STOP-PN2

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

Study Description

Brief Summary

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

Condition or Disease

Prurigo Nodularis

Study Design

Study Type:	Interventional (Clinical Trial)
Estimated Enrollment:	330
Primary Outcome Measures	1. Proportion of participants achieving Itch NRS4 and IGA-CPG-S-TS at Week 24
Actual Study Start Date:	October 2024
Estimated Primary Completion Date:	October 2026

Eligibility Criteria

Ages Eligible for Study:	18 to 75 Years Old
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Study Population

Prurigo Nodularis

Inclusion Criteria

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

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
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

ADDITIONAL DETAILS

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