Pulmonary Disease, Chronic ObstructivePhase 2NCT04882124
Study of Effect of CSJ117 on Symptoms, Pharmacodynamics and Safety in Patients With COPD
A Phase 2 study testing CSJ117 in people with Pulmonary Disease, Chronic Obstructive, run by Novartis Pharmaceuticals at 15 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- CSJ117
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 15 sitesin 6 countries
- Study dates
- 24 Sep 2021to 15 Sep 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
15 sites in 6 countries.
15 sites in 6 countries
United States7 sites
Novartis Investigative Site
Andalusia, Alabama, 36420
Novartis Investigative Site
Crowley, Louisiana, 70526
Novartis Investigative Site
Huntersville, North Carolina, 28078
Novartis Investigative Site
New Orleans, Louisiana, 70115
Novartis Investigative Site
Saint Charles, Missouri, 63301
Novartis Investigative Site
Shelby, North Carolina, 28150
Novartis Investigative Site
St Louis, Missouri, 63141
Hungary3 sites
Novartis Investigative Site
Balassagyarmat, 2660
Novartis Investigative Site
Gödöllő, 2100
Novartis Investigative Site
Szeged, 6722
Japan2 sites
Novartis Investigative Site
Nagoya, Aichi-ken, 457-8511
Novartis Investigative Site
Naka-gun, Ibaraki, 319-1113
Australia1 site
Novartis Investigative Site
South Brisbane, Queensland, 4101
Czechia1 site
Novartis Investigative Site
Ostrava Poruba, Czech Republic, 708 68
About this study
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)
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.
Read the 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.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- CSJ117, Placebo
- Keywords
- Chronic Obstructive Pulmonary Disease, COPD, CSJ117
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSJ117Drug
CSJ117 (4 mg and 8 mg) inhaled once daily for 12 weeks. Delivered via Concept1 device.
PlaceboDrug
Placebo inhaled once daily for 12 weeks. Delivered via Concept1 device
| Study group | Role | What they receive |
|---|---|---|
| CSJ117 8mg | Experimental | Intervention: Drug: CSJ117 Receives: Drug: CSJ117 |
| CSJ117 4mg | Experimental | Intervention: Drug: CSJ117 Receives: Drug: CSJ117 |
| CSJ117 Placebo | Placebo comparator | Intervention: Drug: Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 12 weeks
Secondary outcomes (14)
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.
Measured: Baseline, 12 weeks
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.
Measured: Baseline, 12 weeks
Response in E-RS in total score decrease from baseline
To assess the number of patients who responded to treatment
Measured: Baseline, 12 weeks
Response in CAT in total score decrease from baseline
To assess the number of patients who responded to treatment
Measured: Baseline, 12 weeks
Response in SGRQ-C in total score decrease from baseline
To assess the number of patients who responded to treatment
Measured: Baseline, 12 weeks
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.
Measured: Baseline, 2, 6 and 12 weeks
Puffs of rescue medication per day
To assess use of rescue medication
Measured: 12 weeks
Time to COPD exacerbations via EXACT
Time to COPD exacerbations based on EXACT.
Measured: 12 weeks
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).
Measured: 12 weeks
Time to COPD exacerbations via HCRU
Time to COPD exacerbations based on HCRU
Measured: 12 weeks
Rate and severity of COPD exacerbations via HCRU
Rate and severity of COPD exacerbations based on the Health Care Resource Utilization (HCRU).
Measured: 12 weeks
Pre-dose trough concentration (Ctrough) of CSJ117
To assess pharmacokinetic (PK) parameters of CSJ117 based on total serum concentrations.
Measured: 12 weeks
Accumulation ratio (Racc) of CSJ117
To assess PK parameters of CSJ117 based on total serum concentrations.
Measured: 12 weeks
Measuring anti-drug antibodies
To assess the immunogenicity of CSJ117
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start24 Sep 2021
- Primary completion15 Sep 2022
- Study completion15 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04882124
- Sponsor's protocol ID
- CCSJ117B12201
- Status last verified
- Nov 2022
- First submitted
- 28 Apr 2021
- Last updated
- 28 Nov 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Chow MYT, Pan HW, Lam JKW. Delivery technology of inhaled therapy for asthma and COPD. Adv Pharmacol. 2023;98:273-311. doi: 10.1016/bs.apha.2023.03.001. Epub 2023 Mar 28.
PubMed 37524490
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04882124
- Acronym / sponsor ID
- CCSJ117B12201
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Chronic Obstructive Pulmonary Disease, COPD, CSJ117
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 24 Sep 2021 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 15 Sep 2022 (actual)
- First posted
- 11 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CSJ117 8mg | Experimental | Drug: CSJ117Intervention: Drug: CSJ117 |
| CSJ117 4mg | Experimental | Drug: CSJ117Intervention: Drug: CSJ117 |
| CSJ117 Placebo | Placebo comparator | Drug: PlaceboIntervention: Drug: Placebo |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CSJ117CSJ117 (4 mg and 8 mg) inhaled once daily for 12 weeks. Delivered via Concept1 device. | Drug | CSJ117 4mg, CSJ117 8mg |
| PlaceboPlacebo inhaled once daily for 12 weeks. Delivered via Concept1 device | Drug | CSJ117 Placebo |
Primary outcome
Change from baseline in E-RS score
Time frame: Baseline, 12 weeks
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.
14 secondary outcomes
Change from baseline in CAT score
Time frame: Baseline, 12 weeks
Change from baseline in SGRQ-C score
Time frame: Baseline, 12 weeks
Response in E-RS in total score decrease from baseline
Time frame: Baseline, 12 weeks
Response in CAT in total score decrease from baseline
Time frame: Baseline, 12 weeks
Response in SGRQ-C in total score decrease from baseline
Time frame: Baseline, 12 weeks
Change from baseline in trough FEV1 after 2, 6, and 12 weeks of treatment
Time frame: Baseline, 2, 6 and 12 weeks
Puffs of rescue medication per day
Time frame: 12 weeks
Time to COPD exacerbations via EXACT
Time frame: 12 weeks
Rate and severity of COPD exacerbations via EXACT
Time frame: 12 weeks
Time to COPD exacerbations via HCRU
Time frame: 12 weeks
Rate and severity of COPD exacerbations via HCRU
Time frame: 12 weeks
Pre-dose trough concentration (Ctrough) of CSJ117
Time frame: 12 weeks
Accumulation ratio (Racc) of CSJ117
Time frame: 12 weeks
Measuring anti-drug antibodies
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2022.
- Derived from this study: PubMed 37524490Chow MYT, Pan HW, Lam JKW. Delivery technology of inhaled therapy for asthma and COPD. Adv Pharmacol. 2023;98:273-311. doi: 10.1016/bs.apha.2023.03.001. Epub 2023 Mar 28.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CSJ117 in people with Pulmonary Disease, Chronic Obstructive, run by Novartis Pharmaceuticals at 15 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Hungary, Japan, Australia, Canada and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in E-RS score (time frame: Baseline, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04882124, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2022.