Testing Lunsekimig against a placebo for chronic obstructive pulmonary disease
Official title: 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
- Phase 3
- 3 groups
- Sites in Calgary, Ajax and 4 more cities
- Recruiting
Interventions
- Medication
Lunsekimig
Pharmaceutical form: solution for injection in prefilled syringe. Route of administration: Subcutaneous injection
- Medication
Placebo
Pharmaceutical form: solution for injection. Route of administration: Subcutaneous injection
Canadian Sites (6)
6 of 6 recruiting
- Recruiting
Investigational Site Number : 1240011
Calgary, Alberta
- Recruiting
Investigational Site Number : 1240010
Ajax, Ontario
- Recruiting
Investigational Site Number : 1240004
Guelph, Ontario
- Recruiting
Investigational Site Number : 1240012
Ottawa, Ontario
- Recruiting
Investigational Site Number : 1240009
Stoney Creek, Ontario
- Recruiting
Investigational Site Number : 1240001
Toronto, Ontario
Eligibility Criteria
See who this study is looking for20 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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
- +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
- +Former or current smokers ≥10 pack-years
Exclusion
- −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 ScreeningScreeningThe checks done before joining, to see whether a study fits.Read more →
- −The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trialInterventional studyA study where participants are given something to see what happens.Read more →
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 3 groups in this study.
Groups A and B receive Lunsekimig.
Registry label: A: Lunsekimig dose regimen A · B: Lunsekimig dose regimen B
Group C, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receives Placebo.
Registry label: C: Placebo
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 40 years to 80 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 942 people.
The study is currently expected to finish around January 2030.
The main measurement is taken over: From BaselineBaselineYour starting measurements, taken before treatment begins.Read more → up to 48 weeks.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Annualized rate of moderate-to-severe chronic obstructive pulmonary disease (COPD) exacerbations — measured over From BaselineBaselineYour starting measurements, taken before treatment begins.Read more → up to 48 weeks.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07190209 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About LunsekimigDrug
Pharmaceutical form: solution for injection in prefilled syringe. Route of administration: Subcutaneous injection
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PlaceboDrug
Pharmaceutical form: solution for injection. Route of administration: Subcutaneous injection
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 40 years to 80 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 40 years to 80 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: From BaselineBaselineYour starting measurements, taken before treatment begins.Read more → up to 48 weeks.
The study as a whole is currently expected to finish around 2030-01-22.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 942 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 10 locations, including: Calgary, Alberta, Canada; Ajax, Ontario, Canada; Guelph, Ontario, Canada; Ottawa, Ontario, Canada; Stoney Creek, Ontario, Canada; Toronto, Ontario, Canada, and 4 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Other Sites (4)
University of Michigan Health System - Ann Arbor- Site Number : 8400090
Ann Arbor, Michigan, United States
Pulmonary and Medicine Associates- Site Number : 8400007
Warren, Michigan, United States
Mayo Clinic in Rochester - Minnesota- Site Number : 8400005
Rochester, Minnesota, United States
New York Hospital Queens- Site Number : 8400058
Flushing, New York, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.