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.
- Conditions
- Asthma
- Registration Number
- JPRN-jRCT2080225330
- Lead Sponsor
- ovartis Pharma. K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 625
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pre-dose FEV1 change from baseline (Time Frame: Baseline, Week 12)<br>Average change from baseline in pre-dose FEV1 (Forced expiratory volume in 1 second) at Week 8 and Week 12.
- Secondary Outcome Measures
Name Time Method