A Phase 3 interventional study of Lunsekimig and Placebo in Chronic Obstructive Pulmonary Disease, sponsored by Sanofi. Recruiting at 314 sites in 25 countries. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Sanofi · Phase 3, Interventional, and Treatment
Among 15 studies in Pulmonary Disease, Chronic Obstructive by Sanofi — 7 open to participants now, 7 under way, 3 of them phase 3. Pulmonary Disease, Chronic Obstructive · Sanofi.
Among the 15 studies in Pulmonary Disease, Chronic Obstructive by Sanofi, this one is the 4th largest by planned enrollment of the 12 interventional ones, is one of 4 that started in 2025, is one of 8 in phase 3, and was the 11th registered.
5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.
This study's planned enrollment of 942 is above the median of 62 across 3,839 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →7 of the 15 studies in Pulmonary Disease, Chronic Obstructive by Sanofi are open now, in 12 countries. Each count lists the studies.
Of the 555 Pulmonary Disease, Chronic Obstructive studies recruiting now, 305 (55%) set no upper age limit and 82 (15%) stop at 75 or younger; 29 take children under 18; 87 take healthy volunteers.
This study: 40 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →15 studies; the count open now beside each. This study's row is marked.
First in 2018; this study’s year is marked. 4 started in 2025.
Median enrollment 937 across the 12 interventional studies, 350 across the 3 observational. Of the 8 that completed or were terminated, 6 (75%) have results posted.
Sanofi is the lead sponsor of 1,557 studies on the registry; 91 are open to participants now.
Of its 205 completed or terminated interventional studies of FDA-regulated products, 123 (60%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 15 studies in Pulmonary Disease, Chronic Obstructive by Sanofi, from their registry updates:
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:
All eligible participants will undergo subcutaneous administrations of lunsekimig or matching placebo during a 48-weeks treatment period
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
Concomitant therapies:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive lunsekimig dose regimen A.
Drug: Lunsekimig
Participants will receive lunsekimig dose regimen B
Drug: Lunsekimig
Participants will receive lunsekimig-matching placebo
Drug: Placebo
Pharmaceutical form: solution for injection in prefilled syringe. Route of administration: Subcutaneous injection
Also known as: SAR443765
Pharmaceutical form: solution for injection. Route of administration: Subcutaneous injection
Annualized rate of moderate-to-severe chronic obstructive pulmonary disease (COPD) exacerbations
The annualized moderate or severe COPD exacerbation rate up to 48 weeks treatment period compared to placebo
Time frame: From Baseline up to 48 weeks
Change from baseline in post-Bronchodilator Forced Expiratory Volume in 1 second (post-BD FEV1)
The post-Bronchodilator Forced Expiratory Volume in 1 second is defined as the volume of air exhaled from the lungs in the first second of a forced expiration.
Time frame: From Baseline up to 48 weeks
Change from baseline in pre-Bronchodilator Forced Expiratory Volume in 1 second (pre-BD FEV1)
The pre-Bronchodilator Forced Expiratory Volume in 1 second is defined as the volume of air exhaled from the lungs in the first second of a forced expiration.
Time frame: From Baseline up to 48 weeks
Change from baseline in the SGRQ-C total score
The St. George's Respiratory Questionnaire for patients with chronic obstructive pulmonary disease is derived from the St. George's Respiratory Questionnaire (SGRQ) and is designed to measure and quantify health status in adult patients with chronic airflow limitation. A global score ranges from 0 to 100 with lower scores indicating better quality-of-life.
Time frame: From Baseline up to 48 weeks
SGRQ responder defined as an improvement of ≥4 points in the SGRQ-C total score
Time frame: From Baseline up to 48 weeks
Change from baseline in the Chronic airways assessment Test (CAAT) score
The CAAT is an 8-item patient-reported outcome (PRO) measure designed to assess the impact of chronic airways diseases, including COPD, on patients' health status. The CAAT has a scoring range of 0-40, with higher scores indicating a greater impact of the disease on health status.
Time frame: From Baseline up to 48 weeks
CAAT responder defined as an improvement of ≥2 points in the CAAT total score
Time frame: From Baseline up to 48 weeks
Change from baseline in the E-RS:COPD total score
The Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease (E-RS:COPD) is an 11-item patient-reported outcome (PRO) measure that evaluates the severity of respiratory symptoms in patients with stable COPD. The total score ranges from 0 to 40, with higher scores indicating more severe respiratory symptoms.
Time frame: From Baseline up to 48 weeks
E-RS:COPD responder defined as an improvement of ≥2 points in the E-RS:COPD total score
Time frame: From Baseline up to 48 weeks
Annualized rate of severe COPD exacerbations
Time frame: From Baseline up to 48 weeks
Time to first moderate or severe COPD exacerbation
Time to first occurrence of moderate to severe COPD exacerbation up to 48 weeks
Time frame: From Baseline up to 48 weeks
Time to first severe COPD exacerbation
Time to first occurrence of severe COPD exacerbation up to 48 weeks
Time frame: From Baseline up to 48 weeks
Incidence of participants with TEAEs, including AESIs, and SAEs
Treatment-Emergent Adverse Events (TEAEs), Adverse events of Special Interest (AESIs), Serious Adverse Events (SAEs)
Time frame: From Baseline up to 56 weeks
Incidence of potentially clinically significant laboratory abnormalities
Time frame: From Baseline up to 56 weeks
Serum concentration of lunsekimig
Time frame: From Baseline up to 48 weeks
Incidence and titer of antidrug antibodies (ADAs)
Time frame: From Baseline up to 48 weeks
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Showing the first 100 of 314 sites across 25 countries. Choose a country and city above to see the rest.
Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Started Sep 2025 (actual). Primary completion is estimated for Nov 2029, 50 months after the start.
Of 108 industry-sponsored phase 3 interventional studies under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 36. This study's planned 50 months is above that.
Counting every sponsor, half of 141 studies reached it within 23 months; a quarter within 14 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drug tested here: Lunsekimig
Pulmonary Disease, Chronic Obstructive →