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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Prurigo Nodularis

In brief

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

Key facts

Study ID

NCT06516952

Run by

Incyte Corporation

People needed

349

Starts

2024-10-10

Expected to finish

2027-05-03

Last updated by the study team

2026-05-28

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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.
• Other protocol-defined Inclusion/Exclusion Criteria apply.

Where it is running

• 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
• Illinois Dermatology Institute the Chicago Loop — Chicago, Illinois, United States
• Chicago Cosmetic Surgery and Dermatology — Chicago, Illinois, United States
• Center For Medical Dermatology and Immunology Research — Chicago, Illinois, United States
• Northshore University Healthsystem — Skokie, Illinois, United States
• Dermatology Specialists Research Indiana — Clarksville, Indiana, United States
• Oakland Hills Dermatology — Auburn Hills, Michigan, United States
• Hamzavi Dermatology — Fort Gratiot, Michigan, United States
• Somerset Skin Centre — Troy, Michigan, United States
• Medisearch Clinical Trials — Saint Joseph, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• The University of New Mexico Unm Health Sciences Center Hsc — Albuquerque, New Mexico, United States
• Montefiore Medical Center — East Syracuse, New York, United States
• Skin Center Dermatology Group — New York, New York, United States
• Stony Brook Dermatology Associates — Stony Brook, New York, United States
• Centricity Research Columbus — Columbus, Ohio, United States
• Cahaba Dermatology — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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