Study to Evaluate Efficacy and Safety of PF-04965842 With or Without Topical Medications in Subjects Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis
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Phase
Phase 3
Status
Completed
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
3,166actual
Sites
539
Countries
Argentina, Australia, Belgium +25
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 | 2018-03-08 | actual | When the study began enrolling |
| Primary completion | 2025-12-22 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-12-22 | actual | The whole study's end, after follow-up |
| First posted | 2018-02-06 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-01-15 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Dermatitis, Atopic
Interventions
- Drug: Abrocitinib 100 mg
- Drug: Abrocitinib 200 mg
- Drug: Placebo
- Drug: Abrocitinib 100 mg
- Drug: Abrocitinib 100 mg
- Drug: Abrocitinib 200 mg
Primary outcomes
what the primary-completion date above is the date OFTreatment emergent adverse events
measured Throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years
Serious adverse events and adverse events leading to discontinuation
measured Throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years
Change from baseline in clinical laboratory values
measured Throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years
Change from baseline in electrocardiogram (ECG) measurements
measured Throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years
Change from baseline in vital signs
measured Throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years
Publications
- PMID 42365219 — linked by the registry
- PMID 42162528 — linked by the registry
- PMID 40028832 — linked by the registry
- PMID 39903335 — linked by the registry
- PMID 39104653 — linked by the registry
- PMID 34406619 — 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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