A Phase 3, Multicenter, Double-blind Maintenance Study to Assess Long-term Safety, Tolerability, and Efficacy of Rocatinlimab in Adult and Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-ASCEND)

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT05882877Tipo: INTERVENTIONALInicio: 31 de may de 2023Fin estimado: 30 de jun de 2027

Traducción no disponible, mostrando original

Resumen

The primary objective of this study is to describe the long-term safety and tolerability of rocatinlimab in participants with moderate-to-severe AD.

Edad mínima: 12 YearsEdad máxima: 100 YearsSexo: ALL

Completion of an end of treatment duration visit (Week 24 or Week 52 visit for adult or adolescent studies, respectively) in a rocatinlimab parent study (ROCKET-IGNITE, ROCKET-HORIZON, ROCKET-SHUTTLE, ROCKET-ASTRO, ROCKET-ORBIT, OR ROCKET-VOYAGER) within the past 28 days.
Participants from the parent study ROCKET-ORBIT must achieve an improvement in EASI score at week 52 of at least 60% compared to parent study baseline (EASI 60).

Permanent investigational product discontinuation due to safety-related reasons, protocol-defined stopping rules or conditions/reasons unrelated to efficacy during the rocatinlimab parent study (ROCKET-IGNITE, ROCKET-HORIZON, ROCKET-SHUTTLE, ROCKET-ASTRO, ROCKET-ORBIT, OR ROCKET-VOYAGER), or at the time of Screening or Day 1.

drug

Subcutaneous (SC) injection

other

SC injection

CABA, Buenos Aires, Argentina

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Derqui, Pilar, Buenos Aires, Argentina