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

• Status: Recruiting
• Trial end date: 2023-08-25
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

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