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

Completed · Phase 2 · Has a placebo group

Conditions studied: Pulmonary Disease, Chronic Obstructive

In brief

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.

Key facts

Study ID

NCT04882124

Run by

Novartis Pharmaceuticals

People needed

38

Starts

2021-09-24

Expected to finish

2022-09-15

Last updated by the study team

2022-11-28

Who can join

Age: 40 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

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
• Patients with a body mass index (BMI) of more than 40 kg/m2 Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Novartis Investigative Site — Andalusia, Alabama, United States
• Novartis Investigative Site — Crowley, Louisiana, United States
• Novartis Investigative Site — New Orleans, Louisiana, United States
• Novartis Investigative Site — Saint Charles, Missouri, United States
• Novartis Investigative Site — St Louis, Missouri, United States
• Novartis Investigative Site — Huntersville, North Carolina, United States
• Novartis Investigative Site — Shelby, North Carolina, United States
• Novartis Investigative Site — South Brisbane, Queensland, Australia
• Novartis Investigative Site — Sainte-Foy, Quebec, Canada
• Novartis Investigative Site — Ostrava Poruba, Czech Republic, Czechia
• Novartis Investigative Site — Balassagyarmat, Hungary
• Novartis Investigative Site — Gödöllő, Hungary
• Novartis Investigative Site — Szeged, Hungary
• Novartis Investigative Site — Nagoya, Aichi-ken, Japan
• Novartis Investigative Site — Naka-gun, Ibaraki, Japan

Full record on ClinicalTrials.gov

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