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CompletedNCT04701983AERIFY-1Updated Oct 15, 2026Results posted

Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD)

A Phase 3 interventional study of Itepekimab SAR440340 and Placebo in Chronic Obstructive Pulmonary Disease, sponsored by Sanofi. Completed at 232 sites in 21 countries. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-10-15.

Sponsored by Sanofi · Phase 3, Interventional, and Treatment

Updated Oct 15, 2026Results postedStudy documents posted+3 moreGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
1,127
Allocation
Randomized
Ages
40 Years to 85 Years
Sex
All
01

Study summary

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:

  • Evaluate the efficacy of itepekimab compared with placebo on pulmonary function in former smokers with moderate-to-severe COPD
  • Evaluate the efficacy of itepekimab compared with placebo on occurrence of acute exacerbation of COPD (AECOPD) in former smokers with moderate-to-severe COPD
  • Evaluate the efficacy of itepekimab compared with placebo on severe AECOPD in former smokers with moderate-to-severe COPD
  • Evaluate the efficacy of itepekimab compared with placebo on corticosteroid-treated AECOPD in former smokers with moderate-to-severe COPD
  • Evaluate the efficacy of itepekimab compared with placebo on respiratory symptoms in former smokers with moderate-to-severe COPD
  • Evaluate the efficacy of itepekimab compared with placebo on Forced Expiratory Volume in 1 second (FEV1) slope in former smokers with moderate-to-severe COPD
  • Evaluate the efficacy of itepekimab compared with placebo on health-related quality of life (HRQoL) as assessed by St. George's Respiratory Questionnaire (SGRQ) in former smokers with moderate-to-severe COPD
  • Evaluate the safety and tolerability of itepekimab in former smokers with moderate-to-severe COPD
  • Evaluate the pharmacokinetic (PK) profile of itepekimab in former smokers with moderate-to-severe COPD
  • Evaluate immunogenicity to itepekimab in former smokers with moderate-to-severe COPD
Read the detailed description

The study duration per participant:

  • Screening period was 3-5 weeks
  • Placebo-controlled treatment period was 52 weeks for first approximately 960 randomized participants, and 24 to 52 weeks for potential additional randomized participants
  • Post-investigational medicinal product (IMP) treatment follow-up period was 20 weeks for participants not transitioning to the extension study LTS18133 (NCT06208306)

Note: A long-term, double-blinded extension study had been implemented to allow participants in this study to continue receiving active IMP for an additional period. Only participants completing their End-of-Treatment (EOT) visit per this study protocol was offered to participate in the LTS18133 study (NCT06208306).

02

Conditions studied

  • Chronic Obstructive Pulmonary Disease
03

In context

Pulmonary Disease, Chronic Obstructive

5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.

This study's enrollment of 1,127 is above the median of 62 across 3,839 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

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.

Browse Sanofi studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Oct 15, 2026. See what changed

Ages eligible
40 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  • Participant must be 40 to 85 years of age inclusive
  • Physician diagnosis of for at least 1 year (based on Global Initiative for Chronic Obstructive Lung Disease [GOLD] definition)
  • Smoking history of ≥10 pack-years, but who were not currently smoking, and smoking cessation must have occurred ≥6 months prior to Screening (Visit 1A) with an intention to quit permanently
  • Participants with moderate-to-severe COPD
  • Participant-reported history of signs and symptoms of chronic bronchitis (chronic productive cough for at least 3 months in the year prior to screening in a participant in whom other causes of chronic cough [eg, inadequately treated gastroesophageal reflux or chronic rhinosinusitis; or clinical diagnosis of bronchiectasis] has been excluded)

  • 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 . At least one exacerbation must have occurred while participants were on their current controller therapy:

    • Moderate exacerbations were recorded by the Investigator and were defined as acute worsening of respiratory symptoms that requires either systemic corticosteroids (IM, IV, or oral) and/or antibiotics
    • Severe exacerbations were recorded by the Investigator and were defined as AECOPD that require hospitalization or observation for >24 hours in emergency department/urgent care facility
  • Participants with standard of care controller therapy, for ≥3 months prior to Screening (Visit 1A) and at a stable dose of controller therapy for at least 1 month prior to the screening, including either: inhaled corticosteroid (ICS) + long-acting beta-agonist (LABA), long-acting muscarinic antagonist (LAMA) + LABA or LAMA + LABA + ICS
  • (BMI) ≥18.0 kg/m\^2, or BMI ≥16.0 kg/m\^2 for participants enrolled in East-Asian countries

  • Female participant was not pregnant, not breastfeeding, and at least one of the following conditions applies:

    • not a women of (WOCBP) OR
    • a WOCBP who agrees to follow the guidance during the intervention period and for at least 20 weeks after the last dose of study intervention

Exclusion criteria

Exclusion criteria:

  • Current diagnosis of asthma according to the Global Initiative for Asthma (GINA) guidelines, or documented history of asthma unless asthma resolved before 18 years of age and has not recurred
  • Active smoking or vaping of any products (eg, nicotine, tetrahydrocannabinol [THC]) within 6 months prior to Screening (Visit 1A)
  • new abnormal (ECG) within 6 months prior to, or at Screening (Visit 1A) that may affect the participant's participation in the study
  • Clinically significant and current pulmonary disease other than , eg, sarcoidosis, interstitial lung disease, bronchiectasis (clinical diagnosis), diagnosis of α-1 anti-trypsin deficiency, or another diagnosed pulmonary disease
  • Diagnosis of cor pulmonale, evidence of right cardiac failure, or moderate-to-severe pulmonary hypertension
  • Hypercapnia requiring bilevel positive airway pressure (BiPAP)
  • Moderate or severe exacerbation of COPD (AECOPD) within 4 weeks prior to Screening (Visit 1A)
  • Prior history of / planned: lung pneumonectomy for any reason, or lung volume reduction procedures (including bronchoscopic volume reduction) for COPD. Note: Surgical , or segmentectomy, or wedge resection, or lobectomy for other diseases would not be excluded.
  • Unstable ischemic heart disease, including acute myocardial infarction within the past 1 year prior to Screening, or unstable angina in the 6 months prior to Screening (Visit 1A)
  • Cardiac arrhythmias including paroxysmal (eg, intermittent) atrial fibrillation
  • Uncontrolled hypertension (ie, systolic blood pressure [BP] >180 mm Hg or diastolic BP >110 mm Hg with or without use of anti-hypertensive therapy)
  • Participants with active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection (TBI), or who were at high risk of contracting TB (such as close contact with individuals with active or latent TB) or received Bacillus Calmette-Guérin (BCG)-vaccination within 12 weeks prior to Screening (Visit 1A)
  • History of (HIV) infection or positive HIV 1/2 serology at Screening (Visit 1A)
  • Suspicion of, or confirmed, coronavirus disease 2019 (COVID-19) infection or in contact with known exposure to COVID-19 at Screening (Visit 1A); known history of COVID-19 infection within 4 weeks prior to Screening (Visit 1A); history of requiring mechanical ventilation or extracorporeal membrane oxygenation (ECMO) secondary to COVID-19 within 3 months prior to sScreening (Visit 1A); participants who have had a COVID-19 infection prior Screening (Visit 1A) who have not yet sufficiently recovered to participate in the procedures of a clinical trial
  • Evidence of acute or chronic infection requiring systemic treatment with antibacterial, antiviral, antifungal, antiparasitic, or antiprotozoal medications within 4 weeks before Screening (Visit 1A), significant viral infections within 4 weeks before Screening (Visit 1A) that may not have been treated with antiviral treatment (eg, influenza receiving only symptomatic treatment)
  • Participants with active disease or participants using therapy for autoimmune disease (eg, rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, systemic lupus erythematosus, multiple sclerosis
  • History of within 5 years before Screening (Visit 1A), except completely treated in situ carcinoma of the cervix, completely treated and resolved nonmetastatic squamous or basal cell carcinoma of the skin
  • Previous use of itepekimab

