A Phase 3 interventional study of Itepekimab SAR440340 and Placebo in Chronic Obstructive Pulmonary Disease, sponsored by Sanofi. Completed at 248 sites in 21 countries. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-04-15.
Sponsored by Sanofi · Phase 3, Interventional, and Treatment
Primary Objective:
Evaluate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate-or-severe COPD exacerbations in former smokers with moderate-to-severe COPD
Secondary Objectives:
The study duration per participant:
Documented history of high exacerbation risk defined as having had ≥2 moderate or ≥1 severe exacerbations within the year prior to Screening (Visit 1A), with at least 1 exacerbation treated with systemic corticosteroids. At least one exacerbation must have occurred while participants were on their current controller therapy:
Female participant is not pregnant, not breastfeeding, and at least one of the following conditions applies:
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Subcutaneous (SC) administration of Itepekimab every 2 weeks (Q2W) for up to 52 weeks
Drug: Itepekimab SAR440340
SC administration of Itepekimab every 4 weeks (Q4W) for up to 52 weeks, with alternating SC administration of matching placebo at the 2-week interval between active IMP
Drug: Itepekimab SAR440340 · Drug: Placebo
SC administration of matching placebo Q2W for up to 52 weeks
Drug: Placebo
Pharmaceutical form: solution for injection in pre-filled syringe Route of administration: subcutaneous
Also known as: REGN3500
Pharmaceutical form: solution for injection in pre-filled syringe Route of administration: subcutaneous
Annualized rate of moderate or severe acute exacerbation of COPD (AECOPD)
Annualized rate of moderate or severe AECOPD over the placebo-controlled treatment period
Time frame: Baseline up to End Of Treatment (EOT) (Week 52 for initial randomized participants, Week 24 to 52 for potential additional randomized participants)
Change from baseline in pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1)
FEV1 is the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Time frame: Baseline to Week 24
Change from baseline in post-BD FEV1
FEV1 is the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Time frame: Baseline to Week 24 and Week 52
Change from baseline in pre-BD FEV1
FEV1 is the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Time frame: Baseline to Week 52
Time to first moderate or severe AECOPD
Time to first moderate or severe AECOPD over the placebo-controlled treatment period
Time frame: Baseline through EOT (Week 52 for initial randomized participants, Week 24 to 52 for potential additional randomized participants)
Annualized rate of severe AECOPD
Annualized rate of severe AECOPD over the placebo-controlled treatment period
Time frame: Baseline up to EOT (Week 52 for initial randomized participants, Week 24 to 52 for potential additional randomized participants)
Time to first severe AECOPD
Time to first severe AECOPD over the placebo-controlled treatment period.
Time frame: Baseline through EOT (Week 52 for initial randomized participants, Week 24 to 52 for potential additional randomized participants)
Annualized rate of corticosteroid-treated AECOPD
Annualized rate of corticosteroid-treated AECOPD over the placebo-controlled treatment period.
Time frame: Baseline up to EOT (Week 52 for initial randomized participants, Week 24 to 52 for potential additional randomized participants)
Change from baseline in Evaluating Respiratory Symptoms in COPD (E-RS:COPD) total score
The E-RS: COPD is administered as a part of the 14-item EXACT questionnaire and is completed on a daily basis.The 11-item E-RS:COPD assesses severity of respiratory symptoms overall and severity of individual symptoms such as breathlessness, cough and sputum, and chest symptoms The total score of E-RS:COPD ranges from 0 to 40, with higher values indicating more severe respiratory symptoms.
Time frame: Baseline to Week 24 and Week 52
Rate of change in post-BD FEV1 (L) from baseline (post-BD FEV1 slope)
FEV1 is the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Time frame: Baseline up to EOT (Week 52 for initial randomized participants, Week 24 to 52 for potential additional randomized participants)
Change from baseline in St. George''s Respiratory Questionnaire (SGRQ) total score
The SGRQ is a 50-item questionnaire designed to measure and quantify health status in adult participants with chronic airflow limitation. A global score ranges from 0 to 100. Scores by dimension are calculated for 3 domains: Symptoms, Activity and Impacts (Psycho-social) as well as a total score. A lower score indicates better quality of life.
Time frame: Baseline to Week 24 and Week 52
Proportion of participants with a decrease from baseline of at least 4 points in SGRQ total score
The SGRQ is a 50-item questionnaire designed to measure and quantify health status in adult participants with chronic airflow limitation. A global score ranges from 0 to 100. Scores by dimension are calculated for 3 domains: Symptoms, Activity and Impacts (Psycho-social) as well as a total score. A lower score indicates better quality of life.
Time frame: Baseline to Week 24 and Week 52
Incidence of treatment-emergent adverse events (TEAEs), adverse event of special interests (AESIs), serious adverse events (SAEs), and adverse events (AEs) leading to permanent treatment discontinuation
Time frame: Baseline up to End-of-Study (EOS) (Up to Week 72 for participants not transitioning to the extension study LTS18133; Up to Week 52 for participants transitioning to the extension study LTS18133)
Incidence of potentially clinically significant laboratory test, vital signs, and electrocardiogram (ECGs) abnormalities
Time frame: Baseline up to EOS (Up to Week 72 for participants not transitioning to the extension study LTS18133; Up to Week 52 for participants transitioning to the extension study LTS18133)
Functional itepekimab concentrations in serum
Time frame: Baseline up to EOS (Up to Week 72 for participants not transitioning to the extension study LTS18133; Up to Week 52 for participants transitioning to the extension study LTS18133)
Incidence of treatment-emergent anti-itepekimab antibodies responses
Time frame: Baseline up to EOS (Up to Week 72 for participants not transitioning to the extension study LTS18133; Up to Week 52 for participants transitioning to the extension study LTS18133)
Showing the first 100 of 248 sites across 21 countries.
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
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Pulmonary Disease, Chronic Obstructive→
Sanofi