Trials / Completed
CompletedNCT05651711
A Study Assessing Rocatinlimab (AMG 451) Monotherapy in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon)
A Phase 3, Randomized, 24-week, 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) (ROCKET-Horizon)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 726 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Not accepted
Summary
The co-primary objectives of the study are to: * Evaluate the efficacy of rocatinlimab compared with placebo at Week 24, assessed using Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD). * Evaluate the efficacy of rocatinlimab compared with placebo at Week 24, assessed using Eczema Area and Severity Index (EASI).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Rocatinlimab | Rocatinlimab will be administered through a subcutaneous (SC) injection. |
| OTHER | Placebo | The matching placebo will be administered through a SC injection. |
Timeline
- Start date
- 2022-12-14
- Primary completion
- 2024-06-05
- Completion
- 2024-08-27
- First posted
- 2022-12-15
- Last updated
- 2025-04-03
Locations
197 sites across 21 countries: United States, Australia, Belgium, Brazil, Canada, Czechia, Denmark, Estonia, Finland, Germany, Japan, Mexico, Poland, Portugal, Romania, South Africa, South Korea, Spain, Sweden, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05651711. Inclusion in this directory is not an endorsement.