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

Primary Purpose

Asthma

Status

Terminated

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

CSJ117

Placebo

About this trial

This is an interventional treatment trial for Asthma focused on measuring CSJ117, uncontrolled asthma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Exclusion Criteria:

Patients who have a cigarette smoking history of greater than 10 pack years or current smokers or vapers.
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, untreated and not cured hepatitis C or HIV.
Patients who discontinued monoclonal antibodies (investigational or approved) for asthma due to lack of efficacy

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Arm Label

CSJ117 0.5mg

CSJ117 1mg

CSJ117 2mg

CSJ117 4mg

CSJ117 8mg

Placebo

Arm Description

CSJ117 0.5 mg inhaled once daily

CSJ117 1 mg inhaled once daily

CSJ117 2 mg inhaled once daily

CSJ117 4 mg inhaled once daily

CSJ117 8 mg inhaled once daily

Placebo inhaled once daily

Outcomes

Primary Outcome Measures

Average Change From Baseline in Pre-dose FEV1 at Week 8 and Week 12

FEV1 (forced expiratory volume in one second) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. Pre-dose FEV1 is defined as average of the two FEV1 measurements taken at approximately 45 minutes and 15 minutes prior to dosing. The baseline pre-dose FEV1 value is defined as the average of the values taken approximately 2 hours 45 minutes and 2 hours 15 minutes prior to the first dose of double-blind treatment at Day 1. The least-squares means for change from baseline in pre-dose FEV1 averaged between Week 8 and Week 12 visits for each individual dose group were obtained from a linear mixed effects model for repeated measures (MMRM). A positive average change from baseline in pre-dose FEV1 is considered a favorable outcome.

Secondary Outcome Measures

Average Change From Baseline in FeNO at Week 8 and Week 12

Fractional exhaled Nitric Oxide (FeNO) pre-dose measurements were done at the investigational sites prior to spirometry assessments. FeNO is defined as the mean of two serial measurements. The measurement of exhaled nitric oxide is widely accepted as a non-invasive marker of airway inflammation (inflammation leads to elevation of FeNO). The baseline FeNO pre-dose measurements were taken at the end of the run-in period. The least-squares means for change from baseline in FeNO averaged between Week 8 and Week 12 visits for each individual dose group were obtained from a linear mixed effects model for repeated measures (MMRM). A negative average change from baseline in FeNO is considered a favorable outcome.

Change From Baseline in Morning PEF at Week 12

PEF (Peak Expiratory Flow) is a person's maximum speed of expiration. All participants were instructed to record PEF twice daily before taking any medication using an electronic peak expiratory flow device (eDiary/ePEF), once in the morning and once approximately 12 hours later in the evening at home. At each timepoint, the participant was instructed to perform 3 consecutive manoeuvres within 10 minutes. These PEF values were captured in the eDiary/ePEF. Mean morning and evening PEF values were calculated by weekly intervals. The baseline values of PEF were the mean values in the run-in period. A positive change from baseline in PEF is considered a favorable outcome.

Change From Baseline in Evening PEF at Week 12

Average Change From Baseline in ACQ-5 Score at Week 8 and Week 12

The Asthma Control Questionnaire-5 (ACQ-5) is a five-item, self-completed questionnaire, which is used as a measure of asthma symptom control. Patients were asked to recall how their asthma had been during the previous week and to respond to the symptom questions on a 7-point scale (0=no impairment, 6=maximum impairment). The questions are equally weighted and the overall ACQ-5 score is the mean of all 5 questions, therefore between 0 (totally controlled) and 6 (severely uncontrolled). The baseline values of ACQ-5 were collected at the end of the run-in period. The least-squares means for change from baseline in ACQ-5 score averaged between Week 8 and Week 12 visits for each individual dose group were obtained from a linear mixed effects model for repeated measures (MMRM). A negative change from baseline in ACQ-5 is considered a favorable outcome.

