Last updated 10 days ago
A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis
330 patients around the world
Available in Argentina
Incyte Corporation
7Research sites
330Patients around the world
This study is for people with
Prurigo nodularis
Requirements for the patient
To 75 Years
All Gender
Medical requirements
- 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.
Sites
Instituto de Especialidades de la Salud Rosario Clínica del Tórax
InAER - Investigaciones en Alergia y Enfermedades Respiratorias - CABA, Buenos Aires
Instituto de Neumonología y Dermatología Dr. Luna
Centro de Investigaciones Médicas Mar del Plata SRL
Centro de Investigaciones Reumatológicas
CEDIC Centro de Investigación Clínica - CABA, Buenos Aires
Centro Médico - Buenos Aires Skin S.A. - CABA, Buenos Aires
StudySTOP-PN1
SponsorIncyte Corporation
Conditions
Requirements
To 75 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06516952
