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Prurigo NodularisPhase 3NCT06516952

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

A Phase 3 study testing Povorcitinib in people with Prurigo Nodularis, run by Incyte Corporation at 120 sites in 12 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Prurigo Nodularis
What is being tested?
Povorcitinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
349 participants
Where
120 sitesin 12 countries
Study dates
10 Oct 2024to 3 May 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

120 sites in 12 countries.

120 sites in 12 countries

United States31 sites

  • The University of New Mexico Unm Health Sciences Center Hsc

    Albuquerque, New Mexico, 87131

  • Oakland Hills Dermatology

    Auburn Hills, Michigan, 48326

  • Cahaba Dermatology

    Birmingham, Alabama, 35244

  • Rendon Center the Dermatology and Aesthetic Center

    Boca Raton, Florida, 33486

  • Illinois Dermatology Institute the Chicago Loop

    Chicago, Illinois, 60602

  • Chicago Cosmetic Surgery and Dermatology

    Chicago, Illinois, 60654

  • Center For Medical Dermatology and Immunology Research

    Chicago, Illinois, 60657

  • Dermatology Specialists Research Indiana

    Clarksville, Indiana, 47129

  • Centricity Research Columbus

    Columbus, Ohio, 43213

  • Driven Research Llc

    Coral Gables, Florida, 33134

  • Dermatology Treatment and Research Center

    Dallas, Texas, 75230

  • Wright State Physicians Health Center

    Dayton, Ohio, 45324

  • Montefiore Medical Center

    East Syracuse, New York, 13057

  • Premier Dermatology Clinical Trials Institute At Northwest Arkansas

    Fayetteville, Arkansas, 72703

  • Hamzavi Dermatology

    Fort Gratiot, Michigan, 48059

  • Burke Pharmaceutical Research

    Hot Springs, Arkansas, 71913

  • Dermatology Research Associates

    Los Angeles, California, 90045

  • University of Miami Miller School of Medicine

    Miami, Florida, 33136

  • Frontier Dermatology

    Mill Creek, Washington, 98012

  • International Clinical Research Tennessee Llc

    Murfreesboro, Tennessee, 37130

  • Skin Center Dermatology Group

    New York, New York, 10956

  • Northridge

    Northridge, California, 91325

  • Medisearch Clinical Trials

    Saint Joseph, Missouri, 64506

  • Northshore University Healthsystem

    Skokie, Illinois, 60077

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Stony Brook Dermatology Associates

    Stony Brook, New York, 11790

  • Sweetwater Dermatology

    Sugar Land, Texas, 77479

  • Somerset Skin Centre

    Troy, Michigan, 48084

  • Banner - University Medicine Multispecialty Services Clinic

    Tucson, Arizona, 85718

  • Center For Clinical Studies

    Webster, Texas, 77598

  • Research Institute of the Southeast, Llc

    West Palm Beach, Florida, 33401

Other trials in United States

Canada15 sites

  • Simcoderm Medical and Surgical Dermatology Centre

    Barrie, Ontario, L4M 7G1

  • Dermatology Research Institute

    Calgary, Alberta, T2J 7E1

  • Skin Health

    Cobourg, Ontario, K9A 0Z4

  • Rao Dermatology

    Edmonton, Alberta, T6G 1C3

  • Skin Physicians

    Edmonton, Alberta, T6W 4V4

  • Alpha Research-Lucere Dermatology and Laser Clinic

    Edmonton, Alberta, T6X 0N9

  • Centricity Research London Victoria Multispecialty

    London, Ontario, N6A 2C2

  • Dermeffects

    London, Ontario, N6H 5L5

  • Centre de Recherche Dermatologique de Quebec

    Québec, Quebec, G1V4X7

  • Centre de Recherche Saint-Louis

    Québec, Quebec, G1W 4R4

  • Skinsense Medical Research

    Saskatoon, Saskatchewan, S7K 2C1

  • Park Dermatology

    Sherwood Park, Alberta, T8H 0P1

  • North York Research Inc.

    Toronto, Ontario, M2N 3A6

  • Toronto Research Centre

    Toronto, Ontario, M3H 5Y8

  • Sima Recherche

    Verdun, Quebec, H4G 3E7

Other trials in Canada

Poland15 sites

  • Niepubliczny Zaklad Opieki Zdrowotnej Specjalistyczny Osrodek Dermatologiczny Dermal

    Bialystok, 15-453

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-214

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

    Katowice, 40-600

  • Pro Familia Altera Sp. Z O.O.

