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Evaluation of 611 in Chinese Children With Moderate to Severe Atopic Dermatitis(AD)

2026年8月13日 更新者：Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

A Phase III Clinical Trial to Evaluate the Efficacy and Safety of 611 (Recombinant Humanized Anti-interleukin-4 Receptor Alpha IgG4 Monoclonal Antibody) in Chinese Children (2 Years Old ≤ Age < 12 Years Old) With Moderate to Severe Atopic Dermatitis (AD)

This study is a 2-part (parts A and B) study.The primary objective of the study is to evaluate the efficacy of 611 in Chinese Children with moderate to severe atopic dermatitis (AD).

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

This study comprises Part A and Part B. Part A is a PK study in pediatric participants aged ≥2 years to <6 years with moderate to severe AD; Part B is a Phase III confirmatory trial for pediatric participants aged ≥2 years to <12 years with moderate to severe AD.

The maximum study duration for part A is 30 weeks per participants, including a screening period of up to 6 weeks, a 18-week treatment period, and an 6-week follow-up period.

The maximum study duration for part B is 60 weeks per participants, including a screening period of up to 6 weeks, a 18-week Double blind treatment period, a 36-week maintenance treatment period, and an 6-week follow-up period.

研究类型

介入性

注册 (估计的)

246

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 中国
    • Beijing Municipality
      • Beijing、Beijing Municipality、中国、100045
        • Beijing Children's Hospital, Capital Medical University
        • 首席研究员：
          • Lin Ma
        • 首席研究员：
          • Zigang Xu
        • 接触：
      • Beijing、Beijing Municipality、中国、100050
        • Beijing Friendship hospital, Capital Medical University
        • 首席研究员：
          • Fenglin Zhuo
        • 接触：
    • Guangdong
      • Guangzhou、Guangdong、中国、510091
        • Dermatology Hospital, Southern Medical University
        • 接触：
        • 首席研究员：
          • zhimiao Lin
        • 首席研究员：
          • Xiaoping Pei
    • Hunan
      • Changsha、Hunan、中国、410007
        • Hunan Children's Hospital
        • 首席研究员：
          • Zhu Wei
        • 接触：
    • Zhejiang
      • Hangzhou、Zhejiang、中国、310003
        • Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine
        • 首席研究员：
          • Liming Wu
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子

接受健康志愿者

不

描述

Inclusion Criteria:

  1. The participants and their legally acceptable representatives are able to understand and comply with the research procedures, agree to participate in the research, and sign the Informed Consent Form (ICF) ;
  2. When signing the informed consent form, the age should be ≥ 2 years old and < 6 years old for part A, and ≥ 2 years old and < 12 years old for part B. any gender, with body weight ≥ 15 kg at baseline;
  3. During the screening process, patients were diagnosed with atopic dermatitis (AD) according to the Hanifin - Rajka criteria, and their AD medical history was evaluated by researchers to be ≥ 6 months for participants aged ≥2 years to <6 years, ≥ 3 months for participants aged ≥6 years to <12 years;
  4. At the screening and baseline, the Eczema Area and Severity Index (EASI) score is ≥ 16 points;
  5. At the screening and baseline, the Investigator Global Assessment (IGA) score is ≥3 points;
  6. At the time of screening and baseline, the affected body surface area (BSA) by atopic dermatitis (AD) is ≥10%;
  7. At baseline, the weekly average score of Daily pruritus Numerical Rating Scale (NRS) is ≥ 4 points;
  8. Participants should have relevant medical records, other medical visit records, or other evidence within the previous year for researchers to evaluate. The participants have poor efficacy of topical drug treatment;
  9. Be willing to use a stable dose of emollient (moisturizer) on the affected areas of atopic dermatitis (AD) twice a day for at least 7 days before randomization and continue to use it throughout the study period;
  10. Participants with potential fertility (e.g., females who have experienced menarche or males who have had nocturnal emissions) must agree to avoid sexual activity or use highly effective contraceptive methods throughout the entire study period and for at least 3 months after the last dose of the medication;
  11. The participants (if applicable) and their legally acceptable representatives shall be able to understand and complete (either independently or with the assistance of a guardian) the research - related questionnaire filling.

