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Not recruiting
Phase 3

Povorcitinib

Sponsor:

Incyte Corporation

Code:

NCT06516965

Conditions

Prurigo Nodularis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Povorcitinib

Placebo

Study Details

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

Study ID

NCT06516965

Start date

Oct 10, 2024

Status verified date

Apr, 2026

Completion date

May 3, 2027

Anticipated

Primary completion date

Oct 19, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

330 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Povorcitinib Dose 1

Povorcitinib at the protocol-defined dose.

experimental: Povorcitinib Dose 2

Povorcitinib at the protocol-defined dose.

placebo comparator: Placebo

Placebo at the protocol-defined dose.

Interventions

Povorcitinib

Oral Tablet

Placebo

Oral Tablet

Primary outcome measure

  • Proportion of participants achieving Itch NRS4 and IGA-CPG-S-TS at Week 24 [ Time Frame: Week 24 ]

Central Contacts and Locations

Central contacts

Incyte Corporation Call Center (US)

1.855.463.3463medinfo@incyte.com

Incyte Corporation Call Center (ex-US)

+800 00027423eumedinfo@incyte.com

Locations

Medical Dermatology Specialists Phoenix

Recruiting

Phoenix, Arizona, United States, 85006

First Oc Dermatology Research Inc

Recruiting

Fountain Valley, California, United States, 92708-3701

Clinical Science Institute Clinical Research Specialists Inc

Recruiting

Santa Monica, California, United States, 90404

Schweiger Dermatology

Recruiting

Boca Raton, Florida, United States, 33428

Direct Helpers Research Center

Recruiting

Hialeah, Florida, United States, 33012

Skin Care Research, Llc

Recruiting

Hollywood, Florida, United States, 33201

Ziaderm Research, Llc

Recruiting

Miami, Florida, United States, 33162

Nodal Medical Center, Llc

Recruiting

Tampa, Florida, United States, 33607

University of Maryland School of Medicine

Recruiting

Baltimore, Maryland, United States, 21201

Fivenson Dermatology

Recruiting

Ann Arbor, Michigan, United States, 48103

Henry Ford Health System

Recruiting

Detroit, Michigan, United States, 48202

Michigan Dermatology Institute

Recruiting

Waterford, Michigan, United States, 48328

OPTISKIN

Recruiting

New York, New York, United States, 10128

University of Cincinnati Cancer Institute

Recruiting

Cincinnati, Ohio, United States, 45267

Central Sooner Research

Recruiting

Oklahoma City, Oklahoma, United States, 73118

Paddington Testing Co Inc

Recruiting

Philadelphia, Pennsylvania, United States, 19103

Aesthetic General Dermatology of Seattle

Recruiting

Burien, Washington, United States, 98168

Skin Physicians

Recruiting

Edmonton, Alberta, Canada, T6W 4V4

Simcoderm Medical and Surgical Dermatology Centre

Recruiting

Barrie, Ontario, Canada, L4M 7G1

Dermeffects

Recruiting

London, Ontario, Canada, N6H 5L5

North York Research Inc.

Recruiting

Toronto, Ontario, Canada, M2N 3A6

Centre de Recherche Saint-Louis

Recruiting

Québec, Quebec, Canada, G1W 4R4

Skinsense Medical Research

Recruiting

Saskatoon, Saskatchewan, Canada, S7K 2C1

More Information

Sponsor

Incyte Corporation

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Keywords

  • Prurigo nodularis
  • PN
  • INCB054707
  • chronic pruritus

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-02. This information was provided to ClinicalTrials.gov by Incyte Corporation on 2026-04-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.