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)
1 other identifier
interventional
38
6 countries
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Sep 2021
Shorter than P25 for phase_2
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2021
CompletedFirst Posted
Study publicly available on registry
May 11, 2021
CompletedStudy Start
First participant enrolled
September 24, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2022
CompletedNovember 28, 2022
November 1, 2022
12 months
April 28, 2021
November 25, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline, 12 weeks
Secondary Outcomes (14)
Change from baseline in CAT score
Baseline, 12 weeks
Change from baseline in SGRQ-C score
Baseline, 12 weeks
Response in E-RS in total score decrease from baseline
Baseline, 12 weeks
Response in CAT in total score decrease from baseline
Baseline, 12 weeks
Response in SGRQ-C in total score decrease from baseline
Baseline, 12 weeks
- +9 more secondary outcomes
Study Arms (3)
CSJ117 8mg
EXPERIMENTALIntervention: Drug: CSJ117
CSJ117 4mg
EXPERIMENTALIntervention: Drug: CSJ117
CSJ117 Placebo
PLACEBO COMPARATORIntervention: Drug: Placebo
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Novartis Investigative Site
Andalusia, Alabama, 36420, United States
Novartis Investigative Site
Crowley, Louisiana, 70526, United States
Novartis Investigative Site
New Orleans, Louisiana, 70115, United States
Novartis Investigative Site
Saint Charles, Missouri, 63301, United States
Novartis Investigative Site
St Louis, Missouri, 63141, United States
Novartis Investigative Site
Huntersville, North Carolina, 28078, United States
Novartis Investigative Site
Shelby, North Carolina, 28150, United States
Novartis Investigative Site
South Brisbane, Queensland, 4101, Australia
Novartis Investigative Site
Sainte-Foy, Quebec, G1V 4G5, Canada
Novartis Investigative Site
Ostrava Poruba, Czech Republic, 708 68, Czechia
Novartis Investigative Site
Balassagyarmat, 2660, Hungary
Novartis Investigative Site
Gödöllő, 2100, Hungary
Novartis Investigative Site
Szeged, 6722, Hungary
Novartis Investigative Site
Nagoya, Aichi-ken, 457-8511, Japan
Novartis Investigative Site
Naka-gun, Ibaraki, 319-1113, Japan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2021
First Posted
May 11, 2021
Study Start
September 24, 2021
Primary Completion
September 15, 2022
Study Completion
September 15, 2022
Last Updated
November 28, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will share
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.