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

Novartis

Status and phase: Completed; Phase 2

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: Placebo; Drug: CSJ117

Study type: Interventional

Funder types: Industry

Identifiers

NCT04882124

CCSJ117B12201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 40 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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38 participants in 3 patient groups, including a placebo group

CSJ117 8mg

Experimental group

Description:

Intervention: Drug: CSJ117

Treatment:

Drug: CSJ117

CSJ117 4mg

Experimental group

Description:

Intervention: Drug: CSJ117

Treatment:

Drug: CSJ117

CSJ117 Placebo

Placebo Comparator group

Description:

Intervention: Drug: Placebo

Treatment:

Drug: Placebo