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

NCT06516965 | Active Not Recruiting Phase 3 FDA Drug

• 2 other identifiers: INCB54707-3062024-511881-35-00
• Study Type: interventional
• Target: 346
• Locations: 11 countries
• Sites: 119

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 (119)

Medical Dermatology Specialists Phoenix

Phoenix, Arizona, 85006, United States

Location

Investigate Md

Scottsdale, Arizona, 85255, United States

Location

First Oc Dermatology Research Inc

Fountain Valley, California, 92708-3701, United States

Location

Clinical Science Institute Clinical Research Specialists Inc

Santa Monica, California, 90404, United States

Location

Center For Clinical and Cosmetic Research

Aventura, Florida, 33180, United States

Location

Schweiger Dermatology

Boca Raton, Florida, 33428, United States

Location

Direct Helpers Research Center

Hialeah, Florida, 33012, United States

Location

Skin Care Research, Llc

Hollywood, Florida, 33201, United States

Location

Ziaderm Research, Llc

Miami, Florida, 33162, United States

Location

Nodal Medical Center, Llc

Tampa, Florida, 33607, United States

Location

Trueblue Clinical Research Moore Clinical Research, Inc McR Tampa Clinic Location

Tampa, Florida, 33609, United States

Location

Dermatology Specialists Research

Louisville, Kentucky, 40241, United States

Location

University of Maryland School of Medicine

Baltimore, Maryland, 21201, United States

Location

Dermatology Associates Pc

Rockville, Maryland, 20850, United States

Location

Metro Boston Clinical Partners

Brighton, Massachusetts, 02135-3511, United States

Location

Fivenson Dermatology

Ann Arbor, Michigan, 48103, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Michigan Dermatology Institute

Waterford, Michigan, 48328, United States

Location

Allcutis Research, Llc

Portsmouth, New Hampshire, 03801, United States

Location

Schweiger Dermatology

Hackensack, New Jersey, 07601, United States

Location

OPTISKIN

New York, New York, 10128, United States

Location

University of Cincinnati Cancer Institute

Cincinnati, Ohio, 45267, United States

Location

Central Sooner Research

Oklahoma City, Oklahoma, 73118, United States

Location

Paddington Testing Co Inc

Philadelphia, Pennsylvania, 19103, United States

Location

Yardley Dermatology Associates

Yardley, Pennsylvania, 19067, United States

Location

Modern Research Associates Pllc

Dallas, Texas, 75231, United States

Location

University of Utah Midvalley Dermatology

Murray, Utah, 84107, United States

Location

Aesthetic General Dermatology of Seattle

Burien, Washington, 98168, United States

Location

Novatrials

Charlestown, New South Wales, 02290, Australia

Location

Premier Specialists Pty Ltd

Kogarah, New South Wales, 02217, Australia

Location

Skin & Cancer Foundation Australia

Sydney, New South Wales, 02010, Australia

Location

Westmead Hospital

Westmead, New South Wales, 02145, Australia

Location

Veracity Clinical Research Pty Ltd

Woolloongabba, Queensland, 04102, Australia

Location

The Alfred Hospital

Melbourne, Victoria, 03004, Australia

Location

Fremantle Dermatology

Fremantle, 06160, Australia

Location

Az Sint-Jan Brugge Av

Bruges, 08000, Belgium

Location

Universitair Ziekenhuis Gent (Uz Gent)

Ghent, 09000, Belgium

Location

Grand Hopital de Charleroi - Site Imtr

Gilly, 06060, Belgium

Location

Centre Hospitalier Universitaire (Chu) de Liege - Domaine Universitaire Du Sart Tilman

Liège, 04000, Belgium

Location

Universite Catholique de Louvain (Ucl) - Cliniques Universitaires Saint-Luc

Woluwe-Saint-Lambert, 01200, Belgium

Location

Skin Physicians

Edmonton, Alberta, T6W 4V4, Canada

Location

Alpha Research-Lucere Dermatology and Laser Clinic

Edmonton, Alberta, T6X 0N9, Canada

Location

Simcoderm Medical and Surgical Dermatology Centre

Barrie, Ontario, L4M 7G1, 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 Saint-Louis

Québec, Quebec, G1W 4R4, Canada

Location

Skinsense Medical Research

Saskatoon, Saskatchewan, S7K 2C1, Canada

Location

Centro Medico Skinmed Limitada

Santiago, 7580206, Chile

Location

Centro Internacional de Estudios Clinicos

Santiago, 8420383, Chile

Location

Clinical Research Chile Spa.

Valdivia, 5090000, Chile

Location

Clintrial S.R.O.

Prague, 100 00, Czechia

Location

Sanatorium Profesora Arenbergera

Prague, 110 00, Czechia

Location

Sanixtra Prague

Prague, 158 00, Czechia

Location

University Hospital Rwth Aachen

Aachen, 52074, Germany

Location

Elbe Kliniken Buxtehude

Buxtehude, 21614, Germany

Location

Drk Krankenhaus Chemnitz-Rabenstein

Chemnitz, 09117, Germany

Location

Klinikum Darmstadt

Darmstadt, 64283, Germany

Location

Rosenpark Research Gmbh

Darmstadt, 64283, Germany

Location

University Hospital Carl Gustav Carus

Dresden, 01307, Germany

Location

Klinikum Der Johann Wolfgang Goethe-Universitaet

Frankfurt am Main, 60590, Germany

Location

Universitaetsmedizin Goettingen

Göttingen, 37075, Germany

Location

Magdeburger Company For Medical Studies and Services Gmbh

Magdeburg, 39104, Germany

Location

Dermatologische Gemeinschaftspraxis Dres. Quist

Mainz, 55128, Germany

Location

Technischen Universitaet Muenchen

München, 80802, Germany

Location

University Hospital Muenster

Münster, 48149, Germany

Location

Klinikum Oldenburg Aor

Oldenburg, 26133, Germany

Location

Hautarztpraxis Dr. Hoffmann

Witten, 58453, Germany

Location

Tokyo Medical and Dental University Hospital, Faculty of Medicine

Bunkyō City, 113-8519, Japan

Location

Tokyo Medical University Ibaraki Medical Center - Kasumigaura Campus (Tokyo Medical University Kasum

