Study of Safety of CSJ117 in Participants With Moderate to Severe Uncontrolled Asthma

A 24-week, Multicenter, Randomized, Double-blind, Parallel-arm, Placebo-controlled Extension Study to Assess the Safety of CSJ117, When Added to Existing Standard of Care Asthma Therapy in Patients ≥18 Years of Age

ClinicalTrials.gov Identifier: NCT04946318

Novartis Reference Number: CCSJ117A12201E1

Last Update: May 17, 2022

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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 provide safety and tolerability, pharmacokinetics and immunogenicity data for multiple CSJ117 doses inhaled once daily compared with placebo, in adult asthma participants treated with medium or high dose ICS plus LABA alone or with additional asthma controllers (additional controllers allowed: LTRA, LAMA, Theophylline and its derivatives), who have completed the prior phase llb study CCSJ117A12201C (NCT04410523).

Condition 
Asthma
Phase 
Phase 2
Overall status 
Recruiting
Start date 
Sep 08, 2021
Completion date 
Aug 05, 2024
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) capsules for inhalation once daily delivered via Concept1 inhalation device for 12 or 24 weeks.
Drug
Placebo
Placebo inhaled once daily for 12 or 24 weeks. Delivered via Concept1 device.

Eligibility Criteria

Inclusion Criteria:

All participants must have been treated with a fixed dose combination of fluticasone propionate/salmeterol in one of two doses in stable dose alone or with additional controllers at label approved dosage (allowed only: LTRA, LAMA, Theophylline or its derivatives).
Participants completing the Treatment period and Follow-up period of study CSJ117A12201C and continuing with study CCSJ117A12201E1 must have completed the Treatment period of CSJ117A12201C (i.e. did not discontinue blinded study treatment prematurely) and Follow-up period of study CSJ117A12201C.

Exclusion Criteria:

Participants who were enrolled into prior study CSJ117A12201C and developed a significant and/or permanent health condition during the prior study.
Participants who experienced a serious and drug-related AE in the prior study CSJ117A12201C.
Participants receiving any prohibited medications.
Participants with a history or current diagnosis of ECG abnormalities.
Pregnant or nursing (lactating) women.

Study Locations

United States
Novartis Investigative Site
Recruiting
Bakersfield, 93301
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
Marietta, 30060
Georgia
United States
Novartis Investigative Site
Recruiting
White Marsh, 21162
Maryland
United States
Novartis Investigative Site
Recruiting
Oklahoma City, 73120
Oklahoma
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
McKinney, 75069
Texas
United States
Argentina
Novartis Investigative Site
Recruiting
Caba, C1122AAK
Buenos Aires
Argentina
Novartis Investigative Site
Recruiting
Ranelagh, Partido De Berazate, 1884
Buenos Aires
Argentina
Novartis Investigative Site
Recruiting
Rosario, S2000JKR
Santa Fe
Argentina
Novartis Investigative Site
Recruiting
San Miguel de Tucuman, 4000
Tucuman
Argentina
Novartis Investigative Site
Recruiting
Mendoza, 5500
-
Argentina
Novartis Investigative Site
Recruiting
Parana, 3100
-
Argentina
Belgium
Novartis Investigative Site
Recruiting
Erpent, 5100
-
Belgium
Bulgaria
Novartis Investigative Site
Recruiting
Ruse, 7002
-
Bulgaria
Novartis Investigative Site
Recruiting
Stara Zagora, 6000
-
Bulgaria
Canada
Novartis Investigative Site
Recruiting
Burlington, L7N 3V2
Ontario
Canada
Novartis Investigative Site
Recruiting
Etobicoke, M9V 4B4
Ontario
Canada
Novartis Investigative Site
Recruiting
Montreal, H2V 2K1
Quebec
Canada
Czech Republic
Novartis Investigative Site
Recruiting
Teplice, 415 01
CZE
Czech Republic
Novartis Investigative Site
Recruiting
Lovosice, 41002
-
Czech Republic
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, 12159
-
Germany
Novartis Investigative Site
Recruiting
Frankfurt, 60596
-
Germany
Novartis Investigative Site
Recruiting
Leipzig, D-04299
-
Germany
Novartis Investigative Site
Recruiting
Leipzig, D-04347
-
Germany
Novartis Investigative Site
Recruiting
Witten, 58452
-
Germany
Hungary
Novartis Investigative Site
Recruiting
Balassagyarmat, 2660
-
Hungary
Novartis Investigative Site
Recruiting
Godollo, 2100
-
Hungary
Novartis Investigative Site
Recruiting
Komarom, 2900
-
Hungary
Japan
Novartis Investigative Site
Recruiting
Yokohama-city, 223-0059
Kanagawa
Japan
Novartis Investigative Site
Recruiting
Osaka city, 530 0001
Osaka
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
Novartis Investigative Site
Recruiting
Osaka, 531-0073
-
Japan
Novartis Investigative Site
Recruiting
Osaka, 551-0032
-
Japan
Latvia
Novartis Investigative Site
Recruiting
Riga, 1038
LV
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
-
Philippines
Novartis Investigative Site
Recruiting
Iloilo, 5000
-
Philippines
Novartis Investigative Site
Recruiting
Manila, 1003
-
Philippines
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
Slovakia
Novartis Investigative Site
Recruiting
Levice, 93401
-
Slovakia

Contacts

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

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