Exclusion Criteria:

  1. Intolerance to TCS / TCI treatment or contraindications to TCS / TCI;
  2. Merge other skin comorbidities that may interfere with the research evaluation;
  3. Combined with active parasitic infections (such as helminths) or suspected parasitic infections ;
  4. Any history of vernal keratoconjunctivitis (VKC) and atopic keratoconjunctivitis (AKC) ;
  5. Randomly select patients with any malignant tumor diagnosed within the past 5 years or currently having the disease;
  6. The participant had a severe infection requiring intravenous antibiotics and/or hospitalization within 4 weeks before randomization, or had an active infection requiring oral antibiotics within 2 weeks before randomization, and the investigator evaluated that there might be uncontrollable risks for the participant to participate in this study. Or with a skin infection that requires treatment with topical anti-infective agents within 1 week before randomization;
  7. A history of known or suspected immunosuppression, including a history of invasive opportunistic infections; or those who, although the infection has resolved, are considered by the investigator to be likely to have frequent recurrences;
  8. Active tuberculosis, unless that was well documented that the participants had adequately treated;
  9. Any medical condition that, in the opinion of the investigator, is serious or unstable and may affect the safety of the participants during the study and/or prevent the participants from completing the study, including but not limited to cardiovascular, gastrointestinal, liver, kidney, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, and mental diseases;
  10. Participants who have received topical therapies for AD systemic traditional Chinese medicine for AD, systemic glucocorticoids, or other immunosuppressants / immunomodulators, any cell-depleting agents, monoclonal antibodies within a specified period prior to randomization.
  11. Received live vaccines or live attenuated vaccines within 4 weeks before randomization;
  12. Participants with abnormal laboratory parameters deemed ineligible for enrollment at the Investigator's discretion. ;
  13. At the screening, the test results are positive for hepatitis B, positive for hepatitis C virus antibody (HCVAb), positive for human immunodeficiency virus antibody (HIVAb), and positive for serum Treponema pallidum antibody (TPAb);
  14. Used any investigational drugs within 8 weeks or 5 half-lives (whichever is longer) before randomization;
  15. Had a history of alcohol or drug abuse within 6 months before randomization;
  16. Known to be allergic or intolerant to any components of the investigational drug;
  17. Planned or were expected to undergo major surgical operations during the study period;
  18. According to the investigator's judgment, the participants were not suitable to participate in the study due to other diseases or reasons.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：Part A (Open-label PK study)
Age cohort :≥2 years old to <6 years old
药品：611
Solution for injection, subcutaneous (SC)
实验性的：Part B (Double-blind confirmatory study) 611
The results of part A will be used to guide the enrollment for participants aged ≥2 years to <6 years with AD for part B.
药品：611
Solution for injection, subcutaneous (SC)
安慰剂比较：Part B (Double-blind confirmatory study) placebo
药品：匹配安慰剂
注射液，皮下 (SC)

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Part A: drug concentration.
大体时间：Baseline, Week 24.
concentration of 611(Recombinant Humanized Anti-interleukin-4 Receptor Alpha IgG4 Monoclonal Antibody) .
Baseline, Week 24.
Part B: Number of Participants With Eczema Area and Severity Index (EASI) - 75 Response (>= 75% Improvement in Score From Baseline) at Week 18.
大体时间：Baseline, Week 18.
The EASI score is used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.
Baseline, Week 18.
Part B: Number of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Improvement From Baseline of Greater Than or Equal to (>=) 2 Points From Baseline to Week 18.
大体时间：Baseline to Week 18.
The IGA is an assessment instrument used to rate the severity of AD globally based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity.
Baseline to Week 18.

