Trials / Completed
CompletedNCT05704738
A Study to Evaluate Rocatinlimab (AMG 451) in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)
A Phase 3, Randomized, 52-week, Placebo-controlled, Double-blind Study With Re-randomization to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab (AMG 451) in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-ASTRO)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 532 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 12 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the efficacy and safety of rocatinlimab in monotherapy and combination therapy treatment in adolescent participants.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Rocatinlimab | Subcutaneous (SC) injection |
| DRUG | Placebo | SC injection |
Timeline
- Start date
- 2023-04-20
- Primary completion
- 2025-02-27
- Completion
- 2025-11-25
- First posted
- 2023-01-30
- Last updated
- 2026-01-16
Locations
246 sites across 22 countries: United States, Belgium, Brazil, Canada, Chile, China, Croatia, France, Germany, Greece, Hungary, Israel, Italy, Japan, Mexico, Poland, Puerto Rico, Romania, South Korea, Spain, Taiwan, Thailand
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05704738. Inclusion in this directory is not an endorsement.