Rocatinlimab Maintains Safety Profile in 24-Week AD Study

While advances in biologic and small-molecule therapies have improved patient outcomes, unmet needs in atopic dermatitis (AD) remain regarding durability of response and long-term disease control.¹ Late-breaking results from the phase 3 ROCKET-Ignite trial were presented at the European Academy of Dermatology and Venereology (EADV) 2025 Congress in Paris, France, highlighting the efficacy and safety of rocatinlimab, an investigational OX40 receptor (OX40R) inhibitor.²

Scientific Rationale
The OX40 receptor, transiently expressed on activated effector and memory T cells, contributes to T-cell imbalance and amplifies proinflammatory responses implicated in AD pathogenesis. Rocatinlimab (Amgen; Kyowa Kirin) is a first-in-class therapy designed to rebalance T-cell activity by targeting OX40R and reducing OX40R-positive pathogenic T cells. Previously, the ROCKET-Horizon study demonstrated clinically meaningful improvements with rocatinlimab. The ROCKET-Ignite trial was conducted to further assess efficacy and safety in a global adult population.

Study Design
ROCKET-Ignite (NCT05398445) randomized 760 adults (≥18 years) with moderate to severe AD in a 3:2:2 ratio to receive subcutaneous rocatinlimab 300 mg, rocatinlimab 150 mg, or placebo every 4 weeks, with a week -2 loading dose. Treatment was continued for 24 weeks, with rescue therapy (RT) permitted at any time.

The co-primary endpoints at week 24 were:

• ≥75% improvement from baseline in Eczema Area and Severity Index (EASI 75), and
• Validated Investigator’s Global Assessment for Atopic Dermatitis (vIGA-AD™) score of 0/1 with ≥2-point reduction from baseline.

Efficacy analyses included a full analysis set, in which RT users were considered nonresponders, and a prespecified sensitivity analysis (all data) irrespective of RT use. Safety was assessed in all patients receiving at least 1 dose of study drug.

Efficacy Outcomes
Demographics and baseline disease characteristics were well balanced across treatment arms, with 59% of participants having prior systemic therapy exposure and 21% previously treated with biologics or JAK inhibitors.

Rocatinlimab significantly outperformed placebo on both co-primary endpoints at week 24. In the full analysis set:

• EASI 75 response rates were 42.3% (300 mg) and 36.3% (150 mg) compared with 12.8% for placebo.
• vIGA-AD 0/1 response rates were 23.6% (300 mg) and 19.1% (150 mg) versus 8.7% for placebo.

In the all-data analysis, irrespective of RT use, outcomes were more pronounced:

• EASI 75 response rates were 54.3% (300 mg) and 49.3% (150 mg) versus 20.1% for placebo.
• vIGA-AD 0/1 responses were 27% (300 mg) and 22.8% (150 mg) compared with 11.9% for placebo.

Key secondary endpoints, including EASI 90 and ≥4-point reduction in pruritus numerical rating scale, were also met. Notably, efficacy continued to increase through week 24, suggesting no plateau effect at the study’s endpoint.

Safety Findings
Treatment-emergent adverse events were balanced across arms: 69.3% (300 mg), 70.6% (150 mg), and 69.3% (placebo). Serious adverse events occurred in 4.6%, 2.8%, and 5.5% of patients, respectively. Rates of infection were comparable among groups (38–41%), with no evidence of increased risk in the rocatinlimab arms.

Conclusions
The ROCKET-Ignite study met its co-primary and key secondary endpoints in a diverse, treatment-experienced adult population with moderate to severe AD. Rocatinlimab demonstrated significant improvements in disease severity and symptoms compared with placebo, researchers stated, with consistent efficacy across analyses and a favorable safety profile.

Presented as late-breaking data at EADV 2025 in Paris, these findings, together with prior results from ROCKET-Horizon, provide strong clinical evidence supporting OX40R inhibition as a novel therapeutic strategy for AD. Ongoing and long-term extension studies will be essential to establish durability of response and characterize the long-term safety of rocatinlimab.

References

1. Eichenfield DZ, Knapp KD, Claxton A, et al. Unmet needs of effective advanced systemic therapies in moderate-to-severe atopic dermatitis oatients in the TARGET-DERM AD registry. Dermatitis. 2025;36(3):244-257. doi:10.1089/derm.2024.0191
2. Guttman-Yassky E, Kabashima K, Chovatiya R, et al. Efficacy and safety of OX40-receptor targeting with rocatinlimab in moderate-to-severe atopic dermatitis: Results from the phase 3 ROCKET-Ignite trial. Presented at: European Academy of Dermatology and Venereology Congress 2025; September 17-20, 2025; Paris, France.