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Terms in these criteria, in plain language(12)

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.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

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.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

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.

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.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
1,127 participants (actual)

Study arms

  • Experimental
    Itepekimab Q2W

    Participants received itepekimab 300 mg as an SC injection every 2 weeks (Q2W) for up to 52 weeks.

    Drug: Itepekimab SAR440340

  • Experimental
    Itepekimab Q4W

    Participants received Itepekimab 300 mg as an SC injection every 4 weeks (Q4W) with alternating placebo matching Itepekimab administration at the 2-week interval between active study drug for up to 52 weeks.

    Drug: Itepekimab SAR440340 · Drug: Placebo

  • Placebo comparator
    Placebo

    Participants received placebo matching Itepekimab as subcutaneous (SC) injection every 2 weeks (Q2W) for up to 52 weeks.

    Drug: Placebo

Interventions

  • DrugItepekimab SAR440340

    * Pharmaceutical form: solution for injection in pre-filled syringe * Route of administration: subcutaneous

    Also known as: REGN3500

  • DrugPlacebo

    * Pharmaceutical form: solution for injection in pre-filled syringe * Route of administration: subcutaneous

06

What researchers measure

Primary outcomes

  1. Annualized Rate of Adjudicated Moderate or Severe Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD) Events Over the Placebo-Controlled Treatment Period

    Exacerbations were recorded by Investigator. Moderate exacerbations were defined as acute worsening of respiratory symptoms that required either systemic corticosteroids (such as intramuscular \[IM\], intravenous \[IV\], or oral) and/or antibiotics. Severe exacerbations were defined as AECOPD that required hospitalization, observation for \>24 hours in an emergency department/urgent care facility, or resulted in death. For both moderate and severe events to be counted as 2 separate events, they must be separated by at least 14 days between any course of systemic steroids/antibiotics or 14 days between discharge and new admission in case of hospitalization (severe events only). Annualized rate was the total number of moderate or severe exacerbation events divided by the total observation duration and was estimated based on negative binomial regression. Events were adjudicated by third party.

    Time frame: Baseline (Day 1) up to Week 52 for initial randomized participants; Baseline (Day 1) up to Week 24 to 52 for additional randomized participants

Secondary outcomes

  1. Annualized Rate of Adjudicated Severe Acute Exacerbation of Chronic Obstructive Pulmonary Disease Events Over the Placebo-Controlled Treatment Period

    Exacerbations were recorded by the Investigator. Severe exacerbations were defined as AECOPD that required hospitalization, observation for \>24 hours in an emergency department/urgent care facility, or resulted in death. Annualized rate was the total number of severe exacerbation events divided by the total observation duration and was estimated based on negative binomial regression. Events were adjudicated by third party.

    Time frame: Baseline (Day 1) up to Week 52 for initial randomized participants; Baseline (Day 1) up to Week 24 to 52 for additional randomized participants

  2. Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in One Second at Week 24

    The FEV1 was the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. Pre-BD spirometry was performed after a wash out period of BD according to their action duration. Baseline was defined as the last available value before the first dose of study drug. Model-based average change from baseline to Week 24 is presented.

    Time frame: Baseline (Day 1) to Week 24

  3. Change From Baseline in Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease (E-RS: COPD) Total Score at Week 24

    The E-RS: COPD scale was a patient-reported outcome (PRO) that measured the severity of respiratory symptoms in COPD such as breathlessness, cough and sputum, and chest symptoms. It was derivative of the EXACT tool, which was daily symptom diary that quantified and measured exacerbations of COPD and assessed symptomatic manifestations of COPD exacerbations. E-RS: COPD utilized 11 respiratory symptom items contained in 14-item EXACT instrument. Daily E-RS: COPD RS-Total score was computed by taking the sum of the scores for the 11 items comprising the instrument. Total score ranged from 0 (no symptoms) to 40 (severe symptoms), higher values indicated more severe respiratory symptoms. Baseline was defined as the last available value before the first dose of study drug. Model-based average change from baseline to Week 24 is presented.

    Time frame: Baseline (Day 1) to Week 24

  4. Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in One Second at Week 24

    The FEV1 was the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. Post-BD spirometry was performed after 4 actuations of short-acting beta-agonist (SABA; albuterol, salbutamol) with post-BD reversibility performed at least 15 minutes following the last actuation. Baseline was defined as the last available value before the first dose of study drug. Model-based average change from baseline to Week 24 is presented.

    Time frame: Baseline (Day 1) to Week 24

  5. Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 24

    SGRQ was 50-item PRO instrument developed to measure the health status of participants with airflow obstruction diseases. Questionnaire had 2 parts: part 1 consisted of 8 items pertaining to severity of respiratory symptoms in preceding 4 weeks; part 2 consisted of 42 items related to the daily activity and psychosocial impacts of the individual's respiratory condition. Total SGRQ score indicated impact of disease on overall health status. Total score was calculated by summing all positive responses in questionnaire and expressing result as percentage of total weight for questionnaire and ranged from 0 to 100; 100=worst possible health status; 0=best possible health status. Baseline: last available value before first dose of study drug. Model-based average change from baseline to Week 24 is presented.

