Rocatinlimab (Rocatan) for Atopic Dermatitis
Rocatinlimab is an investigational T-cell rebalancing therapy targeting the OX40 receptor, currently being evaluated in the ROCKET phase 3 clinical trial program for moderate-to-severe atopic dermatitis in adults and adolescents. 1
What is Rocatinlimab?
Mechanism of Action: Rocatinlimab inhibits and reduces pathogenic T cells by targeting the OX40 receptor, representing a novel T-cell rebalancing approach distinct from current biologics and JAK inhibitors. 1
Target Population: The drug is being studied specifically for patients with moderate-to-severe atopic dermatitis who have failed to reach or maintain treatment goals with existing systemic therapies, including biologics and JAK inhibitors. 1
Current Development Status
Phase 3 Program (ROCKET): This is a large, global phase 3 program consisting of eight clinical trials designed to evaluate efficacy, durability of response, and long-term safety. 1
Trial Registration Numbers: NCT05398445, NCT05651711, NCT05724199, NCT05899816, NCT05704738, NCT05633355, NCT05882877, NCT06224192. 1
Study Design: The trials will evaluate rocatinlimab as both monotherapy and combination therapy in adult and adolescent patients with or without prior exposure to biologics or systemic JAK inhibitors. 1
Clinical Context
Important Caveat: Rocatinlimab is not yet FDA-approved and remains investigational. It is only available through participation in clinical trials. 1
The development of this agent addresses an unmet need for patients who experience lack of durable response or safety/tolerability issues with current systemic therapies for atopic dermatitis. 1
Approximately 10% of adults and 20% of children globally are affected by atopic dermatitis, with a significant proportion having moderate-to-severe disease requiring systemic therapy. 1