CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 47 enrolled
Drug / intervention
Tofacitinibdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04246372
NCT04246372Phase 2Completed

Safety and Efficacy of Tofacitinib for Immune Skin Conditions in Down Syndrome

University of Colorado, Denver·interventional·Posted Jan 29, 2020·Updated Dec 11, 2025

In Brief

A Phase 2 clinical trial evaluating Tofacitinib for Down Syndrome and 5 related conditions. Completed, enrolled 47 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedJan 29, 2020
Enrollment StartOct 21, 2020
Primary CompletionOct 30, 2024
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 6.4 years ago

Interventions

Tofacitinibdrug

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