Rocatinlimab Demonstrates Significant Efficacy and Safety in Phase 3 Trials for Moderate-to-Severe Atopic Dermatitis

In the 2 global, double-blind, placebo-controlled, randomized phase 3 ROCKET-IGNITE (IGNITE; NCT05398445) and ROCKET-HORIZON (HORIZON; NCT05651711) clinical trials, rocatinlimab (Amgen and Kyowa Kirin) demonstrated lasting benefits for the treatment of moderate-to-severe atopic dermatitis, also recognized as eczema.^1-4

“These findings represent a major advance for patients living with eczema, who often face years of uncontrolled symptoms and few effective options,” 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 news release.²

What is the Role of Rocatinlimab?

Rocatinlimab is an investigational anti-OX40 monoclonal antibody being studied for the treatment of moderate to severe atopic dermatitis. It works by targeting the OX40 receptor to rebalance T cells, reducing pathogenic effector and memory T cells that drive inflammatory responses in atopic dermatitis. OX40-expressing effector T cells are found in skin lesions of patients and play a key role in disease development.⁵

Rocatinlimab is also being evaluated for moderate to severe uncontrolled asthma, prurigo nodularis, and other inflammatory conditions linked to T cell imbalance. The antibody is still in clinical development, with safety and efficacy not yet approved by any regulatory authority.⁵

Clinical Trial Data Supporting Rocatinlimab Treatment for Eczema

Nearly 1500 patients were followed for 24 weeks across both phase 3 clinical trials. Patients were adults aged 18 years or older with a confirmed diagnosis of atopic dermatitis for at least 1 year and moderate-to-severe disease, defined by an Eczema Area and Severity Index (EASI) score of 16 or higher, a validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) score of 3 or 4, and at least 10% body surface area affected. In the IGNITE study, patients were randomly assigned in a 3-to-2-to-2 ratio to receive 300 mg rocatinlimab, 150 mg rocatinlimab, or a placebo subcutaneously. In the HORIZON study, patients were randomized 3 to 1 to receive 300 mg of rocatinlimab or placebo subcutaneously.^1,2

In both trials, treatment was given for 24 weeks, with doses at weeks 0, 2, and 4, followed by every 4 weeks until the final dose at week 20. The coprimary end points were the proportion of patients achieving EASI-75 (greater than 75% improvement from baseline) and a vIGA-AD score of 0 to 1 (clear or almost clear skin, representing a greater than 2-point improvement at week 24.^1,2

Rocatinlimab treatment led to statistically significant improvements compared with placebo in both clinical trials at week 24. In the IGNITE trial, a higher proportion of patients receiving 300 mg or 150 mg rocatinlimab achieved EASI-75 and vIGA-AD scores of 0 to 1 than those receiving placebo. Similarly, in the HORIZON trial, patients treated with 300 mg rocatinlimab showed significantly greater improvements in both EASI-75 response and vIGA-AD outcomes compared with placebo.^1,2

Further results demonstrated that the therapy led to meaningful reductions in itch, pain, and sleep disturbances, thereby enhancing overall quality of life.^1,2

“By targeting memory T cells through OX40, rocatinlimab not only clears the skin and relieves itch but also 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,” Guttman-Yassky said.²

The overall rates of treatment-emergent adverse events were generally similar between rocatinlimab and placebo groups in both the IGNITE and HORIZON trials. The most common adverse events reported more frequently with rocatinlimab were pyrexia, chills, and aphthous ulcers, each occurring in a minority of patients.^1,2

The study authors noted that a phase 3 trial extension trial is ongoing, which is tracking outcomes for up to 2 years. Additional research is aimed at exploring treatment in pediatric patients combined with other therapies.^1,2

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. The Lancet, Volume 407, Issue 10523, 53 – 66

2. Mount Sinai dermatologist reports Phase 3 success for rocatinlimab in moderate-to-severe eczema. News release. Eurek Alert! November 25, 2025. Accessed January 21, 2026. https://www.eurekalert.org/news-releases/1107503

3. A Study Evaluating Rocatinlimab in Moderate-to-severe Atopic Dermatitis (ROCKET-IGNITE) (ROCKET-Ignite). Updated November 24, 2025. Accessed January 21, 2026. https://clinicaltrials.gov/study/NCT05398445

4. A Study Assessing Rocatinlimab (AMG 451) Monotherapy in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon) (ROCKET-Horizon). Updated April 3, 2025. Accessed January 21, 2026. https://clinicaltrials.gov/study/NCT05651711

5. Amgen and Kyowa Kirin announce top-line results from rocatinlimab phase 3 ASCEND long-term extension study in adults with moderate to severe atopic dermatitis. News release. Amgen. September 8, 2025. Accessed January 21, 2026. https://www.amgen.com/newsroom/press-releases/2025/09/amgen-and-kyowa-kirin-announce-top-line-results-from-rocatinlimab-phase-3-ascend-long-term-extension-study-in-adults-with-moderate-to-severe-atopic-dermatitis