A Randomized, Double-Blind, Placebo-Controlled, Multicenter Proof-of-Concept Study to Evaluate the Efficacy and Safety of IBI3002 in Patients With Moderate to Severe Atopic Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Percentage change from baseline in the Eczema Area and Severity Index (EASI) score at Week 16
研究概览
简要总结
The primary objective of this Phase 2 study is to evaluate the efficacy and safety of IBI3002 in patients with moderate to severe Atopic Dermatitis (AD).
详细描述
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy, safety, tolerability, pharmacokinetics (PK), immunogenicity, and pharmacodynamic (PD) effects of IBI3002 in Chinese participants with moderate-to-severe AD.
A total of approximately 120 participants with moderate-to-severe AD are planned for enrollment. Intensive blood collection, categorized as yes or no, and baseline disease severity, categorized as moderate (vIGA-AD = 3) or severe (vIGA-AD = 4), will be used as a stratification factor. Eligible participants will be randomized to six treatment groups in a 2:1:1:2:2:2 ratio, including multiple dose levels of IBI3002, dupilumab, and matched placebo administered subcutaneously at specified intervals.
The study will assess changes in clinical efficacy measures, PK parameters, immunogenicity, and PD biomarkers over the treatment 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
- •Ability to understand and sign written informed consent prior to any study procedures and willingness to comply with study requirements throughout the study.
- •Age between 18 and 75 years old (inclusive).
- •Body weight ≥40 kg, with a Body Mass Index (BMI) between 18 and 35 kg/m² (inclusive).
- •Participants of childbearing potential and their partners must agree to strictly follow contraceptive measures specified in the protocol during the study and for 6 months after study completion.
- •At the time of screening, meet the diagnostic criteria for atopic dermatitis according to the 2014 American Academy of Dermatology consensus, and have been diagnosed with AD for at least 12 months.
- •At screening and randomization, participants must have an EASI score ≥16, vIGA-AD score ≥3, involved body surface area (BSA) ≥10%, and baseline PP-NRS ≥
- •History of inadequate response to topical therapy within the past 12 months, or documented medical reasons making topical therapy unsuitable (e.g., severe adverse reactions or safety concerns).
排除标准
- •Clinically significant diseases that may affect safety or study participation, including but not limited to psychiatric, CNS, cardiovascular, digestive, respiratory, urinary, hematologic, or metabolic disorders.
- •Known history of active tuberculosis or clinically suspected tuberculosis (including but not limited to pulmonary tuberculosis, lymph node tuberculosis, tuberculous pleurisy, etc.); or chest imaging suggestive of suspected tuberculosis; or any other clinical evidence of latent tuberculosis.
- •History of malignant tumors, except for surgically removed or cured localized basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) of the skin.
- •History of severe systemic allergic reactions (e.g., anaphylaxis, laryngeal edema).
- •Fainting at the sight of needles, blood, or inability to tolerate intravenous puncture.
- •Pregnant or breastfeeding women, or female participants who test positive for pregnancy during screening or at randomization.
- •Receipt of other investigational drugs within 3 months or 5 half-lives before randomization (whichever is longer), or current participation in another clinical trial.
- •Had a serious infection (defined as requiring hospitalization or intravenous anti-infective therapy) or trauma within the 3 months prior to randomization, or a history of surgery within 3 months, or an infection requiring oral medication within 1 month, or plans to undergo surgery during the study period.
- •Receipt of any live vaccines (except influenza vaccine) within 1 month before randomization, or planning to receive vaccination during the study.
- •History of parasitic infections within 6 months before screening, or planning to travel to parasite-endemic countries/regions in Africa, South America, and southern parts of Asia (including Southeast Asia, India, Nepal) within 6 months after study completion.
研究组 & 干预措施
IBI3002 Dose Level 1 with Dosing Interval 1
Participants will receive IBI3002 Dose Level 1subcutaneously according to the study schedule.
干预措施: Placebo (Drug)
IBI3002 Dose Level 1 with Dosing Interval 2
Participants will receive IBI3002 Dose Level 1 subcutaneously according to the study schedule.
干预措施: IBI3002 (Drug)
IBI3002 Dose Level 2 with Dosing Interval 2
Participants will receive IIBI3002 Dose Level 2subcutaneously according to the study schedule.
干预措施: IBI3002 (Drug)
IBI3002 Dose Level 2 with Dosing Interval 2
Participants will receive IIBI3002 Dose Level 2subcutaneously according to the study schedule.
干预措施: Placebo (Drug)
Placebo
Matched placebo will be administered subcutaneously according to the study schedule.
干预措施: Placebo (Drug)
IBI3002 Dose Level 3 with Dosing Interval 2
Participants will receive IBI3002 Dose Level 3 subcutaneously according to the study schedule.
干预措施: IBI3002 (Drug)
IBI3002 Dose Level 1 with Dosing Interval 1
Participants will receive IBI3002 Dose Level 1subcutaneously according to the study schedule.
干预措施: IBI3002 (Drug)
IBI3002 Dose Level 1 with Dosing Interval 2
Participants will receive IBI3002 Dose Level 1 subcutaneously according to the study schedule.
干预措施: Placebo (Drug)
Dupilumab
Participants will receive dupilumab 300mg Q2w subcutaneously, with a loading dose of 600mg.
干预措施: Placebo (Drug)
Dupilumab
Participants will receive dupilumab 300mg Q2w subcutaneously, with a loading dose of 600mg.
干预措施: Dupilumab (Drug)
结局指标
主要结局
Percentage change from baseline in the Eczema Area and Severity Index (EASI) score at Week 16
时间窗: Week 16
Percentage change from baseline in the EASI score at Week 16 in participants with moderate to severe AD after administration of IBI3002. EASI is used to assess the severity and extent of AD by evaluating four disease signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification. The total EASI score ranges from 0 to 72, with higher scores indicating more severe disease. EASI-50: ≥ 50% reduction in score from baseline; EASI-75: ≥ 75% reduction in score from baseline; EASI-90: ≥ 90% reduction in score from baseline. EASI-100: 100% reduction in score from baseline.
次要结局
- Immunogenicity of IBI3002 following multiple doses(Up to 20 weeks)
- Number of participants with Adverse Events (AEs)/Serious Adverse Events (SAEs)(Up to 20 weeks)
- Pharmacokinetic parameter Cmax of IBI3002 following multiple doses(Up to 20 weeks)
- Pharmacokinetic parameter Tmax of IBI3002 following multiple doses(Up to 20 weeks)
- Pharmacokinetic parameter AUC of IBI3002 following multiple doses(Up to 20 weeks)
- Percentage of participants with a validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0 (clear) or 1 (almost Clear) and a reduction ≥ 2 points from baseline at Week 16(Week 16)
- Proportion of participants with a ≥ 50% improvement from baseline in EASI (EASI-50) at Week 16(Week 16)
- Proportion of participants with a ≥ 75% improvement from baseline in EASI (EASI-75) at Week 16(Week 16)
- Proportion of participants with a ≥ 90% improvement from baseline in EASI (EASI-90) at Week 16(Week 16)
- Proportion of participants with a 100% Improvement from baseline in EASI (EASI-100) at Week 16(Week 16)
- Proportion of participants achieving vIGA-AD 0 or 1 at Week 16(Week 16)
- Proportion of participants with ≥2-point reduction from baseline in vIGA-AD score at Week 16(Week 16)
- Proportion of participants with ≥4-point reduction from baseline in weekly average of daily Peak Pruritus Numerical Rating Scale (PP-NRS) during at Week 16(Week 16)