A Study to Assess Adverse Events and Change in Disease Activity Comparing Oral Upadacitinib to Subcutaneous Dupilumab in Children From 2 to Less Than 12 Years of Age With Moderate to Severe Atopic Dermatitis
← catalyst calendarNCT06461897 · readout ≤ 1,442 d
Sponsored by AbbVie (industry) · ABBV — their whole pipeline →.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · Single · Treatment
Enrollment
675estimated
Sites
150
Countries
Argentina, Australia, Austria +23
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-08-19 | actual | When the study began enrolling |
| Primary completion | Jul 2030 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jul 2030 | estimated | The whole study's end, after follow-up |
| First posted | 2024-06-17 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-06 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Atopic Dermatitis
Interventions
- Drug: Upadacitinib — also filed as ABT-494, RINVOQ®, RINVOQ LQ
- Drug: Dupilumab
Primary outcomes
what the primary-completion date above is the date OFPercentage of Participants Achieving a 75% Reduction from Baseline in Eczema Area and Severity Index 75 (EASI 75) Score (other than US)
measured At Week 16
Percentage of participants achieving validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) 0 or 1 with a reduction from Baseline of ≥ 2 points (US and China only, descriptive)
measured Week 16
Number of Participants with Adverse Events (AEs)
measured Up to Approximately Week 172
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