Kyowa Kirin to present phase 3 ROCKET HORIZON trial results for atopic dermatitis at AAD 2025

Kyowa Kirin Co., Ltd  announced that results of the Phase 3 ROCKET HORIZON trial of rocatinlimab, an investigational therapy targeting the OX40 receptor (OX40R) in patients with moderate-to-severe atopic dermatitis (AD), will be presented at the American Academy of Dermatology (AAD) 2025 Annual Meeting to be held in Orlando, Florida from March 7-11, 2025. AD, a chronic, heterogeneous, inflammatory disease characterized by skin redness, pruritus, and pain, is driven by skin barrier disruption and T cell–dependent inflammatory pathways. Expansion of OX40R+ pathogenic T cells leads to T-cell imbalance, a root cause of inflammatory diseases including AD.

Title:  Rocatinlimab Significantly Improved Clinical Signs and Symptoms by Targeting OX40R+ T cells in Patients with Moderate-to-Severe Atopic Dermatitis: Results from the Phase III ROCKET HORIZON Trial Presenter: Emma Guttman-Yassky, MD, PhD Date:  Saturday, March 8th  Time:  1-4 pm EST Location: Orange County Convention Center, Chapin Theater Level 2, Orlando, Fla. ROCKET HORIZON and the ROCKET Phase 3 Program ROCKET HORIZON is a Phase III, randomized, placebo-controlled, double-blind trial assessing the efficacy, safety and tolerability of rocatinlimab monotherapy in adults with moderate to severe atopic dermatitis.

The trial includes 726 adult patients who were randomized to receive rocatinlimab or placebo administered through a subcutaneous injection every four weeks for 24 weeks with a loading dose at week two. Key endpoints were assessed at week 16 and week 24. Co-primary endpoints for the trial are achievement of a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-ADTM) score of 0 (clear) or 1 (almost clear) with a ≥ 2-point reduction from baseline at week 24 and achievement of ≥ 75% reduction from baseline in Eczema Area and Severity Index score (EASI-75) at week 24. (In the US, revised Investigator Global Assessment (rIGA) replaces vIGA as co-primary endpoint). Key secondary endpoints assess the impact of rocatinlimab on itch, sleep, and quality of life as well as safety and tolerability. ROCKET is a comprehensive, global Phase III clinical trial program comprised of eight studies intended to establish the safety and efficacy profile of rocatinlimab in adults and adolescents with moderate to severe atopic dermatitis (AD) as well as multiple dosing regimens.