NCT06012812

A Study to Extend Efficacy and Safety of SHR-1819 Injection in Adult Patients With Moderate to Severe Atopic Dermatitis

A Multicenter, Open-label, Extended Study Evaluating the Safety and Efficacy of SHR-1819 Injection in Adult Subjects With Moderate to Severe Atopic Dermatitis Who Have Previously Participated in SHR-1819 Studies for the Treatment of Atopic Dermatitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicenter, open-label, extended study to evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of SHR-1819 injection in adult subjects with moderate to severe atopic dermatitis who have previously participated in the SHR-1819 injection study for atopic dermatitis (defined as the main study, referred to as the main study hereinafter).

Conditions

• Moderate to Severe Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	SHR-1819 injection	SHR-1819 injection 300 mg Q2W

Timeline

• Start date: 2023-09-06
• Primary completion: 2025-06-05
• Completion: 2025-06-05
• First posted: 2023-08-28
• Last updated: 2026-03-05

Locations

1 site across 1 country: China