Study of Effect of CSJ117 on Symptoms, Pharmacodynamics and Safety in Patients With COPD

A 12-week Randomized, participant-and Investigator-blinded, Placebo-controlled, Parallel Group Study to Explore the Efficacy, Pharmacodynamics, Safety, and Pharmacokinetics of Two Doses of Inhaled CSJ117 in Adults With Chronic Obstructive Pulmonary Disease (COPD)

ClinicalTrials.gov Identifier: NCT04882124

Novartis Reference Number: CCSJ117B12201

Last Update: May 10, 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

This is a Phase 2 study in patients with chronic obstructive pulmonary disease (COPD) to assess the efficacy, pharmacodynamics (PD), pharmacokinetics (PK), and safety of two dose levels of CSJ117 in comparison to placebo. For this, the impact of CSJ117 on disease symptom burden and lung function will be explored.

Condition 
Pulmonary Disease, Chronic Obstructive
Phase 
Phase 2
Overall status 
Recruiting
Start date 
Sep 24, 2021
Completion date 
Aug 25, 2023
Gender 
All
Age(s)
40 Years and older (Adult, Older Adult)

Interventions

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

Eligibility Criteria

Inclusion Criteria:

Male and female COPD patients aged ≥40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure
Current or ex-smokers who have a smoking history of at least 10 pack years
Patients who have been treated with a triple combination of LABA/LAMA/ICS for the last 3 months prior to screening
Patients with a documented diagnosis of COPD for at least 1 year prior to screening visit

Exclusion Criteria:

Patients with a past or current medical history of asthma
Patients who have had a COPD exacerbation that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization, or a respiratory tract infection in the 4 weeks prior to screening, or hospitalization between screening and prior to treatment.
Use of other investigational drugs (approved or unapproved) within 30 days or 5 half-lives prior to screening, or until the expected pharmacodynamic effect has returned to baseline (e.g., biologics), whichever is longer; or longer if required by local regulations
Pregnant or nursing (lactating) women, and women of childbearing potential not willing to use acceptable effective methods of contraception during study participation
Patients with a body mass index (BMI) of more than 40 kg/m2 Other protocol-defined inclusion/exclusion criteria may apply

Study Locations

United States
Novartis Investigative Site
Recruiting
Andalusia, 36420
Alabama
United States
Novartis Investigative Site
Recruiting
Westminster, 92683
California
United States
Novartis Investigative Site
Recruiting
Greenacres City, 33467
Florida
United States
Novartis Investigative Site
Recruiting
Louisville, 40215
Kentucky
United States
Novartis Investigative Site
Recruiting
Crowley, 70526
Louisiana
United States
Novartis Investigative Site
Recruiting
New Orleans, 70115
Louisiana
United States
Novartis Investigative Site
Recruiting
Zachary, 70791
Louisiana
United States
Novartis Investigative Site
Recruiting
Columbia, 65203
Missouri
United States
Novartis Investigative Site
Recruiting
Saint Charles, 63301
Missouri
United States
Novartis Investigative Site
Recruiting
Saint Louis, 63141
Missouri
United States
Novartis Investigative Site
Recruiting
Charlotte, 28277
North Carolina
United States
Novartis Investigative Site
Recruiting
Gastonia, 28054
North Carolina
United States
Novartis Investigative Site
Recruiting
Huntersville, 28078
North Carolina
United States
Novartis Investigative Site
Recruiting
Shelby, 28150
North Carolina
United States
Novartis Investigative Site
Recruiting
Union, 29379
South Carolina
United States
Novartis Investigative Site
Recruiting
Boerne, 78006
Texas
United States
Novartis Investigative Site
Recruiting
Andalusia, 36420
Alabama
United States
Novartis Investigative Site
Recruiting
Westminster, 92683
California
United States
Novartis Investigative Site
Recruiting
Greenacres City, 33467
Florida
United States
Novartis Investigative Site
Recruiting
Louisville, 40215
Kentucky
United States
Novartis Investigative Site
Recruiting
Crowley, 70526
Louisiana
United States
Novartis Investigative Site
Recruiting
New Orleans, 70115
Louisiana
United States
Novartis Investigative Site
Recruiting
Zachary, 70791
Louisiana
United States
Novartis Investigative Site
Recruiting
Columbia, 65203
Missouri
United States
Novartis Investigative Site
Recruiting
Saint Charles, 63301
Missouri
United States
Novartis Investigative Site
Recruiting
Saint Louis, 63141
Missouri
United States
Novartis Investigative Site
Recruiting
Charlotte, 28277
North Carolina
United States
Novartis Investigative Site
Recruiting
Gastonia, 28054
North Carolina
United States
Novartis Investigative Site
Recruiting
Huntersville, 28078
North Carolina
United States
Novartis Investigative Site
Recruiting
Shelby, 28150
North Carolina
United States
Novartis Investigative Site
Recruiting
Union, 29379
South Carolina
United States
Novartis Investigative Site
Recruiting
Boerne, 78006
Texas
United States
Novartis Investigative Site
Recruiting
Andalusia, 36420
Alabama
United States
Novartis Investigative Site
Recruiting
Westminster, 92683
California
United States
Novartis Investigative Site
Recruiting
Greenacres City, 33467
Florida
United States
Novartis Investigative Site
Recruiting
Louisville, 40215
Kentucky
United States
Novartis Investigative Site
Recruiting
Crowley, 70526
Louisiana
United States
Novartis Investigative Site
Recruiting
New Orleans, 70115
Louisiana
United States
Novartis Investigative Site
Recruiting
Zachary, 70791
Louisiana
United States
Novartis Investigative Site
Recruiting
Columbia, 65203
Missouri
United States
Novartis Investigative Site
Recruiting
Saint Charles, 63301
Missouri
United States
Novartis Investigative Site
Recruiting
Saint Louis, 63141
Missouri
United States
Novartis Investigative Site
Recruiting
Charlotte, 28277
North Carolina
United States
Novartis Investigative Site
Recruiting
Gastonia, 28054
North Carolina
United States
Novartis Investigative Site
Recruiting
Huntersville, 28078
North Carolina
United States
Novartis Investigative Site
Recruiting
Shelby, 28150
North Carolina
United States
Novartis Investigative Site
Recruiting
Union, 29379
South Carolina
United States
Novartis Investigative Site
Recruiting
Boerne, 78006
Texas
United States
Argentina
Novartis Investigative Site
Recruiting
Caba, C1122AAK
Buenos Aires
Argentina
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Caba, C1122AAK
Buenos Aires
Argentina
Novartis Investigative Site
Recruiting
Caba, C1122AAK
Buenos Aires
Argentina
Australia
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Westmead, 2145
New South Wales
Australia
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South Brisbane, 4101
Queensland
Australia
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Malvern East, 3145
Victoria
Australia
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Westmead, 2145
New South Wales
Australia
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South Brisbane, 4101
Queensland
Australia
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Malvern East, 3145
Victoria
Australia
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Westmead, 2145
New South Wales
Australia
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South Brisbane, 4101
Queensland
Australia
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Clayton, 3168
Victoria
Australia
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Malvern East, 3145
Victoria
Australia
Belgium
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Jette, 1090
Brussel
Belgium
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Bruxelles, 1000
-
Belgium
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Erpent, 5100
-
Belgium
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Jette, 1090
Brussel
Belgium
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Bruxelles, 1000
-
Belgium
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Erpent, 5100
-
Belgium
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Jette, 1090
Brussel
Belgium
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Bruxelles, 1000
-
Belgium
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Erpent, 5100
-
Belgium
Canada
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Sainte Foy, G1V 4G5
Quebec
Canada
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St-Charles-Borromee, J6E 2B4
Quebec
Canada
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Sainte Foy, G1V 4G5
Quebec
Canada
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St-Charles-Borromee, J6E 2B4
Quebec
Canada
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Sainte Foy, G1V 4G5
Quebec
Canada
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St-Charles-Borromee, J6E 2B4
Quebec
Canada
Czech Republic
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Ostrava Poruba, 708 68
Czech Republic
Czech Republic
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Teplice, 415 01
Czech Republic
Czech Republic
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Cesky Krumlov, 381 01
-
Czech Republic
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Ostrava Poruba, 708 68
Czech Republic
Czech Republic
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Teplice, 415 01
Czech Republic
Czech Republic
Novartis Investigative Site
Recruiting
Cesky Krumlov, 381 01
-
Czech Republic
Novartis Investigative Site
Recruiting
Ostrava Poruba, 708 68
Czech Republic
Czech Republic
Novartis Investigative Site
Recruiting
Teplice, 415 01
Czech Republic
Czech Republic
Novartis Investigative Site
Recruiting
Cesky Krumlov, 381 01
-
Czech Republic
France
Novartis Investigative Site
Recruiting
Tours Cedex 9, 37044
Indre Et Loire
France
Novartis Investigative Site
Recruiting
Grenoble Cedex 9, 38043
-
France
Novartis Investigative Site
Recruiting
Lyon Cedex 04, 69317
-
France
Novartis Investigative Site
Recruiting
Marseille, 13915
-
France
Novartis Investigative Site
Recruiting
Pessac Cedex, 33604
-
France
Novartis Investigative Site
Recruiting
Tours Cedex 9, 37044
Indre Et Loire
France
Novartis Investigative Site
Recruiting
Grenoble Cedex 9, 38043
-
France
Novartis Investigative Site
Recruiting
Lyon Cedex 04, 69317
-
France
Novartis Investigative Site
Recruiting
Marseille, 13915
-
France
Novartis Investigative Site
Recruiting
Pessac Cedex, 33604
-
France
Novartis Investigative Site
Recruiting
Tours Cedex 9, 37044
Indre Et Loire
France
Novartis Investigative Site
Recruiting
Grenoble Cedex 9, 38043
-
France
Novartis Investigative Site
Recruiting
Lyon Cedex 04, 69317
-
France
Novartis Investigative Site
Recruiting
Marseille, 13915
-
France
Novartis Investigative Site
Recruiting
Pessac Cedex, 33604
-
France
Hungary
Novartis Investigative Site
Recruiting
Balassagyarmat, 2660
-
Hungary
Novartis Investigative Site
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Budapest, 1121
-
Hungary
Novartis Investigative Site
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Godollo, 2100
-
Hungary
Novartis Investigative Site
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Szeged, 6722
-
Hungary
Novartis Investigative Site
Recruiting
Balassagyarmat, 2660
-
Hungary
Novartis Investigative Site
Recruiting
Budapest, 1121
-
Hungary
Novartis Investigative Site
Recruiting
Godollo, 2100
-
Hungary
Novartis Investigative Site
Recruiting
Szeged, 6722
-
Hungary
Novartis Investigative Site
Recruiting
Balassagyarmat, 2660
-
Hungary
Novartis Investigative Site
Recruiting
Budapest, 1121
-
Hungary
Novartis Investigative Site
Recruiting
Godollo, 2100
-
Hungary
Novartis Investigative Site
Recruiting
Szeged, 6722
-
Hungary
Israel
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Haifa, 3436212
-
Israel
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Jerusalem, 91031
-
Israel
Novartis Investigative Site
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Jerusalem, 9112001
-
Israel
Novartis Investigative Site
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Rehovot, 76100
-
Israel
Novartis Investigative Site
Recruiting
Haifa, 3436212
-
Israel
Novartis Investigative Site
Recruiting
Jerusalem, 91031
-
Israel
Novartis Investigative Site
Recruiting
Jerusalem, 9112001
-
Israel
Novartis Investigative Site
Recruiting
Rehovot, 76100
-
Israel
Novartis Investigative Site
Recruiting
Haifa, 3436212
-
Israel
Novartis Investigative Site
Recruiting
Jerusalem, 91031
-
Israel
Novartis Investigative Site
Recruiting
Jerusalem, 9112001
-
Israel
Novartis Investigative Site
Recruiting
Rehovot, 76100
-
Israel
Japan
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Nagoya, 457-8511
Aichi
Japan
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Naka-gun, 319-1113
Ibaraki
Japan
Novartis Investigative Site
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Chuo ku, 104-0031
Tokyo
Japan
Novartis Investigative Site
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Toshima, 170-0003
Tokyo
Japan
Novartis Investigative Site
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Osaka, 531-0073
-
Japan
Novartis Investigative Site
Recruiting
Nagoya, 457-8511
Aichi
Japan
Novartis Investigative Site
Recruiting
Naka-gun, 319-1113
Ibaraki
Japan
Novartis Investigative Site
Recruiting
Chuo ku, 104-0031
Tokyo
Japan
Novartis Investigative Site
Recruiting
Toshima, 170-0003
Tokyo
Japan
Novartis Investigative Site
Recruiting
Osaka, 531-0073
-
Japan
Novartis Investigative Site
Recruiting
Nagoya, 457-8511
Aichi
Japan
Novartis Investigative Site
Recruiting
Naka-gun, 319-1113
Ibaraki
Japan
Novartis Investigative Site
Recruiting
Chuo ku, 104-0031
Tokyo
Japan
Novartis Investigative Site
Recruiting
Toshima, 170-0003
Tokyo
Japan
Novartis Investigative Site
Recruiting
Osaka, 531-0073
-
Japan
Philippines
Novartis Investigative Site
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Manila, 1000
-
Philippines
Novartis Investigative Site
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Manila, 1000
-
Philippines
Novartis Investigative Site
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Manila, 1000
-
Philippines
Germany
Novartis Investigative Site
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Leipzig, D-04299
-
Germany

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