Description
Inclusion Criteria:
- * Males or females with DS between 12 and 50 years of age who weigh at least 40 kg.
- * Diagnosis of at least one active immune skin condition, including but not limited to:
- 1. Moderate-to-severe atopic dermatitis
- 2. Alopecia areata affecting at least 25% of the scalp
- 3. Moderate-to-severe hidradenitis suppurativa
- 4. Moderate-to-severe psoriasis
- 5. Moderate-to-severe vitiligo.
- * Be willing to avoid pregnancy or fathering children.
- * Must present with a study partner or legal guardian who can complete, or assist with completing, study materials as appropriate.
- Exclusion Criteria
- * Weigh less than 40 kg.
- * Pregnancy or breast feeding.
- * No study partner or legal guardian.
- * Vaccination with live attenuated virus within six weeks of inclusion in the study or planned during the study.
- * Clinically significant chronic or active viral infection including but not limited to HIV, hepatitis, CMV, EBV, HSV.
- * Severe renal impairment.
- * History of malignant solid tumor cancer within five years prior to study entry or where there is current evidence of recurrent or metastatic disease.
- * Poor venous access not allowing repeated blood tests or non-compliance with venipuncture requirements.
- * Prior treatment with a JAK inhibitor or with an investigational agent, device, or procedure within 21 days of enrollment.
- * Concomitant treatment with other immunosuppressants (e.g. corticosteroids, methotrexate) or strong CP3A4 or CYP2C19 inhibitors or inducers (e.g. ketoconazole, fluconazole).
- * Known allergies, hypersensitivity, or intolerance to Tofacitinib.
- * History of thrombotic disorder.
- * Superficial skin infection within 2 weeks of inclusion in the study.
- * History of disseminated herpes zoster, disseminated herpes simplex, or recurrent localized dermatomal herpes zoster.
- * Intravenous antimicrobial therapy within 3 months of inclusion in the study.
- * Oral antimicrobials within 2 weeks of inclusion in the study.
- * Participants may be excluded for other unforeseen reasons at the study doctor's discretion.
- * Unable to provide assent in cases where informed consent is obtained from other authorized representative.
- * Kidney transplant within the last two years
- * Any history of heart attack or stroke.
- * Any history of lymphoma.
- * Past or current smokers.
Ages Eligible for Study:
12 Years to 50 Years (CHILD, ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
No