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

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CSJ117
Placebo
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring Chronic Obstructive Pulmonary Disease, COPD, CSJ117

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

CSJ117 8mg

CSJ117 4mg

CSJ117 Placebo

Arm Description

Intervention: Drug: CSJ117

Intervention: Drug: CSJ117

Intervention: Drug: Placebo

Outcomes

Primary Outcome Measures

Change from baseline in E-RS score
The Evaluating Respiratory Symptoms (E-RS) scale is based on the 11 respiratory symptom items included in the EXACT Tool (a validated 14-item electronic questionnaire). These 11 items generate a total score of 0-40, with higher scores indicating more severe respiratory symptoms.

Secondary Outcome Measures

Change from baseline in CAT score
The COPD assessment test (CAT) is a short instrument used to quantify the symptom burden of COPD and will be used to assess the health status of participants. The assessment consists of 8 items, each presented as a semantic 6-point differential scale, providing a total score out of 40. A higher score indicates a worse health status.
Change from baseline in SGRQ-C score
The St. George Respiratory Questionnaire for COPD patients Specific Version (SGRQ-C) contains 40 items divided into two parts covering three aspects of health related to COPD: symptoms, activity and impacts. Total score ranges between 0 and 100, with higher scores indicating greater impairment of health status.
Response in E-RS in total score decrease from baseline
To assess the number of patients who responded to treatment
Response in CAT in total score decrease from baseline
To assess the number of patients who responded to treatment
Response in SGRQ-C in total score decrease from baseline
To assess the number of patients who responded to treatment
Change from baseline in trough FEV1 after 2, 6, and 12 weeks of treatment
Forced expiratory volume in 1 second (FEV1) 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.
Puffs of rescue medication per day
To assess use of rescue medication
Time to COPD exacerbations via EXACT
Time to COPD exacerbations based on EXACT.
Rate and severity of COPD exacerbations via EXACT
Rate and severity of COPD exacerbations based on the Exacerbations of chronic obstructive pulmonary disease tool (EXACT).
Time to COPD exacerbations via HCRU
Time to COPD exacerbations based on HCRU
Rate and severity of COPD exacerbations via HCRU
Rate and severity of COPD exacerbations based on the Health Care Resource Utilization (HCRU).
Pre-dose trough concentration (Ctrough) of CSJ117
To assess pharmacokinetic (PK) parameters of CSJ117 based on total serum concentrations.
Accumulation ratio (Racc) of CSJ117
To assess PK parameters of CSJ117 based on total serum concentrations.
Measuring anti-drug antibodies
To assess the immunogenicity of CSJ117

Full Information

First Posted
April 28, 2021
Last Updated
November 25, 2022
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT04882124
Brief Title
Study of Effect of CSJ117 on Symptoms, Pharmacodynamics and Safety in Patients With COPD
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
September 24, 2021 (Actual)
Primary Completion Date
September 15, 2022 (Actual)
Study Completion Date
September 15, 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
No

5. Study Description

Brief Summary
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.
Detailed Description
This is a randomized, participant- and investigator-blinded, placebo-controlled, parallel group, multicenter study with two fixed-dose levels of CSJ117 (4 mg, 8 mg) administered once-daily via oral inhalation over 12 weeks in participants with COPD, prone for exacerbations and symptomatic at baseline despite background maintenance triple therapy (inhaled corticosteroids/long acting beta-2 agonist/long acting muscarinic antagonist (ICS/LABA/LAMA) combination, standard of care in this population) for at least three months prior to screening. The study will include: Screening period of up to 2 weeks to assess eligibility. Run-in period of 4 weeks where participants will be placed on fixed-dose triple background therapy (ICS/LABA/LAMA) that will be used until the patient's last study treatment. Treatment period of 12 weeks. Participants will be stratified by eosinophil levels and then randomized 1:1:1 to either 4 mg CSJ117, 8 mg CSJ117, or placebo. Follow-up period of 55 days following the last dose of study drug. The primary objective of the study is to assess the effect of CSJ117 on disease/symptom burden after 12 weeks of treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
Chronic Obstructive Pulmonary Disease, COPD, CSJ117