    Time frame: Baseline (Day 1) to Week 24

  6. Percentage of Participants With a Decrease From Baseline of at Least 4 Points in St. George's Respiratory Questionnaire Total Score at Week 24

    SGRQ was 50-item PRO instrument developed to measure health status of participants with airflow obstruction diseases. Questionnaire had 2 parts: part 1 consisted of 8 items pertaining to the severity of respiratory symptoms in preceding 4 weeks; part 2 consisted of 42 items related to daily activity and psychosocial impacts of the individual's respiratory condition. The total SGRQ score indicated the impact of disease on overall health status. Total score was calculated by summing all positive responses in questionnaire and expressing result as percentage of total weight for questionnaire and ranged from 0 to 100; 100 represented the worst possible health status and 0 indicated the best possible health status. Baseline was defined as the last available value before the first dose of study drug. Percentages are rounded off to tenth decimal place.

    Time frame: Baseline (Day 1) and Week 24

  7. Rate of Change in Post-Bronchodilator Forced Expiratory Volume in One Second From Baseline (Post-Bronchodilator Forced Expiratory Volume in One Second Slope) After Week 4

    The rate of change from baseline in post-BD FEV1 (or post-BD FEV1 slope) after a period of initial BD effect (after Week 4) were estimated to assess the rate of decline in lung function over time, commonly observed in participants with inadequately controlled COPD. The FEV1 was the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. Post-BD spirometry was performed after 4 actuations of SABA (albuterol, salbutamol) with post-BD reversibility performed at least 15 minutes following the last actuation. Baseline was defined as the last available value before the first dose of study drug.

    Time frame: Baseline (Day 1) and from Week 8 up to Week 52 for initial randomized participants; Baseline (Day 1) and from Week 8 up to a variable study treatment period (i.e., 24 weeks minimum and 52 weeks maximum) for additional randomized participants

  8. Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in One Second at Week 52

    The FEV1 was the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. Post-BD spirometry was performed after 4 actuations of SABA (albuterol, salbutamol) with post-BD reversibility performed at least 15 minutes following the last actuation. Baseline was defined as the last available value before the first dose of study drug. Model-based average change from baseline to Week 52 is presented.

    Time frame: Baseline (Day 1) to Week 52

  9. Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in One Second at Week 52

    The FEV1 was the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. Pre-BD spirometry was performed after a wash out period of BD according to their action duration. Baseline was defined as the last available value before the first dose of study drug. Model-based average change from baseline to Week 52 is presented.

    Time frame: Baseline (Day 1) to Week 52

  10. Probability of Participants With First Adjudicated Moderate or Severe Acute Exacerbation of Chronic Obstructive Pulmonary Disease in Weeks 12, 24, 36 and 52 Over the Placebo-Controlled Treatment Period

    Exacerbations were recorded by Investigator. Moderate exacerbations: acute worsening of respiratory symptoms that required either systemic corticosteroids (such as IM, IV, or oral) and/or antibiotics. Severe exacerbations: AECOPD that required hospitalization, observation for \>24 hours in an emergency department/urgent care facility, or resulted in death. Probability of participants with first adjudicated moderate or severe AECOPD in Weeks 12, 24, 36, and 52 was based on Kaplan-Meier estimates. Events were adjudicated by third party.

    Time frame: Baseline (Day 1) up to Weeks 12, 24, 36 and 52

  11. Probability of Participants With First Adjudicated Severe Acute Exacerbation of Chronic Obstructive Pulmonary Disease in Weeks 12, 24, 36 and 52 Over the Placebo-Controlled Treatment Period

    Exacerbations were recorded by Investigator. Severe exacerbations were defined as AECOPD that required hospitalization, observation for \>24 hours in an emergency department/urgent care facility, or resulted in death. Probability of participants with first adjudicated severe AECOPD in Weeks 12, 24, 36, and 52 was based on Kaplan-Meier estimates. Events were adjudicated by third party.

    Time frame: Baseline (Day 1) up to Weeks 12, 24, 36 and 52

  12. Annualized Rate of Corticosteroid-Treated Acute Exacerbation of Chronic Obstructive Pulmonary Disease Events Over Placebo-Controlled Treatment Period

    Exacerbations were recorded by Investigator. Moderate/severe AECOPD events which were treated with regimen containing systemic corticosteroids for AECOPD;at time of AECOPD were considered. Moderate exacerbations: acute worsening of respiratory symptoms that required either systemic corticosteroids (IM,IV, or oral) and/or antibiotics. Severe exacerbations: AECOPD that required hospitalization, observation for \>24 hours in emergency department/urgent care facility or resulted in death. For moderate and severe events to be counted as 2 separate events, they must be separated by at least 14 days between any course of systemic steroids/antibiotics or 14 days between discharge and new admission in case of hospitalization (severe events). Annualized rate: total number of corticosteroid-treated AECOPD events divided by total observation duration and was estimated based on negative binomial regression.

    Time frame: Baseline (Day 1) up to Week 52 for initial randomized participants; Baseline (Day 1) up to Week 24 to 52 for additional randomized participants

  13. Change From Baseline in Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease Total Score at Week 52

    E-RS: COPD scale was PRO that measured severity of respiratory symptoms in COPD: breathlessness,cough and sputum,chest symptoms. It was derivative of EXACT tool which was daily symptom diary that quantified and measured exacerbations of COPD and assessed symptomatic manifestations of COPD exacerbations. E-RS: COPD used 11 respiratory symptom items contained in 14-item EXACT instrument. Daily E-RS: COPD RS-Total score was computed by taking sum of scores for 11 items comprising instrument. Total score:0 (no symptoms) to 40 (severe symptoms); higher values=more severe respiratory symptoms. Baseline: last available value before first dose of study drug. Model-based average change from baseline to Week 52 is presented.

    Time frame: Baseline (Day 1) to Week 52

  14. Change From Baseline in St. George's Respiratory Questionnaire Total Score at Week 52

    SGRQ was 50-item PRO instrument developed to measure health status of participants with airflow obstruction diseases. Questionnaire had 2 parts: part 1 had 8 items pertaining to severity of respiratory symptoms in preceding 4 weeks; part 2 had 42 items related to daily activity and psychosocial impacts of individual's respiratory condition. Total score was calculated by summing all positive responses in questionnaire and expressing result as percentage of total weight for questionnaire; ranged 0 to 100;100=worst possible health status;0=best possible health status. Baseline: last available value before first dose of study drug. Model-based average change from baseline to Week 52 is presented.

