Status:
TERMINATED
Study of Efficacy and Safety of CSJ117 in Patients With Severe Uncontrolled Asthma
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Asthma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the efficacy and safety of multiple CSJ117 doses (0.5; 1; 2; 4 and 8 mg) inhaled once daily compared with placebo, when added to standard-of-care (SoC) asthma...
Detailed Description
This was a randomized, multicenter, multi-national, double-blind, placebo-controlled, parallel-arm study evaluating the effect of 5 dose levels of CSJ117 in adult subjects with inadequately controlled...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Patients who have a cigarette smoking history of greater than 10 pack years or current smokers
- 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 until 12 weeks after last study drug treatment
- Patients with a history of immunodeficiency disease or hepatitis B, untreated and not cured hepatitis C or HIV.
Key Trial Info
Start Date :
September 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 6 2022
Estimated Enrollment :
335 Patients enrolled
Trial Details
Trial ID
NCT04410523
Start Date
September 9 2020
End Date
September 6 2022
Last Update
June 20 2024
Active Locations (113)
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1
Novartis Investigative Site
Bakersfield, California, United States, 93301
2
Novartis Investigative Site
Huntington Beach, California, United States, 92647
3
Novartis Investigative Site
Los Angeles, California, United States, 90017
4
Novartis Investigative Site
Los Angeles, California, United States, 90025