A Phase 2b trial evaluating rocatinlimab for moderate to severe atopic dermatitis in adults demonstrated significant improvements in SCORing Atopic Dermatitis (SCORAD) scores compared to placebo after 16 weeks. The results, presented at the 2024 Fall Clinical Dermatology Conference, highlight the potential of rocatinlimab as a novel treatment option. Rocatinlimab functions as a T-cell rebalancing therapy by inhibiting and reducing pathogenic T cells via targeting the OX40 receptor.
Trial Design and Methods
The Phase 2b trial randomized patients to receive placebo or one of four rocatinlimab regimens: 150 mg every 4 weeks, 300 mg every 2 weeks, 600 mg every 2 weeks, or 600 mg every 4 weeks, all administered subcutaneously. SCORAD was assessed at weeks 16, 24, 36, and 56. Baseline AD severity was defined by EASI (Eczema Area and Severity Index) and IGA (Investigator's Global Assessment) scores, with moderate AD defined as an EASI score of ≥16 to <21 and an IGA score of 3, and severe AD as an EASI score ≥21 and an IGA score of 4. Statistical significance was defined as a p-value less than 0.05.
Key Findings
At week 16, SCORAD scores significantly improved in all rocatinlimab treatment cohorts compared to placebo, irrespective of baseline characteristics such as age, BMI, disease duration, and AD severity. The average baseline characteristics included a mean age of 37.9 years (SD 14.7), 59.2% male, a disease duration of 16.2 years (SD 14.9), a BMI of 25.2 (SD 6.0), an EASI score of 31.5 (SD 12.7), an IGA score of 147 (SD not provided), and a SCORAD score of 68.3 (SD 13.8).
Implications and Future Directions
According to Guttman-Yassky et al., the observed SCORAD responses, coupled with previous data showing continued improvements up to week 36 and maintenance during the 20-week off-treatment period, suggest the potential for disease modification with rocatinlimab. The drug is currently being investigated further in the comprehensive Phase 3 ROCKET program, marking a significant step forward in exploring its therapeutic potential for atopic dermatitis.
