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

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

NCT06516965

Run by

Incyte Corporation

People needed

346

Starts

2024-10-10

Expected to finish

2027-05-03

Last updated by the study team

2026-04-14

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

• Investigate Md — Scottsdale, Arizona, United States
• First Oc Dermatology Research Inc — Fountain Valley, California, United States
• Clinical Science Institute Clinical Research Specialists Inc — Santa Monica, California, United States
• Center For Clinical and Cosmetic Research — Aventura, Florida, United States
• Schweiger Dermatology — Boca Raton, Florida, United States
• Direct Helpers Research Center — Hialeah, Florida, United States
• Skin Care Research, Llc — Hollywood, Florida, United States
• Ziaderm Research, Llc — Miami, Florida, United States
• Nodal Medical Center, Llc — Tampa, Florida, United States
• Trueblue Clinical Research Moore Clinical Research, Inc McR Tampa Clinic Location — Tampa, Florida, United States
• Dermatology Specialists Research — Louisville, Kentucky, United States
• University of Maryland School of Medicine — Baltimore, Maryland, United States
• Dermatology Associates Pc — Rockville, Maryland, United States
• Metro Boston Clinical Partners — Brighton, Massachusetts, United States
• Fivenson Dermatology — Ann Arbor, Michigan, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Michigan Dermatology Institute — Waterford, Michigan, United States
• Allcutis Research, Llc — Portsmouth, New Hampshire, United States
• Schweiger Dermatology — Hackensack, New Jersey, United States
• OPTISKIN — New York, New York, United States
• University of Cincinnati Cancer Institute — Cincinnati, Ohio, United States
• Central Sooner Research — Oklahoma City, Oklahoma, United States
• Paddington Testing Co Inc — Philadelphia, Pennsylvania, United States
• Yardley Dermatology Associates — Yardley, Pennsylvania, United States
• Medical Dermatology Specialists Phoenix — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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