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

Study category: Genetics/Personalized Health

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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

Adult

Eligibility

Adults with Down syndrome between the ages of 18 and 60 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 vitiligo

Phase

II - Research Studies that gather preliminary data on whether a drug works in people who have a certain condition/disease (that is, the drug's effectiveness). For example, participants receiving the drug may be compared to similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied.

Type of Study

Treatment

Location

University of Colorado Hospital

Principal Investigator
Joaquin Espinosa

Joaquin Espinosa

Study ID

Protocol Number: 19-1362

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