A phase II clinical trial found that cendakimab, an anti–interleukin-13 monoclonal antibody, may improve symptoms in adult patients with moderate to severe atopic dermatitis who had an inadequate response to topical medications.
In the randomized, double-blind, placebo-controlled study, published in JAMA Dermatology, researchers demonstrated that cendakimab met its primary endpoint of reducing Eczema Area and Severity Index (EASI) scores at week 16 compared with placebo.
The researchers enrolled 221 patients with a mean age of 37.7 years from 69 sites across the United States, Japan, Canada, Poland, and Czech Republic between May 2021 and November 202. The patients were randomly assigned to receive subcutaneous cendakimab at doses of 360 mg every 2 weeks, 720 mg every 2 weeks, or 720 mg once weekly; or placebo for 16 weeks. The mean baseline EASI score was 28.4.
The mean percentage change in EASI scores from baseline to week 16 was significantly greater among the patients who received 720 mg of cendakimab once weekly vs placebo (−84.4% vs −62.7%, P = .003).
After a follow-up of 16 weeks, the researchers found that the Validated Investigator Global Assessment for Atopic Dermatitis score of clear/almost clear with ≥ 2-point reduction was 33.3% among the patients who received 720 mg of cendakimab once weekly vs 9.4% among those who received placebo. Further, EASI-75 achievement was 50.0% among those in the 720-mg once weekly group vs 26.3% among those in the placebo group; and a ≥ 4-point reduction in Pruritus Numeric Rating Scale was achieved among 33.3% of those in the 720-mg once weekly group vs 14.8% among those in the placebo group.
The researchers reported that treatment-emergent adverse events were mostly mild to moderate, with higher rates of conjunctivitis in the cendakimab groups. No new safety signals were identified.
The 720-mg every 2 weeks group did not reach statistical significance for the primary endpoint (−76.0% vs −62.7%, P = .06). The 360-mg every 2 weeks group showed a treatment effect comparable to 720 mg once weekly (−16.3%, nominal P = .03 vs placebo), but significance could not be claimed as a result of the hierarchical testing sequence.
The researchers concluded that the findings may establish the safety and efficacy of cendakimab in adult patients with moderate to severe atopic dermatitis, with improvement seen at all doses over 16 weeks. The results of the study support the role of interleukin-13 inhibition in treating atopic dermatitis and warrant further investigation of cendakimab in larger trials.
Conflict of interest disclosures are available in the study.