Two Global Phase 3 Trials Confirm Efficacy of Rocatinlimab for People With Moderate-to-Severe Atopic Dermatitis

Two global, randomized, double-blind, placebo-controlled phase 3 trials demonstrated that rocatinlimab significantly improved clinical signs of moderate-to-severe atopic dermatitis (AD) at 24 weeks compared with placebo and was generally well tolerated, according to findings from the ROCKET-IGNITE and ROCKET-HORIZON studies.¹

“These findings represent a major advance for patients living with eczema, who often face years of uncontrolled symptoms and few effective options,” lead author Emma Guttman-Yassky, MD, PhD, Waldman Professor and System Chair of the Kimberly and Eric J. Waldman Department of Dermatology at the Icahn School of Medicine at Mount Sinai, said in a press release. “By targeting memory T cells through OX40, rocatinlimab not only clears the skin and relieves itch, but continues to improve patients’ lives over time with a strong safety profile. This is the first phase 3 proof that rebalancing these immune cells can transform how we treat atopic dermatitis.”²

IGNITE and HORIZON were conducted in 19 countries each and enrolled adults aged ≥18 years with confirmed AD for ≥1 year, Eczema Area and Severity Index (EASI) ≥16, validated Investigator’s Global Assessment for AD (vIGA-AD) score of 3–4, and ≥10% affected body surface area.¹

• IGNITE: Participants were randomized 3:2:2 to subcutaneous rocatinlimab 300 mg (n=328), 150 mg (n=217), or placebo (n=222).
• HORIZON: Participants were randomized 3:1 to rocatinlimab 300 mg (n=543) or placebo (n=183).

Treatment was administered at weeks 0, 2, and 4, then every 4 weeks through week 20, with efficacy assessed at week 24. Rescue therapy was permitted beginning day 1; participants who used rescue therapy were classified as nonresponders for all subsequent visits.¹

The coprimary endpoints for both trials were EASI-75 response (≥75% improvement) and vIGA-AD score of 0–1 with ≥2-point improvement, each evaluated at week 24. Both trials met all coprimary endpoints, with statistically significant improvements for rocatinlimab versus placebo.¹

EASI-75 Response at Week 24

IGNITE

• 300 mg: 138/326 (42%)
  • Difference vs placebo: 29.5% (95% CI, 22.3–36.1; P<.001)
• 150 mg: 78/215 (36%)
  • Difference vs placebo: 23.4% (95% CI, 15.4–30.9; P<.001)
• Placebo: 28/219 (13%)

HORIZON

• 300 mg: 178/543 (33%)
  • Difference vs placebo: 19.1% (95% CI, 12.4–25.2; P<.001)
• Placebo: 25/183 (14%)

vIGA-AD 0–1 Response at Week 24

IGNITE

• 300 mg: 77/326 (24%)
  • Difference vs placebo: 14.9% (95% CI, 8.8–20.6; P<.001)
• 150 mg: 41/215 (19%)
  • Difference vs placebo: 10.3% (95% CI, 3.8–16.6; P=.002)
• Placebo: 19/219 (9%)

HORIZON

• 300 mg: 105/543 (19%)
  • Difference vs placebo: 12.8% (95% CI, 7.6–17.3; P<.001)
• Placebo: 12/183 (7%)

Treatment-emergent adverse event (TEAE) rates were generally similar between rocatinlimab and placebo groups in both studies. Adverse events occurring in ≥4% of participants and at ≥2 times that of placebo frequency included¹:

• Pyrexia: 105/870 (12%) with 300 mg; 26/214 (12%) with 150 mg
• Chills: 48/870 (6%) with 300 mg; 5/214 (2%) with 150 mg
• Aphthous ulcers: 38/870 (4%) with 300 mg; 6/214 (3%) with 150 mg

Investigators reported that most pyrexia and chills events were injection-related, occurred primarily after the first dose, and were mild or moderate in severity. Serious adverse events occurred in 2%–5% of rocatinlimab-treated participants and 4%–6% of placebo-treated participants. No deaths were reported in either study.¹

References:

1. Guttman-Yassky E, Kabashima K, Worm M, et al. Efficacy and safety of rocatinlimab for the treatment of moderate-to-severe atopic dermatitis in ROCKET-IGNITE and ROCKET-HORIZON: two global, double-blind, placebo-controlled, randomised phase 3 clinical trials. Lancet. Published online November 25, 2025. doi:10.1016/S0140-6736(25)01865-3
2. Mount Sinai Dermatologist Reports Phase 3 Success for Rocatinlimab in Moderate-to-Severe Eczema. Mount Sinai. News release. November 25, 2025. Accessed December 11, 2025. https://www.mountsinai.org/about/newsroom/2025/mount-sinai-dermatologist-reports-phase-3-success-for-rocatinlimab-in-moderate-to-severe-eczema