Key clinical point: Rademikibart administered at 2-week (Q2W) and 4-week (Q4W) intervals was well-tolerated and effective in improving the overall symptoms in adults with moderate-to-severe atopic dermatitis (AD).
Major finding: At week 16, the least squares mean percent reductions in the Eczema Area Severity Index scores with 300 mg Q2W (−63.0%; P = .0007), 150 mg Q2W (−57.6%; P = .0067), and 300 mg Q4W (−63.5%; P = .0004) rademikibart were significantly higher than that with placebo (−39.7%). Treatment-emergent adverse event rates were similar with rademikibart (48.2%) and placebo (53.6%).
Study details: This phase 2 trial included 226 anti-interleukin (IL)-4R a/IL-13 treatment-naive adults with moderate-to-severe AD who were randomly assigned (1:1:1:1) to receive rademikibart (300 mg Q2W, 150 mg Q2W, or 300 mg Q4W) or placebo for 16 weeks following a 600 mg loading dose of rademikibart or placebo, respectively, on day 1.
Disclosures: This study was funded by Connect Biopharma. Ten authors declared being employees or shareholders of Connect Biopharma. The other authors declared being consultants of or having other ties with various sources, including Connect Biopharma.
Source: Silverberg JI et al. Efficacy and safety of rademikibart (CBP-201), a next-generation monoclonal antibody targeting IL-4Rα, in adults with moderate-to-severe atopic dermatitis: A phase 2 randomized trial (CBP-201-WW001). J Allergy Clin Immunol. 2023 (Dec 27). doi: 10.1016/j.jaci.2023.11.924