NCT07330934招募中2 期
A Multi-Center, Randomized, Double-Blind, Parallel, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy and Safety of IBI356 in Adult Participants With Moderate to Severe Atopic Dermatitis
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 403
- 试验地点
- 1
- 主要终点
- Percent change from baseline in Eczema Area and Severity Index (EASI) score
研究概览
简要总结
This is a multi-center, randomized, double-blind, parallel, placebo-controlled phase 2 clinical study. A total of 403 adult participants with moderate to severe AD are planned to be enrolled to evaluate efficacy, safety, PK characteristics, immunogenicity, and changes in PD characteristics of IBI356.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to understand and sign the informed consent form (ICF);
- •Aged ≥ 18 years, male or female;
- •Diagnosis of AD for at least 1 year (defined by the American Academy of Dermatology Consensus Criteria);
- •EASI score of 16 or higher at baseline, vIGA-AD of 3 or 4 at baseline, AD involvement of 10% or more of BSA at baseline, weekly average of daily PP-NRS of ≥ 4 at baseline;
- •Participants with documented inadequate response to topical medications or for whom topical treatments are otherwise medically inadvisable.
排除标准
- •Presence of diseases that may affect the safety or efficacy, including but not limited to psychistric disorders, central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, and hematological or metabolic system diseases.
- •Known history of active tuberculosis or clinically suspected tuberculosis; or chest imaging suggesting evidence of suspected tuberculosis; or any other clinical evidence of latent tuberculosis.
- •Has known or suspected helminth or other parasitic infection.
- •History of malignancy, except excised or curatively treated localized basal cell carcinoma (BCC) or cutaneous squamous cell carcinoma (cSCC).
- •History of severe drug allergy or anaphylaxis.
- •Fainting, hemophobia, or inability to tolerate venipuncture.
- •Women who are pregnant or breastfeeding, or female participants who have a positive pregnancy test at screening or randomization.
- •Have received an organ or hematopoietic stem cell transplant.
- •Positive HBsAg; or positive HBcAb with positive HBV-DNA; or positive hepatitis C antibody with positive HCV-RNA; or positive treponema pallidum antibody; or positive HIV serology at screening.
- •Having received any of the specified therapy within the specified timeframe(s) prior to the baseline visit.
- •The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
研究组 & 干预措施
IBI356 dose 4
Experimental
Participants receive IBI356 through W16
干预措施: IBI356 (Drug)
IBI356 dose 2
Experimental
Participants receive IBI356 through W16
干预措施: IBI356 (Drug)
Dupilumab
Experimental
Participants receive dupilumab through W16
干预措施: Dupilumab (Drug)
IBI356 dose 5
Experimental
Participants receive IBI356 through W16
干预措施: IBI356 (Drug)
IBI356 dose 1
Experimental
Participants receive IBI356 through W16
干预措施: IBI356 (Drug)
Placebo
Placebo Comparator
Participants receive placebo through W16
干预措施: Placebo (Drug)
IBI356 dose 3
Experimental
Participants receive IBI356 through W16
干预措施: IBI356 (Drug)
结局指标
主要结局
Percent change from baseline in Eczema Area and Severity Index (EASI) score
时间窗: week 24
The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD.
次要结局
- Proportion of participants achieving Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) of 0 (clear) or 1 (almost clear) with a ≥2-point reduction(week 16, 24)
- Proportion of participants with EASI-75/90/100(week16, 24)
- Proportion of participants with a ≥4-point reduction from baseline in the weekly average of the Peak Pruritus-Numerical Rating Scale (PP-NRS)(week 16, 24)
- Change in EASI from baseline(Baseline to Week 48)
- Change in DLQI from baseline(Baseline to Week 48)
- Change in POEM from baseline(Baseline to Week 48)
- Incidences of adverse events (AEs), treatment emergent adverse events (TEAEs), and serious adverse events (SAEs)(Baseline to Week 48)
- Serum IBI356 concentrations at prespecified timepoints(Baseline to Week 24)
- Percentage of Participants with Treatment-emergent ADA of IBI356(Baseline to Week 24)
- Serum IL-13 (PD marker) be assessed as dose-dependent drug responses(Baseline to Week 48)
研究者
研究点 (1)
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