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

RECRUITINGPHASE3

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

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis

NCT06516952•Incyte Corporation

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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.

Locations (121)

Cahaba Dermatology

Birmingham, Alabama, United States

Banner - University Medicine Multispecialty Services Clinic

Tucson, Arizona, United States

Premier Dermatology Clinical Trials Institute At Northwest Arkansas

Fayetteville, Arkansas, United States

Burke Pharmaceutical Research

Hot Springs, Arkansas, United States

Dermatology Research Associates

Los Angeles, California, United States

Northridge

Northridge, California, United States

Rendon Center the Dermatology and Aesthetic Center

Boca Raton, Florida, United States

Driven Research Llc

Coral Gables, Florida, United States

University of Miami Miller School of Medicine

Miami, Florida, United States

Research Institute of the Southeast, Llc

West Palm Beach, Florida, United States

Key Dates

Start Date

October 10, 2024

Primary Completion Date

October 19, 2026

Completion Date

May 3, 2027

Last Updated

March 16, 2026

Enrollment

330

ESTIMATED participants

Conditions

Prurigo Nodularis

Interventions

Povorcitinib

DRUG

Placebo

DRUG

Contacts

Incyte Corporation Call Center (US)

CONTACT

1.855.463.3463 medinfo@incyte.com

Incyte Corporation Call Center (ex-US)

CONTACT

+800 00027423 eumedinfo@incyte.com

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Healthy ParticipantsHealthy Subjects+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 16, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035 in Healthy Participants and in Adults With Autoimmune Dermatological Diseases

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