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A Study of SHR-1819 in Patients With Moderate-to-severe Atopic Dermatitis | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

NCT07321951•Guangdong Hengrui Pharmaceutical Co., Ltd

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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.

Locations (2)

Dermatology Hospital of Southern Medical University

Guangzhou, Guangdong, China

Hangzhou Third People's Hospital

Hangzhou, Zhejiang, China

Key Dates

Start Date

January 9, 2026

Primary Completion Date

June 1, 2027

Completion Date

August 1, 2027

Last Updated

January 22, 2026

Enrollment

200

ESTIMATED participants

Conditions

Moderate-to-severe Atopic Dermatitis

Interventions

SHR-1819 Injection

DRUG

SHR-1819 Injection Blank Preparation

DRUG

Contacts

Ran Li

CONTACT

+86-0518-82342973 ran.li@hengrui.com

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Moderate-to-Severe Atopic Dermatitis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 22, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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