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NCT04246372 · ClinicalTrials.gov registry record · Phase 2
Tofacitinib for Immune Skin Conditions in Down Syndrome
A Phase 2 study, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- Phase 2
- Development phase
- 47
- Enrollment target
NCT04246372: Completed Phase 2 study, sponsored by University of Colorado, Denver.
NCT04246372 is a Phase 2 study that has completed, run by University of Colorado, Denver. The registered enrollment target is 47 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04246372, a Phase 2 study, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 47 participants
- Enrollment target
Study 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.
Primary Outcome
Safety as measured by the number of serious adverse events definitely related to tofacitinib treatment.
Interventions
- DRUG Tofacitinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2020-10-21 |
| Est. Completion | 2024-10-30 |
| Phase | Phase 2 |
What the finished NCT04246372 record still lists
NCT04246372 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 1 intervention - of which Tofacitinib is the first listed.
NCT04246372 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04246372 about?
NCT04246372 is a clinical study titled "Tofacitinib for Immune Skin Conditions in Down Syndrome". 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 ...
What is the current status of trial NCT04246372?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 47 participants. The study started on 2020-10-21. Estimated completion is 2024-10-30.
What interventions are being tested in trial NCT04246372?
The interventions under investigation include: Tofacitinib (DRUG).
Who is sponsoring clinical trial NCT04246372?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04246372's enrollment target sits among peer trials
47 1283rd of 2000 higher than 715 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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