Actively Recruiting
Evaluation of 611 in Chinese Adolescents With Moderate to Severe Atopic Dermatitis
Led by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. · Updated on 2025-11-18
180
Participants Needed
3
Research Sites
112 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary objective of the study was to evaluate the efficacy of 611 in Chinese Adolescents with moderate to severe atopic dermatitis.
CONDITIONS
Official Title
Evaluation of 611 in Chinese Adolescents With Moderate to Severe Atopic Dermatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects and their legal guardians can understand and agree to the study procedures and sign informed consent.
- Age is 12 years or older and under 18 years at consent.
- Body weight is 30 kg or more at screening and baseline.
- Diagnosed with atopic dermatitis according to Hanifin-Rajka criteria with a history of 6 months or more.
- Eczema Area and Severity Index (EASI) score is 16 or higher at screening and baseline.
- Investigator Global Assessment (IGA) score is 3 or higher at screening and baseline.
- Atopic dermatitis affects 10% or more of body surface area at screening and baseline.
- Weekly average Numerical Rating Scale (NRS) for itch is 4 or higher at baseline.
- Have relevant medical records or evidence from the past year for evaluation.
- Poor response or unsuitable for topical drug treatment.
- Willing to use a stable dose of moisturizer twice daily on affected areas for at least 7 days before randomization and throughout the study.
- Subjects with fertility potential must agree to avoid sexual activity or use highly effective contraception during the study and for at least 3 months after the last dose.
- Subjects have no plans for reproduction, sperm, or egg donation during the study and for at least 3 months after last dose.
- Able to understand and complete research questionnaires independently or with assistance.
You will not qualify if you...
- Have other skin conditions that might interfere with study evaluations.
- Have active or suspected parasitic infections.
- History of vernal keratoconjunctivitis or atopic keratoconjunctivitis.
- Malignant tumors diagnosed within the past 5 years or currently active (except certain types cured for 1 year or more).
- Severe infection requiring hospitalization or intravenous antibiotics within 4 weeks before randomization.
- Active infection requiring oral antibiotics within 2 weeks before randomization.
- Known or suspected immunosuppression or history of invasive opportunistic infections.
- Evidence or suspicion of active tuberculosis or insufficient evidence of prior treatment.
- Severe or unstable diseases that could affect safety or study completion.
- Recent use of topical treatments for atopic dermatitis within 2 weeks before randomization.
- Recent use of certain systemic traditional Chinese medicines or topical Chinese herbal medicines within specified timeframes.
- Recent use of systemic immunosuppressants or immunomodulators within 4 weeks or 5 half-lives.
- Recent phototherapy or light-based treatments within 4 weeks.
- Allergen-specific immunotherapy within 6 months.
- Recent monoclonal antibody or cell-depleting therapy within specified periods.
- Previous poor response to anti-IL-4 and/or IL-13 drugs.
- Previous use of 611.
- Started prescription or additive-containing emollients during screening.
- Received live or live attenuated vaccines within 4 weeks before randomization.
- Abnormal lab values judged unsuitable by researchers.
- Positive tests for hepatitis B, hepatitis C, HIV, or syphilis.
- Use of investigational drugs within 8 weeks or 5 half-lives.
- History of alcohol or drug abuse within 6 months.
- Allergic or intolerant to study drug components.
- Planned major surgery during the study.
- Pregnant, planning pregnancy, or breastfeeding.
- Other reasons judged by investigators making participation unsuitable.
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
2
The Fourth Affiliated Hospital Zhejiang University School of Medicine
Jinhua, Zhejiang, China, 322000
Actively Recruiting
3
Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine
Nanchang, Zhejiang, China, 310003
Actively Recruiting
Research Team
Q
Qinghong Zhou, Master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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