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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).

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

246

段階

  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • 中国
    • Beijing Municipality
      • Beijing、Beijing Municipality、中国、100045
        • Beijing Children's Hospital, Capital Medical University
        • 主任研究者：
          • Lin Ma
        • 主任研究者：
          • Zigang Xu
        • コンタクト：
      • Beijing、Beijing Municipality、中国、100050
        • Beijing Friendship hospital, Capital Medical University
        • 主任研究者：
          • Fenglin Zhuo
        • コンタクト：
    • Guangdong
      • Guangzhou、Guangdong、中国、510091
        • Dermatology Hospital, Southern Medical University
        • コンタクト：
          • Zhimiao Lin, Doctor
          • 電話番号：+86 13681438841
          • メール：alvinlzm@126.com
        • 主任研究者：
          • zhimiao Lin
        • 主任研究者：
          • Xiaoping Pei
    • Hunan
      • Changsha、Hunan、中国、410007
        • Hunan Children's Hospital
        • 主任研究者：
          • Zhu Wei
        • コンタクト：
          • Zhu Wei, Doctor
          • 電話番号：+86 13467622617
          • メール：34438881@qq.com
    • Zhejiang
      • Hangzhou、Zhejiang、中国、310003
        • Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine
        • 主任研究者：
          • Liming Wu
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：4倍

武器と介入

参加者グループ / アーム
介入・治療
実験的：Part A (Open-label PK study)
Age cohort :≥2 years old to <6 years old
薬：611
Solution for injection, subcutaneous (SC)
実験的：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.
薬：611
Solution for injection, subcutaneous (SC)
プラセボコンパレーター：Part B (Double-blind confirmatory study) placebo
薬：一致するプラセボ
注射用溶液、皮下 (SC)

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Part A: drug concentration.
時間枠：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.
時間枠：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.
時間枠：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.

二次結果の測定

結果測定
メジャーの説明
時間枠
Part A: Adverse events (AEs), measurement of vital signs, physical examination, electrocardiogram and laboratory tests at each visit.
時間枠：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.
時間枠：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.
時間枠：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).
時間枠：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).
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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) .
時間枠：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).
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.

その他の成果指標

結果測定
メジャーの説明
時間枠
Part B: drug concentration.
時間枠：Baseline to Week 60.
concentration of 611.
Baseline to Week 60.
Part B: Percentage of Participants With Anti-drug Antibodies and Neutralizing Antibodies.
時間枠：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.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

捜査官

  • 主任研究者：Lin Ma, Doctor、Beijing Children's Hospital
  • 主任研究者：ZiGang Xu, Doctor、Beijing Children's Hospital

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年9月1日

一次修了 (推定)

2027年9月1日

研究の完了 (推定)

2028年7月1日

試験登録日

最初に提出

2026年8月7日

QC基準を満たした最初の提出物

2026年8月13日

最初の投稿 (実際)

2026年8月17日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月17日

QC基準を満たした最後の更新が送信されました

2026年8月13日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • SSGJ-611-PED-AD-III-02

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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