    Time frame: Baseline (Day 1) to Week 52

  15. Percentage of Participants With a Decrease From Baseline of at Least 4 Points in St. George's Respiratory Questionnaire Total Score at Week 52

    SGRQ was 50-item PRO instrument developed to measure health status of participants with airflow obstruction diseases. Questionnaire had 2 parts: part 1 consisted of 8 items pertaining to severity of respiratory symptoms in preceding 4 weeks; part 2 consisted of 42 items related to daily activity and psychosocial impacts of individual's respiratory condition. Total score was calculated by summing all positive responses in questionnaire and expressing result as percentage of total weight for questionnaire and ranged from 0 to 100; 100=worst possible health status; 0=best possible health status. Baseline: last available value before first dose of study drug. Percentages rounded off to tenth decimal place.

    Time frame: Baseline (Day 1) and Week 52

  16. Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), TEAEs of Special Interest (TEAESIs) and TEAEs Leading to Permanent Treatment Discontinuation

    AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Serious AE (SAE) was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. AESI was any AE (serious or non-serious) of scientific and medical concern specific to Sponsor's product or program, for which ongoing monitoring and immediate notification by Investigator to Sponsor was required. TEAEs were AEs that developed, worsened or became serious during the treatment-emergent period.

    Time frame: 1st dose (Day 1) up to 22 weeks post last dose (considering maximum treatment exposure) for who did not enter LTS18133 (approximately 78 weeks); up to EOT (considering maximum treatment exposure) for who entered LTS18133 (approximately 58 weeks)

  17. Functional Itepekimab Concentrations in Serum

    Blood samples were collected at specified timepoints to obtain serum concentrations of itepekimab.

    Time frame: Baseline (Day 1), Weeks 2, 4, 8, 12, 24, 36, 52 (EOT), 58 and 72 (EOS) (Weeks 58 and 72 applicable for participants not transitioning to the LTS18133 study)

  18. Number of Participants With Treatment-Emergent Anti-Itepekimab Antibodies Response

    Blood samples were collected to evaluate antibodies to itepekimab. Treatment-emergent response was defined as a positive response in the anti-drug antibody (ADA) assay post first dose when baseline results were negative or missing.

    Time frame: 1st dose (Day 1) up to 22 weeks post last dose (considering maximum treatment exposure) for who did not enter LTS18133 (approximately 78 weeks); up to EOT (considering maximum treatment exposure) for who entered LTS18133 (approximately 58 weeks)

07

Results

Posted Oct 15, 2026

Participant flow

This study was conducted at 232 sites in 21 countries. A total of 2294 participants were screened from 16-Dec-2020 to 20-May-2024, of which 1167 were screen failures due to not meeting eligibility criteria. 1127 participants were randomized in 1:1:1 ratio into 3 arms. Note:Reason for not completed=Reason for study intervention discontinuation.

Participant flow — Overall Study
MilestonePlacebo Q2WItepekimab 300 mg Q4WItepekimab 300 mg Q2W
Started375377375
Completed324329327
Not completed514848
Withdrew: Adverse event14139
Withdrew: Progressive disease101
Withdrew: Lack of efficacy102
Withdrew: Poor compliance to protocol010
Withdrew: Withdrawal by subject302624
Withdrew: Other: not related to coronavirus disease 20195711
Withdrew: Randomized, not exposed011

Outcome measures

PrimaryAnnualized Rate of Adjudicated Moderate or Severe Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD) Events Over the Placebo-Controlled Treatment Period

Exacerbations were recorded by Investigator. Moderate exacerbations were defined as acute worsening of respiratory symptoms that required either systemic corticosteroids (such as intramuscular \[IM\], intravenous \[IV\], or oral) and/or antibiotics. Severe exacerbations were defined as AECOPD that required hospitalization, observation for \>24 hours in an emergency department/urgent care facility, or resulted in death. For both moderate and severe events to be counted as 2 separate events, they must be separated by at least 14 days between any course of systemic steroids/antibiotics or 14 days between discharge and new admission in case of hospitalization (severe events only). Annualized rate was the total number of moderate or severe exacerbation events divided by the total observation duration and was estimated based on negative binomial regression. Events were adjudicated by third party.

Time frame:
Baseline (Day 1) up to Week 52 for initial randomized participants; Baseline (Day 1) up to Week 24 to 52 for additional randomized participants
Reported as:
Number · events per participant year
Annualized Rate of Adjudicated Moderate or Severe Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD) Events Over the Placebo-Controlled Treatment Period
events per participant yearPlacebo Q2WItepekimab 300 mg Q4WItepekimab 300 mg Q2W
Annualized Rate of Adjudicated Moderate or Severe Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD) Events Over the Placebo-Controlled Treatment Period0.891 ± 0.7630.708 ± 0.6020.650 ± 0.550
Statistical analysis
  • Placebo Q2W vs Itepekimab 300 mg Q4W · Negative binomial regression model · p = = 0.0213 · Rate ratio: 0.795 · 95% CI 0.654 to 0.966
  • Placebo Q2W vs Itepekimab 300 mg Q2W · Negative binomial regression model · p = = 0.0019 · Rate ratio: 0.729 · 95% CI 0.598 to 0.890
SecondaryAnnualized Rate of Adjudicated Severe Acute Exacerbation of Chronic Obstructive Pulmonary Disease Events Over the Placebo-Controlled Treatment Period

Exacerbations were recorded by the Investigator. Severe exacerbations were defined as AECOPD that required hospitalization, observation for \>24 hours in an emergency department/urgent care facility, or resulted in death. Annualized rate was the total number of severe exacerbation events divided by the total observation duration and was estimated based on negative binomial regression. Events were adjudicated by third party.

Time frame:
Baseline (Day 1) up to Week 52 for initial randomized participants; Baseline (Day 1) up to Week 24 to 52 for additional randomized participants
Reported as:
Number · events per participant year
Annualized Rate of Adjudicated Severe Acute Exacerbation of Chronic Obstructive Pulmonary Disease Events Over the Placebo-Controlled Treatment Period
events per participant yearPlacebo Q2WItepekimab 300 mg Q4WItepekimab 300 mg Q2W
Annualized Rate of Adjudicated Severe Acute Exacerbation of Chronic Obstructive Pulmonary Disease Events Over the Placebo-Controlled Treatment Period0.142 ± 0.1000.093 ± 0.0640.079 ± 0.052
Statistical analysis
  • Placebo Q2W vs Itepekimab 300 mg Q4W · Negative binomial regression model · p = = 0.0567 · Rate ratio: 0.659 · 95% CI 0.430 to 1.012
  • Placebo Q2W vs Itepekimab 300 mg Q2W · Negative binomial regression model · p = = 0.0100 · Rate ratio: 0.556 · 95% CI 0.356 to 0.869
SecondaryChange From Baseline in Pre-Bronchodilator Forced Expiratory Volume in One Second at Week 24

The FEV1 was the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. Pre-BD spirometry was performed after a wash out period of BD according to their action duration. Baseline was defined as the last available value before the first dose of study drug. Model-based average change from baseline to Week 24 is presented.

