RightFit
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, Placebo-controlled, 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 lunsekimig shots under the skin against placebo shots, which have no active drug. It looks at how well the drug works and how safe it is in adults ages 40 to 80 with poorly controlled COPD, a long-term lung disease, and raised levels of blood cells called eosinophils. 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

  • Age 40 to 80, with COPD diagnosed by a doctor at least 1 year ago.
  • Breathing tests after medicine to open the airways: FEV1 of 20% to 70% of the expected value, and FEV1/FVC below 0.70. These measure how much air you can blow out.
  • Current or former smoker with at least 10 pack-years of smoking, such as 1 pack a day for 10 years.
  • Score of at least 10 on the Chronic Airways Assessment Test, a survey about symptoms.
  • At least 2 moderate COPD flare-ups or 1 severe flare-up in the past year.
  • Use of all 3 COPD treatments—ICS, LABA, and LAMA—for at least 12 weeks in a row. These reduce swelling and help open the airways.
  • Blood eosinophil count of at least 150 cells per microliter. Eosinophils are a type of white blood cell.
  • Body mass index (BMI), a measure based on height and weight, from 18 to 40.

Who can't join

  • Asthma now or in childhood, or a mix of asthma and COPD.
  • A major lung disease other than COPD.
  • Long-term oxygen use above 4 liters per minute, or needing more than 2 liters per minute to keep blood oxygen above 88% at rest.
  • A health problem that is not stable and could affect your safety or the study results.
  • Active tuberculosis (TB), a bacterial infection, or TB that was not fully treated.
  • Cancer now or in the past.
  • Long-term use of macrolide antibiotics or PDE-3 or PDE-4 medicines, unless treatment has been stable for more than 6 months.
  • Use of biologic medicines or medicines that suppress the immune system throughout the body within 4 months before screening, or within 5 drug half-lives. A half-life is the time it takes the body to clear half of a drug.

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 (76)

AL

AZ

CA

CO

  • Alpine Clinical Research Center - Boulder - 47th Street- Site Number : 8400005 · Boulder, CO 80301More trials in Boulder
  • Critical Care Pulmonary & Sleep Associates- Site Number : 8400081 · Lakewood, CO 80228More trials in Lakewood

DC

FL

GA

IL

IN

LA

MA

MD

MI

MO

NC

NJ

  • Bioluminux Clinical Research - Hamilton, New Jersey- Site Number : 8400037 · Hamilton, NJ 08690More trials in Hamilton
  • Rutgers Institute For Infectious & Inflammatory Diseases (I3d)- Site Number : 8400093 · Newark, NJ 07103More trials in Newark

NV

NY

OH

OK

OR

  • The Oregon Clinic - Portland - Northwest 22nd Avenue- Site Number : 8400065 · Portland, OR 97210More trials in Portland

PA

SC

TN

TX

WV