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

Last Update: Mar 24, 2021

See if you pre-qualify

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 
Apr 14, 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 at least 1 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
Huntington Beach, 92647
California
United States
Novartis Investigative Site
Recruiting
Los Angeles, 90017
California
United States
Novartis Investigative Site
Recruiting
Los Angeles, 90025
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, 80206
Colorado
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
Bangor, 04401
Maine
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
Charlotte, 28207
North Carolina
United States
Novartis Investigative Site
Recruiting
Raleigh, 27607
North Carolina
United States
Novartis Investigative Site
Recruiting
Oklahoma City, 73120
Oklahoma
United States
Novartis Investigative Site
Recruiting
Tulsa, 74136
Oklahoma
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, 75230
Texas
United States
Novartis Investigative Site
Recruiting
Dallas, 75231
Texas
United States
Novartis Investigative Site
Recruiting
McKinney, 75069
Texas
United States
Novartis Investigative Site
Recruiting
San Antonio, 78251
Texas
United States
Novartis Investigative Site
Recruiting
Murray, 84107
Utah
United States
Novartis Investigative Site
Recruiting
Madison, 53792
Wisconsin
United States
Argentina
Novartis Investigative Site
Recruiting
Caba, C1056ABJ
Buenos Aires
Argentina
Novartis Investigative Site
Recruiting
Caba, C1122AAK
Buenos Aires
Argentina
Novartis Investigative Site
Recruiting
Mar del Plata, 7600
Buenos Aires
Argentina
Novartis Investigative Site
Recruiting
Santa Fe, S2000DBS
Rosario
Argentina
Novartis Investigative Site
Recruiting
Rosario, S2000JKR
Santa Fe
Argentina
Novartis Investigative Site
Recruiting
Buenos Aires, C1425FVH
-
Argentina
Novartis Investigative Site
Recruiting
Parana, 3100
-
Argentina
Belgium
Novartis Investigative Site
Recruiting
Jette, 1090
Brussel
Belgium
Novartis Investigative Site
Recruiting
Erpent, 5100
-
Belgium
Novartis Investigative Site
Recruiting
Liege, 4000
-
Belgium
Novartis Investigative Site
Recruiting
Mechelen, 2800
-
Belgium
Bulgaria
Novartis Investigative Site
Recruiting
Plovdiv, 4000
BGR
Bulgaria
Novartis Investigative Site
Recruiting
Stara Zagora, 6000
-
Bulgaria
Canada
Novartis Investigative Site
Recruiting
Burlington, L7N 3V2
Ontario
Canada
Novartis Investigative Site
Recruiting
Toronto, M6H 3M2
Ontario
Canada
Novartis Investigative Site
Recruiting
Trois Rivieres, G8T 7A1
Quebec
Canada
Novartis Investigative Site
Recruiting
Quebec, G1V 4W2
-
Canada
Czech Republic
Novartis Investigative Site
Recruiting
Teplice, 415 01
CZE
Czech Republic
Novartis Investigative Site
Recruiting
Jindrichuv Hradec, 377 01
-
Czech Republic
Novartis Investigative Site
Recruiting
Lovosice, 41002
-
Czech Republic
Novartis Investigative Site
Recruiting
Varnsdorf, 40747
-
Czech Republic
Germany
Novartis Investigative Site
Recruiting
Peine, 31224
Niedersachsen
Germany
Novartis Investigative Site
Recruiting
Koblenz, 56068
Rheinland-Pfalz
Germany
Novartis Investigative Site
Recruiting
Bamberg, 96049
-
Germany
Novartis Investigative Site
Recruiting
Berlin, 10119
-
Germany
Novartis Investigative Site
Recruiting
Berlin, 10717
-
Germany
Novartis Investigative Site
Recruiting
Berlin, 10969
-
Germany
Novartis Investigative Site
Recruiting
Berlin, 12157
-
Germany
Novartis Investigative Site
Recruiting
Berlin, 12159
