NCT07767253尚未招募3 期
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)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 246
- 试验地点
- 5
- 主要终点
- Part A: drug concentration.
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Part A: Open Label Part B: Masked, Randomized
入排标准
- 年龄范围
- 2 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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) ;
- •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;
- •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;
- •At the screening and baseline, the Eczema Area and Severity Index (EASI) score is ≥ 16 points;
- •At the screening and baseline, the Investigator Global Assessment (IGA) score is ≥3 points;
- •At the time of screening and baseline, the affected body surface area (BSA) by atopic dermatitis (AD) is ≥10%;
- •At baseline, the weekly average score of Daily pruritus Numerical Rating Scale (NRS) is ≥ 4 points;
- •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;
- •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;
- •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;
- •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.
排除标准
- •Intolerance to TCS / TCI treatment or contraindications to TCS / TCI;
- •Merge other skin comorbidities that may interfere with the research evaluation;
- •Combined with active parasitic infections (such as helminths) or suspected parasitic infections ;
- •Any history of vernal keratoconjunctivitis (VKC) and atopic keratoconjunctivitis (AKC) ;
- •Randomly select patients with any malignant tumor diagnosed within the past 5 years or currently having the disease;
- •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;
- •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;
- •Active tuberculosis, unless that was well documented that the participants had adequately treated;
- •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;
- •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.
- •Received live vaccines or live attenuated vaccines within 4 weeks before randomization;
- •Participants with abnormal laboratory parameters deemed ineligible for enrollment at the Investigator's discretion. ;
- •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);
- •Used any investigational drugs within 8 weeks or 5 half-lives (whichever is longer) before randomization;
- •Had a history of alcohol or drug abuse within 6 months before randomization;
- •Known to be allergic or intolerant to any components of the investigational drug;
- •Planned or were expected to undergo major surgical operations during the study period;
- •According to the investigator's judgment, the participants were not suitable to participate in the study due to other diseases or reasons.
研究组 & 干预措施
Part B (Double-blind confirmatory study) placebo
Placebo Comparator
干预措施: Matching placebo (Drug)
Part B (Double-blind confirmatory study) 611
Experimental
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.
干预措施: 611 (Drug)
Part A (Open-label PK study)
Experimental
Age cohort :≥2 years old to <6 years old
干预措施: 611 (Drug)
结局指标
主要结局
Part A: drug concentration.
时间窗: Baseline, Week 24.
concentration of 611(Recombinant Humanized Anti-interleukin-4 Receptor Alpha IgG4 Monoclonal Antibody) .
Part B: Number of Participants With Eczema Area and Severity Index (EASI) - 75 Response (>= 75% Improvement in Score From Baseline) at Week 18.
时间窗: 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.
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.
时间窗: 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.
次要结局
- Part A: Adverse events (AEs), measurement of vital signs, physical examination, electrocardiogram and laboratory tests at each visit.(Baseline, Week 24.)
- 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.(Baseline to Week 60.)
- 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.(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.(Baseline to Week24.)
- Part A: Number of Participants With EASI-50 (>=50% Improvement From Baseline).(Baseline, Week 24.)
- Part A: Number of Participants With EASI-90 (>=90% Improvement From Baseline).(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.(Baseline to Week 24.)
- Part A: Percentage of Participants With Anti-drug Antibodies and Neutralizing Antibodies.(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.(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.(Baseline, Week 60.)
- Part B: Number of Participants With EASI-50 (>=50% Improvement From Baseline) .(Baseline, Week 60.)
- Part B: Number of Participants With EASI-90 (>=90% Improvement From Baseline).(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.(Baseline to Week 60.)
- Part B: Topical Corticosteroid (TCS) Medication-free Days From Baseline to Week 18.(Baseline to Week 18.)
- Part B:Adverse events (AEs), measurement of vital signs, physical examination, electrocardiogram and laboratory tests at each visit.(Up to 60 Weeks.)
研究者
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