RecruitingPhase 3NCT06516952
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
Sponsor
Incyte Corporation
Enrollment
330 participants
Start Date
Oct 10, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to evaluate effect of povorcitinib on itch and skin lesions in participants with prurigo nodularis.
Eligibility
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria6
- 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 Criteria8
- 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.
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Interventions
DRUGPovorcitinib
Oral Tablet
DRUGPlacebo
Oral Tablet
Locations(121)
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NCT06516952
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