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

Active Not RecruitingPhase 3

Sponsor: Incyte Corporation

Conditions: Prurigo Nodularis

Interventions: Povorcitinib, Placebo

Countries: United States, Australia, Belgium, Canada, Chile, Czechia, Germany, Japan

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

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (119)

Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Fountain Valley, California, United States
Santa Monica, California, United States
Aventura, Florida, United States
Boca Raton, Florida, United States
Hialeah, Florida, United States
Hollywood, Florida, United States
Miami, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
Louisville, Kentucky, United States
Baltimore, Maryland, United States
Rockville, Maryland, United States
Brighton, Massachusetts, United States
Ann Arbor, Michigan, United States
Detroit, Michigan, United States
Waterford, Michigan, United States
Portsmouth, New Hampshire, United States
Hackensack, New Jersey, United States
New York, New York, United States
Cincinnati, Ohio, United States
Oklahoma City, Oklahoma, United States
Philadelphia, Pennsylvania, United States
Yardley, Pennsylvania, United States
Dallas, Texas, United States
Murray, Utah, United States
Burien, Washington, United States
Charlestown, New South Wales, Australia
Kogarah, New South Wales, Australia
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