Kyowa Kirin Announces Late-Breaking Abstract Presentation at the American Academy of Dermatology Annual Meeting 2025
Kyowa Kirin (TSE: 4151) announced that results from their Phase 3 ROCKET HORIZON trial of rocatinlimab, an investigational therapy for moderate-to-severe atopic dermatitis (AD), will be presented at the American Academy of Dermatology Annual Meeting 2025 in Orlando.
The ROCKET HORIZON trial is a Phase 3, randomized, placebo-controlled study involving 726 adult patients. Participants received either rocatinlimab or placebo via subcutaneous injection every four weeks for 24 weeks, with a loading dose at week two. The trial's co-primary endpoints focus on achieving specific scores in the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) and Eczema Area and Severity Index (EASI-75) at week 24.
Rocatinlimab targets the OX40 receptor (OX40R), addressing T-cell imbalance, a root cause of inflammatory diseases including AD. The ROCKET Phase 3 program comprises eight studies evaluating rocatinlimab's safety and efficacy across multiple dosing regimens in adults and adolescents with moderate to severe AD.
Kyowa Kirin (TSE: 4151) ha annunciato che i risultati del loro studio di Fase 3 ROCKET HORIZON su rocatinlimab, una terapia sperimentale per la dermatite atopica (AD) da moderata a grave, saranno presentati al Meeting Annuale dell'American Academy of Dermatology 2025 a Orlando.
Lo studio ROCKET HORIZON è uno studio di Fase 3, randomizzato e controllato con placebo, che coinvolge 726 pazienti adulti. I partecipanti hanno ricevuto rocatinlimab o placebo tramite iniezione sottocutanea ogni quattro settimane per 24 settimane, con una dose di carico alla seconda settimana. Gli obiettivi co-principali dello studio si concentrano sul raggiungimento di punteggi specifici nella Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) e nell'Eczema Area and Severity Index (EASI-75) alla settimana 24.
Rocatinlimab agisce sul recettore OX40 (OX40R), affrontando lo squilibrio delle cellule T, una causa principale delle malattie infiammatorie, inclusa l'AD. Il programma ROCKET di Fase 3 comprende otto studi che valutano la sicurezza e l'efficacia di rocatinlimab attraverso diversi regimi di dosaggio in adulti e adolescenti con AD da moderata a grave.
Kyowa Kirin (TSE: 4151) anunció que los resultados de su ensayo de Fase 3 ROCKET HORIZON sobre rocatinlimab, una terapia experimental para la dermatitis atópica (AD) de moderada a grave, se presentarán en la Reunión Anual de la Academia Americana de Dermatología 2025 en Orlando.
El ensayo ROCKET HORIZON es un estudio de Fase 3, aleatorizado y controlado con placebo que involucra a 726 pacientes adultos. Los participantes recibieron rocatinlimab o placebo mediante inyección subcutánea cada cuatro semanas durante 24 semanas, con una dosis de carga en la semana dos. Los objetivos co-principales del ensayo se centran en alcanzar puntuaciones específicas en la Evaluación Global Validada por Investigadores para la Dermatitis Atópica (vIGA-AD) y el Índice de Área y Severidad del Eczema (EASI-75) en la semana 24.
Rocatinlimab se dirige al receptor OX40 (OX40R), abordando el desequilibrio de las células T, una causa raíz de enfermedades inflamatorias, incluida la AD. El programa ROCKET de Fase 3 comprende ocho estudios que evalúan la seguridad y eficacia de rocatinlimab en varios regímenes de dosificación en adultos y adolescentes con AD de moderada a grave.
교와 키린 (TSE: 4151)은 중등도에서 중증 아토피 피부염(AD)을 위한 실험적 치료제인 로카틴리맙의 3상 ROCKET HORIZON 시험 결과가 2025년 올랜도에서 열리는 미국 피부과 학회 연례 회의에서 발표될 것이라고 발표했습니다.
ROCKET HORIZON 시험은 726명의 성인 환자를 포함하는 3상, 무작위, 위약 대조 연구입니다. 참가자들은 24주 동안 매 4주마다 로카틴리맙 또는 위약을 피하 주사로 투여받았으며, 2주차에 로딩 도스를 받았습니다. 시험의 공동 주요 목표는 24주 차에 아토피 피부염에 대한 검증된 연구자 글로벌 평가(vIGA-AD)와 피부염 영역 및 중증도 지수(EASI-75)에서 특정 점수를 달성하는 것입니다.
로카틴리맙은 OX40 수용체(OX40R)를 표적으로 하여 T세포 불균형을 해결하며, 이는 AD를 포함한 염증성 질환의 근본 원인입니다. ROCKET 3상 프로그램은 중등도에서 중증 AD를 가진 성인 및 청소년에서 로카틴리맙의 안전성과 효능을 다양한 투여 요법으로 평가하는 8개의 연구로 구성되어 있습니다.
