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ROCKET: a phase 3 program evaluating the efficacy and safety of rocatinlimab in moderate-to-severe atopic dermatitis
Emma Guttman-Yassky1, Eric Simpson2, Robert Bissonnette3
1Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Abstract:
Atopic dermatitis (AD) is a chronic inflammatory disease affecting ~ 10% of adults and ~ 20% of children globally. Many patients with moderate-to-severe AD receiving systemic therapies, including biologics and Janus kinase (JAK) inhibitors, fail to reach or maintain treatment goals due to lack of durable response or safety/tolerability issues. Rocatinlimab is a T-cell rebalancing therapy that inhibits and reduces pathogenic T cells by targeting the OX40 receptor. ROCKET, a large, global phase 3 program of eight clinical trials (NCT05398445; NCT05651711; NCT05724199; NCT05899816; NCT05704738; NCT05633355; NCT05882877; NCT06224192), will evaluate the efficacy, durability of response, and long-term safety of rocatinlimab as monotherapy and combination therapy in adult and adolescent patients with moderate-to-severe AD with or without prior exposure to biologics or systemic JAK inhibitors.
Insights
Rocatinlimab, a novel T-cell therapy, is being evaluated in the ROCKET clinical trials for moderate-to-severe atopic dermatitis (AD). This therapy targets OX40 to rebalance T cells, aiming for improved treatment outcomes in AD patients.
Area of Science:
- Immunology
- Dermatology
- Clinical Trials
Background:
- Atopic dermatitis (AD) affects millions globally, with many patients inadequately responding to current systemic therapies like biologics and JAK inhibitors.
- Treatment challenges include lack of durable response and safety concerns, necessitating novel therapeutic approaches.
Purpose of the Study:
- To evaluate the efficacy, durability, and long-term safety of rocatinlimab in adults and adolescents with moderate-to-severe AD.
- To assess rocatinlimab as both monotherapy and in combination with other treatments.
Main Methods:
- The ROCKET program comprises eight global Phase 3 clinical trials.
- Participants include adult and adolescent patients with moderate-to-severe AD, with or without prior systemic therapy exposure.
- Rocatinlimab targets the OX40 receptor to modulate T-cell activity.
Main Results:
- Efficacy, durability of response, and long-term safety are the primary endpoints being evaluated.
- The study includes patients with varying levels of prior treatment exposure, including biologics and JAK inhibitors.
Conclusions:
- Rocatinlimab represents a potential new therapeutic option for moderate-to-severe atopic dermatitis.
- The ROCKET program will provide comprehensive data on its clinical profile in a diverse patient population.
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