Upadacitinib for Prurigo Nodularis

Eligibility Criteria

• 1. Male or female adult 18-64 years of age at time of screening.
• 2. Diagnosis of prurigo nodularis for ≥ 3 months.
• 3. 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 .
• 4. Failure of at least a 2-week course of medium to super potent TCS or TCS is not medically advisable for subject.
• 5. 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.
• 6. Subject is a candidate for systemic therapy per investigator discretion.
• 7. Able and willing to give written informed consent prior to performance of any study-related procedures.
• 8. Subject must be in general good health as judged by the Investigator, based on medical history, physical examination.
• 1. Presence of skin condition other than prurigo nodularis or atopic dermatitis that may interfere with study assessments.
• 2. Diagnosis of active atopic dermatitis at screening and baseline.
• 3. PN secondary to medications.
• 4. PN secondary to medical conditions such as neuropathy or psychiatric disease.
• 5. Severe concomitant illness(es) under poor control that, in the investigator's judgment, would adversely affect the patient's participation in the study.
• 6. Severe renal conditions (eg, patients with uremia and/or on dialysis)
• 7. Participants with uncontrolled thyroid disease.
• 8. Active tuberculosis or non-tuberculous mycobacterial infection, or a history of incompletely treated tuberculosis unless documented adequately treated. Patients with latent TB at screening may be enrolled if tuberculosis treatment is initiated prior to first dose.
• 9. Diagnosed active endoparasitic infections; suspected or high risk of endoparasitic infection, unless clinical and (if necessary) laboratory assessment have ruled out active infection before randomization.
• 10. Active chronic or acute infection (except HIV infection) requiring treatment with systemic antibiotics, antivirals, antiprotozoals, or antifungals within 2 weeks before the screening visit or during the screening period.
• 11. Known or suspected immunodeficiency.
• 12. Active malignancy or history of malignancy within 5 years before the baseline visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin.