RecruitingPhase 2NCT07321951
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
Sponsor
Guangdong Hengrui Pharmaceutical Co., Ltd
Enrollment
200 participants
Start Date
Jan 9, 2026
Study Type
INTERVENTIONAL
Conditions
Summary
This trial was designed to evaluate the efficacy and safety of SHR-1819 in adult patients with moderate-to-severe atopic dermatitis.
Eligibility
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria5
- At the time of signing the informed consent, the subjects are ≥18 years old and ≤75 years old, male or female.
- 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.
- 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.
- Have atopic dermatitis at the time of screening and have an investigator-assessed history of atopic dermatitis for at least 1 year before screening.
- Have moderate to severe atopic dermatitis during the screening period and on the day of the first dose.
Exclusion Criteria6
- Have other active skin disease or skin complications due to other conditions that may affect the evaluation of Atopic Dermatitis (AD).
- A history of spring keratoconjunctivitis and/or atopic keratoconjunctivitis within 6 months prior to screening.
- Has malignancy or has a history of malignancy.
- Have serious concomitant diseases and other conditions that the investigator considers inappropriate to participate in this trial.
- Hypersensitivity to the study drug or any ingredient in the study drug.
- Females who are pregnant or lactating.
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Interventions
DRUGSHR-1819 Injection
SHR-1819 injection.
DRUGSHR-1819 Injection Blank Preparation
SHR-1819 injection blank preparation.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07321951
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