A 12-week, multicenter, randomized, double-blind, parallel-arm, placebo-controlled study to assess the efficacy and safety of CSJ117, when added to existing asthma therapy in patients =18 years of age with severe uncontrolled asthma.

ovartis Pharma AG0 个研究点目标入组 625 人开始时间: 2020年11月23日最近更新: 2022年8月8日

研究概览

暂无简介。

•1. Diagnosed asthma
•2. Male and female patients aged >18 and <75 years
•3. Patients who have been treated with medium or high dose ICS plus LABA with up to 2 additional controller
•4. Morning pre-BD FEV1 value of = 40% and = 85% of the predicted normal
•5. A positive reversibility test at run-in or in up to two unscheduled
•visits. If not demonstrated, historical information within 1 year prior to
•screening may be used
•6. ACQ-5 score of = 1.5 at screening and end of run-in visits.
•7. History of at least 1 asthma exacerbations within the 12 months prior to Screening Visit that required treatment with systemic corticosteroids (tablets, suspension or injection).
•8. Other protocol-defined inclusion criteria may apply
•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 562
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 63

•1. Patients who have a cigarette smoking history of greater than 10 pack years or current smokers.
•2. Pregnant or nursing (lactating) women
•3. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using specified methods of
•contraception during dosing of study drug and 12 weeks after last study drug treatment (end of follow up)
•4. Patients with a history of immunodeficiency disease or hepatitis B, untreated and not cured hepatitis C or HIV.
•5. Other protocol-defined exclusion criteria may apply

发起方