A Study of SHR-1819 in Patients With Moderate-to-severe Atopic Dermatitis

A Multicenter, Randomized, Double-blind, Phase II Study to Evaluate the Efficacy and Safety of SHR-1819 Injection in Adult Patients With Moderate to Severe Atopic Dermatitis

This trial was designed to evaluate the efficacy and safety of SHR-1819 in adult patients with moderate-to-severe atopic dermatitis.

Study Overview

• Status: Active, not recruiting
• Conditions: Moderate-to-severe Atopic Dermatitis
• Intervention / Treatment: Drug: SHR-1819 Injection; Drug: SHR-1819 Injection Blank Preparation

• Study Type: Interventional
• Enrollment (Actual): 201
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510091
      • Dermatology Hospital of Southern Medical University
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Hangzhou Third People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. At the time of signing the informed consent, the subjects are ≥18 years old and ≤75 years old, male or female.
2. The subjects have voluntarily signed the informed consent form prior to the start of any procedures related to the study, are able to communicate smoothly with the researcher, understand and are willing to strictly abide by the requirements of this clinical research protocol to complete the study.
3. Topical emollients are applied at a stable dose twice daily for at least 7 days before the first dose in the run-in phase and continued for the duration of the study.
4. Have atopic dermatitis at the time of screening and have an investigator-assessed history of atopic dermatitis for at least 1 year before screening.
5. Have moderate to severe atopic dermatitis during the screening period and on the day of the first dose.

Exclusion Criteria:

1. Have other active skin disease or skin complications due to other conditions that may affect the evaluation of Atopic Dermatitis (AD).
2. A history of spring keratoconjunctivitis and/or atopic keratoconjunctivitis within 6 months prior to screening.
3. Has malignancy or has a history of malignancy.
4. Have serious concomitant diseases and other conditions that the investigator considers inappropriate to participate in this trial.
5. Hypersensitivity to the study drug or any ingredient in the study drug.
6. Females who are pregnant or lactating.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHR-1819 Injection Group with Dose 1	Drug: SHR-1819 Injection; SHR-1819 injection.; Drug: SHR-1819 Injection Blank Preparation; SHR-1819 injection blank preparation.
Experimental: SHR-1819 Injection Group with Dose 2	Drug: SHR-1819 Injection; SHR-1819 injection.; Drug: SHR-1819 Injection Blank Preparation; SHR-1819 injection blank preparation.
Experimental: SHR-1819 Injection Group with Dose 3	Drug: SHR-1819 Injection; SHR-1819 injection.; Drug: SHR-1819 Injection Blank Preparation; SHR-1819 injection blank preparation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of participants who achieved EASI-75 (≥75% decrease in the score on the Eczema Area and Severity Index (EASI) from the baseline).	Eczema Area and Severity Index score using the Eczema Area and Severity Index scale.	Week 24.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of participants with a baseline daily Itch Numeric Rating Scale (I-NRS) score of ≤4 per week.	The Itch Numeric Rating Scale score using the Itch Numeric Rating Scale.	Week 24.
Adverse events (AEs).		About 42 weeks.
The concentration of SHR-1819 in serum.		From week -16 to week -8, about every 4 weeks; From week 0 to week 32, about every 8 weeks.

Collaborators and Investigators

• Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: December 21, 2025
• First Submitted That Met QC Criteria: January 5, 2026
• First Posted (Actual): January 7, 2026

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: SHR-1819-207

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No