Time frame:
Baseline (Day 1) to Week 24
Reported as:
Least squares mean · liters
Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in One Second at Week 24
litersPlacebo Q2WItepekimab 300 mg Q4WItepekimab 300 mg Q2W
Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in One Second at Week 240.026 ± 0.0140.035 ± 0.0140.032 ± 0.014
Statistical analysis
  • Placebo Q2W vs Itepekimab 300 mg Q4W · MMRM · p = = 0.5962 · Least squares (ls) mean difference: 0.010 · 95% CI -0.026 to 0.045
  • Placebo Q2W vs Itepekimab 300 mg Q2W · MMRM · p = = 0.7453 · Ls mean difference: 0.006 · 95% CI -0.030 to 0.041
SecondaryChange From Baseline in Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease (E-RS: COPD) Total Score at Week 24

The E-RS: COPD scale was a patient-reported outcome (PRO) that measured the severity of respiratory symptoms in COPD such as breathlessness, cough and sputum, and chest symptoms. It was derivative of the EXACT tool, which was daily symptom diary that quantified and measured exacerbations of COPD and assessed symptomatic manifestations of COPD exacerbations. E-RS: COPD utilized 11 respiratory symptom items contained in 14-item EXACT instrument. Daily E-RS: COPD RS-Total score was computed by taking the sum of the scores for the 11 items comprising the instrument. Total score ranged from 0 (no symptoms) to 40 (severe symptoms), higher values indicated more severe respiratory symptoms. Baseline was defined as the last available value before the first dose of study drug. Model-based average change from baseline to Week 24 is presented.

Time frame:
Baseline (Day 1) to Week 24
Reported as:
Least squares mean · score on a scale
Change From Baseline in Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease (E-RS: COPD) Total Score at Week 24
score on a scalePlacebo Q2WItepekimab 300 mg Q4WItepekimab 300 mg Q2W
Change From Baseline in Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease (E-RS: COPD) Total Score at Week 24-0.967 ± 0.277-1.540 ± 0.274-1.716 ± 0.275
Statistical analysis
  • Placebo Q2W vs Itepekimab 300 mg Q4W · MMRM · p = = 0.1329 · Ls mean difference: -0.572 · 95% CI -1.319 to 0.174
  • Placebo Q2W vs Itepekimab 300 mg Q2W · MMRM · p = = 0.0499 · Ls mean difference: -0.748 · 95% CI -1.496 to -0.000
SecondaryChange From Baseline in Post-Bronchodilator Forced Expiratory Volume in One Second at Week 24

The FEV1 was the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. Post-BD spirometry was performed after 4 actuations of short-acting beta-agonist (SABA; albuterol, salbutamol) with post-BD reversibility performed at least 15 minutes following the last actuation. Baseline was defined as the last available value before the first dose of study drug. Model-based average change from baseline to Week 24 is presented.

Time frame:
Baseline (Day 1) to Week 24
Reported as:
Least squares mean · liters
Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in One Second at Week 24
litersPlacebo Q2WItepekimab 300 mg Q4WItepekimab 300 mg Q2W
Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in One Second at Week 240.038 ± 0.0140.051 ± 0.0140.044 ± 0.014
Statistical analysis
  • Placebo Q2W vs Itepekimab 300 mg Q4W · MMRM · p = = 0.4656 · Ls mean difference: 0.013 · 95% CI -0.023 to 0.049
  • Placebo Q2W vs Itepekimab 300 mg Q2W · MMRM · p = = 0.7441 · Ls mean difference: 0.006 · 95% CI -0.030 to 0.042
SecondaryChange From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 24

SGRQ was 50-item PRO instrument developed to measure the health status of participants with airflow obstruction diseases. Questionnaire had 2 parts: part 1 consisted of 8 items pertaining to severity of respiratory symptoms in preceding 4 weeks; part 2 consisted of 42 items related to the daily activity and psychosocial impacts of the individual's respiratory condition. Total SGRQ score indicated impact of disease on overall health status. Total score was calculated by summing all positive responses in questionnaire and expressing result as percentage of total weight for questionnaire and ranged from 0 to 100; 100=worst possible health status; 0=best possible health status. Baseline: last available value before first dose of study drug. Model-based average change from baseline to Week 24 is presented.

Time frame:
Baseline (Day 1) to Week 24
Reported as:
Least squares mean · score on a scale
Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 24
score on a scalePlacebo Q2WItepekimab 300 mg Q4WItepekimab 300 mg Q2W
Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 24-4.131 ± 0.844-7.461 ± 0.824-6.661 ± 0.827
Statistical analysis
  • Placebo Q2W vs Itepekimab 300 mg Q4W · MMRM · p = = 0.0032 · Ls mean difference: -3.329 · 95% CI -5.539 to -1.119
  • Placebo Q2W vs Itepekimab 300 mg Q2W · MMRM · p = = 0.0251 · Ls mean difference: -2.529 · 95% CI -4.742 to -0.316
SecondaryPercentage of Participants With a Decrease From Baseline of at Least 4 Points in St. George's Respiratory Questionnaire Total Score at Week 24

SGRQ was 50-item PRO instrument developed to measure health status of participants with airflow obstruction diseases. Questionnaire had 2 parts: part 1 consisted of 8 items pertaining to the severity of respiratory symptoms in preceding 4 weeks; part 2 consisted of 42 items related to daily activity and psychosocial impacts of the individual's respiratory condition. The total SGRQ score indicated the impact of disease on overall health status. Total score was calculated by summing all positive responses in questionnaire and expressing result as percentage of total weight for questionnaire and ranged from 0 to 100; 100 represented the worst possible health status and 0 indicated the best possible health status. Baseline was defined as the last available value before the first dose of study drug. Percentages are rounded off to tenth decimal place.

