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Prurigo NodularisPhase 3NCT06516965

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

A Phase 3 study testing Povorcitinib in people with Prurigo Nodularis, run by Incyte Corporation at 119 sites in 11 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
346 participants
Where
119 sitesin 11 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

119 sites in 11 countries.

119 sites in 11 countries

United States28 sites

  • Fivenson Dermatology

    Ann Arbor, Michigan, 48103

  • Center For Clinical and Cosmetic Research

    Aventura, Florida, 33180

  • University of Maryland School of Medicine

    Baltimore, Maryland, 21201

  • Schweiger Dermatology

    Boca Raton, Florida, 33428

  • Metro Boston Clinical Partners

    Brighton, Massachusetts, 02135-3511

  • Aesthetic General Dermatology of Seattle

    Burien, Washington, 98168

  • University of Cincinnati Cancer Institute

    Cincinnati, Ohio, 45267

  • Modern Research Associates Pllc

    Dallas, Texas, 75231

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • First Oc Dermatology Research Inc

    Fountain Valley, California, 92708-3701

  • Schweiger Dermatology

    Hackensack, New Jersey, 07601

  • Direct Helpers Research Center

    Hialeah, Florida, 33012

  • Skin Care Research, Llc

    Hollywood, Florida, 33201

  • Dermatology Specialists Research

    Louisville, Kentucky, 40241

  • Ziaderm Research, Llc

    Miami, Florida, 33162

  • University of Utah Midvalley Dermatology

    Murray, Utah, 84107

  • OPTISKIN

    New York, New York, 10128

  • Central Sooner Research

    Oklahoma City, Oklahoma, 73118

  • Paddington Testing Co Inc

    Philadelphia, Pennsylvania, 19103

  • Medical Dermatology Specialists Phoenix

    Phoenix, Arizona, 85006

  • Allcutis Research, Llc

    Portsmouth, New Hampshire, 03801

  • Dermatology Associates Pc

    Rockville, Maryland, 20850

  • Clinical Science Institute Clinical Research Specialists Inc

    Santa Monica, California, 90404

  • Investigate Md

    Scottsdale, Arizona, 85255

  • Nodal Medical Center, Llc

    Tampa, Florida, 33607

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

    Tampa, Florida, 33609

  • Michigan Dermatology Institute

    Waterford, Michigan, 48328

  • Yardley Dermatology Associates

    Yardley, Pennsylvania, 19067

Other trials in United States

Japan19 sites

  • Tokyo Medical and Dental University Hospital, Faculty of Medicine

    Bunkyō City, 113-8519

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

    Inashiki-gun

  • Noguchi Dermatology Clinic

    Kamimashiki-gun, 861-3101

  • Nippon Medical School Musashikosugi Hospital

    Kawasaki-shi, 211-8533

  • University of Occupational and Environmental Health, Japan

    Kitakyushu, 807-8555

  • Shimizu Dermatology Clinic

    Kobe, 657-0846

  • Aoi Dermatology Clinic

    Kumamoto, 861-2236

  • Dokkyo Medical University Saitama Medical Center

    Minamikoshigaya, 343-8555

  • Central Japan International Medical Center

    Minokamo, 505-8510

  • Niigata University Medical & Dental Hospital

    Niigata, 951-8520

  • Medical Corporation Jun Dermatology Clinic

    Osaka, 558-0003

  • Tanpopo Dermatology Clinic

    Ōta-ku, 143-0023

  • Kume Derma Clinic

    Sakai, 593-8324

  • Sapporo Skin Clinic

    Sapporo, 600063

  • Tohoku University Hospital

    Sendai, 980-8574

  • Tokyo Medical University Hospital

    Shinjuku-ku, 160-0023

  • National Defense Medical College Hospital

    Tokorozawa, 359-0042

  • Queen'S Square Medical Facilities

    Yokohama, 220-6208

  • Nomura Dermatology Clinic

    Yokohama, 221-0825

Other trials in Japan

Germany14 sites

  • University Hospital Rwth Aachen

    Aachen, 52074

  • Elbe Kliniken Buxtehude

    Buxtehude, 21614

  • Drk Krankenhaus Chemnitz-Rabenstein

    Chemnitz, 09117

  • Klinikum Darmstadt

    Darmstadt, 64283

  • Rosenpark Research Gmbh

    Darmstadt, 64283

  • University Hospital Carl Gustav Carus

    Dresden, 01307

  • Klinikum Der Johann Wolfgang Goethe-Universitaet

    Frankfurt am Main, 60590

  • Universitaetsmedizin Goettingen

    Göttingen, 37075

  • Magdeburger Company For Medical Studies and Services Gmbh

    Magdeburg, 39104

  • Dermatologische Gemeinschaftspraxis Dres. Quist

    Mainz, 55128

  • Technischen Universitaet Muenchen

    München, 80802

  • University Hospital Muenster

    Münster, 48149

  • Klinikum Oldenburg Aor

    Oldenburg, 26133

  • Hautarztpraxis Dr. Hoffmann

    Witten, 58453

Other trials in Germany

Spain13 sites

  • Hospital General Universitario Dr Balmis

    Alicante, 03010

  • Hospital Universitari Germans Trias I Pujol (Hugtp)

