A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Phase 3 Trial Evaluating the Efficacy, Safety, and Immunogenicity of GR1802 Injection in Patients With Moderate to Severe Atopic Dermatitis
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- Proportion of subjects achieving EASI-75 at week 16
研究概览
简要总结
This is a multi-center, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety, PK, PD and immumogenicity of GR1802 injection in comparison to placebo in patients with atopic dermatitis. Patients will receive GR1802 injection or Placebo every 2 Weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Diagnosed with AD according to Williams criteria with a history of at least 12 months before Screening, with below requirements: 1) EASI score ≥16 at Screening and Baseline; 2) IGA score ≥3 at Screening and Baseline; 3) ≥10% BSA of AD involvement at Screening and Baseline; 4) Pruritus NRS average score ≥4 at Baseline.
- •Inadequate response or intolerance to topical glucocorticoid therapy for AD within 6 months prior to screening.
排除标准
- •Not enough washing-out period for previous therapy.
- •Concurrent disease/status which may potentially affect the efficacy/safety judgement.
- •Abnormal laboratory test results at screening that, in the judgment of the investigator, may affect the subject's ability to complete the trial.
- •Women who are pregnant or breastfeeding, or planning to become pregnant, breastfeeding during the study.
结局指标
主要结局
Proportion of subjects achieving EASI-75 at week 16
时间窗: at Week 16
The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\], and lichenification) will each be assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe).
Proportion of subjects with IGA score of 0 or 1 and a reduction of IGA score by ≥2 points from baseline at week 16
时间窗: at Week 16
IGA is an assessment instrument used in clinical studies to rate the severity of AD globally, based on a 5-point scale ranging from 0 (clear) to 4 (severe).
次要结局
- Changes from baseline in Dermatology Life Quality Index (DLQI)(Baseline up to Week 52)
- Changes from baseline in Scoring Atopic Dermatitis Index (SCORAD)(Baseline up to Week 52)
- Percent change of EASI score from baseline(Baseline up to Week 52)
- Percent change of NRS score from baseline(Baseline up to Week 52)
- Body surface area (BSA) of involvement of atopic dermatitis(Baseline up to Week 52)
- Immunogenicity: anti-drug antibody (ADA) and neutralizing antibody (Nab)(Baseline up to Week 60)
- Incidence of adverse events (AEs), abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.(Baseline up to Week 60)
- Changes from baseline in The Patient-Oriented Eczema Measures for Eczema(POEM)(Baseline up to Week 52)