Time frame:
Baseline (Day 1) and Week 24
Reported as:
Number · percentage of participants
Percentage of Participants With a Decrease From Baseline of at Least 4 Points in St. George's Respiratory Questionnaire Total Score at Week 24
percentage of participantsPlacebo Q2WItepekimab 300 mg Q4WItepekimab 300 mg Q2W
Percentage of Participants With a Decrease From Baseline of at Least 4 Points in St. George's Respiratory Questionnaire Total Score at Week 2435.745.143.2
Statistical analysis
  • Placebo Q2W vs Itepekimab 300 mg Q4W · Regression, Logistic · p = = 0.0094 · Odds ratio (or): 1.505 · 95% CI 1.106 to 2.049
  • Placebo Q2W vs Itepekimab 300 mg Q2W · Regression, Logistic · p = = 0.0596 · Odds ratio (or): 1.345 · 95% CI 0.988 to 1.830
SecondaryRate of Change in Post-Bronchodilator Forced Expiratory Volume in One Second From Baseline (Post-Bronchodilator Forced Expiratory Volume in One Second Slope) After Week 4

The rate of change from baseline in post-BD FEV1 (or post-BD FEV1 slope) after a period of initial BD effect (after Week 4) were estimated to assess the rate of decline in lung function over time, commonly observed in participants with inadequately controlled COPD. The FEV1 was the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. Post-BD spirometry was performed after 4 actuations of SABA (albuterol, salbutamol) with post-BD reversibility performed at least 15 minutes following the last actuation. Baseline was defined as the last available value before the first dose of study drug.

Time frame:
Baseline (Day 1) and from Week 8 up to Week 52 for initial randomized participants; Baseline (Day 1) and from Week 8 up to a variable study treatment period (i.e., 24 weeks minimum and 52 weeks maximum) for additional randomized participants
Reported as:
Least squares mean · liters per year
Rate of Change in Post-Bronchodilator Forced Expiratory Volume in One Second From Baseline (Post-Bronchodilator Forced Expiratory Volume in One Second Slope) After Week 4
liters per yearPlacebo Q2WItepekimab 300 mg Q4WItepekimab 300 mg Q2W
Rate of Change in Post-Bronchodilator Forced Expiratory Volume in One Second From Baseline (Post-Bronchodilator Forced Expiratory Volume in One Second Slope) After Week 4-0.019 ± 0.027-0.006 ± 0.0270.002 ± 0.027
Statistical analysis
  • Placebo Q2W vs Itepekimab 300 mg Q4W · MMRM · p = = 0.4865 · Ls mean difference: 0.013 · 95% CI -0.024 to 0.051
  • Placebo Q2W vs Itepekimab 300 mg Q2W · MMRM · p = = 0.2710 · Ls mean difference: 0.021 · 95% CI -0.017 to 0.059
SecondaryChange From Baseline in Post-Bronchodilator Forced Expiratory Volume in One Second at Week 52

The FEV1 was the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. Post-BD spirometry was performed after 4 actuations of SABA (albuterol, salbutamol) with post-BD reversibility performed at least 15 minutes following the last actuation. Baseline was defined as the last available value before the first dose of study drug. Model-based average change from baseline to Week 52 is presented.

Time frame:
Baseline (Day 1) to Week 52
Reported as:
Least squares mean · liters
Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in One Second at Week 52
litersPlacebo Q2WItepekimab 300 mg Q4WItepekimab 300 mg Q2W
Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in One Second at Week 520.003 ± 0.0160.036 ± 0.0160.028 ± 0.015
SecondaryChange From Baseline in Pre-Bronchodilator Forced Expiratory Volume in One Second at Week 52

The FEV1 was the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. Pre-BD spirometry was performed after a wash out period of BD according to their action duration. Baseline was defined as the last available value before the first dose of study drug. Model-based average change from baseline to Week 52 is presented.

Time frame:
Baseline (Day 1) to Week 52
Reported as:
Least squares mean · liters
Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in One Second at Week 52
litersPlacebo Q2WItepekimab 300 mg Q4WItepekimab 300 mg Q2W
Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in One Second at Week 52-0.009 ± 0.0160.016 ± 0.0160.019 ± 0.016
SecondaryProbability of Participants With First Adjudicated Moderate or Severe Acute Exacerbation of Chronic Obstructive Pulmonary Disease in Weeks 12, 24, 36 and 52 Over the Placebo-Controlled Treatment Period

Exacerbations were recorded by Investigator. Moderate exacerbations: acute worsening of respiratory symptoms that required either systemic corticosteroids (such as IM, IV, or oral) and/or antibiotics. Severe exacerbations: AECOPD that required hospitalization, observation for \>24 hours in an emergency department/urgent care facility, or resulted in death. Probability of participants with first adjudicated moderate or severe AECOPD in Weeks 12, 24, 36, and 52 was based on Kaplan-Meier estimates. Events were adjudicated by third party.

Time frame:
Baseline (Day 1) up to Weeks 12, 24, 36 and 52
Reported as:
Number · probability of participants
Probability of Participants With First Adjudicated Moderate or Severe Acute Exacerbation of Chronic Obstructive Pulmonary Disease in Weeks 12, 24, 36 and 52 Over the Placebo-Controlled Treatment Period
probability of participantsPlacebo Q2WItepekimab 300 mg Q4WItepekimab 300 mg Q2W
Week 120.192 ± 0.1530.140 ± 0.1070.130 ± 0.098
Week 240.339 ± 0.2910.245 ± 0.2020.245 ± 0.202
Week 360.420 ± 0.3680.352 ± 0.3030.330 ± 0.282
Week 520.535 ± 0.4800.448 ± 0.3950.421 ± 0.368
SecondaryProbability of Participants With First Adjudicated Severe Acute Exacerbation of Chronic Obstructive Pulmonary Disease in Weeks 12, 24, 36 and 52 Over the Placebo-Controlled Treatment Period

Exacerbations were recorded by Investigator. Severe exacerbations were defined as AECOPD that required hospitalization, observation for \>24 hours in an emergency department/urgent care facility, or resulted in death. Probability of participants with first adjudicated severe AECOPD in Weeks 12, 24, 36, and 52 was based on Kaplan-Meier estimates. Events were adjudicated by third party.