Average Change From Baseline in AQLQ+12 Score at Week 8 and Week 12

The Asthma Quality of Life Questionnaire+12 (AQLQ+12) is a disease specific questionnaire, which is used as a measure of health-related quality of life. The AQLQ+12 comprises a total of 32 individual questions that span a total of 4 domains: symptoms, activity limitation, emotional function, and environmental stimuli. Patients are asked to recall their experiences during the previous 2 weeks and to score each item on a 7-point scale (7 = not at all impaired to 1 = severely impaired). The overall AQLQ+12 score is the mean of all 32 individual responses, therefore between 7 and 1 with higher scores indicating less impairment in health-related quality of life. The baseline values of AQLQ+12 were collected at the end of the run-in period. The least-squares means for change from baseline in AQLQ+12 score averaged between Week 8 and Week 12 visits were obtained from a linear mixed effects model for repeated measures (MMRM). A positive change from baseline is considered a favorable outcome.

Change From Baseline in ADSD Score at Week 8 and Week 12

Asthma Daytime Symptom Diary (ADSD) and Asthma Nighttime Symptom Diary (ANSD) are patient reported outcome measures of asthma symptom severity. Patients recorded asthma symptoms twice daily in the eDiary. Severity of daytime asthma symptoms were assessed before going to bed and severity of nighttime symptoms upon waking. Both diaries comprised of 6 items assessing breathing symptoms (difficulty breathing, wheezing, and shortness of breath), chest symptoms (chest tightness and chest pain), and cough symptoms (cough). All items were assessed using an 11-point numeric rating scale ranging from 0 ('None') to 10 ('As bad as you can imagine'). The overall score is the mean of all 6 individual responses, therefore between 0 and 10 with higher scores indicating more severe symptoms. Mean daily scores of both diaries were calculated by weekly intervals. The baseline values were defined as the average score during the run-in period. A negative change from baseline is a favorable outcome.

Change From Baseline in ANSD Score at Week 8 and Week 12

Change From Baseline in Number of Puffs of SABA Taken Per Day at Week 12

Participants were given a short acting β2-agonist (SABA) such as salbutamol (100 µg) or albuterol (90 µg) to use as rescue medication throughout the study. Participants recorded in the eDiary, once in the morning and once in the evening, the use of rescue medication (number of puffs of SABA taken in the previous 12 hours). The total number of puffs of SABA taken per day was calculated and the mean daily use of puffs of SABA was derived by weekly intervals. The baseline value of number of puffs of SABA taken per day is the average of total daily SABA use during the run-in period. A negative change from baseline is considered a favorable outcome.

Number of Participants With On-treatment Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period

Number of participants with AEs and SAEs, including asthma exacerbations, changes from baseline in vital signs, electrocardiograms and laboratory results qualifying and reported as AEs during the on-treatment period. The on-treatment period is between the date of first dose of double-blind study treatment and date of the last dose of randomized study treatment. Grades to characterize the severity of the adverse events were based on the Common Terminology Criteria for Adverse Events (CTCAE). For CTCAE, Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death related to AE. The number of participants in each category is reported in the table.

Number of Participants With Anti-CSJ117 Antibodies

Immunogenicity (antibody formation against CSJ117) was evaluated in serum by a validated bridging electrochemiluminescence immunoassay (ECLIA).

CSJ117 Serum Concentration

CSJ117 concentration was determined in serum by a validated immunoassay method. Concentrations below the lower limit of quantification (LLOQ) were treated as "zero".

Full Information

NCT ID

NCT04410523

First Posted

May 6, 2020

Last Updated

July 18, 2023

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT04410523

Brief Title

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

Official Title

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.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Terminated

Why Stopped

Sponsor Desicion

Study Start Date

September 9, 2020 (Actual)

Primary Completion Date

July 12, 2022 (Actual)

Study Completion Date

September 6, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

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 asthma despite medium to high dose inhaled corticosteroid (ICS) plus long-acting beta agonist (LABA). Subjects were assigned to one of the following six treatment arms/groups in a ratio of 2:1:1:1:2:2: Placebo inhaled once daily CSJ117 0.5 mg inhaled once daily CSJ117 1.0 mg inhaled once daily CSJ117 2.0 mg inhaled once daily CSJ117 4.0 mg inhaled once daily CSJ117 8.0 mg inhaled once daily The study included: A screening period of approximately 2 weeks A single blinded placebo run-in period of 4 weeks (extended to 8 weeks for subjects experiencing an asthma exacerbation or respiratory tract infection during the run-in period) A double blinded treatment period of 12 weeks A follow-up period of up to 12 weeks, study drug free, following the last dose of study treatment. Patients who successfully completed 12 weeks of treatment in this study could be offered participation in the Safety Extension Study CCSJ117A12201E1 (NCT04946318).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

