Last updated 17 days ago

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

330 patients around the world

Available in Chile

Incyte Corporation

3Research sites

330Patients around the world

This study is for people with

Prurigo nodularis

To 75 Years

All Gender

: 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.

: 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.

Centro Médico Skinmed

Del Inca 4446, 7580206 Las Condes, Región Metropolitana, Chile

Centro Internacional de Estudios Clínicos - CIEC

Calle Manzano 343, Oficina 410-411, Comuna de Recoleta, Región Metropolitana, 8420383

Clinical Research Chile SpA

Beauchef 683, Valdivia, Los Ríos

SponsorIncyte Corporation

Conditions

Requirements

To 75 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT06516965