Tofacitinib for Immune Skin Conditions in Down Syndrome

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT04246372
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Tofacitinib — DRUG
    Treatment with oral Tofacitinib for immune mediated skin conditions in adults with Down syndrome

Study Details

People with Down syndrome (DS) display widespread immune dysregulation, including several immune skin conditions. This study hypothesizes that pharmacological inhibition of the increased interferon (IFN) signaling seen in DS is safe and could improve associated skin conditions. The study evaluates the safety and efficacy treatment with Tofacitinib, an FDA-approved drug known to block IFN signaling, in adolescents and adults with DS and an autoimmune and/or autoinflammatory skin condition. Investigators will also measure the impact of interferon inhibition on a variety of molecular markers, as well as the cognitive abilities and quality of life of participants.

Key Dates

Start date
Oct 21, 2020
Status verified
Nov 2025
Primary completion
Oct 30, 2024
Completion
Oct 30, 2024

Study Design

Enrollment
47 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: On Treatment
    Tofacitinib 5mg oral tablets twice daily for 16 weeks

Primary Outcome Measure

Number of Serious Adverse Events (SAE) Definitely Related to Tofacitinib Treatment. [ Time Frame: Baseline to 16 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Linda Crnic Institute for Down SyndromeAuroraColorado80045-

Related coverage on Hipa.ai

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By research site
Linda Crnic Institute for Down Syndrome· Aurora, CO

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