Keywords

CSJ117, uncontrolled asthma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

335 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CSJ117 0.5mg

Arm Type

Experimental

Arm Description

CSJ117 0.5 mg inhaled once daily

Arm Title

CSJ117 1mg

Arm Type

Experimental

Arm Description

CSJ117 1 mg inhaled once daily

Arm Title

CSJ117 2mg

Arm Type

Experimental

Arm Description

CSJ117 2 mg inhaled once daily

Arm Title

CSJ117 4mg

Arm Type

Experimental

Arm Description

CSJ117 4 mg inhaled once daily

Arm Title

CSJ117 8mg

Arm Type

Experimental

Arm Description

CSJ117 8 mg inhaled once daily

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo inhaled once daily

Intervention Type

Drug

Intervention Name(s)

CSJ117

Intervention Description

CSJ117 inhaled once daily (in the morning) for 12 weeks. Delivered via Concept1 device. CSJ117 = inhaled monoclonal antibody fragment

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Run-in period (all arms): Placebo inhaled once daily (in the morning) for 4 weeks. Placebo dosing extended to 8 weeks in case of asthma exacerbation or respiratory tract infection during this period. Treatment period (Placebo arm only): Placebo inhaled once daily (in the morning) for 12 weeks. Delivered via Concept1 device.

Primary Outcome Measure Information:

Title

Average Change From Baseline in Pre-dose FEV1 at Week 8 and Week 12

Description

Time Frame

Baseline, Weeks 8-12

Secondary Outcome Measure Information:

Title

Average Change From Baseline in FeNO at Week 8 and Week 12

Description

Time Frame

Baseline, Weeks 8-12

Title

Change From Baseline in Morning PEF at Week 12

Description

Time Frame

Baseline, Week 12

Title

Change From Baseline in Evening PEF at Week 12

Description

Time Frame

Baseline, Week 12

Title

Average Change From Baseline in ACQ-5 Score at Week 8 and Week 12

Description

Time Frame

Baseline, Weeks 8-12

Title

Average Change From Baseline in AQLQ+12 Score at Week 8 and Week 12

Description

Time Frame

Baseline, Weeks 8-12

Title

Change From Baseline in ADSD Score at Week 8 and Week 12

Description

Time Frame

Baseline, Week 8 and Week 12

Title

Change From Baseline in ANSD Score at Week 8 and Week 12

Description

Time Frame

Baseline, Week 8 and Week 12

Title

Change From Baseline in Number of Puffs of SABA Taken Per Day at Week 12

Description

Time Frame

Baseline, Week 12

Title

Number of Participants With On-treatment Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period

Description

Time Frame

From first dose of double-blind study treatment up to last dose (Week 12)

Title

Number of Participants With Anti-CSJ117 Antibodies

Description

Immunogenicity (antibody formation against CSJ117) was evaluated in serum by a validated bridging electrochemiluminescence immunoassay (ECLIA).

Time Frame

Day 1 and Weeks 2, 4, 8, 12, 14, 16, 20 and 24

Title

CSJ117 Serum Concentration

Description

CSJ117 concentration was determined in serum by a validated immunoassay method. Concentrations below the lower limit of quantification (LLOQ) were treated as "zero".

Time Frame

Day 1 and Week 12: pre-dose, 2 and 4 hours post-dose; Weeks 2, 4 and 8: pre-dose and 4 hours post-dose; Weeks 14, 16, 20 and 24: pre-dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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. 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 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.

