A Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis
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Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
1,533actual
Sites
193
Countries
Australia, Austria, Belgium +21
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 | 2018-08-09 | actual | When the study began enrolling |
| Primary completion | 2021-02-16 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2030-10-23 | estimated | The whole study's end, after follow-up |
| First posted | 2018-06-26 | actual | When this record first appeared on the registry |
| Results posted | 2022-03-31 | actual | When the sponsor posted results to the registry |
| Record updated | 2025-12-23 | 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: Placebo
- Drug: Upadacitinib — also filed as ABT-494, RINVOQ™
- Drug: Topical corticosteroids (TCS)
Primary outcomes
what the primary-completion date above is the date OFMain Study: Percentage of Participants Achieving at Least a 75% Reduction in Eczema Area and Severity Index Score (EASI 75) From Baseline at Week 16
measured Baseline and Week 16
Main Study: Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 or 1 With a Reduction From Baseline of ≥ 2 Points at Week 16
measured Baseline and Week 16
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2020-04-29 · 14.8 MB · Prot_000.pdf
Statistical Analysis Planposted 2020-06-03 · 733 KB · SAP_001.pdf
Publications
- PMID 42530735 — linked by the registry
- PMID 40900410 — linked by the registry
- PMID 40875187 — linked by the registry
- PMID 39441580 — linked by the registry
- PMID 37691437 — linked by the registry
- PMID 37247226 — linked by the registry
- PMID 37043227 — linked by the registry
- PMID 36754548 — linked by the registry
- PMID 36333616 — linked by the registry
- PMID 35714786 — linked by the registry
- PMID 34023009 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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