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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
EU CTIS ID: 2024-518016-39-00
What this study is testing
To evaluate the efficacy of lunsekimig as measured by the annualized rate of moderate to severe chronic obstructive pulmonary disease (COPD) exacerbations
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- - 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
You likely can't join if
- - 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
See the full eligibility 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
- - 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: o long-term macrolides or phosphodiesterase Type 3 (PDE-3) or PDE-4 inhibitors unless on stable therapy for >6 months o any biologic therapy or systemic immunosuppressant within 4 months or 5 half-lives prior to Screening
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Japan
- Canada
- United States
- Mexico
- Chile
- Brazil
- Argentina
- Georgia
- Saudi Arabia
- Turkey
- China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Japan; Canada; United States; Mexico; Chile and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.