Facility Information:

Facility Name

Novartis Investigative Site

City

Bakersfield

State/Province

California

ZIP/Postal Code

93301

Country

United States

Facility Name

Novartis Investigative Site

City

Huntington Beach

State/Province

California

ZIP/Postal Code

92647

Country

United States

Facility Name

Novartis Investigative Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90017

Country

United States

Facility Name

Novartis Investigative Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90025

Country

United States

Facility Name

Novartis Investigative Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

Facility Name

Novartis Investigative Site

City

Mission Viejo

State/Province

California

ZIP/Postal Code

92691

Country

United States

Facility Name

Novartis Investigative Site

City

San Jose

State/Province

California

ZIP/Postal Code

95117

Country

United States

Facility Name

Novartis Investigative Site

City

Denver

State/Province

Colorado

ZIP/Postal Code

80206

Country

United States

Facility Name

Novartis Investigative Site

City

Marietta

State/Province

Georgia

ZIP/Postal Code

30060

Country

United States

Facility Name

Novartis Investigative Site

City

Bangor

State/Province

Maine

ZIP/Postal Code

04401

Country

United States

Facility Name

Novartis Investigative Site

City

White Marsh

State/Province

Maryland

ZIP/Postal Code

21162

Country

United States

Facility Name

Novartis Investigative Site

City

North Dartmouth

State/Province

Massachusetts

ZIP/Postal Code

02747-3322

Country

United States

Facility Name

Novartis Investigative Site

City

Columbia

State/Province

Missouri

ZIP/Postal Code

65203

Country

United States

Facility Name

Novartis Investigative Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

Novartis Investigative Site

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68134

Country

United States

Facility Name

Novartis Investigative Site

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27607

Country

United States

Facility Name

Novartis Investigative Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73120

Country

United States

Facility Name

Novartis Investigative Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15241

Country

United States

Facility Name

Novartis Investigative Site

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29607

Country

United States

Facility Name

Novartis Investigative Site

City

Boerne

State/Province

Texas

ZIP/Postal Code

78006

Country

United States

Facility Name

Novartis Investigative Site

City

McKinney

State/Province

Texas

ZIP/Postal Code

75069

Country

United States

Facility Name

Novartis Investigative Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1056ABJ

Country

Argentina

Facility Name

Novartis Investigative Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1122AAK

Country

Argentina

Facility Name

Novartis Investigative Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1414AIF

Country

Argentina

Facility Name

Novartis Investigative Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1425BEN

