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

Pulmonary Disease, Chronic Obstructive Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04882124
• Other study ID #: CCSJ117B12201
• Status: Completed
• Phase: Phase 2
• Start date: September 24, 2021
• Est. completion date: September 15, 2022

Study information

• Verified date: November 2022
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: September 15, 2022
• Est. primary completion date: September 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

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

Locations

Country	Name	City	State
Australia	Novartis Investigative Site	South Brisbane	Queensland
Canada	Novartis Investigative Site	Sainte Foy	Quebec
Czechia	Novartis Investigative Site	Ostrava Poruba	Czech Republic
Hungary	Novartis Investigative Site	Balassagyarmat
Hungary	Novartis Investigative Site	Godollo
Hungary	Novartis Investigative Site	Szeged
Japan	Novartis Investigative Site	Nagoya	Aichi
Japan	Novartis Investigative Site	Naka-gun	Ibaraki
United States	Novartis Investigative Site	Andalusia	Alabama
United States	Novartis Investigative Site	Crowley	Louisiana
United States	Novartis Investigative Site	Huntersville	North Carolina
United States	Novartis Investigative Site	New Orleans	Louisiana
United States	Novartis Investigative Site	Saint Charles	Missouri
United States	Novartis Investigative Site	Saint Louis	Missouri
United States	Novartis Investigative Site	Shelby	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Czechia,  Hungary,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline, 12 weeks
Secondary	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.	Baseline, 12 weeks
Secondary	Response in E-RS in total score decrease from baseline	To assess the number of patients who responded to treatment	Baseline, 12 weeks
Secondary	Response in CAT in total score decrease from baseline	To assess the number of patients who responded to treatment	Baseline, 12 weeks
Secondary	Response in SGRQ-C in total score decrease from baseline	To assess the number of patients who responded to treatment	Baseline, 12 weeks
Secondary	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.	Baseline, 2, 6 and 12 weeks
Secondary	Puffs of rescue medication per day	To assess use of rescue medication	12 weeks
Secondary	Time to COPD exacerbations via EXACT	Time to COPD exacerbations based on EXACT.	12 weeks
Secondary	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).	12 weeks
Secondary	Time to COPD exacerbations via HCRU	Time to COPD exacerbations based on HCRU	12 weeks
Secondary	Rate and severity of COPD exacerbations via HCRU	Rate and severity of COPD exacerbations based on the Health Care Resource Utilization (HCRU).	12 weeks
Secondary	Pre-dose trough concentration (Ctrough) of CSJ117	To assess pharmacokinetic (PK) parameters of CSJ117 based on total serum concentrations.	12 weeks
Secondary	Accumulation ratio (Racc) of CSJ117	To assess PK parameters of CSJ117 based on total serum concentrations.	12 weeks
Secondary	Measuring anti-drug antibodies	To assess the immunogenicity of CSJ117	12 weeks