    Katowice, 40-648

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

    Krakow, 30-348

  • Diamond Clinic Sp. Z O.O.

    Krakow, 31-559

  • Niepubliczny Zaklad Opieki Zdrowotnej Med-Laser

    Lublin, 20-406

  • Mazowieckie Centrum Badan Klinicznych

    Pruszków, 05-800

  • Laser Clinic

    Szczecin, 70-332

  • Nzoz Gyncentrum - Oddzial Warszawa

    Warsaw, 00-124

  • Clinical Research Group Sp. Z.O.O

    Warsaw, 01-142

  • Centrum Medyczne Evimed

    Warsaw, 02-625

  • Klinika Ambroziak Sp. Z O.O.

    Warsaw, 02-953

  • Dermaceum Centrum Badan Klinicznych

    Wroclaw, 53-613

  • Penta Hospitals Przychodnie, Wroclaw Wejherowska

    Wroclaw, 54-239

Other trials in Poland

Germany13 sites

  • Aachen University Hospital

    Aachen, 52074

  • Fachklinik Bad Bentheim

    Bad Bentheim, 48455

  • Hautzentrum Friedrichshain Studien

    Berlin, 10247

  • Charite Universitatsmedizin Berlin

    Berlin, 12203

  • Klinikum Dortmund Ggmbh

    Dortmund, 44137

  • Universitaetsklinik Und Poliklinik Fuer Dermatologie Und Venerologie

    Halle, 06120

  • Universitaetsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • Universitatsklinik Heidelberg

    Heidelberg, 69115

  • Universitaetsklinikum Leipzig

    Leipzig, 04103

  • Universitaetsklinikum Schleswig-Holstein (Uksh) - Campus Luebeck

    Lübeck, 23538

  • Universitaetsmedizin Der Johannes - Gutenberg Universitaet Mainz

    Mainz, 55131

  • Universitaetsklinikum Giessen Und Marburg Gmbh

    Marburg, 35043

  • Universitaets-Hautklinik Eberhard-Karls-Universitaet Tuebingen

    Tübingen, 72076

Other trials in Germany

Italy9 sites

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

    Catania, 95123

  • Clinical Research Centre - Cast

    Chieti, 66013

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

    L’Aquila, 67100

  • Uoc Dermatologia Ospedale Maggiore Policlinico, Fondazione Irccs Ca' Granda

    Milan, 20122

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

    Naples, 80131

  • Azienda Ospedaliera Di Perugia

    Perugia, 06129

  • Azienda Ospedaliero Universitaria Pisana - Ospedale S. Chiara

    Pisa, 56126

  • Catholic University of the Sacred Heart

    Rome, 00168

  • Irccs Istituto Clinico Humanitas

    Rozzano, 20089

Other trials in Italy

France8 sites

  • Hopital Prive D Antony

    Antony, 92160

  • Hospital Morvan

    Brest, 29200

  • Cabinet Medical- Chemin de Paradis

    Martigues, 13500

  • Ghrmsa Hopital Emile Muller

    Mulhouse, 68100

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

    Nantes, 44093

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

    Paris, 75010

  • Hopitaux Drome Nord - Site de Romans Sur Isere

    Romans-sur-Isère, 26102

  • Hopital Larrey

    Toulouse, 31400

Other trials in France

South Korea8 sites

  • Korea University Ansan Hospital

    Ansan-si, 15355

  • Soon Chun Hyang University Bucheon Hospital

    Bucheon-si, 14584

  • Pusan National University Hospital (Pnuh)

    Busan, 49241

  • Pusan National University Yangsan Hospital

    Busan, 50612

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

    Incheon, 21431

  • Jeonbuk National University Hospital

    Jeonju, 54907

  • Seoul National University Hospital

    Seoul, 03080

  • Konkuk University Medical Center

    Seoul, 05030

Other trials in South Korea

Argentina7 sites

  • Conexa Investigacion Clinica S.A.

    Buenos Aires, 01012

  • Cedic - Centro de Investigacion Clinica

    Buenos Aires, C1060ABN

  • Instituto de Neumonologia Y Dermatologia

    Buenos Aires, C1425BEA

  • Instituto de Investigaciones En Alergia Y Enfermedades Respiratorias (Inaer)

    Buenos Aires, C1425BEN

  • Centro de Investigaciones Medicas Mar Del Plata

    Mar del Plata, B7600FYK

  • Instituto Especialidades de La Salud Rosario - Clinica Del Torax

    Rosario, S2000

  • Investigaciones Reumatologicas Tucuman S.R.L.

