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Anti-IL-4Rα antibody SHR-1819 for moderate-to-severe atopic dermatitis: a randomized phase 2 study
Chaoying Gu1, Huibin Yin1, Bin Yang2
1Department of Dermatology, Huashan Hospital Affiliated to Fudan University, No. 12 Middle Wulumuqi Road, Shanghai, 200040, China.
BMC Medicine
|May 29, 2026
Summary
SHR-1819, a novel monoclonal antibody, shows promising efficacy in treating moderate-to-severe atopic dermatitis (AD). The drug demonstrated significant improvements in Eczema Area and Severity Index scores and was well-tolerated by patients.
Area of Science:
- Immunology
- Dermatology
- Pharmacology
Background:
- Atopic dermatitis (AD) is a chronic type 2 inflammatory skin disease.
- Interleukin-4 receptor alpha (IL-4Rα) is a key target for AD treatment.
- SHR-1819 is a novel monoclonal antibody targeting IL-4Rα.
Purpose of the Study:
- To evaluate the efficacy and safety of SHR-1819 in patients with moderate-to-severe atopic dermatitis.
- To determine the optimal dosage and administration frequency of SHR-1819.
Main Methods:
- A phase 2, randomized, double-blind, placebo-controlled study.
- 157 patients with moderate-to-severe AD were randomized to receive SHR-1819 (300 mg Q2W, 600 mg Q2W, or 600 mg Q4W) or placebo for 16 weeks.
- The primary endpoint was the proportion of patients achieving a ≥75% reduction from baseline in Eczema Area and Severity Index (EASI) score (EASI-75) at week 16.
Main Results:
- SHR-1819 groups showed numerically higher EASI-75 rates compared to placebo at week 16 (up to 85.4% vs. 37.8%).
- SHR-1819 treatment led to significant improvements in Investigator's Global Assessment (IGA) scores and pruritus.
- Treatment-related adverse events were comparable between SHR-1819 and placebo groups, with injection site reactions being the most common.
Conclusions:
- SHR-1819 demonstrated promising efficacy in improving atopic dermatitis signs and symptoms.
- The drug exhibited a favorable safety profile, pharmacokinetic, and pharmacodynamic characteristics.
- SHR-1819 represents a potential new therapeutic option for moderate-to-severe atopic dermatitis.
