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NCT04921969 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess the Efficacy and Safety of Ruxolitinib Cream in Children With Atopic Dermatitis (TRuE-AD3)
A Phase 3 study, sponsored by Incyte Corporation.
- Completed
- Registry status
- Phase 3
- Development phase
- 330
- Enrollment target
NCT04921969 is a Phase 3 study that has completed, run by Incyte Corporation. The registered enrollment target is 330 participants.
The verdict
NCT04921969, a Phase 3 study, has completed, sponsored by Incyte Corporation.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 330 participants
- Enrollment target
Study Summary
The purpose of the study is to assess the efficacy and safety of ruxolitinib cream in children with Atopic Dermatitis. This is a randomized, double-blind, Vehicle Controlled study. Participants will be randomized 2:2:1 to blinded treatment with ruxolitinib cream 0.75% ,1.5% , or vehicle cream, with stratification by baseline IGA score and age. At Week 8, efficacy will be evaluated. Participants who complete Week 8 assessments with no additional safety concerns will continue into the 44-week Long Term Safety (LTS) period with the same treatment regimen, except those initially randomized to vehicle cream will be rerandomized (1:1) in a blinded manner to 1 of the 2 active treatment groups (ruxolitinib cream 0.75% or 1.5%).
Interventions
- DRUG Ruxolitinib
- DRUG Vehicle Cream
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 330 participants |
| Start Date | 2021-07-19 |
| Est. Completion | 2024-04-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04921969
The ClinicalTrials.gov registry entry for NCT04921969 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 330 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Incyte Corporation, which has 239 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Ruxolitinib is the first listed.
NCT04921969 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04921969 about?
NCT04921969 is a clinical study titled "A Study to Assess the Efficacy and Safety of Ruxolitinib Cream in Children With Atopic Dermatitis (TRuE-AD3)". The purpose of the study is to assess the efficacy and safety of ruxolitinib cream in children with Atopic Dermatitis. This is a randomized, double-blind, Vehicle Controlled study. Participants will be randomized 2:2:1 to blinded treatment with ruxolitinib cream 0.75% ,1.5% , or vehicle cream, with ...
What is the current status of trial NCT04921969?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 330 participants. The study started on 2021-07-19. Estimated completion is 2024-04-08.
What interventions are being tested in trial NCT04921969?
The interventions under investigation include: Ruxolitinib (DRUG), Vehicle Cream (DRUG).
Who is sponsoring clinical trial NCT04921969?
This trial is sponsored by Incyte Corporation, which has 239 total clinical trials registered on ClinicalTrials.gov.
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