Chronic Obstructive Pulmonary Disease
Conditions
Brief summary
This is a parallel, Phase 2b/Phase 3, 3-arm study to investigate the efficacy, safety, and tolerability of subcutaneous (SC) treatment with lunsekimig compared with placebo in adult participants (aged 40 to 80 years, inclusive) with inadequately controlled Chronic obstructive pulmonary disease (COPD) characterized by an eosinophilic phenotype. Participation to the study consists of 3 periods: * Screening period of up to 4 weeks * Randomized intervention period of approximately 48 weeks * Follow-up period: Approximately 8 weeks The study duration will be up to 60 weeks.
Detailed description
All eligible participants will undergo subcutaneous administrations of lunsekimig or matching placebo during a 48-weeks treatment period
Interventions
DRUGLunsekimig
Pharmaceutical form: solution for injection in prefilled syringe. Route of administration: Subcutaneous injection
DRUGPlacebo
Pharmaceutical form: solution for injection. Route of administration: Subcutaneous injection
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Between 40 to 80 years of age * Physician diagnosed chronic obstructive pulmonary disease (COPD) ≥1 year * Post-bronchodilator forced expiratory volume in 1 second (post-BD FEV1) ≥ 20% and ≤ 70% of predicted value and FEV1/FVC (forced expiratory volume in 1 second /forced vital capacity) \<0.70 * Former or current smokers ≥10 pack-years * Chronic Airways Assessment Test (CAAT) ≥10 * ≥2 moderate or ≥1 severe COPD exacerbations in the prior year * Triple (ICS+LABA+LAMA) COPD therapy ≥12 consecutive weeks * EOS (blood eosinophil count) ≥ 150 cells/μL * 18.0 ≤ Body Mass Index ≤ 40.0 kg/m2
Exclusion criteria
Participants are excluded from the study if any of the following criteria apply: * Asthma, including pediatric asthma, or asthma-COPD overlap syndrome (ACOS) * Significant pulmonary disease other than COPD * Long-term oxygen therapy \>4.0 L/min or requirement of \>2.0 L/min to maintain oxygen saturation \>88% at rest * Unstable disorder that can impact participants safety or study outcomes * Active or incompletely treated tuberculosis * Current or past malignancies * Concomitant therapies: * long-term macrolides or phosphodiesterase Type 3 (PDE-3) or PDE-4 inhibitors unless on stable therapy for \> 6 months * any biologic therapy or systemic immunosuppressant within 4 months or 5 half-lives prior to Screening The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Annualized rate of moderate-to-severe chronic obstructive pulmonary disease (COPD) exacerbations | From Baseline up to 48 weeks | The annualized moderate or severe COPD exacerbation rate up to 48 weeks treatment period compared to placebo |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in post-Bronchodilator Forced Expiratory Volume in 1 second (post-BD FEV1) | From Baseline up to 48 weeks | The post-Bronchodilator Forced Expiratory Volume in 1 second is defined as the volume of air exhaled from the lungs in the first second of a forced expiration. |
| Change from baseline in pre-Bronchodilator Forced Expiratory Volume in 1 second (pre-BD FEV1) | From Baseline up to 48 weeks | The pre-Bronchodilator Forced Expiratory Volume in 1 second is defined as the volume of air exhaled from the lungs in the first second of a forced expiration. |
| Change from baseline in the SGRQ-C total score | From Baseline up to 48 weeks | The St. George's Respiratory Questionnaire for patients with chronic obstructive pulmonary disease is derived from the St. George's Respiratory Questionnaire (SGRQ) and is designed to measure and quantify health status in adult patients with chronic airflow limitation. A global score ranges from 0 to 100 with lower scores indicating better quality-of-life. |
| SGRQ responder defined as an improvement of ≥4 points in the SGRQ-C total score | From Baseline up to 48 weeks | — |
| Change from baseline in the Chronic airways assessment Test (CAAT) score | From Baseline up to 48 weeks | The CAAT is an 8-item patient-reported outcome (PRO) measure designed to assess the impact of chronic airways diseases, including COPD, on patients' health status. The CAAT has a scoring range of 0-40, with higher scores indicating a greater impact of the disease on health status. |
| CAAT responder defined as an improvement of ≥2 points in the CAAT total score | From Baseline up to 48 weeks | — |
| Change from baseline in the E-RS:COPD total score | From Baseline up to 48 weeks | The Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease (E-RS:COPD) is an 11-item patient-reported outcome (PRO) measure that evaluates the severity of respiratory symptoms in patients with stable COPD. The total score ranges from 0 to 40, with higher scores indicating more severe respiratory symptoms. |
| E-RS:COPD responder defined as an improvement of ≥2 points in the E-RS:COPD total score | From Baseline up to 48 weeks | — |
| Annualized rate of severe COPD exacerbations | From Baseline up to 48 weeks | — |
| Time to first moderate or severe COPD exacerbation | From Baseline up to 48 weeks | Time to first occurrence of moderate to severe COPD exacerbation up to 48 weeks |
| Time to first severe COPD exacerbation | From Baseline up to 48 weeks | Time to first occurrence of severe COPD exacerbation up to 48 weeks |
| Incidence of participants with TEAEs, including AESIs, and SAEs | From Baseline up to 56 weeks | Treatment-Emergent Adverse Events (TEAEs), Adverse events of Special Interest (AESIs), Serious Adverse Events (SAEs) |
| Incidence of potentially clinically significant laboratory abnormalities | From Baseline up to 56 weeks | — |
| Serum concentration of lunsekimig | From Baseline up to 48 weeks | — |
| Incidence and titer of antidrug antibodies (ADAs) | From Baseline up to 48 weeks | — |
Countries
Argentina, Australia, Brazil, Canada, Chile, China, New Zealand, South Africa, South Korea, Taiwan, United Kingdom, United States
Contacts
CONTACTTrial Transparency email recommended (Toll free for US & Canada)
Outcome results
None listed