Time frame:
Baseline (Day 1) up to Weeks 12, 24, 36 and 52
Reported as:
Number · probability of participants
Probability of Participants With First Adjudicated Severe Acute Exacerbation of Chronic Obstructive Pulmonary Disease in Weeks 12, 24, 36 and 52 Over the Placebo-Controlled Treatment Period
probability of participantsPlacebo Q2WItepekimab 300 mg Q4WItepekimab 300 mg Q2W
Week 120.038 ± 0.0220.016 ± 0.0070.019 ± 0.009
Week 240.069 ± 0.0460.038 ± 0.0220.036 ± 0.020
Week 360.092 ± 0.0650.055 ± 0.0350.056 ± 0.035
Week 520.127 ± 0.0940.096 ± 0.0670.091 ± 0.064
SecondaryAnnualized Rate of Corticosteroid-Treated Acute Exacerbation of Chronic Obstructive Pulmonary Disease Events Over Placebo-Controlled Treatment Period

Exacerbations were recorded by Investigator. Moderate/severe AECOPD events which were treated with regimen containing systemic corticosteroids for AECOPD;at time of AECOPD were considered. Moderate exacerbations: acute worsening of respiratory symptoms that required either systemic corticosteroids (IM,IV, or oral) and/or antibiotics. Severe exacerbations: AECOPD that required hospitalization, observation for \>24 hours in emergency department/urgent care facility or resulted in death. For moderate and severe events to be counted as 2 separate events, they must be separated by at least 14 days between any course of systemic steroids/antibiotics or 14 days between discharge and new admission in case of hospitalization (severe events). Annualized rate: total number of corticosteroid-treated AECOPD events divided by total observation duration and was estimated based on negative binomial regression.

Time frame:
Baseline (Day 1) up to Week 52 for initial randomized participants; Baseline (Day 1) up to Week 24 to 52 for additional randomized participants
Reported as:
Number · events per participant year
Annualized Rate of Corticosteroid-Treated Acute Exacerbation of Chronic Obstructive Pulmonary Disease Events Over Placebo-Controlled Treatment Period
events per participant yearPlacebo Q2WItepekimab 300 mg Q4WItepekimab 300 mg Q2W
Annualized Rate of Corticosteroid-Treated Acute Exacerbation of Chronic Obstructive Pulmonary Disease Events Over Placebo-Controlled Treatment Period0.706 ± 0.5910.558 ± 0.4630.518 ± 0.429
SecondaryChange From Baseline in Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease Total Score at Week 52

E-RS: COPD scale was PRO that measured severity of respiratory symptoms in COPD: breathlessness,cough and sputum,chest symptoms. It was derivative of EXACT tool which was daily symptom diary that quantified and measured exacerbations of COPD and assessed symptomatic manifestations of COPD exacerbations. E-RS: COPD used 11 respiratory symptom items contained in 14-item EXACT instrument. Daily E-RS: COPD RS-Total score was computed by taking sum of scores for 11 items comprising instrument. Total score:0 (no symptoms) to 40 (severe symptoms); higher values=more severe respiratory symptoms. Baseline: last available value before first dose of study drug. Model-based average change from baseline to Week 52 is presented.

Time frame:
Baseline (Day 1) to Week 52
Reported as:
Least squares mean · score on a scale
Change From Baseline in Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease Total Score at Week 52
score on a scalePlacebo Q2WItepekimab 300 mg Q4WItepekimab 300 mg Q2W
Change From Baseline in Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease Total Score at Week 52-0.750 ± 0.319-1.493 ± 0.319-1.293 ± 0.318
SecondaryChange From Baseline in St. George's Respiratory Questionnaire Total Score at Week 52

SGRQ was 50-item PRO instrument developed to measure health status of participants with airflow obstruction diseases. Questionnaire had 2 parts: part 1 had 8 items pertaining to severity of respiratory symptoms in preceding 4 weeks; part 2 had 42 items related to daily activity and psychosocial impacts of individual's respiratory condition. Total score was calculated by summing all positive responses in questionnaire and expressing result as percentage of total weight for questionnaire; ranged 0 to 100;100=worst possible health status;0=best possible health status. Baseline: last available value before first dose of study drug. Model-based average change from baseline to Week 52 is presented.

Time frame:
Baseline (Day 1) to Week 52
Reported as:
Least squares mean · score on a scale
Change From Baseline in St. George's Respiratory Questionnaire Total Score at Week 52
score on a scalePlacebo Q2WItepekimab 300 mg Q4WItepekimab 300 mg Q2W
Change From Baseline in St. George's Respiratory Questionnaire Total Score at Week 52-5.527 ± 0.944-7.108 ± 0.939-6.444 ± 0.931
SecondaryPercentage of Participants With a Decrease From Baseline of at Least 4 Points in St. George's Respiratory Questionnaire Total Score at Week 52

SGRQ was 50-item PRO instrument developed to measure health status of participants with airflow obstruction diseases. Questionnaire had 2 parts: part 1 consisted of 8 items pertaining to severity of respiratory symptoms in preceding 4 weeks; part 2 consisted of 42 items related to daily activity and psychosocial impacts of individual's respiratory condition. Total score was calculated by summing all positive responses in questionnaire and expressing result as percentage of total weight for questionnaire and ranged from 0 to 100; 100=worst possible health status; 0=best possible health status. Baseline: last available value before first dose of study drug. Percentages rounded off to tenth decimal place.

Time frame:
Baseline (Day 1) and Week 52
Reported as:
Number · percentage of participants
Percentage of Participants With a Decrease From Baseline of at Least 4 Points in St. George's Respiratory Questionnaire Total Score at Week 52
percentage of participantsPlacebo Q2WItepekimab 300 mg Q4WItepekimab 300 mg Q2W
Percentage of Participants With a Decrease From Baseline of at Least 4 Points in St. George's Respiratory Questionnaire Total Score at Week 5237.141.840.0
SecondaryNumber of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), TEAEs of Special Interest (TEAESIs) and TEAEs Leading to Permanent Treatment Discontinuation

AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Serious AE (SAE) was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. AESI was any AE (serious or non-serious) of scientific and medical concern specific to Sponsor's product or program, for which ongoing monitoring and immediate notification by Investigator to Sponsor was required. TEAEs were AEs that developed, worsened or became serious during the treatment-emergent period.

Time frame:
1st dose (Day 1) up to 22 weeks post last dose (considering maximum treatment exposure) for who did not enter LTS18133 (approximately 78 weeks); up to EOT (considering maximum treatment exposure) for who entered LTS18133 (approximately 58 weeks)
Reported as:
Count of participants · Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), TEAEs of Special Interest (TEAESIs) and TEAEs Leading to Permanent Treatment Discontinuation
ParticipantsPlacebo Q2WItepekimab 300 mg Q4WItepekimab 300 mg Q2W
TEAEs256257251
TESAEs827268
TEAESIs575152
TEAEs leading to permanent treatment discontinuation14119
SecondaryFunctional Itepekimab Concentrations in Serum

Blood samples were collected at specified timepoints to obtain serum concentrations of itepekimab.

