albuquerque, New Mexico, 87131, United States

Location

Montefiore Medical Center

East Syracuse, New York, 13057, United States

Location

Skin Center Dermatology Group

New York, New York, 10956, United States

Location

Stony Brook Dermatology Associates

Stony Brook, New York, 11790, United States

Location

Centricity Research Columbus

Columbus, Ohio, 43213, United States

Location

Wright State Physicians Health Center

Dayton, Ohio, 45324, United States

Location

International Clinical Research Tennessee Llc

Murfreesboro, Tennessee, 37130, United States

Location

Dermatology Treatment and Research Center

Dallas, Texas, 75230, United States

Location

Sweetwater Dermatology

Sugar Land, Texas, 77479, United States

Location

Center For Clinical Studies

Webster, Texas, 77598, United States

Location

Frontier Dermatology

Mill Creek, Washington, 98012, United States

Location

Conexa Investigacion Clinica S.A.

Buenos Aires, 01012, Argentina

Location

Cedic - Centro de Investigacion Clinica

Buenos Aires, C1060ABN, Argentina

Location

Instituto de Neumonologia Y Dermatologia

Buenos Aires, C1425BEA, Argentina

Location

Instituto de Investigaciones En Alergia Y Enfermedades Respiratorias (Inaer)

Buenos Aires, C1425BEN, Argentina

Location

Centro de Investigaciones Medicas Mar Del Plata

Mar del Plata, B7600FYK, Argentina

Location

Instituto Especialidades de La Salud Rosario - Clinica Del Torax

Rosario, S2000, Argentina

Location

Investigaciones Reumatologicas Tucuman S.R.L.

San Miguel de Tucumán, T4000AXL, Argentina

Location

Medical University Graz University Clinic For Dermatology and Venerology

Graz, 08036, Austria

Location

Wiener Krankenanstaltenverbund (Kav) - Krankenhaus Hietzing Mit Neurologischem Zentrum Rosenhuegel

Vienna, 01130, Austria

Location

Medical Center Medconsult Pleven

Lovech, 05500, Bulgaria

Location

Medical Center Medconsult Pleven Ood

Pleven, 05800, Bulgaria

Location

Diagnostic-Consultative Centre Pulmed Eood

Plovdiv, 04002, Bulgaria

Location

Medical Center Prolet Eood

Rousse, 07000, Bulgaria

Location

Medical Center Unimed Eood

Sevlievo, 05400, Bulgaria

Location

Diagnostic-Consultative Center Ascendent Eood

Sofia, 01202, Bulgaria

Location

Diagnostic-Consultative Center Aleksandrovska Eood

Sofia, 01431, Bulgaria

Location

Dermatology Research Institute

Calgary, Alberta, T2J 7E1, Canada

Location

Rao Dermatology

Edmonton, Alberta, T6G 1C3, Canada

Location

Skin Physicians

Edmonton, Alberta, T6W 4V4, Canada

Location

Alpha Research-Lucere Dermatology and Laser Clinic

Edmonton, Alberta, T6X 0N9, Canada

Location

Park Dermatology

Sherwood Park, Alberta, T8H 0P1, Canada

Location

Simcoderm Medical and Surgical Dermatology Centre

Barrie, Ontario, L4M 7G1, Canada

Location

Skin Health

Cobourg, Ontario, K9A 0Z4, Canada

Location

Centricity Research London Victoria Multispecialty

London, Ontario, N6A 2C2, Canada

Location

Dermeffects

London, Ontario, N6H 5L5, Canada

Location

North York Research Inc.

Toronto, Ontario, M2N 3A6, Canada

Location

Toronto Research Centre

Toronto, Ontario, M3H 5Y8, Canada

Location

Centre de Recherche Dermatologique de Quebec

Québec, Quebec, G1V4X7, Canada

Location

Centre de Recherche Saint-Louis

Québec, Quebec, G1W 4R4, Canada

Location

Sima Recherche

Verdun, Quebec, H4G 3E7, Canada

Location

Skinsense Medical Research

Saskatoon, Saskatchewan, S7K 2C1, Canada

Location

Hopital Prive D Antony

Antony, 92160, France

Location

Hospital Morvan

Brest, 29200, France

Location

Cabinet Medical- Chemin de Paradis

Martigues, 13500, France

Location

Ghrmsa Hopital Emile Muller

Mulhouse, 68100, France

Location

Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hopital Hotel Dieu

Nantes, 44093, France

Location

Chu Paris-Gh St-Louis Lariboisiere F.Widal Hopital Saint-Louis

Paris, 75010, France

Location

Hopitaux Drome Nord - Site de Romans Sur Isere

Romans-sur-Isère, 26102, France

Location

Hopital Larrey

Toulouse, 31400, France

Location

Aachen University Hospital

Aachen, 52074, Germany

Location

Fachklinik Bad Bentheim

Bad Bentheim, 48455, Germany

Location

Hautzentrum Friedrichshain Studien

Berlin, 10247, Germany

Location

Charite Universitatsmedizin Berlin

Berlin, 12203, Germany

Location

Klinikum Dortmund Ggmbh

Dortmund, 44137, Germany

Location

Universitaetsklinik Und Poliklinik Fuer Dermatologie Und Venerologie

Halle, 06120, Germany

Location

Universitaetsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Universitatsklinik Heidelberg