-
Germany
Novartis Investigative Site
Recruiting
Berlin, 12203
-
Germany
Novartis Investigative Site
Recruiting
Darmstadt, 64283
-
Germany
Novartis Investigative Site
Recruiting
Frankfurt, 60596
-
Germany
Novartis Investigative Site
Recruiting
Hamburg, 20354
-
Germany
Novartis Investigative Site
Recruiting
Hamburg, 22299
-
Germany
Novartis Investigative Site
Recruiting
Hannover, 30167
-
Germany
Novartis Investigative Site
Recruiting
Hannover, 30173
-
Germany
Novartis Investigative Site
Recruiting
Leipzig, 04275
-
Germany
Novartis Investigative Site
Recruiting
Leipzig, 04357
-
Germany
Novartis Investigative Site
Recruiting
Mainz, 55128
-
Germany
Novartis Investigative Site
Recruiting
Marburg, 35037
-
Germany
Novartis Investigative Site
Recruiting
Potsdam, 14467
-
Germany
Novartis Investigative Site
Recruiting
Witten, 58452
-
Germany
Guatemala
Novartis Investigative Site
Recruiting
Guatemala City, 01010
GTM
Guatemala
Novartis Investigative Site
Recruiting
Guatemala City, 01011
GTM
Guatemala
Novartis Investigative Site
Recruiting
Guatemala City, 01010
-
Guatemala
Novartis Investigative Site
Recruiting
Guatemala City, 01011
-
Guatemala
Hungary
Novartis Investigative Site
Recruiting
Szazhalombatta, 2440
HUN
Hungary
Novartis Investigative Site
Recruiting
Balassagyarmat, 2660
-
Hungary
Novartis Investigative Site
Recruiting
Godollo, 2100
-
Hungary
Novartis Investigative Site
Recruiting
Komarom, 2900
-
Hungary
Novartis Investigative Site
Recruiting
Sellye, 7960
-
Hungary
Novartis Investigative Site
Recruiting
Szeged, 6722
-
Hungary
Japan
Novartis Investigative Site
Recruiting
Yokohama-city, 223-0059
Kanagawa
Japan
Novartis Investigative Site
Recruiting
Chuo ku, 104-0031
Tokyo
Japan
Novartis Investigative Site
Recruiting
Chuo-ku, 103-0003
Tokyo
Japan
Novartis Investigative Site
Recruiting
Chuo-ku, 103-0028
Tokyo
Japan
Novartis Investigative Site
Recruiting
Kodaira, 187-0024
Tokyo
Japan
Novartis Investigative Site
Recruiting
Setagaya-Ku, 157-0072
Tokyo
Japan
Novartis Investigative Site
Recruiting
Setagaya-ku, 158-0097
Tokyo
Japan
Novartis Investigative Site
Recruiting
Toshima ku, 170 0003
Tokyo
Japan
Novartis Investigative Site
Recruiting
Toshima, 170-0003
Tokyo
Japan
Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul, 03312
Korea
Korea, Republic of
Novartis Investigative Site
Recruiting
Daegu, 705703
-
Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul, 05505
-
Korea, Republic of
Latvia
Novartis Investigative Site
Recruiting
Jurmala, LV-2015
LVA
Latvia
Novartis Investigative Site
Recruiting
Riga, 1011
LV
Latvia
Novartis Investigative Site
Recruiting
Riga, LV-1038
LV
Latvia
Novartis Investigative Site
Recruiting
Daugavpils, LV-5401
-
Latvia
Novartis Investigative Site
Recruiting
Daugavpils, LV-5417
-
Latvia
Novartis Investigative Site
Recruiting
Riga, LV 1002
-
Latvia
Philippines
Novartis Investigative Site
Recruiting
Iloilo city, 5000
Iloilo
Philippines
Novartis Investigative Site
Recruiting
Iloilo City, 5000
-
Philippines
Novartis Investigative Site
Recruiting
Iloilo, 5000
-
Philippines
Poland
Novartis Investigative Site
Recruiting
Bialystok, 15 276
-
Poland
Novartis Investigative Site
Recruiting
Katowice, 40-648
-
Poland
Novartis Investigative Site
Recruiting
Krakow, 30033
-
Poland
Novartis Investigative Site
Recruiting
Lodz, 90-153
-
Poland
Novartis Investigative Site
Recruiting
Poznan, 60-693
-
Poland
Novartis Investigative Site
Recruiting
Poznan, 60-823
-
Poland

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]