Trial reportBMC medicine2026
Anti-IL-4Rα antibody SHR-1819 for moderate-to-severe atopic dermatitis: a randomized phase 2 study.
Trial report in BMC medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05549947 (A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacokinetics of SHR-1819 Injection in Adults With Moderate to Severe Atopic Dermatitis), which is not on this map. Not yet cited in PubMed.
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A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacokinetics of SHR-1819 Injection in Adults With Moderate to Severe Atopic Dermatitis
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29 authors.
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Abstract
backgroundSHR-1819 is a novel monoclonal antibody targeting IL-4Rα, developed for the treatment of type 2 inflammatory diseases such as atopic dermatitis (AD). This phase 2 study aimed to evaluate SHR-1819 for treating moderate-to-severe AD.
methodsPatients with an Eczema Area and Severity Index (EASI) score ≥ 16, an Investigator's Global Assessment (IGA) score ≥ 3, and ≥ 10% body surface area affected by AD were randomized (1:1:1:1) to receive SHR-1819 at 300 mg every 2 weeks (Q2W), 600 mg Q2W, 600 mg every 4 weeks (Q4W), or placebo for 16 weeks. Patients were required to use topical moisturizer at least 7 days before randomization, twice daily, and continuously throughout the entire study period. Primary endpoint was the proportion of patients achieving a ≥ 75% reduction from baseline in EASI score (EASI-75) at week 16.
resultsA total of 157 patients received treatment (n = 39, 40, and 41 in the SHR-1819 300 mg Q2W, 600 mg Q2W, and 600 mg Q4W groups; n = 37 in the placebo group). At week 16, the EASI-75 rate was numerically higher in the SHR-1819 groups, compared with the placebo group (69.2% [95% CI: 53.6%-81.4%] at 300 mg Q2W, 75.0% [95% CI: 59.8%-85.8%] at 600 mg Q2W, and 85.4% [95% CI: 71.6%-93.1%] at 600 mg Q4W vs. 37.8% [95% CI: 24.1%-53.9%]; all nominal p < 0.01). Compared with placebo, more patients treated with SHR-1819 achieved IGA score 0-1 and ≥ 2 points reduction, and had ≥ 4 points reduction in weekly average daily Peak Pruritus Numerical Rating Scale score. Treatment-related adverse events (TRAEs) were comparable between the SHR-1819 and placebo groups (45.8% vs. 40.5%). The most common TRAE with SHR-1819 was injection site reaction (10.8%), increased blood bilirubin (5.8%), and conjunctivitis (5.0%). Dose-proportional increases in SHR-1819 concentrations were observed within the studied range. SHR-1819 revealed notable reductions in thymus and activation-regulated chemokine, immunoglobulin E, and eotaxin-3 levels across all doses.
conclusionsSHR-1819 demonstrated promising efficacy in improving the signs and symptoms of AD, with a well-tolerated safety profile and favorable pharmacokinetic, and pharmacodynamic characteristics.
trial registrationClinicalTrials.gov, NCT05549947; registered on September 22, 2022.
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