Study Description
Brief Summary
The primary objective of this study is to describe the safety and tolerability of rocatinlimab in adolescents with moderate-to-severe AD.
Condition or Disease
Moderate-to-Severe Atopic Dermatitis
Study Design
Study Type: | Interventional (Clinical Trial) |
Actual Enrollment: | 170 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 3, Open-label, 52-week Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab (AMG 451) in Adolescent Subjects Aged ≥ 12 to < 18 Years With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Orbit) |
Actual Study Start Date: | December 23, 2022 |
Actual Primary Completion Date: | March 14, 2025 |
Actual Study Completion Date: | March 14, 2025 |
Eligibility Criteria
Ages Eligible for Study: | 12 Years to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
- Age ≥ 12 to < 18 years at day 1.
- Participant has a diagnosis of AD (according to American Academy of Dermatology Consensus Criteria [Eichenfield, 2014]) that has been present for at least 6 months before signing of informed consent
- History of inadequate response to TCS (Topical Corticosteroid) of medium or higher potency within 6 months (with or without topical calcineurin inhibitors [TCI])
- Eczema Area and Severity Index (EASI) score ≥ 16
- vIGA-AD score ≥ 3
- ≥ 10% BSA of AD involvement at day 1 pre-enrollment
Exclusion Criteria
- Treatment with a biological product within 12 weeks or 5 half-lives, whichever is longer, prior to Day 1
- Treatment with any of the following medications or therapies within 4 weeks or 5 half-lives, whichever is longer, prior to Day 1:
- Systemic corticosteroids
- Systemic immunosuppressants
- Phototherapy
- Oral or topical janus kinase inhibitors
- Treatment with any of the following agents within 1 week before day 1 pre-enrollment:
- TCS
- TCI
- Anti-pruritic agents
- Topical phosphodiesterase type 4 (PDE4) inhibitors
- Other topical immunosuppressive agents
- Combination topical agents