A Study Assessing Rocatinlimab (AMG 451) Monotherapy in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon)
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).
Timeline
- Start
- 2022-12-14
- Primary completion
- 2024-06-05
- Completion
- 2024-08-27
Outcome
Met primary endpoint
registry analysis (superiority test); Placebo vs Rocatinlimab 300 mg Q4W; p < 0.001; Common risk difference percentage 11.5 (95% CI 6.7 to 15.5) NCT05651711 ↗
registry analysis (superiority test); Placebo vs Rocatinlimab 300 mg Q4W; p < 0.001; Common risk difference percentage 19.1 (95% CI 12.4 to 25.2) NCT05651711 ↗
release “HORIZON met its co-primary endpoints” kyowakirin.com ↗
release “ROCKET-IGNITE and ROCKET-HORIZON studies in nearly 1,500 adults with msAD were published in The Lancet1. Both studies evaluated rocatinlimab monotherapy and met all co-primary” kyowakirin.com ↗
Publications
- Background Guttman-Yassky E, Simpson E, Bissonnette R, Eichenfield LF, Kabashima K, Luna PC, Hercogova JT, Spelman L, Worm M, Esfandiari E, Arai T, Mano H, Charuworn P, Wang A, Kricorian G. ROCKET: a phase 3 program evaluating the efficacy and safety of rocatinlimab in moderate-to-severe atopic dermatitis. Immunotherapy. 2025 Feb;17(2):83-94. doi: 10.1080/1750743X.2025.2464528. Epub 2025 Feb 26.
- Background Guttman-Yassky E, Kabashima K, Worm M, Luna PC, Hong HC, Chovatiya R, Bernstein JA, Kern JS, Ehst BD, Magnolo N, Herranz-Pinto P, Stein Gold L, Sofen H, Pink AE, Esfandiari E, Arai T, Yang Y, Shi R, Barragan C, Kricorian G, Schwartz-Sagi L, Bissonnette R. Efficacy and safety of rocatinlimab for the treatment of moderate-to-severe atopic dermatitis in ROCKET-IGNITE and ROCKET-HORIZON: two global, double-blind, placebo-controlled, randomised phase 3 clinical trials. Lancet. 2026 Jan 3;407(10523):53-66. doi: 10.1016/S0140-6736(25)01865-3. Epub 2025 Nov 25.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rocatinlimab | Monoclonal antibody | — | Subcutaneous |