A Randomized, Double-Blind, Placebo-Controlled, Sequential Ascending, Repeated-Dose Study of the Safety, Tolerability, and Pharmacokinetics of Subcutaneous REGN668 in Patients With Moderate-to-Severe Atopic Dermatitis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 37
- 主要终点
- Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)
研究概览
简要总结
The purpose of this study is to assess the safety and tolerability of repeated subcutaneous (SC) doses of Dupilumab in participants with moderate-to-severe atopic dermatitis (AD).
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
- Triple (Participant, 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
- •Male or female, 18 years or older;
- •Chronic AD diagnosed by the Eichenfield revised criteria of Hannifin and Rajka that had been present for at least 3 years before the screening visit;
- •Eczema Area and Severity Index (EASI) score ≥ 12 at the screening and baseline visits;
- •Investigator's Global Assessment (IGA) score ≥ 3 at the screening and baseline visits;
- •≥ 10% body surface area (BSA) of AD involvement at the screening and baseline visits;
- •History of inadequate response to a stable (≥ 1 month) regimen of topical corticosteroids or calcineurin inhibitors as treatment for AD within 3 months before the screening visit.
排除标准
- •Positive Hepatitis B surface antigen, and/or positive Hepatitis C antibody at the screening visit;
- •Treatment with an investigational drug within 8 weeks or within 5 half-lives, if known, whichever is longer, before the baseline visit;
- •Treatment with leukotriene inhibitors within 4 weeks before the baseline visit;
- •Treatment with systemic corticosteroids within 4 weeks before the baseline visit;
- •Treatment with topical corticosteroids, tacrolimus, and/or pimecrolimus within 1 week before the baseline visit;
- •Systemic treatment for AD with an immunosuppressive/immunomodulating substance within 4 weeks before the baseline visit;
- •Chronic or acute infection requiring treatment with oral or IV antibiotics, antivirals, or antifungals within 4 weeks before the screening visit or superficial skin infections within 1 week before the screening visit;
- •Known history of human immunodeficiency virus (HIV) infection;
- •History of clinical parasite infection, other than treated trichomoniasis;
- •History of malignancy within 5 years before the baseline visit, with the following exceptions: participants with a history of completely treated carcinoma in-situ of cervix, and non-metastatic squamous or basal cell carcinoma of the skin were allowed;
- •Any medical or psychiatric condition which, in the opinion of the investigator or the sponsor's medical monitor, would place the participant at risk, interfere with participation in the study, or interfere with the interpretation of study results;
- •Pregnant or breast-feeding women;
- •Unwilling to use adequate birth control, if of reproductive potential and sexually active.
研究组 & 干预措施
Placebo
Placebo (for Dupilumab) as a single subcutaneous (SC) injection on Day 1, 8, 15, and 22
干预措施: Placebo (Drug)
Placebo
Placebo (for Dupilumab) as a single subcutaneous (SC) injection on Day 1, 8, 15, and 22
干预措施: Background treatment (Other)
Dupilumab 150 mg
Dupilumab 150 mg as a single SC injection on Day 1, 8, 15, and 22
干预措施: Dupilumab (Drug)
Dupilumab 150 mg
Dupilumab 150 mg as a single SC injection on Day 1, 8, 15, and 22
干预措施: Background treatment (Other)
Dupilumab 300 mg
Dupilumab 300 mg as a single SC injection on Day 1, 8, 15, and 22
干预措施: Dupilumab (Drug)
Dupilumab 300 mg
Dupilumab 300 mg as a single SC injection on Day 1, 8, 15, and 22
干预措施: Background treatment (Other)
结局指标
主要结局
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)
时间窗: Baseline up to end of study (up to Day 85)
An adverse event (AE) was defined as any untoward medical occurrence in a participant who received investigational medicinal product (IMP) without regard to possibility of causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a study drug, whether or not considered related to the study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was considered as medically important event. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to the end of study visit \[Day 85\]). Any TEAE included participants with both serious and non-serious AEs.
次要结局
- Pharmacokinetics of Dupilumab: Time of the Last Positive (Quantifiable) Concentration (Tlast)(Day 22 (pre-dose), 25, 29, 36, 43, 50, 57, 64, 71 and Day 85)
- Pharmacokinetics of Dupilumab: Peak Plasma Concentration (Cmax)(Day 22 (pre-dose), 25, 29, 36, 43, 50, 57, 64, 71 and Day 85)
- Pharmacokinetics of Dupilumab: Last Positive (Quantifiable) Concentration (Clast)(Day 22 (pre-dose), 25, 29, 36, 43, 50, 57, 64, 71 and Day 85)