Actively Recruiting
Evaluation of 611 (Anti-IL-4 Receptor Alpha Antibody) in Chinese Adolescents Aged 12 to 17 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
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of 611, a recombinant humanized anti-interleukin-4 receptor alpha IgG4 monoclonal antibody, in Chinese adolescents aged 12 to under 18 years with moderate to severe atopic dermatitis. This Phase 3, multi-center, randomized, double-blind, placebo-controlled clinical trial aims to assess how well 611 works and its safety in this population. The study is sponsored by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. and addresses the need for new treatments for adolescents with atopic dermatitis who have not responded well to topical therapies. The study lasts up to 64 weeks and includes several phases: a screening period of up to 4 weeks, a 16-week double-blind treatment period where participants receive either 611 or a matching placebo by subcutaneous injection every two weeks, followed by a 36-week maintenance treatment period where 611 is given every two or three weeks. Participants in the placebo group receive a loading dose at week 16 before maintenance treatment. After treatment, there is an 8-week follow-up period. During the study, participants will have regular assessments including the Eczema Area and Severity Index (EASI) and Investigator's Global Assessment (IGA) to measure skin improvement. Researchers will also track pruritus severity using a numerical rating scale. Safety will be closely monitored throughout, and participants will be asked to use a stable dose of moisturizer twice daily. The primary outcome focuses on achieving significant improvement in eczema severity at week 16. The study ensures ongoing observation and evaluation through week 60 and includes collection of medical history, questionnaires, and laboratory tests to monitor health and treatment effects.
CONDITIONS
Brief 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 between 12 and under 18 years at consent, with no gender restriction
- Body weight of at least 30 kg at screening and baseline
- Diagnosed with atopic dermatitis for at least 6 months according to Hanifin-Rajka criteria
- Eczema Area and Severity Index (EASI) score of 16 or higher at screening and baseline
- Investigator Global Assessment (IGA) score of 3 or higher at screening and baseline
- At least 10% of body surface area affected by atopic dermatitis at screening and baseline
- Weekly average pruritus Numerical Rating Scale (NRS) score of 4 or higher at baseline
- Poor response or medically unsuitable for topical treatments
- Willing to use a stable dose of moisturizer twice daily for at least 7 days before randomization and throughout the study
- Agreement to use effective contraception or avoid reproduction during the study and for 3 months after last dose
- Ability to understand and complete study questionnaires independently or with help
You will not qualify if you...
- Other skin conditions that may interfere with study evaluation
- Active or suspected parasitic infections
- History of vernal or atopic keratoconjunctivitis
- Malignant tumors diagnosed within past 5 years or current, excluding some cured skin cancers
- Recent severe infections requiring IV antibiotics or hospitalization
- Known or suspected immunosuppression or invasive opportunistic infections
- Evidence or suspicion of active tuberculosis without sufficient treatment proof
- Severe or unstable diseases that may affect safety or study completion
- Recent use of topical or systemic treatments for atopic dermatitis including corticosteroids, immunosuppressants, phototherapy, allergen immunotherapy, or monoclonal antibodies
- Prior use of 611
- Initiation of prescription emollients with additives during screening
- Recent live or live attenuated vaccines
- Abnormal lab results judged unsuitable for study
- Positive tests for hepatitis B, hepatitis C, HIV, or syphilis antibodies
- Use of investigational drugs within 8 weeks prior to randomization
- History of alcohol or drug abuse within 6 months
- Known allergy or intolerance to study drug components
- Planned major surgery during the study
- Pregnancy, breastfeeding, or planning pregnancy during the study
- Any other reason judged by investigator to make participation unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 16 weeks for double-blind treatment, followed by 36 weeks of maintenance treatment
Participants receive 611 or placebo through subcutaneous injections during a double-blind treatment period followed by a maintenance treatment period.
Subcutaneous injections every 2 weeks during double-blind period; injections every 2 or 3 weeks during maintenance period
Duration - 8 weeks
Participants are monitored for safety and study outcomes after completing treatment.
Visits during 8-week follow-up period
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
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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