CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 769 enrolled
Drug / intervention
Rocatinlimab +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05398445
NCT05398445Phase 3Completed

A Phase 3, 24-week, Randomized, Placebo-controlled, Double-blind Study to Assess the Efficacy, Safety and Tolerability of Rocatinlimab (AMG 451) Monotherapy in Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD)

Amgen·interventional·Posted Jun 1, 2022·Updated Nov 24, 2025

In Brief

A Phase 3 clinical trial evaluating Rocatinlimab and Placebo for Atopic Dermatitis. Completed, enrolled 769 participants across 202 sites in 21 countries.

Detailed Summary

The purpose of this study is to evaluate the efficacy and safety of rocatinlimab in monotherapy treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Brazil, Canada, China, Croatia, Czechia, Germany, Greece, Hungary, Italy, Japan, Latvia, Netherlands, Poland, Portugal, Puerto Rico, Slovakia, South Korea, Spain, Taiwan, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2023202420252026
First PostedJun 1, 2022
Enrollment StartMay 31, 2022
Primary CompletionNov 28, 2024
Study CompletionJan 13, 2025
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 4.1 years ago

Interventions

Rocatinlimabdrug

Participants will receive Rocatinlimab subcutaneously.

Placebodrug

Participants will receive a placebo subcutaneously.