Actively Recruiting
A Study of SHR-1819 Injection in Adolescents With Severe Atopic Dermatitis
Led by Guangdong Hengrui Pharmaceutical Co., Ltd · Updated on 2026-04-07
201
Participants Needed
2
Research Sites
88 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial was designed to evaluate the efficacy and safety of SHR-1819 in adolescents with moderate-to-severe atopic dermatitis.
CONDITIONS
Official Title
A Study of SHR-1819 Injection in Adolescents With Severe Atopic Dermatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 12 to 17 years with body weight 30 kg or more
- Diagnosis of atopic dermatitis for at least 6 months before screening
- Moderate to severe atopic dermatitis at screening with EASI score 16 or higher, IGA score 3 or higher, and body surface area affected 10% or more
- Average itch intensity score of 4 or higher on the Pruritus Numerical Rating Scale
- Documented inadequate response to topical treatments within 6 months or topical treatments are medically inadvisable
- Stable dose of topical moisturizer applied twice daily for at least 7 consecutive days before baseline visit
- Participant and parent/legal guardian provide informed consent and agree to comply with study procedures
You will not qualify if you...
- Other active skin diseases or skin complications affecting assessment
- History of vernal or atopic keratoconjunctivitis within 6 months
- Use of certain topical medications within 1 week before randomization, including corticosteroids, calcineurin inhibitors, traditional Chinese medicine for atopic dermatitis, and others
- Use of 2 or more bleach baths within 2 weeks before randomization
- Use of systemic glucocorticoids, immunosuppressants, JAK inhibitors, systemic traditional Chinese medicine, or phototherapy within 4 weeks before randomization
- Use of investigational drugs or devices within 8 weeks before randomization
- Use of biological products within 10 weeks before randomization
- Receipt of live or attenuated vaccines within 3 months before randomization
- Use of cell-depleting agents within 6 months before randomization
- Allergen-specific immunotherapy within 6 months before randomization
- Current or history of malignant tumors
- Major surgery within 3 months before first dose or planned major surgery during study
- Severe comorbid diseases or conditions unsuitable for participation
- Recent immunosuppressive diseases or suspected infections
- Infection treated with systemic antimicrobials within 2 weeks before randomization or superficial skin infections
- History of recurrent or disseminated herpes infections within 1 year before screening
- Suspected or confirmed active tuberculosis
- Positive tests for HIV, syphilis, or hepatitis C
- Abnormal laboratory tests or electrocardiogram within 4 weeks before randomization
- Known allergy to study drug or components
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China, 110002
Actively Recruiting
2
Xinhua Hospital Affiliated to Shanghai JiaoTong University School of Medicine
Shanghai, Shanghai Municipality, China, 200092
Actively Recruiting
Research Team
X
Xiaoyan Bai
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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