A Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)
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Phase
Phase 3
Status
Completed
Study type
Interventional
Design
Na · None · Treatment
Enrollment
187actual
Sites
77
Countries
Argentina, Australia, Brazil +6
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 | 2023-01-30 | actual | When the study began enrolling |
| Primary completion | 2025-07-31 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-07-31 | actual | The whole study's end, after follow-up |
| First posted | 2022-12-01 | actual | When this record first appeared on the registry |
| Results posted | 2026-07-24 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-07-24 | 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
Intervention
- Drug: Rocatinlimab — also filed as AMG 451
Primary outcome
what the primary-completion date above is the date OFNumber of Participants Who Experienced Treatment-emergent Serious Adverse Events (TESAEs)
measured From first dose of trial intervention to end of trial; median (min, max) duration was 52.1 (2.0, 70.1) weeks
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2024-09-17 · 2.5 MB · Prot_000.pdf
Statistical Analysis Planposted 2025-03-31 · 906 KB · SAP_001.pdf
Publications
- PMID 40012373 — cited as background
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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