Lunsekimig
DrugPharmaceutical form: solution for injection in prefilled syringe. Route of administration: Subcutaneous injection
Other names: SAR443765
NCT Number: NCT07190209
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.
Interested in participating?
Request Info40 year–80 year
All sexes
Interventional
Phase 3
Investigational Site Number : 0320007, La Plata, Buenos Aires, Argentina
All eligible participants will undergo subcutaneous administrations of lunsekimig or matching placebo during a 48-weeks treatment period
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants are excluded from the study if any of the following criteria apply:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
Pharmaceutical form: solution for injection in prefilled syringe. Route of administration: Subcutaneous injection
Other names: SAR443765
Pharmaceutical form: solution for injection. Route of administration: Subcutaneous injection
Time frame: From Baseline up to 48 weeks
The annualized moderate or severe COPD exacerbation rate up to 48 weeks treatment period compared to placebo
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From Baseline up to 48 weeks
Time frame: 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.
Time frame: From Baseline up to 48 weeks
Time frame: 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.
Time frame: From Baseline up to 48 weeks
Time frame: From Baseline up to 48 weeks
Time frame: From Baseline up to 48 weeks
Time to first occurrence of moderate to severe COPD exacerbation up to 48 weeks
Time frame: From Baseline up to 48 weeks
Time to first occurrence of severe COPD exacerbation up to 48 weeks
Time frame: From Baseline up to 56 weeks
Treatment-Emergent Adverse Events (TEAEs), Adverse events of Special Interest (AESIs), Serious Adverse Events (SAEs)
Time frame: From Baseline up to 56 weeks
Time frame: From Baseline up to 48 weeks
Time frame: From Baseline up to 48 weeks
Contact information is provided by the study sponsor or research team.
Sanofi
Industry
A Phase 2b/Phase 3, Randomized, Double-blind, Placebocontrolled, Multicenter Study, to Investigate the Efficacy and Safety of Lunsekimig in Adult Participants With Inadequately Controlled Chronic Obstructive Pulmonary Disease (COPD) Characterized by an Eosinophilic Phenotype
Acronym: PERSEPHONE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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