Trials / Completed
CompletedNCT05398445
A Study Evaluating Rocatinlimab in Moderate-to-severe Atopic Dermatitis (ROCKET-IGNITE)
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)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 769 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the efficacy and safety of rocatinlimab in monotherapy treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Rocatinlimab | Participants will receive Rocatinlimab subcutaneously. |
| DRUG | Placebo | Participants will receive a placebo subcutaneously. |
Timeline
- Start date
- 2022-05-31
- Primary completion
- 2024-11-28
- Completion
- 2025-01-13
- First posted
- 2022-06-01
- Last updated
- 2025-11-24
Locations
202 sites across 21 countries: United States, Argentina, Brazil, Canada, China, Croatia, Czechia, Germany, Greece, Hungary, Italy, Japan, Latvia, Netherlands, Poland, Portugal, Puerto Rico, Slovakia, South Korea, Spain, Taiwan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05398445. Inclusion in this directory is not an endorsement.