Safety and efficacy of tofacitinib for immune skin conditions in Down syndrome

Primary Objective

This study is designed to determine whether tofacitinib is a safe and effective treatment for immune skin conditions in adults with Down syndrome, and to further our understanding of the immune system in Down syndrome. Tofacitinib is an FDA-approved drug currently used to treat arthritis and ulcerative colitis.

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Description

This study is designed to determine whether tofacitinib is a safe and effective treatment for immune skin conditions in adults with Down syndrome, and to further our understanding of the immune system in Down syndrome. This is a single arm, open-label study. All participants will receive tofacitinib. Tofacitinib is an FDA-approved drug currently used to treat arthritis and ulcerative colitis. Participants must attend eight study visits at the University of Colorado Anschutz Medical Campus during the 18-week trial and have a study partner available to attend the visits with them. A blood draw for safety monitoring is required at each visit. Participants will be given tofacitinib at no cost for the duration of the study.

Details
Age
Child to Adult
Eligibility
Adolescents and adults with Down syndrome between the ages of 12 and 50 years who have at least one active skin condition such as: - Alopecia areata affecting at least 25% of the scalp - Moderate-to-severe atopic dermatitis or eczema - Moderate-to-severe hidradenitis suppurativa or boils - Moderate-to-severe psoriasis - Moderate-to-severe vitiligoOther eligibility requirements exist. Only study personnel can determine eligibility.
Locations

Childrens Hospital Colorado
Outpatient CTRC
University of Colorado Hospital

Principal Investigator
Photograph of Joaquin Espinosa

Joaquin Espinosa

Study ID

Protocol Number: 19-1362

More information available at ClinicalTrials.gov: NCT04246372

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