A Study Evaluating Rocatinlimab in Moderate-to-severe Atopic Dermatitis (ROCKET-IGNITE)

Summary

The purpose of this study is to evaluate the efficacy and safety of rocatinlimab in monotherapy treatment.

Timeline

Start

2022-05-31

Primary completion

2024-11-28

Completion

2025-01-13

Outcome

Met primary endpoint

paper Both trials met their coprimary endpoints. PMID 41314226 ↗

release “The IGNITE study, which evaluated two dose strengths of rocatinlimab, met its co-primary endpoints” amgen.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.
• 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	150 mg	Subcutaneous
Subject	Rocatinlimab	Monoclonal antibody	300 mg	Subcutaneous

Indications