Inashiki-gun, Japan

Location

Noguchi Dermatology Clinic

Kamimashiki-gun, 861-3101, Japan

Location

Nippon Medical School Musashikosugi Hospital

Kawasaki-shi, 211-8533, Japan

Location

University of Occupational and Environmental Health, Japan

Kitakyushu, 807-8555, Japan

Location

Shimizu Dermatology Clinic

Kobe, 657-0846, Japan

Location

Aoi Dermatology Clinic

Kumamoto, 861-2236, Japan

Location

Dokkyo Medical University Saitama Medical Center

Minamikoshigaya, 343-8555, Japan

Location

Central Japan International Medical Center

Minokamo, 505-8510, Japan

Location

Niigata University Medical & Dental Hospital

Niigata, 951-8520, Japan

Location

Medical Corporation Jun Dermatology Clinic

Osaka, 558-0003, Japan

Location

Tanpopo Dermatology Clinic

Ōta-ku, 143-0023, Japan

Location

Kume Derma Clinic

Sakai, 593-8324, Japan

Location

Sapporo Skin Clinic

Sapporo, 600063, Japan

Location

Tohoku University Hospital

Sendai, 980-8574, Japan

Location

Tokyo Medical University Hospital

Shinjuku-ku, 160-0023, Japan

Location

National Defense Medical College Hospital

Tokorozawa, 359-0042, Japan

Location

Queen'S Square Medical Facilities

Yokohama, 220-6208, Japan

Location

Nomura Dermatology Clinic

Yokohama, 221-0825, Japan

Location

Akk Medical Sp. Z O.O. - Centrum Medyczne Tu Sie Leczy

Gdansk, 80-280, Poland

Location

Care Clinic Sp. Z O.O.

Katowice, 40-568, Poland

Location

Santa Familia Ptg Lodz

Lodz, 90-302, Poland

Location

Dermoklinika Centrum Medyczne S.C., M. Kierstan, J. Narbutt, A. Lesiak

Lodz, 90-436, Poland

Location

Luxderm Specjalistyczny Gabinet Dermatologiczny Prof. Dr. Hab. N. Med. Dorota Krasowska

Lublin, 20-573, Poland

Location

Clinical Research Center Spolka Z Ograniczona Odpowiedzialnoscia Medic-R Spolka Komandytowa

Poznan, 61-731, Poland

Location

Uniwersytecki Szpital Kliniczny Im. Fryderyka Chopina W Rzeszowie

Rzeszów, 35-055, Poland

Location

Mics Centrum Medyczne Torun

Torun, 87-100, Poland

Location

High-Med. Przychodnia Specjalistyczna

Warsaw, 01-817, Poland

Location

Panstwowy Instytut Medyczny Mswia

Warsaw, 02-507, Poland

Location

Royalderm Agnieszka Nawrocka

Warsaw, 02-692, Poland

Location

Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spolka Partnerska

Wroclaw, 50566, Poland

Location

Hospital General Universitario Dr Balmis

Alicante, 03010, Spain

Location

Hospital Universitari Germans Trias I Pujol (Hugtp)

Badalona, 08916, Spain

Location

Hospital de La Santa Creu I Sant Pau

Barcelona, 08041, Spain

Location

Hospital Universitario Reina Sofia

Córdoba, 14004, Spain

Location

Hospital Clinico Universitario San Cecilio

Granada, 18016, Spain

Location

Hospital Universitario Ramon Y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Universitario Puerta de Hierro de Majadahonda

Majadahonda, 28222, Spain

Location

Hospital de Manises

Manises, 46940, Spain

Location

Area Sanitaria de Santiago de Compostela Y Barbanza - Complejo Hospitalario Universitario de Santiag

Santiago de Compostela, 15706, Spain

Location

Hospital Universitario Virgen Del Rocio

Seville, 41013, Spain

Location

Universitat de Valencia - Hospital Universitari I Politecnic La Fe de Valencia (Hospital La Fe Bulev

Valencia, 46026, Spain

Location

The Dudley Group Nhs Foundation Trust

Dudley, DY1 2HQ, United Kingdom

Location

Ipswich Hospital, East Suffolk and North Essex Nhs Foundation Trust

Ipswich, IP4 5PD, United Kingdom

Location

Broadgreen Hospital - Liverpool University Hospitals Nhs Foundation Trust

Liverpool, L14 3LB, United Kingdom

Location

The Royal London Hospital - Barts Health Nhs Trust

London, E1 1FR, United Kingdom

Location

Guy'S Hospital - Guy'S & St Thomas' Nhs Foundation Trust

London, SE1 9RT, United Kingdom

Location

Poole Hospital - University Hospitals Dorset Nhs Foundation Trust

Poole, BH15 2JB, United Kingdom

Location

Surrey and Sussex Healthcare Nhs Trust - East Surrey Hospital

Redhill, United Kingdom

Location

Related Links

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

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: April 14, 2026

Record last verified: 2026-04

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

JP (19); GB (7); PL (12); BE (5); DE (14); CA (8); ES (13); US (28); CL (3); AU (7); CZ (3)