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. K.K.0 个研究点目标入组 625 人开始时间: 2020年8月21日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

研究类型: Interventional
分配方式: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment

•Diagnosed asthma
•Male and female patients aged >=18 and =<75 years
•Patients who have been treated with medium or high dose ICS plus LABA with up to 2 additional controllers
•Morning pre-BD FEV1 value of >= 40% and =< 85% of the predicted normal
•A positive reversibility test
•ACQ-5 score of >= 1.5 at screening and end of run-in visits.

•Patients who have a cigarette smoking history of greater than 10 pack years or current smokers or vapers.
•Pregnant or nursing (lactating) women
•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 one week after last study drug treatment
•Patients with a history of immunodeficiency disease or hepatitis B, untreated and not cured hepatitis C or HIV.
•Patients who discontinued monoclonal antibodies (investigational or approved) for asthma due to lack of efficacy

发起方

ovartis Pharma. K.K.