Study of Efficacy and Safety of CSJ117 in Patients With Severe Uncontrolled Asthma

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.

ClinicalTrials.gov Identifier: NCT04410523

Novartis Reference Number: CCSJ117A12201C

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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 therapy in adult patients with uncontrolled asthma with respect to change from baseline in FEV1 at the end of 12 weeks of treatment.

Condition 
Asthma
Phase 
Phase 2
Overall status 
Recruiting
Enrollment count 
625 participants
Start date 
Sep 09, 2020
Completion date 
Mar 02, 2022
Gender 
All
Age(s)
18 Years - 75 Years (Adult, Older Adult)

Interventions

Drug
CSJ117
CSJ117 (0.5 mg, 1mg, 2mg, 4 mg and 8 mg) inhaled once daily for 12 weeks. Delivered via Concept1 device.
Drug
Placebo
Placebo inhaled once daily for 16 weeks. Delivered via Concept1 device

Eligibility Criteria

Inclusion Criteria:

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.
History of 1 or 2 asthma exacerbations within the 12 months prior to Screening Visit that required treatment with systemic corticosteroids (tablets, suspension or injection).

Exclusion Criteria:

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 one week after last study drug treatment
Patients with a history of immunodeficiency disease or hepatitis B or hepatitis C or HIV.

Study Locations

United States
Novartis Investigative Site
Recruiting
Birmingham, 35209
Alabama
United States
Novartis Investigative Site
Recruiting
Bakersfield, 93301
California
United States
Novartis Investigative Site
Recruiting
Encinitas, 92024
California
United States
Novartis Investigative Site
Recruiting
Los Angeles, 90017
California
United States
Novartis Investigative Site
Recruiting
Los Angeles, 90048
California
United States
Novartis Investigative Site
Recruiting
Mission Viejo, 92691
California
United States
Novartis Investigative Site
Recruiting
San Diego, 92117
California
United States
Novartis Investigative Site
Recruiting
San Jose, 95117
California
United States
Novartis Investigative Site
Recruiting
Stockton, 95207
California
United States
Novartis Investigative Site
Recruiting
Denver, 80230
Colorado
United States
Novartis Investigative Site
Recruiting
Miami, 33176
Florida
United States
Novartis Investigative Site
Recruiting
Winter Park, 32789
Florida
United States
Novartis Investigative Site
Recruiting
Marietta, 30060
Georgia
United States
Novartis Investigative Site
Recruiting
Kansas City, 66160
Kansas
United States
Novartis Investigative Site
Recruiting
White Marsh, 21162
Maryland
United States
Novartis Investigative Site
Recruiting
North Dartmouth, 02747-3322
Massachusetts
United States
Novartis Investigative Site
Recruiting
Minneapolis, 55402
Minnesota
United States
Novartis Investigative Site
Recruiting
Columbia, 65203
Missouri
United States
Novartis Investigative Site
Recruiting
Rolla, 65401
Missouri
United States
Novartis Investigative Site
Recruiting
Saint Louis, 63141
Missouri
United States
Novartis Investigative Site
Recruiting
Missoula, 59808
Montana
United States
Novartis Investigative Site
Recruiting
Omaha, 68134
Nebraska
United States
Novartis Investigative Site
Recruiting
Charlotte, 28207
North Carolina
United States
Novartis Investigative Site
Recruiting
Raleigh, 27607
North Carolina
United States
Novartis Investigative Site
Recruiting
Pittsburgh, 15241
Pennsylvania
United States
Novartis Investigative Site
Recruiting
Greenville, 29607
South Carolina
United States
Novartis Investigative Site
Recruiting
Boerne, 78006
Texas
United States
Novartis Investigative Site
Recruiting
Dallas, 75231
Texas
United States
Novartis Investigative Site
Recruiting
San Antonio, 78251
Texas
United States
Novartis Investigative Site
Recruiting
Murray, 84107
Utah
United States
Japan
Novartis Investigative Site
Recruiting
Yokohama-city, 223-0059
Kanagawa
Japan
Novartis Investigative Site
Recruiting
Chuo-ku, 103-0003
Tokyo
Japan
Novartis Investigative Site
Recruiting
Setagaya-Ku, 157-0072
Tokyo
Japan
Novartis Investigative Site
Recruiting
Toshima ku, 170 0003
Tokyo
Japan

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
1-888-669-6682
Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]