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NCT Number: NCT07190209

Efficacy, Safety, and Tolerability Study of Lunsekimig Compared With Placebo in Adult Participants With Inadequately Controlled Chronic Obstructive Pulmonary Disease (COPD) Characterized by an Eosinophilic Phenotype

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.

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigational Site Number : 0320007, La Plata, Buenos Aires, Argentina

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About this study

All eligible participants will undergo subcutaneous administrations of lunsekimig or matching placebo during a 48-weeks treatment period

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lunsekimig

Drug

Pharmaceutical form: solution for injection in prefilled syringe. Route of administration: Subcutaneous injection

Other names: SAR443765

Placebo

Drug

Pharmaceutical form: solution for injection. Route of administration: Subcutaneous injection

Primary outcomes

  1. Annualized rate of moderate-to-severe chronic obstructive pulmonary disease (COPD) exacerbations

    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

Secondary outcomes

  1. Change from baseline in post-Bronchodilator Forced Expiratory Volume in 1 second (post-BD FEV1)

    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.

  2. Change from baseline in pre-Bronchodilator Forced Expiratory Volume in 1 second (pre-BD FEV1)

    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.

  3. Change from baseline in the SGRQ-C total score

    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.

  4. SGRQ responder defined as an improvement of ≥4 points in the SGRQ-C total score

    Time frame: From Baseline up to 48 weeks

  5. Change from baseline in the Chronic airways assessment Test (CAAT) score

    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.

  6. CAAT responder defined as an improvement of ≥2 points in the CAAT total score

    Time frame: From Baseline up to 48 weeks

  7. Change from baseline in the E-RS:COPD total score

    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.

  8. E-RS:COPD responder defined as an improvement of ≥2 points in the E-RS:COPD total score

    Time frame: From Baseline up to 48 weeks

  9. Annualized rate of severe COPD exacerbations

    Time frame: From Baseline up to 48 weeks

  10. Time to first moderate or severe COPD exacerbation

    Time frame: From Baseline up to 48 weeks

    Time to first occurrence of moderate to severe COPD exacerbation up to 48 weeks

  11. Time to first severe COPD exacerbation

    Time frame: From Baseline up to 48 weeks

    Time to first occurrence of severe COPD exacerbation up to 48 weeks

  12. Incidence of participants with TEAEs, including AESIs, and SAEs

    Time frame: From Baseline up to 56 weeks

    Treatment-Emergent Adverse Events (TEAEs), Adverse events of Special Interest (AESIs), Serious Adverse Events (SAEs)

  13. Incidence of potentially clinically significant laboratory abnormalities

    Time frame: From Baseline up to 56 weeks

  14. Serum concentration of lunsekimig

    Time frame: From Baseline up to 48 weeks

  15. Incidence and titer of antidrug antibodies (ADAs)

    Time frame: From Baseline up to 48 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

[email protected]

800-633-1610 ext. option 6

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2029
Study completion
2030
First posted
Sep 24, 2025
Registry last updated
Jun 15, 2026

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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