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NCT07598643 · ClinicalTrials.gov registry record · Phase 2
Modulation of the Immune System in Down Syndrome for Improved Outcomes and Neurodevelopment - 1
A Phase 2 study, sponsored by University of Colorado, Denver.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 92
- Enrollment target
NCT07598643 is a Phase 2 study that is actively recruiting participants, run by University of Colorado, Denver. The registered enrollment target is 92 participants.
The verdict
NCT07598643, a Phase 2 study, is actively recruiting participants, sponsored by University of Colorado, Denver.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 92 participants
- Enrollment target
Study Summary
This protocol describes a phase 2, double-blind, randomized, placebo-controlled clinical trial for Janus kinase (JAK) inhibition in Down syndrome (DS). This trial will evaluate the safety and efficacy of a 6-month treatment with the JAK1/3 inhibitor tofacitinib (XELJANZ) in individuals ages 6-22 (inclusive) with DS. There will be two main arms for this study: a treatment arm and a placebo control arm. Participants will be randomized into the treatment or placebo arm. Those completing 6 months in the placebo arm may be eligible to participate in a cross-over, open-label extension arm to receive 6 months of tofacitinib treatment. Participants will be evaluated during a Screening visit to determine eligibility, complete a Baseline visit if eligible, and be monitored via safety clinical laboratories and in-person evaluations by study doctors at 1 month, 3 months (mid-point visit) and 6 months (endpoint visit). An interim analysis of safety will be completed by an independent Data and Safety Monitoring Board (DSMB) after 40 participants have completed 6 months of treatment or placebo (20 in each arm).
Interventions
- DRUG Placebo
- DRUG Tofacitinib Oral Solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2026-05 |
| Est. Completion | 2030-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07598643
The ClinicalTrials.gov registry entry for NCT07598643 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 92 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT07598643 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07598643 about?
NCT07598643 is a clinical study titled "Modulation of the Immune System in Down Syndrome for Improved Outcomes and Neurodevelopment - 1". This protocol describes a phase 2, double-blind, randomized, placebo-controlled clinical trial for Janus kinase (JAK) inhibition in Down syndrome (DS). This trial will evaluate the safety and efficacy of a 6-month treatment with the JAK1/3 inhibitor tofacitinib (XELJANZ) in individuals ages 6-22 (in...
What is the current status of trial NCT07598643?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 92 participants. The study started on 2026-05. Estimated completion is 2030-08.
What interventions are being tested in trial NCT07598643?
The interventions under investigation include: Placebo (DRUG), Tofacitinib Oral Solution (DRUG).
Who is sponsoring clinical trial NCT07598643?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
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