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)
Overview
- Phase
- Phase 2
- Intervention
- Placebo
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Change from baseline in E-RS score
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Detailed 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.
Investigators
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
Arms & Interventions
CSJ117 Placebo
Intervention: Drug: Placebo
Intervention: Placebo
CSJ117 8mg
Intervention: Drug: CSJ117
Intervention: CSJ117
CSJ117 4mg
Intervention: Drug: CSJ117
Intervention: CSJ117
Outcomes
Primary Outcomes
Change from baseline in E-RS score
Time Frame: Baseline, 12 weeks
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.
Secondary Outcomes
- 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)
- Change from baseline in CAT score(Baseline, 12 weeks)
- Change from baseline in trough FEV1 after 2, 6, and 12 weeks of treatment(Baseline, 2, 6 and 12 weeks)
- Puffs of rescue medication per day(12 weeks)
- Rate and severity of COPD exacerbations via HCRU(12 weeks)
- Pre-dose trough concentration (Ctrough) of CSJ117(12 weeks)
- Response in SGRQ-C in total score decrease from baseline(Baseline, 12 weeks)
- Rate and severity of COPD exacerbations via EXACT(12 weeks)
- Time to COPD exacerbations via HCRU(12 weeks)
- Measuring anti-drug antibodies(12 weeks)
- Time to COPD exacerbations via EXACT(12 weeks)
- Accumulation ratio (Racc) of CSJ117(12 weeks)