A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Assess the Safety of REGN668 Administered Concomitantly With Topical Corticosteroids to Patients With Moderate-to-Severe Atopic Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 31
- 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 was to assess the safety of Dupilumab administered concomitantly with topical corticosteroids (TCS) in patients 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 and female patients aged 18 years or older
- •Chronic AD that had been present for at least 2 years
排除标准
- •Prior treatment with Dupilumab
- •Hypersensitivity to corticosteroids or to any other ingredients contained by the TCS product used in the study
- •AD lesions located on face, flexural, and genital areas
- •Certain treatments and medical procedures, undertaken within a particular time frame prior to the baseline visit, preclude eligibility for participation in the study
- •Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit
- •Treatment with an investigational drug within 8 weeks
- •Known history of human immunodeficiency virus (HIV) infection
- •Presence of certain laboratory abnormalities at the screening visit
- •History of certain opportunistic infections or certain clinical parasite infections
- •History of malignancy within 5 years before the baseline visit, with certain exceptions
- •Pregnant or breast-feeding women
- •Travel within 12 months of study start to areas endemic for parasitic infections, such as developing countries in Africa and the tropical and subtropical regions of Asia
- •History of alcohol or drug abuse within 2 years of the screening visit
- •Any medical or psychiatric condition which, in the opinion of the investigator or the sponsor's medical monitor, would place the patient at risk, interfere with participation in the study, or interfere with the interpretation of study results
研究组 & 干预措施
Placebo QW
Placebo (for Dupilumab) once weekly (QW) for 4 weeks by subcutaneous injection with the background therapy of potent topical corticosteroid (TCS) for up to 28 days
干预措施: Placebo (for Dupilumab) (Drug)
Placebo QW
Placebo (for Dupilumab) once weekly (QW) for 4 weeks by subcutaneous injection with the background therapy of potent topical corticosteroid (TCS) for up to 28 days
干预措施: Topical Corticosteroid (TCS) (Other)
Dupilumab 300 mg QW
Dupilumab 300 mg once weekly (QW) for 4 weeks by subcutaneous injection with the background therapy of potent TCS for up to 28 days
干预措施: Dupilumab (Drug)
Dupilumab 300 mg QW
Dupilumab 300 mg once weekly (QW) for 4 weeks by subcutaneous injection with the background therapy of potent TCS for up to 28 days
干预措施: Topical Corticosteroid (TCS) (Other)
结局指标
主要结局
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)
时间窗: Baseline up to the end of study (up to Day 78)
Any untoward medical occurrence in a subject who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on-treatment period (from start of administration of first dose of study drug to the end of study \[up to Day 78\]). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.
次要结局
未报告次要终点