    San Miguel de Tucumán, T4000AXL

Other trials in Argentina

Bulgaria7 sites

  • Medical Center Medconsult Pleven

    Lovech, 05500

  • Medical Center Medconsult Pleven Ood

    Pleven, 05800

  • Diagnostic-Consultative Centre Pulmed Eood

    Plovdiv, 04002

  • Medical Center Prolet Eood

    Rousse, 07000

  • Medical Center Unimed Eood

    Sevlievo, 05400

  • Diagnostic-Consultative Center Ascendent Eood

    Sofia, 01202

  • Diagnostic-Consultative Center Aleksandrovska Eood

    Sofia, 01431

Other trials in Bulgaria

Switzerland3 sites

  • Inselspital Bern

    Bern, 03010

  • Dsc Clinic Buochs

    Buochs, 06374

  • Universitatsspital Zurich

    Zurich, 08091

Other trials in Switzerland

Austria2 sites

  • Medical University Graz University Clinic For Dermatology and Venerology

    Graz, 08036

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

    Vienna, 01130

Other trials in Austria

Netherlands2 sites

  • Amsterdam Universitair Medisch Centrum, Locatie Amsterdam Medisch Centrum

    Amsterdam, 1105 AZ

  • Maxima Medisch Centrum

    Veldhoven, 5504 DB

Other trials in Netherlands

About this study

Official title: 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.

Being tested
Povorcitinib, Placebo
Keywords
Prurigo nodularis, PN, INCB054707, chronic pruritus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PovorcitinibDrug

    Also called INCB054707

    Oral Tablet

  • PlaceboDrug

    Oral Tablet

Study groups in NCT06516952
Study groupRoleWhat they receive
Povorcitinib Dose 1ExperimentalPovorcitinib at the protocol-defined dose.
Receives: Drug: Povorcitinib
Povorcitinib Dose 2ExperimentalPovorcitinib at the protocol-defined dose.
Receives: Drug: Povorcitinib
PlaceboPlacebo comparatorPlacebo at the protocol-defined dose.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Week 24

Secondary outcomes (24)

  1. 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.

    Measured: Week 24

  2. 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.

    Measured: Week 24

  3. 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.

    Measured: Week 4

  4. Time to Itch NRS4

    Defined as time taken for the participant to achieve a ≥4 improvement in Itch NRS score from baseline.

    Measured: Up to 52 weeks

  5. 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".

    Measured: Up to 52 weeks

  6. 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".

    Measured: Up to 52 weeks

  7. 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.

    Measured: Up to 52 weeks

  8. 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.

    Measured: Up to 52 weeks

  9. 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.

    Measured: Up to 52 weeks

  10. 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.

    Measured: Up to 52 weeks

  11. 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.

    Measured: Up to 52 weeks

  12. 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.

    Measured: Up to 52 weeks

  13. 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.

    Measured: Up to 52 weeks

  14. 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.

    Measured: Up to 52 weeks

  15. 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".

    Measured: Up to 52 weeks

  16. 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".

    Measured: Up to 52 weeks

  17. 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).

    Measured: Up to 52 weeks

  18. 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).

    Measured: Up to 52 weeks

  19. 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.

    Measured: Up to 52 weeks

  20. 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.

    Measured: Up to 52 weeks

  21. 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.

    Measured: Up to 52 weeks

  22. 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.

    Measured: Up to 52 weeks

  23. 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.

    Measured: Up to 52 weeks

  24. 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.

    Measured: Up to 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2024
  2. Study start10 Oct 2024
  3. Primary completion19 Oct 2026 (estimated)
  4. Study completion3 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
349 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06516952
Sponsor's protocol ID
INCB54707-305
Other IDs
2024-511879-16-00
Status last verified
May 2026
First submitted
18 Jul 2024
Last updated
28 May 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Povorcitinib in people with Prurigo Nodularis, run by Incyte Corporation at 120 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 120 sites in United States, Canada, Poland, Germany, Italy and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants achieving Itch NRS4 and IGA-CPG-S-TS at Week 24 (time frame: Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06516952.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.

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