A Study to Assess Long-term Safety, Tolerability, and Efficacy of Rocatinlimab in Adult and Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)
← catalyst calendarSponsored by Amgen (industry) · AMGN — their whole pipeline →.
Phase
Phase 3
Status
Terminated
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
2,621actual
Sites
547
Countries
Argentina, Australia, Austria +39
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
Why the sponsor stopped it
Sponsor Decision
As filed on the registry record, in the sponsor's own words.
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-05-31 | actual | When the study began enrolling |
| Primary completion | 2026-07-01 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-07-01 | actual | The whole study's end, after follow-up |
| First posted | 2023-05-31 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-16 | 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: Rocatinlimab — also filed as AMG 451, KHK4083
- Other: Placebo
Primary outcome
what the primary-completion date above is the date OFNumber of Participants With Treatment-emergent Adverse Events
measured Up to 116 weeks
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.
Permalink · AMGN's whole pipeline · Catalyst calendar · Every registered study · What changed