Lunsekimig for Chronic Obstructive Pulmonary Disease
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
Recruiting
Phase 3Interventional Study
Chronic Obstructive Pulmonary Disease
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
40 – 80
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
942 (estimated)
Sponsor
Sanofi · Industry
Who this trial is looking for
This trial is looking for adults aged 40 to 80 with chronic obstructive pulmonary disease (COPD) that isn't well controlled. Participants will receive either lunsekimig or a placebo for approximately 48 weeks, followed by an 8-week follow-up.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 40 to 80 years old.
I have been diagnosed with chronic obstructive pulmonary disease (COPD) for at least 1 year.
I am a former or current smoker with at least 10 pack-years.
I have had at least 2 moderate or 1 severe COPD flare-ups in the past year.
I have been on triple therapy for COPD for at least 12 weeks.
My blood eosinophil count is at least 150 cells/μL.
My BMI is between 18.0 and 40.0 kg/m2.
You may not be able to join if
I have asthma or asthma-COPD overlap syndrome.
I have significant lung disease other than COPD.
I need long-term oxygen therapy of more than 4.0 L/min.
I have active or untreated tuberculosis.
I have had cancer in the past.
I am currently taking certain long-term medications like macrolides.
I have had any biologic therapy or systemic immunosuppressants in the last 4 months.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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:
* …
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.
Trial Locations
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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 vita…
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
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