    Badalona, 08916

  • Hospital de La Santa Creu I Sant Pau

    Barcelona, 08041

  • Hospital Universitario Reina Sofia

    Córdoba, 14004

  • Hospital Clinico Universitario San Cecilio

    Granada, 18016

  • Hospital Universitario Ramon Y Cajal

    Madrid, 28034

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Universitario Puerta de Hierro de Majadahonda

    Majadahonda, 28222

  • Hospital de Manises

    Manises, 46940

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

    Santiago de Compostela, 15706

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013

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

    Valencia, 46026

Other trials in Spain

Poland12 sites

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

    Gdansk, 80-280

  • Care Clinic Sp. Z O.O.

    Katowice, 40-568

  • Santa Familia Ptg Lodz

    Lodz, 90-302

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

    Lodz, 90-436

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

    Lublin, 20-573

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

    Poznan, 61-731

  • Uniwersytecki Szpital Kliniczny Im. Fryderyka Chopina W Rzeszowie

    Rzeszów, 35-055

  • Mics Centrum Medyczne Torun

    Torun, 87-100

  • High-Med. Przychodnia Specjalistyczna

    Warsaw, 01-817

  • Panstwowy Instytut Medyczny Mswia

    Warsaw, 02-507

  • Royalderm Agnieszka Nawrocka

    Warsaw, 02-692

  • Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spolka Partnerska

    Wroclaw, 50566

Other trials in Poland

Canada8 sites

  • Simcoderm Medical and Surgical Dermatology Centre

    Barrie, Ontario, L4M 7G1

  • Skin Physicians

    Edmonton, Alberta, T6W 4V4

  • Alpha Research-Lucere Dermatology and Laser Clinic

    Edmonton, Alberta, T6X 0N9

  • Dermeffects

    London, Ontario, N6H 5L5

  • Centre de Recherche Saint-Louis

    Québec, Quebec, G1W 4R4

  • Skinsense Medical Research

    Saskatoon, Saskatchewan, S7K 2C1

  • North York Research Inc.

    Toronto, Ontario, M2N 3A6

  • Toronto Research Centre

    Toronto, Ontario, M3H 5Y8

Other trials in Canada

Australia7 sites

  • Novatrials

    Charlestown, New South Wales, 02290

  • Fremantle Dermatology

    Fremantle, 06160

  • Premier Specialists Pty Ltd

    Kogarah, New South Wales, 02217

  • The Alfred Hospital

    Melbourne, Victoria, 03004

  • Skin & Cancer Foundation Australia

    Sydney, New South Wales, 02010

  • Westmead Hospital

    Westmead, New South Wales, 02145

  • Veracity Clinical Research Pty Ltd

    Woolloongabba, Queensland, 04102

Other trials in Australia

United Kingdom7 sites

  • The Dudley Group Nhs Foundation Trust

    Dudley, DY1 2HQ

  • Ipswich Hospital, East Suffolk and North Essex Nhs Foundation Trust

    Ipswich, IP4 5PD

  • Broadgreen Hospital - Liverpool University Hospitals Nhs Foundation Trust

    Liverpool, L14 3LB

  • The Royal London Hospital - Barts Health Nhs Trust

    London, E1 1FR

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

    London, SE1 9RT

  • Poole Hospital - University Hospitals Dorset Nhs Foundation Trust

    Poole, BH15 2JB

  • Surrey and Sussex Healthcare Nhs Trust - East Surrey Hospital

    Redhill

Other trials in United Kingdom

Belgium5 sites

  • Az Sint-Jan Brugge Av

    Bruges, 08000

  • Universitair Ziekenhuis Gent (Uz Gent)

    Ghent, 09000

  • Grand Hopital de Charleroi - Site Imtr

    Gilly, 06060

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

    Liège, 04000

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

    Woluwe-Saint-Lambert, 01200

Other trials in Belgium

Chile3 sites

  • Centro Medico Skinmed Limitada

    Santiago, 7580206

  • Centro Internacional de Estudios Clinicos

    Santiago, 8420383

  • Clinical Research Chile Spa.

    Valdivia, 5090000

Other trials in Chile

Czechia3 sites

  • Clintrial S.R.O.

    Prague, 100 00

  • Sanatorium Profesora Arenbergera

    Prague, 110 00

  • Sanixtra Prague

    Prague, 158 00

Other trials in Czechia

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 NCT06516965
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
346 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06516965
Sponsor's protocol ID
INCB54707-306
Other IDs
2024-511881-35-00
Status last verified
Apr 2026
First submitted
18 Jul 2024
Last updated
14 Apr 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 119 sites in 11 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 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 119 sites in United States, Japan, Germany, Spain, Poland and 6 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 NCT06516965.

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 14 Apr 2026.

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