A PHASE IIB, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER, DOSE-RANGING STUDY TO ASSESS THE EFFICACY AND SAFETY OF MSTT1041A IN PATIENTS WITH UNCONTROLLED SEVERE ASTHMA

Genentech, Inc.0 个研究点目标入组 501 人开始时间: 2016年9月12日最近更新: 2019年11月25日

适应症

试验速览

暂无简介。

•- Age 18-75 years
•- Body mass index (BMI) of 18-35 kg/square meter (kg/m2) and weight >= 40 kg at screening
•- Documented physician-diagnosed asthma
•- On high dose inhaled corticosteroid (ICS) therapy plus at least one additional allowed controller medication
•- Forced expiratory volume in 1 second (FEV1) of 40%-80% of predicted
•- Evidence of uncontrolled asthma
•- Use of contraceptive measures
•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 401
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 100

•- Diagnosis of mimics of asthma
•- Diagnosis of occupational asthma, aspirin-sensitive asthma, asthma-chronic obstructive pulmonary disease overlap syndrome, or bronchiolitis, as determined by the investigator
•- Pregnant or lactating, or intending to become pregnant during the study or within 20 weeks after the last dose of MSTT1041A
•- Recent history of smoking
•- History or evidence of substance abuse that would pose a risk to patient safety, interfere with the conduct of the study, have an impact on the study results
•- Asthma exacerbation within 4 weeks prior to screening
•- Intubation for respiratory failure due to asthma within 12 months prior to screening
•- Comorbid conditions that may interfere with evaluation of investigational medicinal product
•- Known sensitivity to any of the active substances or their excipients to be administered during dosing
•- Positive pregnancy test
•The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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