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CSJ117 8mg
Arm Type
Experimental
Arm Description
Intervention: Drug: CSJ117
Arm Title
CSJ117 4mg
Arm Type
Experimental
Arm Description
Intervention: Drug: CSJ117
Arm Title
CSJ117 Placebo
Arm Type
Placebo Comparator
Arm Description
Intervention: Drug: Placebo
Intervention Type
Drug
Intervention Name(s)
CSJ117
Intervention Description
CSJ117 (4 mg and 8 mg) inhaled once daily for 12 weeks. Delivered via Concept1 device.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo inhaled once daily for 12 weeks. Delivered via Concept1 device
Primary Outcome Measure Information:
Title
Change from baseline in E-RS score
Description
The Evaluating Respiratory Symptoms (E-RS) scale is based on the 11 respiratory symptom items included in the EXACT Tool (a validated 14-item electronic questionnaire). These 11 items generate a total score of 0-40, with higher scores indicating more severe respiratory symptoms.
Time Frame
Baseline, 12 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in CAT score
Description
The COPD assessment test (CAT) is a short instrument used to quantify the symptom burden of COPD and will be used to assess the health status of participants. The assessment consists of 8 items, each presented as a semantic 6-point differential scale, providing a total score out of 40. A higher score indicates a worse health status.
Time Frame
Baseline, 12 weeks
Title
Change from baseline in SGRQ-C score
Description
The St. George Respiratory Questionnaire for COPD patients Specific Version (SGRQ-C) contains 40 items divided into two parts covering three aspects of health related to COPD: symptoms, activity and impacts. Total score ranges between 0 and 100, with higher scores indicating greater impairment of health status.
Time Frame
Baseline, 12 weeks
Title
Response in E-RS in total score decrease from baseline
Description
To assess the number of patients who responded to treatment
Time Frame
Baseline, 12 weeks
Title
Response in CAT in total score decrease from baseline
Description
To assess the number of patients who responded to treatment
Time Frame
Baseline, 12 weeks
Title
Response in SGRQ-C in total score decrease from baseline
Description
To assess the number of patients who responded to treatment
Time Frame
Baseline, 12 weeks
Title
Change from baseline in trough FEV1 after 2, 6, and 12 weeks of treatment
Description
Forced expiratory volume in 1 second (FEV1) 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.
Time Frame
Baseline, 2, 6 and 12 weeks
Title
Puffs of rescue medication per day
Description
To assess use of rescue medication
Time Frame
12 weeks
Title
Time to COPD exacerbations via EXACT
Description
Time to COPD exacerbations based on EXACT.
Time Frame
12 weeks
Title
Rate and severity of COPD exacerbations via EXACT
Description
Rate and severity of COPD exacerbations based on the Exacerbations of chronic obstructive pulmonary disease tool (EXACT).
Time Frame
12 weeks
Title
Time to COPD exacerbations via HCRU
Description
Time to COPD exacerbations based on HCRU
Time Frame
12 weeks
Title
Rate and severity of COPD exacerbations via HCRU
Description
Rate and severity of COPD exacerbations based on the Health Care Resource Utilization (HCRU).
Time Frame
12 weeks
Title
Pre-dose trough concentration (Ctrough) of CSJ117
Description
To assess pharmacokinetic (PK) parameters of CSJ117 based on total serum concentrations.
Time Frame
12 weeks
Title
Accumulation ratio (Racc) of CSJ117
Description
To assess PK parameters of CSJ117 based on total serum concentrations.
Time Frame
12 weeks
Title
Measuring anti-drug antibodies
Description
To assess the immunogenicity of CSJ117
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Novartis Investigative Site
City
Andalusia
State/Province
Alabama
ZIP/Postal Code
36420
Country
United States
Facility Name
Novartis Investigative Site
City
Crowley
State/Province
Louisiana
ZIP/Postal Code
70526
Country
United States
Facility Name
Novartis Investigative Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Novartis Investigative Site
City
Saint Charles
State/Province
Missouri
ZIP/Postal Code
63301
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
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
Facility Name
Novartis Investigative Site
City
Shelby
State/Province
North Carolina
ZIP/Postal Code
28150
Country
United States
Facility Name
Novartis Investigative Site
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Novartis Investigative Site
City
Sainte Foy
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Novartis Investigative Site
City
Ostrava Poruba
State/Province
Czech Republic
ZIP/Postal Code
708 68
Country
Czechia
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
Szeged
ZIP/Postal Code
6722
Country
Hungary
Facility Name
Novartis Investigative Site
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
457-8511
Country
Japan
Facility Name
Novartis Investigative Site
City
Naka-gun
State/Province
Ibaraki
ZIP/Postal Code
319-1113
Country
Japan

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

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