ArticleClinical and translational allergy2025
Efficacy and Safety of Stapokibart in Adults With Moderate-to-Severe Atopic Dermatitis With and Without Type 2 Comorbidities: A Post Hoc Analysis of a Phase 3 Trial.
Article in Clinical and translational allergy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05265923 (A Randomized, Double Blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of CM310 in Patients With Moderate-to-severe Atopic Dermatitis), which is not on this map. Cited by 2 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized, Double Blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of CM310 in Patients With Moderate-to-severe Atopic Dermatitis
Who cites it
2 citing papers in PubMed.
- Stapokibart (CM310) in Atopic Dermatitis: A Narrative Review of a Next-Generation IL-4Rα Antagonist.Dermatology practical & conceptual · 2026Review
- Efficacy and Safety of Stapokibart in Adults With Moderate-to-Severe Atopic Dermatitis With and Without Type 2 Comorbidities: A Post Hoc Analysis of a Phase 3 Trial.Clinical and translational allergy · 2025Article
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Authors and funding
27 authors.
Funding
Abstract
backgroundAtopic dermatitis (AD) often coexists with other type 2 inflammatory diseases. Stapokibart, a humanized IgG4 monoclonal antibody targeting interleukin-4 receptor alpha subunit, showed high efficacy and favorable safety in a phase 3 trial. This post-hoc analysis aimed to compare the efficacy and safety of stapokibart in AD patients with and without type 2 comorbidities.
methodsDuring 16-week double-blind period, participants were randomly assigned to stapokibart 600 (loading dose)-300 mg (n = 251) or placebo (n = 249) treatment every other week (Q2W). All patients received stapokibart 300 mg Q2W during subsequent 36-week maintenance period. Patients with ≥ 1 of the following conditions were classified into comorbid subgroup: allergic rhinitis, asthma, food allergies, chronic urticaria, or chronic obstructive pulmonary disease. Post-hoc outcomes included response rates of ≥ 75%/90% improvement in Eczema Area and Severity Index score (EASI-75/90), Investigator's Global Assessment score of 0 or 1 (IGA 0/1) with ≥ 2-point reduction, and ≥ 4-point reduction in weekly average of daily peak pruritus numerical rating scale score (PP-NRS4), and the percentage change from baseline in weekly average of daily PP-NRS score. Treatment-emergent adverse events (TEAEs) were also analyzed by subgroups.
resultsNinety-two patients (36.7%) in stapokibart group and 102 (41.0%) in placebo group had type 2 comorbidities. The demographic characteristics and baseline disease scores were generally comparable across four groups. At week 16, stapokibart demonstrated superior efficacy over placebo in patients with and without type 2 comorbidities. In patients with comorbidities, the response rates of EASI-75, IGA 0/1, and PP-NRS4 in stapokibart and placebo groups were 77.2% versus 26.5%, 55.4% versus 17.6%, and 43.5% versus 12.7%, respectively. In patients without comorbidities, these response rates were 61.0% versus 25.3%, 37.7% versus 15.1%, and 31.4% versus 11.0%, respectively (all p values < 0.0001). All patients showed further improvements in efficacy outcomes during weeks 20-52. TEAEs occurred in 88.8% and 87.7% of comorbid and non-comorbid patients over weeks 0-52. The incidence of conjunctivitis was 5.9% and 5.0%, respectively.
conclusionStapokibart was effective and safe in adults with moderate-to-severe AD both with and without type 2 comorbidities in both short-term and long-term treatment.
trial registrationClinicalTrials.gov identifier: NCT05265923.
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