Heidelberg, 69115, Germany

Location

Universitaetsklinikum Leipzig

Leipzig, 04103, Germany

Location

Universitaetsklinikum Schleswig-Holstein (Uksh) - Campus Luebeck

Lübeck, 23538, Germany

Location

Universitaetsmedizin Der Johannes - Gutenberg Universitaet Mainz

Mainz, 55131, Germany

Location

Universitaetsklinikum Giessen Und Marburg Gmbh

Marburg, 35043, Germany

Location

Universitaets-Hautklinik Eberhard-Karls-Universitaet Tuebingen

Tübingen, 72076, Germany

Location

Azienda Ospedaliero-Universitaria Policlinico Vittorio Emanuele Ospedale Gaspare Rodolico Di Catania

Catania, 95123, Italy

Location

Clinical Research Centre - Cast

Chieti, 66013, Italy

Location

Azienda Sanitaria Locale 1 (Asl 1) - Ospedale Regionale San Salvatore

L’Aquila, 67100, Italy

Location

Uoc Dermatologia Ospedale Maggiore Policlinico, Fondazione Irccs Ca' Granda

Milan, 20122, Italy

Location

Aou Universita Della Campania Luigi Vanvitelli, Azienda Ospedaliero Universitaria Federico Ii Di Nap

Naples, 80131, Italy

Location

Azienda Ospedaliera Di Perugia

Perugia, 06129, Italy

Location

Azienda Ospedaliero Universitaria Pisana - Ospedale S. Chiara

Pisa, 56126, Italy

Location

Catholic University of the Sacred Heart

Rome, 00168, Italy

Location

Irccs Istituto Clinico Humanitas

Rozzano, 20089, Italy

Location

Amsterdam Universitair Medisch Centrum, Locatie Amsterdam Medisch Centrum

Amsterdam, 1105 AZ, Netherlands

Location

Maxima Medisch Centrum

Veldhoven, 5504 DB, Netherlands

Location

Niepubliczny Zaklad Opieki Zdrowotnej Specjalistyczny Osrodek Dermatologiczny Dermal

Bialystok, 15-453, Poland

Location

Uniwersyteckie Centrum Kliniczne

Gdansk, 80-214, Poland

Location

Gyncentrum Sp. Z O.O., Nzoz Holsamed- Oddzial Libero

Katowice, 40-600, Poland

Location

Pro Familia Altera Sp. Z O.O.

Katowice, 40-648, Poland

Location

Centrum Badan Klinicznych, Jagiellonskie Centrum Innowacji Sp.Z.O.O.

Krakow, 30-348, Poland

Location

Diamond Clinic Sp. Z O.O.

Krakow, 31-559, Poland

Location

Niepubliczny Zaklad Opieki Zdrowotnej Med-Laser

Lublin, 20-406, Poland

Location

Mazowieckie Centrum Badan Klinicznych

Pruszków, 05-800, Poland

Location

Laser Clinic

Szczecin, 70-332, Poland

Location

Nzoz Gyncentrum - Oddzial Warszawa

Warsaw, 00-124, Poland

Location

Clinical Research Group Sp. Z.O.O

Warsaw, 01-142, Poland

Location

Centrum Medyczne Evimed

Warsaw, 02-625, Poland

Location

Klinika Ambroziak Sp. Z O.O.

Warsaw, 02-953, Poland

Location

Dermaceum Centrum Badan Klinicznych

Wroclaw, 53-613, Poland

Location

Penta Hospitals Przychodnie, Wroclaw Wejherowska

Wroclaw, 54-239, Poland

Location

Korea University Ansan Hospital

Ansan-si, 15355, South Korea

Location

Soon Chun Hyang University Bucheon Hospital

Bucheon-si, 14584, South Korea

Location

Pusan National University Hospital (Pnuh)

Busan, 49241, South Korea

Location

Pusan National University Yangsan Hospital

Busan, 50612, South Korea

Location

The Catholic University of Korea, Incheon St. Mary'S Hospital

Incheon, 21431, South Korea

Location

Jeonbuk National University Hospital

Jeonju, 54907, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Konkuk University Medical Center

Seoul, 05030, South Korea

Location

Inselspital Bern

Bern, 03010, Switzerland

Location

Dsc Clinic Buochs

Buochs, 06374, Switzerland

Location

Universitatsspital Zurich

Zurich, 08091, Switzerland

Location

Related Links

• A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis (STOP-PN1)

Study Officials

• Incyte Medical Monitor

  Incyte Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: July 24, 2024
• Study Start: October 10, 2024
• Primary Completion (Estimated): October 19, 2026
• Study Completion (Estimated): May 3, 2027
• Last Updated: May 28, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
• 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.

Locations

BU (7); IT (9); AR (7); AU (2); NL (2); FR (8); CA (15); DE (13); CH (3); PL (15); US (31); KR (8)