NCT06173284已完成3 期
A Multi-Centered, Randomized, Double-Blinded, Placebo-Controlled Phase III Clinical Trial, to Evaluate the Efficacy and Safety of 611 (Recombinant Humanized Anti-interleukin-4 Receptor Alpha IgG4 Monoclonal Antibody) in Chinese Adults With Moderate to Severe Atopic Dermatitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 519
- 试验地点
- 4
- 主要终点
- Number of Participants with Eczema Area and Severity Index (EASI) - 75 Response (>= 75% Improvement in Score From Baseline) at Week 16
研究概览
简要总结
The primary objective of the study was to evaluate the efficacy of 611 in Chinese adults with moderate to severe atopic dermatitis.
详细描述
The maximum study duration was 64 weeks per participants, including a screening period of up to 4 weeks, a 52-week treatment period, and an 8-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)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must be able to understand and comply with the requirements of the study. and must participate voluntarily and sign the written informed consent.
- •Male or female adults ages 18 to 75 years old when signing the informed consent.
- •AD (according to Hanifin-Rajka Criteria) that had been present for at least 1 years before the screening visit.
- •Eczema Area and Severity Index (EASI) score greater than or equal to (>=) 16 at the screening and baseline visits.
- •Investigator's Global Assessment (IGA) score >=3 (on the 0 to 4 IGA scale, in which 3 was moderate and 4 was severe) at the screening and baseline visits.
- •Participants with >=10 percent (%) body surface area (BSA) of AD involvement at the screening and baseline visits.
- •Baseline Pruritus Numerical Rating Scale (NRS) average score for maximum itch intensity >=
- •Recent history (within 12 months before the screening visit) of inadequate response to treatment with topical medications or for whom topical treatments were otherwise medically inadvisable (e.g., because of important side effects or safety risks).
- •Have applied a stable dose of topical emollient (moisturizer) twice daily for at least the 7 consecutive days immediately before the baseline visit.
- •Female subjects of reproductive age (and their male partners) and male subjects (and their female partners) must use highly effective contraception throughout the study period and for at least 3 months after the last dose. The subjects had no plans to pregnancy, donate sperm or donate egg during the whole study period and for at least 3 months after the last dose.
排除标准
- •Presence of skin comorbidities that may interfere with study assessments
- •Presence of active endoparasitic infections; or suspected endoparasitic.
- •Any history of vernal keratoconjunctivitis (VKC) and atopic keratoconjunctivitis (AKC).
- •History of malignancy within 5 years before the baseline visit, except completely treated in situ carcinoma of the cervix at least 1 year, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin at least 1 year.
- •Active chronic or acute infection requiring treatment with systemic anti-infective therapy within 2 weeks before the baseline visit, or superficial skin infections within 1 week before the baseline visit.
- •Known or suspected history of immunosuppression, including history of invasive opportunistic infections (e.g., histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis) despite infection resolution: or unusually frequent infections, per investigator judgment.
- •Active TB, 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 subject's safety and/or prevent the subject from completing the study
- •Treatment with topical drugs such as corticosteroids, topical calcineurin inhibitors, PDE inhibitors, or Janus kinase (JAK) inhibitors within 2 weeks before baseline;
- •The lab abnormalities at screening or baseline and not suitable for inclusion in the study judged by investigator;
- •Patients who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening.
- •History of alcohol or drug abuse within 6 months before baseline.
- •History of hypersensitivity to 611 or their excipients.
- •Have been vaccinated with live (attenuated) vaccine within 2 months before baseline or planned during the study period;
- •Have used any investigational drug/treatment within 12 weeks before baseline;
- •Planned or anticipated major surgical procedure during the patient's participation in this study.
- •Pregnant or lactating women, or subjects with pregnancy or lactation plans during the study period.
- •Any reason which, in the opinion of investigator, would prevent the subject from participating in the study.
研究组 & 干预措施
611
Experimental
Induction treatment period : subcutaneous injection, 611 600mg (loading dose, week 0) + 300mg Q2W (from Week 2 to Week 14, 7 cycles) Maintenance treatment period : subcutaneous injection, 611 300mg Q2W or Q4W
干预措施: 611 (Drug)
Placebo
Placebo Comparator
Induction treatment period : subcutaneous injection, placebo Q2W (from Week 0 to Week 14, 7 cycles) Maintenance treatment period : subcutaneous injection, 611 600mg (loading dose, week 16) + 300mg Q2W or Q4W
干预措施: Matching placebo (Drug)
结局指标
主要结局
Number of Participants with Eczema Area and Severity Index (EASI) - 75 Response (>= 75% Improvement in Score From Baseline) at Week 16
时间窗: Baseline, Week 16
The EASI score was 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.
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 16
时间窗: Baseline，Week 16
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
- Number of Participants With EASI-50 (>=50% Improvement From Baseline)(Baseline to Week 60)
- Change From Baseline in Percent Body Surface Area (BSA) of AD Involvement(Baseline to Week 60)
- Change From Baseline in Weekly Average of Pruritus NRS(Baseline to Week 60)
- Change From Baseline in Patient Oriented Eczema Measure (POEM)(Baseline to Week 60)
- Number of Participants With EASI-90 (>=90% Improvement From Baseline)(Baseline to Week 60)
- Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score(Baseline to Week 60)
- Number of Participants Who Achieved >=4 Points/ >=3 Points With Improvement From Baseline in Weekly Average of Pruritus Numerical Rating Scale (NRS) Score From Baseline(Baseline to Week 60)
- Percentage Change From Baseline in EASI Score(Baseline to Week 60)
- Percentage of patients having achieved EASI-75 at Week 16 who continue to exhibit EASI-75 at Week 52 (EASI-75 calculated relative to baseline EASI score)(Baseline to Week 52)
- Percentage of patients having achieved IGA 0 or 1 and a ≥2-point improvement from Baseline at Week 16 who continue to exhibit an IGA 0 or 1 and a ≥2-point improvement from Baseline at Week 52(Baseline to Week 52)
- Adverse events (AEs), measurement of vital signs，physical examination，electrocardiogram and laboratory tests at each visit.(Up to 60 Weeks)
- Minimum concentration (Cmin)(Baseline to Week 60)
- Percentage of Participants With Anti-drug Antibodies and Neutralizing Antibodies.(Baseline to Week 60.)
- Change in serum concentrations of Pharmacodynamics indicators.(Baseline to Week 60.)
研究者
研究点 (4)
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