A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis (STOP-PN2)

Recruiting

• Conditions: Prurigo Nodularis

• Registration Number: jRCT2031240699
• Lead Sponsor: Incyte Biosciences Japan G.K.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-21
• Study Start: 2025-04-11
• Last Update Posted: 2025-05-26

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Male and female participants 18 to 75 years of age.
2. Clinical diagnosis of PN for at least 3 months prior to Screening visit.
3. Pruritus, defined as an average Itch NRS score >= 7 during the 7 days prior to Day 1/Baseline.
4. 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.
5. Documented history of treatment failure, demonstrated intolerance, or contraindication to a previous PN treatment.
6. Willingness to avoid pregnancy or fathering children.

Exclusion Criteria

1. Chronic pruritus due to a condition other than PN or neuropathic and psychogenic pruritus.
2. Diagnosis of PN secondary to medications.
3. Active AD lesions (signs and symptoms other than dry skin) within 3 months prior to Screening visit.
4. Women who are pregnant (or are considering pregnancy) or breastfeeding.
5. 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.
6. Evidence of infection with TB, HBV, HCV or HIV.
7. History of failure to any topical or systemic JAK or TYK2 inhibitor as treatment of PN or any inflammatory disease.
8. Laboratory values outside of the protocol-defined ranges. Other protocol-defined Inclusion/Exclusion Criteria apply.

Study & Design

• Study Type: Interventional
• Study Design: parallel assignment