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Recruiting Phase 3 NCT06516965

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

Trial Parameters

Condition Prurigo Nodularis
Sponsor Incyte Corporation
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 330
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2024-10-10
Completion 2026-10-19
Interventions
PovorcitinibPlacebo

Brief Summary

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

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 t

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