Country

Argentina

Facility Name

Novartis Investigative Site

City

Mar del Plata

State/Province

Buenos Aires

ZIP/Postal Code

7600

Country

Argentina

Facility Name

Novartis Investigative Site

City

Ranelagh, Partido De Berazate

State/Province

Buenos Aires

ZIP/Postal Code

1884

Country

Argentina

Facility Name

Novartis Investigative Site

City

San Salvador

State/Province

Entre Rios

ZIP/Postal Code

E3218CHH

Country

Argentina

Facility Name

Novartis Investigative Site

City

Concepcion del Uruguay

State/Province

Entre Ríos

ZIP/Postal Code

3260

Country

Argentina

Facility Name

Novartis Investigative Site

City

Santa Fe

State/Province

Rosario

ZIP/Postal Code

S2000DBS

Country

Argentina

Facility Name

Novartis Investigative Site

City

Rosario

State/Province

Santa Fe

ZIP/Postal Code

S2000DBS

Country

Argentina

Facility Name

Novartis Investigative Site

City

Rosario

State/Province

Santa Fe

ZIP/Postal Code

S2000JKR

Country

Argentina

Facility Name

Novartis Investigative Site

City

San Miguel de Tucuman

State/Province

Tucuman

ZIP/Postal Code

4000

Country

Argentina

Facility Name

Novartis Investigative Site

City

San Miguel de Tucuman

State/Province

Tucuman

ZIP/Postal Code

T4000IFL

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos Aires

ZIP/Postal Code

1900

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos Aires

ZIP/Postal Code

C1125ABE

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos Aires

ZIP/Postal Code

C1425FVH

Country

Argentina

Facility Name

Novartis Investigative Site

City

Caba

ZIP/Postal Code

C1430CAE

Country

Argentina

Facility Name

Novartis Investigative Site

City

Mendoza

ZIP/Postal Code

5500

Country

Argentina

Facility Name

Novartis Investigative Site

City

Parana

ZIP/Postal Code

3100

Country

Argentina

Facility Name

Novartis Investigative Site

City

Erpent

ZIP/Postal Code

5100

Country

Belgium

Facility Name

Novartis Investigative Site

City

Liege

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Ruse

ZIP/Postal Code

7002

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Stara Zagora

ZIP/Postal Code

6000

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Ajax

State/Province

Ontario

ZIP/Postal Code

L1S 2J5

Country

Canada

Facility Name

Novartis Investigative Site

City

Burlington

State/Province

Ontario

ZIP/Postal Code

L7N 3V2

Country

Canada

Facility Name

Novartis Investigative Site

City

Etobicoke

State/Province

Ontario

ZIP/Postal Code

M9V 4B4

Country

Canada

Facility Name

Novartis Investigative Site

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 3Z5

Country

Canada

Facility Name

Novartis Investigative Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2V 2K1

