RecruitingPhase 3

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 4 weeks, 60 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well lunsekimig works and how safe it is compared with a placebo, a treatment with no active drug. It is for adults ages 40 to 80 with COPD, a long-term lung disease, that is not well controlled and with raised levels of blood cells called eosinophils. Treatment is given as shots under the skin, and the study lasts up to 60 weeks.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 40 to 80 years old and were diagnosed with COPD by a doctor at least 1 year ago.
  • After medicine to open your airways, breathing tests show FEV1 of 20% to 70% of the expected value and FEV1/FVC below 0.70. These tests measure how much air you can blow out.
  • You smoke now or used to smoke, with at least 10 pack-years of smoking, such as 1 pack a day for 10 years.
  • Your score on the CAAT, a test of lung symptoms, is at least 10.
  • You had at least 2 moderate COPD flare-ups or 1 severe flare-up in the past year.
  • You have used all 3 COPD medicines—ICS, LABA, and LAMA—for at least 12 weeks in a row.
  • Your blood eosinophil count is at least 150 cells per microliter. Eosinophils are a type of white blood cell.
  • Your body mass index (BMI), a measure based on height and weight, is 18 to 40.

Who can't join

  • You have asthma, had asthma as a child, or have both asthma and COPD.
  • You have another major lung disease besides COPD.
  • You use long-term oxygen above 4 liters per minute, or need more than 2 liters per minute to keep your oxygen level above 88% while resting.
  • You have a health problem that is not stable and could affect your safety or the study results.
  • You have active tuberculosis (TB), an infection, or TB that has not been fully treated.
  • You have cancer now or had it in the past.
  • You use long-term macrolide antibiotics or PDE-3 or PDE-4 medicines, unless treatment has been stable for more than 6 months.
  • You used a biologic medicine or medicine that lowers immune activity throughout the body within the study's required waiting period before screening: 4 months or 5 drug half-lives. A half-life is the time it takes half the drug to leave your body.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (75)

AZ

CA

FL

GA

IL

IN

KS

LA

MA

MI

MN

NC

ND

NJ

NV

NY

OH

OK

OR

PA

SC

SD

TN

TX

VA

  • Tidewater Physicians Multispecialty Group Clinical Research - Williamsburg- Site Number : 8400081 · Williamsburg, VA 23188More trials in Williamsburg