What question did this study set out to answer?

The study aimed to assess the efficacy and safety of SHR-1819, an anti-IL-4Rα antibody, for moderate-to-severe atopic dermatitis.

May 31, 2026Open Access

Anti-IL-4Rα antibody SHR-1819 for moderate-to-severe atopic dermatitis: a randomized phase 2 study

Key Points

The study aimed to assess the efficacy and safety of SHR-1819, an anti-IL-4Rα antibody, for moderate-to-severe atopic dermatitis.
Randomized (1:1:1:1) trial involving 157 patients with moderate-to-severe atopic dermatitis treatment groups: SHR-1819 300 mg Q2W, 600 mg Q2W, 600 mg Q4W, or placebo.
Primary endpoint: EASI-75 at week 16, requiring baseline EASI score ≥ 16.
Secondary endpoints evaluated IGA scores and pruritus ratings.
EASI-75 at week 16: 69.2% for 300 mg Q2W, 75.0% for 600 mg Q2W, 85.4% for 600 mg Q4W vs. 37.8% for placebo (all p < 0.01).
Increased IGA score 0-1 and ≥ 2 points reduction observed with SHR-1819.
Adverse events were similar between treatment and placebo, with injection site reactions being the most common.

Abstract

SHR-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. Patients 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. A 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. SHR-1819 demonstrated promising efficacy in improving the signs and symptoms of AD, with a well-tolerated safety profile and favorable pharmacokinetic, and pharmacodynamic characteristics. ClinicalTrials.gov, NCT05549947; registered on September 22, 2022.

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Cite This Study

Gu et al. (Thu,) studied this question.

synapsesocial.com/papers/6a1bcfb05783ba022b6fbbc0 https://doi.org/https://doi.org/10.1186/s12916-026-04952-3

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