Country

Canada

Facility Name

Novartis Investigative Site

City

Trois Rivieres

State/Province

Quebec

ZIP/Postal Code

G8T 7A1

Country

Canada

Facility Name

Novartis Investigative Site

City

Teplice

State/Province

CZE

ZIP/Postal Code

415 01

Country

Czechia

Facility Name

Novartis Investigative Site

City

Jindrichuv Hradec

ZIP/Postal Code

377 01

Country

Czechia

Facility Name

Novartis Investigative Site

City

Lovosice

ZIP/Postal Code

41002

Country

Czechia

Facility Name

Novartis Investigative Site

City

Varnsdorf

ZIP/Postal Code

40747

Country

Czechia

Facility Name

Novartis Investigative Site

City

Peine

State/Province

Niedersachsen

ZIP/Postal Code

31224

Country

Germany

Facility Name

Novartis Investigative Site

City

Bamberg

ZIP/Postal Code

96049

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10119

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10717

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10969

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

12159

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

12203

Country

Germany

Facility Name

Novartis Investigative Site

City

Darmstadt

ZIP/Postal Code

64283

Country

Germany

Facility Name

Novartis Investigative Site

City

Frankfurt

ZIP/Postal Code

60596

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

20354

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

22299

Country

Germany

Facility Name

Novartis Investigative Site

City

Hannover

ZIP/Postal Code

30173

Country

Germany

Facility Name

Novartis Investigative Site

City

Leipzig

ZIP/Postal Code

D-04299

Country

Germany

Facility Name

Novartis Investigative Site

City

Leipzig

ZIP/Postal Code

D-04347

Country

Germany

Facility Name

Novartis Investigative Site

City

Mainz

ZIP/Postal Code

55128

Country

Germany

Facility Name

Novartis Investigative Site

City

Potsdam

ZIP/Postal Code

14467

Country

Germany

Facility Name

Novartis Investigative Site

City

Witten

ZIP/Postal Code

58452

Country

Germany

Facility Name

Novartis Investigative Site

City

Guatemala City

State/Province

GTM

ZIP/Postal Code

01010

Country

Guatemala

Facility Name

Novartis Investigative Site

City

Guatemala City

State/Province

GTM

ZIP/Postal Code

01011

Country

Guatemala

Facility Name

Novartis Investigative Site

City

Guatemala City

ZIP/Postal Code

01010

Country

Guatemala

Facility Name

Novartis Investigative Site

City

Guatemala City

ZIP/Postal Code

01011

Country

Guatemala

Facility Name

Novartis Investigative Site

City

Balassagyarmat

ZIP/Postal Code

2660

Country

Hungary

Facility Name

Novartis Investigative Site

City

Godollo

ZIP/Postal Code

2100

Country

Hungary

Facility Name

Novartis Investigative Site

City

Komarom

ZIP/Postal Code

2900

Country

Hungary

Facility Name

Novartis Investigative Site

City

Pecs

ZIP/Postal Code

7635

Country

Hungary

Facility Name

Novartis Investigative Site

City

Szeged

ZIP/Postal Code

6722

Country

Hungary

Facility Name

Novartis Investigative Site

City

Yokohama-city

State/Province

Kanagawa

ZIP/Postal Code

223-0059

Country

Japan

Facility Name

Novartis Investigative Site

City

Osaka city

State/Province

Osaka

ZIP/Postal Code

530 0001

Country

Japan

Facility Name

Novartis Investigative Site

City

Chuo ku

State/Province

Tokyo

ZIP/Postal Code

104-0031

Country

Japan

Facility Name

Novartis Investigative Site

City

Chuo-ku

State/Province

Tokyo

ZIP/Postal Code

103-0003

Country

Japan

Facility Name

Novartis Investigative Site

City

Chuo-ku

State/Province

Tokyo

ZIP/Postal Code

103-0028

Country

Japan

Facility Name

Novartis Investigative Site

City

Kodaira

State/Province

Tokyo

ZIP/Postal Code

187-0024

Country

Japan

Facility Name

Novartis Investigative Site

City

Setagaya-Ku

State/Province

Tokyo

ZIP/Postal Code

157-0072

Country

Japan

Facility Name

Novartis Investigative Site

City

Setagaya-ku

State/Province

Tokyo

ZIP/Postal Code

158-0097

Country

Japan

Facility Name

Novartis Investigative Site

City

Toshima ku

State/Province

Tokyo

ZIP/Postal Code

170 0003

Country

Japan

Facility Name

Novartis Investigative Site

City

Toshima

State/Province

Tokyo

ZIP/Postal Code

170-0003

Country

Japan

Facility Name

Novartis Investigative Site

City

Osaka

ZIP/Postal Code

531-0073

Country

Japan

Facility Name

Novartis Investigative Site

City

Osaka

ZIP/Postal Code

551-0032

Country

Japan

Facility Name

Novartis Investigative Site

City

Riga

State/Province

ZIP/Postal Code

1011

Country

Latvia

Facility Name

Novartis Investigative Site

City

Riga

State/Province

ZIP/Postal Code

1038

Country

Latvia

Facility Name

Novartis Investigative Site

City

Daugavpils

ZIP/Postal Code

LV-5401

Country

Latvia

Facility Name

Novartis Investigative Site

City

Daugavpils

ZIP/Postal Code

LV-5417

Country

Latvia

Facility Name

Novartis Investigative Site

City

Riga

ZIP/Postal Code

LV 1002

Country

Latvia

Facility Name

Novartis Investigative Site

City

Bulacan

ZIP/Postal Code

3020

Country

Philippines

Facility Name

Novartis Investigative Site

City

Iloilo City

ZIP/Postal Code

5000

Country

Philippines

Facility Name

Novartis Investigative Site

City

Iloilo

ZIP/Postal Code

5000

Country

Philippines

Facility Name

Novartis Investigative Site

City

Manila

ZIP/Postal Code

1000

Country

Philippines

Facility Name

Novartis Investigative Site

City

Manila

ZIP/Postal Code

1003

Country

Philippines

Facility Name

Novartis Investigative Site

City

Bialystok

ZIP/Postal Code

15-044

Country

Poland

Facility Name

Novartis Investigative Site

City

Krakow

ZIP/Postal Code

30033

Country

Poland

Facility Name

Novartis Investigative Site

City

Krakow

ZIP/Postal Code

31-011

Country

Poland

Facility Name

Novartis Investigative Site

City

Lodz

ZIP/Postal Code

90-153

Country

Poland

Facility Name

Novartis Investigative Site

City

Poznan

ZIP/Postal Code

60-693

Country

Poland

Facility Name

Novartis Investigative Site

City

Poznan

ZIP/Postal Code

60-823

Country

Poland

Facility Name

Novartis Investigative Site

City

Izhevsk

ZIP/Postal Code

426061

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Saint Petersburg

ZIP/Postal Code

194354

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Saint-Petersburg

ZIP/Postal Code

194354

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Saratov

ZIP/Postal Code

410012

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

St Petersburg

ZIP/Postal Code

194354

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Ulyanovsk

ZIP/Postal Code

432063

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Levice

ZIP/Postal Code

93401

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Presov

ZIP/Postal Code

080 01

Country

Slovakia

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.

Learn more about this trial

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

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

Asthma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial