A 24 Week, Open-Label Study to Evaluate the Efficacy and Safety of Upadacitinib in Patients With Moderate-to-Severe Prurigo Nodularis
A single center, open-label study of 25 subjects to assess 24 weeks upadacitinib in patients with moderate-to-severe prurigo nodularis.
• Male or female adult 18-64 years of age at time of screening.
• Diagnosis of prurigo nodularis for ≥ 3 months.
• Moderate-to-Severe prurigo nodularis as determined by at least 10 PN lesions on legs and/or arms and/or trunk at screening and baseline .
• Failure of at least a 2-week course of medium to super potent TCS or TCS is not medically advisable for subject.
• Females of childbearing potential must not have a positive serum pregnancy test at the Screening Visit and must have a negative urine pregnancy test at the Baseline Visit prior to study drug dosing. Note: subjects with borderline pregnancy test at Screening must have a serum pregnancy test ≥ 3 days later to determine eligibility.
• If female, subject must be postmenopausal OR permanently surgically sterile OR for females of childbearing potential practicing at least one protocol specified method of birth control, that is effective from the Baseline Visit through at least 30 days after the last dose of study drug. Female subject must not be pregnant, breastfeeding or considering becoming pregnant during the study or for approximately 30 days after the last dose of the study drug.
• Subject is a candidate for systemic therapy per investigator discretion.
• Able and willing to give written informed consent prior to performance of any study-related procedures.
• Subject must be in general good health as judged by the Investigator, based on medical history, physical examination.