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)

ClinicalTrials.gov Identifier: NCT04882124

Novartis Reference Number: CCSJ117B12201

Last Update: May 10, 2022

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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.

Condition

Pulmonary Disease, Chronic Obstructive

Phase

Phase 2

Overall status

Recruiting

Start date

Sep 24, 2021

Completion date

Aug 25, 2023

Gender

All

Age(s)

40 Years and older (Adult, Older Adult)

Interventions

Drug

CSJ117

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

Drug

Placebo

Placebo inhaled once daily for 12 weeks. Delivered via Concept1 device

Drug

CSJ117

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

Drug

Placebo

Placebo inhaled once daily for 12 weeks. Delivered via Concept1 device

Drug

CSJ117

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

Drug

Placebo

Placebo inhaled once daily for 12 weeks. Delivered via Concept1 device

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