次要结果测量

结果测量
措施说明
大体时间
Part A: Adverse events (AEs), measurement of vital signs, physical examination, electrocardiogram and laboratory tests at each visit.
大体时间：Baseline, Week 24.
The incidence and severity of treatment emergent adverse event (TEAE), including Serious Adverse Event (SAE), as well as clinical symptoms, and any abnormalities of vital signs, physical examinations, electrocardiogram, laboratory tests and, etc.
Baseline, Week 24.
Part A: Number of Participants With Eczema Area and Severity Index (EASI) - 75 Response (>= 75% Improvement in Score From Baseline) at each efficacy evaluation visit point.
大体时间：Baseline, Week 24.
The EASI score is used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.
Baseline, Week 24.
Part A: Number of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Improvement From Baseline of Greater Than or Equal to (>=) 2 Points From Baseline to each efficacy evaluation visit point.
大体时间：Baseline to Week24.
The IGA is an assessment instrument used to rate the severity of AD globally based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity.
Baseline to Week24.
Part A: Number of Participants With EASI-50 (>=50% Improvement From Baseline).
大体时间：Baseline, Week 24.
The EASI score is used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.
Baseline, Week 24.
Part A: Number of Participants With EASI-90 (>=90% Improvement From Baseline).
大体时间：Baseline, Week 24.
The EASI score is used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.
Baseline, Week 24.
Part A: Number of Participants Who Achieved >=4 Points Points With Improvement From Baseline in Weekly Average of Daily pruritus Numerical Rating Scale (NRS) Score From Baseline.
大体时间：Baseline to Week 24.
pruritus Numerical Rating Scale (NRS) is an assessment tool used to report the intensity of a participant's pruritus(itch), during a 24-hour recall period. Participants were asked the following question: how would you rate your itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]), higher scores indicated greater severity.
Baseline to Week 24.
Part A: Percentage of Participants With Anti-drug Antibodies and Neutralizing Antibodies.
大体时间：Baseline to Week 24.
Immunogenicity assessment will be based on Anti-drug Antibodies (ADAs) response and development of Neutralizing Antibodies (NABs). Percentage is calculated based on the number of evaluable participants and calculated by number of participants with treatment-emergent positive anti-drug antibodies / number of evaluable participants * 100%.
Baseline to Week 24.
Part A: Change in serum concentrations of Thymus and activation regulated chemokine (TARC), IgE, lactate dehydrogenase (LDH) , Change in whole blood eosinophil counts.
大体时间：Baseline to Week 24.
Change in serum concentrations of TARC, IgE, LDH , Change in whole blood eosinophil counts.
Baseline to Week 24.
Part B: Number of Participants With Eczema Area and Severity Index (EASI) - 75 Response (>= 75% Improvement in Score From Baseline) at each efficacy evaluation visit point except for Week 18.
大体时间：Baseline, Week 60.
The EASI score is used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.
Baseline, Week 60.
Part B: Number of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Improvement From Baseline of Greater Than or Equal to (>=) 2 Points From Baseline to each efficacy evaluation visit point except for Week 18.
大体时间：Baseline to Week 60.
The IGA is an assessment instrument used to rate the severity of AD globally based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity.
Baseline to Week 60.
Part B: Number of Participants With EASI-50 (>=50% Improvement From Baseline) .
大体时间：Baseline, Week 60.
The EASI score is used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.
Baseline, Week 60.
Part B: Number of Participants With EASI-90 (>=90% Improvement From Baseline).
大体时间：Baseline, Week 60.
The EASI score is used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.
Baseline, Week 60.
Part B: Number of Participants Who Achieved >=4 Points Points With Improvement From Baseline in Weekly Average of Daily pruritus Numerical Rating Scale (NRS) From Baseline.
大体时间：Baseline to Week 60.
pruritus Numerical Rating Scale (NRS) is an assessment tool used to report the intensity of a participant's pruritus(itch), during a 24-hour recall period. Participants were asked the following question: how would you rate your itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]), higher scores indicated greater severity.
Baseline to Week 60.
Part B: Topical Corticosteroid (TCS) Medication-free Days From Baseline to Week 18.
大体时间：Baseline to Week 18.
TCS medication-free days is calculated as the number of days that a participant used neither TCS nor system rescue therapy divided by the study days of each period.
Baseline to Week 18.
Part B:Adverse events (AEs), measurement of vital signs, physical examination, electrocardiogram and laboratory tests at each visit.
大体时间：Up to 60 Weeks.
The incidence and severity of treatment emergent adverse event (TEAE), including Serious Adverse Event (SAE), as well as clinical symptoms, and any abnormalities of vital signs, physical examinations, electrocardiogram, laboratory tests and, etc.
Up to 60 Weeks.

其他结果措施

结果测量
措施说明
大体时间
Part B: drug concentration.
大体时间：Baseline to Week 60.
concentration of 611.
Baseline to Week 60.
Part B: Percentage of Participants With Anti-drug Antibodies and Neutralizing Antibodies.
大体时间：Baseline to Week 60.
Immunogenicity assessment will be based on Anti-drug Antibodies (ADAs) response and development of Neutralizing Antibodies (NABs). Percentage is calculated based on the number of evaluable participants and calculated by number of participants with treatment-emergent positive anti-drug antibodies / number of evaluable participants * 100%.
Baseline to Week 60.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

调查人员

  • 首席研究员：Lin Ma, Doctor、Beijing Children's Hospital
  • 首席研究员：ZiGang Xu, Doctor、Beijing Children's Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月1日

初级完成 (估计的)

2027年9月1日

研究完成 (估计的)

2028年7月1日

研究注册日期

首次提交

2026年8月7日

首先提交符合 QC 标准的

2026年8月13日

首次发布 (实际的)

2026年8月17日

研究记录更新

最后更新发布 (实际的)

2026年8月17日

上次提交的符合 QC 标准的更新

2026年8月13日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • SSGJ-611-PED-AD-III-02

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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