Rademikibart Shows High Long-Term Efficacy in Atopic Dermatitis
Rademikibart, a next-generation anti–IL-4 receptor alpha monoclonal antibody, demonstrated robust and sustained efficacy in moderate-to-severe atopic dermatitis (AD) through 52 weeks, according to Phase 3 RADIANT-AD data presented by Cheng Zhou, MD, at the American Academy of Dermatology (AAD) 2026 Annual Meeting.
The randomized, double-blind, placebo-controlled trial enrolled 259 patients aged 12 years and older, including both adults and adolescents, with disease inadequately controlled by topical therapy. Patients received rademikibart 300 mg every 2 weeks following a 600 mg loading dose, with a 16-week placebo-controlled phase followed by a 36-week open-label extension.
Dr. Zhou highlighted the need for additional treatment options, noting that “there is still high unmet medical need in atopic dermatitis,” particularly for therapies capable of achieving deeper and more durable responses.
At Week 16, rademikibart significantly improved all key endpoints compared with placebo (all P < .0001), including IGA 0/1 (47.7% vs 17.6%), EASI-75 (74.2% vs 34.4%), EASI-90 (43.0% vs 14.5%), and ≥3-point pruritus NRS improvement (54.7% vs 27.5%).
“The response continued to rise through week 52,” Dr. Zhou said, with IGA 0/1 reaching 87.1%, EASI-75 96.6%, and EASI-90 85.3%. Pruritus responses also increased over time, with more than 90% of patients achieving clinically meaningful itch reduction.
Rademikibart is designed to bind a distinct IL-4Rα epitope with higher affinity than existing therapies.
“It is a next-generation IL-4 antibody modified to have a better affinity to the IL-4 receptor alpha,” Dr. Zhou said.
Safety findings were comparable to placebo during the double-blind phase and remained favorable through 52 weeks. Treatment-emergent adverse events occurred in 60.9% of rademikibart-treated patients vs 64.9% with placebo at Week 16, with low rates of serious adverse events and discontinuations. Conjunctivitis and injection-site reactions were infrequent.