Upadacitinib for Prurigo Nodularis

Inclusion 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 legsand/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 notmedically advisable for subject.

5. Females of childbearing potential must not have a positive serum pregnancy test atthe Screening Visit and must have a negative urine pregnancy test at the BaselineVisit prior to study drug dosing. Note: subjects with borderline pregnancy test atScreening must have a serum pregnancy test ≥ 3 days later to determine eligibility. If female, subject must be postmenopausal OR permanently surgically sterile OR forfemales of childbearing potential practicing at least one protocol specified methodof birth control, that is effective from the Baseline Visit through at least 30 daysafter 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.

6. Subject is a candidate for systemic therapy per investigator discretion.

7. Able and willing to give written informed consent prior to performance of anystudy-related procedures.

8. Subject must be in general good health as judged by the Investigator, based onmedical history, physical examination.

Exclusion Criteria:

1. Presence of skin condition other than prurigo nodularis or atopic dermatitis thatmay 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'sjudgment, 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 ofincompletely treated tuberculosis unless documented adequately treated. Patientswith latent TB at screening may be enrolled if tuberculosis treatment is initiatedprior to first dose.

9. Diagnosed active endoparasitic infections; suspected or high risk of endoparasiticinfection, unless clinical and (if necessary) laboratory assessment have ruled outactive infection before randomization.

10. Active chronic or acute infection (except HIV infection) requiring treatment withsystemic antibiotics, antivirals, antiprotozoals, or antifungals within 2 weeksbefore 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 andresolved non-metastatic squamous or basal cell carcinoma of the skin.