Kyowa Kirin (TSE: 4151) a annoncé que les résultats de leur essai de Phase 3 ROCKET HORIZON sur rocatinlimab, une thérapie expérimentale pour la dermatite atopique (AD) modérée à sévère, seront présentés lors de la Réunion Annuelle de l'American Academy of Dermatology 2025 à Orlando.
L'essai ROCKET HORIZON est une étude de Phase 3, randomisée et contrôlée par placebo impliquant 726 patients adultes. Les participants ont reçu soit rocatinlimab soit un placebo par injection sous-cutanée toutes les quatre semaines pendant 24 semaines, avec une dose de charge à la semaine deux. Les objectifs co-principaux de l'essai portent sur l'atteinte de scores spécifiques dans l'Évaluation Globale Validée par les Investigateurs pour la Dermatite Atopique (vIGA-AD) et l'Indice de Surface et de Sévérité de l'Eczéma (EASI-75) à la semaine 24.
Rocatinlimab cible le récepteur OX40 (OX40R), abordant le déséquilibre des cellules T, une cause fondamentale des maladies inflammatoires, y compris l'AD. Le programme ROCKET de Phase 3 comprend huit études évaluant la sécurité et l'efficacité de rocatinlimab à travers plusieurs schémas posologiques chez des adultes et des adolescents atteints d'AD modérée à sévère.
Kyowa Kirin (TSE: 4151) gab bekannt, dass die Ergebnisse ihrer Phase-3-Studie ROCKET HORIZON zu rocatinlimab, einer experimentellen Therapie für mittelschwere bis schwere atopische Dermatitis (AD), auf dem Jahreskongress der American Academy of Dermatology 2025 in Orlando präsentiert werden.
Die ROCKET HORIZON-Studie ist eine Phase-3, randomisierte, placebokontrollierte Studie mit 726 erwachsenen Patienten. Die Teilnehmer erhielten entweder rocatinlimab oder ein Placebo alle vier Wochen über 24 Wochen, mit einer Lade-Dosis in der zweiten Woche. Die primären Endpunkte der Studie konzentrieren sich darauf, spezifische Punktzahlen in der Validierten Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) und dem Eczema Area and Severity Index (EASI-75) in Woche 24 zu erreichen.
Rocatinlimab zielt auf den OX40-Rezeptor (OX40R) ab und adressiert das Ungleichgewicht der T-Zellen, eine Grundursache für entzündliche Erkrankungen, einschließlich AD. Das ROCKET-Programm der Phase 3 umfasst acht Studien zur Bewertung der Sicherheit und Wirksamkeit von rocatinlimab bei verschiedenen Dosierungsschemata bei Erwachsenen und Jugendlichen mit mittelschwerer bis schwerer AD.
- Large-scale Phase 3 trial with 726 patients demonstrates development progress
- Comprehensive clinical program with 8 studies shows robust development strategy
- None.
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 3 ROCKET
HORIZON Trial
Presenter: Emma Guttman-Yassky, MD, PhD
Date: Saturday, March 8th Time: 1 -4 pm EST
Location:
ROCKET HORIZON and the ROCKET Phase 3 Program
ROCKET HORIZON is a Phase 3, 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. 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 ≥
About Moderate to Severe Atopic Dermatitis
Atopic dermatitis, the most common form of eczema, is a chronic inflammatory disease that causes excessively dry, itchy skin that can be painful. People with moderate to severe atopic dermatitis experience chronic symptoms, intensified by unpredictable flare-ups that can be painful and disruptive to everyday life. Almost half of these patients report severe itching, leading to repeated scratching which can cause the skin to thicken and become vulnerable to infection. Atopic dermatitis (all severities) affects 15
About Rocatinlimab
Rocatinlimab is an anti-OX40 receptor human monoclonal antibody being investigated for the treatment of moderate-to-severe atopic dermatitis. Rocatinlimab is also being studied for moderate to severe uncontrolled asthma and, prurigo nodularis. The initial antibody was discovered in collaboration between Kyowa Kirin and La Jolla Institute for Immunology. Rocatinlimab is currently under clinical investigation, and its safety and efficacy have not been evaluated by the
Amgen and Kyowa Kirin Collaboration
On June 1, 2021, Kyowa Kirin and Amgen entered into an agreement to jointly develop and commercialize rocatinlimab. Under the terms of the agreement, Amgen leads the development, manufacturing, and commercialization for rocatinlimab for all markets globally, except
About Kyowa Kirin
Kyowa Kirin aims to discover and deliver novel medicines and treatments with life-changing value. As a
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SOURCE Kyowa Kirin
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