NCT06552520进行中（未招募）3 期
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of TQH2722 Injection in the Treatment of Moderate to Severe Atopic Dermatitis in Subjects
Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.73 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2024年10月8日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 500
- 试验地点
- 73
- 主要终点
- Participants who achieved EASI-75 (≥75% improvement from baseline) on the eczema Area and Severity score (EASI)
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled clinical trial with 500 participants. In this study, the safety evaluation used the common toxic reaction criteria of the National Cancer Institute to evaluate the adverse events of the drugs, and the effectiveness evaluation used the eczema area and severity score and the overall investigator score to confirm the efficacy.
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
- •The age of signing the informed consent is 18-75 years old, regardless of gender.
- •Meet the 2014 American Academy of Dermatology (AAD) standards, diagnosed as AD.
- •During screening and baseline visit, eczema area and severity score (EASI) ≥16 points; Investigator global score (IGA) ≥3 points; Affected body surface area (BSA) ≥10%; Baseline pruritus Peak Value Scale (NRS) weekly mean ≥4 points.
- •Have received at least 4 weeks of moderate-to-strong action or at least 2 weeks of super effective external glucocorticoid (TCS) treatment or sufficient duration of systemic glucocorticoid treatment, the efficacy is not sufficient; Or subjects cannot receive the above treatment due to adverse reactions or potential risks.
排除标准
- •Used immunosuppressants/immunomodulatory drugs, ultraviolet phototherapy, systemic Chinese medicine treatment within 4 weeks before randomization.
- •Received topical calcineurin inhibitors (TCS), topical calcineurin inhibitors (TCI), and other topical preparations within 2 weeks before randomization.
- •Received anti-interleukin-4 receptor alpha (IL-4R) monoclonal antibodies, anti-ige monoclonal antibodies, or other biologic agents within 12 weeks or 5 half-lives (whichever is longer) prior to randomization.
- •Had received live attenuated vaccine within 12 weeks prior to randomization or planned to receive it during the study period.
- •Use of antihistamines within 1 week prior to randomization (unless you have received steady doses of antihistamines for at least 7 days).
- •Received allergen specific immunotherapy within 6 months before randomization.
- •There are skin comorbidities that may interfere with study evaluation.
- •There is a history of clinically significant illness that the investigator believes poses a risk to the safety of the subject and is poorly controlled.
- •A known or suspected history of immunosuppression (immune deficiency).
- •Subjects with any type of active malignancy or a history of malignancy (except cervical cancer or non-metastatic cutaneous squamous cell carcinoma, basal cell carcinoma, and papillary thyroid carcinoma that have been cured for more than 5 years prior to the screening period).
- •Subject may have active Mycobacterium tuberculosis infection.
- •Subjects with severe liver and kidney function impairment.
- •Screening period HIV antibody positive, or have a history of HIV infection.
- •Screening period of treponema pallidum antibody positive.
- •Participated in clinical trials of other drugs or medical devices within 12 weeks prior to randomization.
- •Treatment-requiring infections were present in the 4 weeks prior to randomization.
- •During the study period, subjects plan to undergo major surgical operations.
- •Pregnant or lactating women.
- •Alcohol, drug abuse and known drug dependence.
- •History of atopic keratoconjunctivitis with corneal involvement.
- •The subject has any medical or psychiatric symptoms that interfere with participation in the study or with the interpretation of the study results.
研究组 & 干预措施
TQH2722 injection
Experimental
TQH2722 injection, 14 days for a treatment cycle
干预措施: TQH2722 injection (Drug)
Placebo of TQH2722 injection
Placebo Comparator
Placebo of TQH2722 injection, 14 days for a treatment cycle
干预措施: Placebo of TQH2722 injection (Drug)
结局指标
主要结局
Participants who achieved EASI-75 (≥75% improvement from baseline) on the eczema Area and Severity score (EASI)
时间窗: Baseline to 16 weeks after treatment
Percentage of participants who achieved EASI-75 (≥75% improvement from baseline) on the eczema Area and Severity score (EASI)
Subjects with an Investigator's Overall Rating (IGA) score (5-scale) of 0 or 1 and ≥2 points decline from baseline
时间窗: Baseline to 16 weeks after treatment
Percentage of subjects with an Investigator's Overall Rating (IGA) score (5-scale) of 0 or 1 and ≥2 points decline from baseline.
次要结局
- Eczema area and severity score (EASI) change from baseline(From baseline to week 60)
- Rate of change from baseline in the Investigator's overall Score (IGA)(After medication to 60 weeks)
- Change rate of atopic dermatitis score (SCORAD) from baseline(After medication to 60 weeks)
- Incidence of neutralizing antibodies (Nab)(After medication to 60 weeks)
- Rate of change in dermatological quality of life (DLQI) score from baseline(After medication to 60 weeks)
- Change in patients' self-assessment of eczema (POEM) from baseline(After medication to 60 weeks)
- The incidence of adverse events(After medication to 60 weeks)
- The incidence and titer of drug-resistant antibodies (ADA) in subjects(After medication to 60 weeks)
- Change of body surface area from baseline in moderate to severe atopic dermatitis(After medication to 60 weeks)
- Steady valley concentration of TQH2722(After medication to 60 weeks)
- Change in daily Peak Itch Digital Rating Scale (NRS) score from baseline(After medication to 60 weeks)
研究者
研究点 (73)
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