EUCTR2019-003751-10-IT进行中（未招募）1 期
A randomized, double-blind, placebo-controlled dose-ranging study to evaluate the efficacy, safety, and tolerability of SAR440340 (anti-IL-33 mAb) in patients with moderate-to-severe asthma - .
SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENT0 个研究点目标入组 1,120 人开始时间: 2021年5月24日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Participant must be >/= 18 to -Adult participants with a physician diagnosis of asthma for at least 12 months prior to screening (Visit 1) based on the Global Initiative for Asthma (GINA) 2019 Guidelines.
- •-Existing treatment with medium to high dose ICS (>/=500 mcg of fluticasone propionate daily or equipotent ICS daily dosage to a maximum of 2000 mcg/day of fluticasone propionate or equivalent) in combination with a LABA. Up to two additional controller medications are allowed (LAMA and/or LTRA). Current treatment should be initiated at least 3 months prior to Visit 1 and should be stable >/=1 month prior to Visit 1.
- •-Pre-bronchodilator forced expiratory volume (FEV1) >/=40% and -Asthma Control Questionnaire 5-question version (ACQ-5) score >/=1.5 at Visits 1 and 2, prior to randomization.
- •-Patients with reversibility of at least 12% and 200 mL in FEV1 after administration of 2 to 4 puffs (200-400 mcg) of albuterol/salbutamol or levalbuterol/levosalbutamol during screening.
- •-Must have experienced, within 1 year prior to Visit 1, any of the following events:
- •At least two episodes of treatment with a systemic steroid (oral or parenteral) for worsening asthma;
- •One episode of hospitalization for worsening asthma.
- •-Capable of giving signed informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 974
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 146
排除标准
- •-Chronic obstructive pulmonary disease (COPD) or other lung diseases (eg, idiopathic pulmonary fibro-sis, etc) which may impair lung function or another diagnosed pulmonary or systemic disease.
- •-Either clinical or imaging (Chest X-ray, CT, MRI) evidence of lung disease(s) other than asthma within 12 months of Visit 1.
- •-A subject who experiences a severe asthma exacerbation at any time from 4 weeks prior to the Screening (Visit 1) up to and including the Baseline Visit (Visit 2).
- •-History of life threatening asthma in past 1 year prior to screening.
- •-Current smoker or cessation of smoking within 6 months prior to Visit 1. Current vaping or cessation of vaping within 6 months prior to Visit 1 is also not allowed.
- •-A patient with a history of clinically significant renal, hepatic, cardiovascular, metabolic, neurologic, hematologic, ophthalmologic, respiratory, gastrointestinal, cerebrovascular or other significant medical illness or disorder.
- •-Patients with a history of a systemic hypersensitivity reaction to a monoclonal antibody.
- •-Anti-IgE therapy within 130 days prior to Visit 1 or any other biologic therapy or systemic immunosuppressant to treat inflammatory disease or autoimmune disease and other diseases, within 2 months or 5 halflives prior to Visit 1, whichever is longer.
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