Time frame:
Baseline (Day 1), Weeks 2, 4, 8, 12, 24, 36, 52 (EOT), 58 and 72 (EOS) (Weeks 58 and 72 applicable for participants not transitioning to the LTS18133 study)
Reported as:
Mean · nanogram per milliliter
Functional Itepekimab Concentrations in Serum
nanogram per milliliterItepekimab 300 mg Q4WItepekimab 300 mg Q2W
Baseline (Day 1)39.81 ± 751.92258.37 ± 3078.89
Week 217830.12 ± 8205.7818936.75 ± 8318.27
Week 412284.90 ± 5707.8031087.23 ± 12584.82
Week 818841.12 ± 8126.7644814.68 ± 19783.62
Week 1222067.98 ± 9990.1851708.37 ± 23574.86
Week 2422904.65 ± 12099.6055431.09 ± 27162.48
Week 3622937.91 ± 12368.4456922.53 ± 26813.21
Week 5222926.65 ± 13059.1357228.05 ± 30415.75
Week 587409.11 ± 4876.0819240.26 ± 14129.78
Week 72679.20 ± 671.562408.63 ± 6902.68
SecondaryNumber of Participants With Treatment-Emergent Anti-Itepekimab Antibodies Response

Blood samples were collected to evaluate antibodies to itepekimab. Treatment-emergent response was defined as a positive response in the anti-drug antibody (ADA) assay post first dose when baseline results were negative or missing.

Time frame:
1st dose (Day 1) up to 22 weeks post last dose (considering maximum treatment exposure) for who did not enter LTS18133 (approximately 78 weeks); up to EOT (considering maximum treatment exposure) for who entered LTS18133 (approximately 58 weeks)
Reported as:
Count of participants · Participants
Number of Participants With Treatment-Emergent Anti-Itepekimab Antibodies Response
ParticipantsPlacebo Q2WItepekimab 300 mg Q4WItepekimab 300 mg Q2W
Number of Participants With Treatment-Emergent Anti-Itepekimab Antibodies Response1167

Adverse events

Collected over AE: 1st dose (Day 1) up to 22 weeks post last dose (considering maximum treatment exposure) for those who did not enter LTS18133 (approximately 78 weeks); up to EOT (considering maximum treatment exposure) for those who entered LTS18133 (approximately 58 weeks). Deaths: from Day 1 to EOT for those who entered LTS18133, i.e., up to approximately 58 weeks; Day 1 up to end of follow-up for death for each participant for those who did not enter LTS18133, i.e., up to approximately 242 weeks.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo Q2W9/374 (2.4%)82/374 (21.9%)96/374 (25.7%)
Itepekimab 300 mg Q4W4/377 (1.1%)72/377 (19.1%)89/377 (23.6%)
Itepekimab 300 mg Q2W5/374 (1.3%)68/374 (18.2%)83/374 (22.2%)
Most frequent serious events
Showing 10 of 125
Most frequent serious events
EventPlacebo Q2WItepekimab 300 mg Q4WItepekimab 300 mg Q2W
Chronic Obstructive Pulmonary DiseaseRespiratory, thoracic and mediastinal disorders29/37426/37722/374
PneumoniaInfections and infestations17/37414/37710/374
Infective Exacerbation Of Chronic Obstructive Airways DiseaseInfections and infestations9/3747/3775/374
Covid-19Infections and infestations5/3740/3772/374
Covid-19 PneumoniaInfections and infestations1/3741/3775/374
InfluenzaInfections and infestations2/3740/3770/374
Lower Respiratory Tract InfectionInfections and infestations2/3740/3771/374
Lung Neoplasm MalignantNeoplasms benign, malignant and unspecified (incl cysts and polyps)2/3741/3770/374
Cerebrovascular AccidentNervous system disorders0/3740/3772/374
Ischaemic StrokeNervous system disorders2/3740/3770/374
Most frequent other events
Most frequent other events
EventPlacebo Q2WItepekimab 300 mg Q4WItepekimab 300 mg Q2W
Covid-19Infections and infestations31/37431/37723/374
HeadacheNervous system disorders26/37421/37723/374
NasopharyngitisInfections and infestations23/37421/37725/374
Upper Respiratory Tract InfectionInfections and infestations25/37424/37719/374

Baseline characteristics

The randomized population included all participants with a treatment kit number allocated and recorded in the interactive response technology database, and regardless of whether the treatment kit was used or not.

Age, Continuous
Age, Continuous(years)Placebo Q2WItepekimab 300 mg Q4WItepekimab 300 mg Q2WTotal
Mean67.7 ± 7.668.5 ± 7.467.7 ± 7.768.0 ± 7.5
Sex: Female, Male
Sex: Female, Male(Participants)Placebo Q2WItepekimab 300 mg Q4WItepekimab 300 mg Q2WTotal
Female124108133365
Male251269242762
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Placebo Q2WItepekimab 300 mg Q4WItepekimab 300 mg Q2WTotal
American Indian or Alaska Native79723
Asian707475219
Native Hawaiian or Other Pacific Islander0000
Black or African American108826
White285286284855
More than one race1001
Unknown or Not Reported2013
08

Study locations

232 sites
  • University of Alabama at Birmingham Site Number : 8400012
    Birmingham, Alabama 34294, United States
  • Jasper Summit Research Site Number : 8400178
    Jasper, Alabama 35501, United States
  • Chandler Clinical Trials (Elite Clinical Network) Site Number : 8400034
    Chandler, Arizona 85286, United States
  • Pulmonary Associates Site Number : 8400392
    Phoenix, Arizona 85027, United States
  • Noble Clinical Research Site Number : 8400182
    Tucson, Arizona 85704-7876, United States
  • Tucson Clinical Research Institute Site Number : 8400431
    Tucson, Arizona 85712, United States
  • California Research Institute Site Number : 8400400
    Huntington Park, California 90255, United States
  • Modena Allergy + Asthma Site Number : 8400036
    La Jolla, California 92037, United States
  • Imax Clinical Trials LLC 1 Site Number : 8400419
    La Palma, California 90623, United States
  • Downtown LA Research Center Inc. Site Number : 8400027
    Los Angeles, California 90017, United States
  • MACRO Trials Site Number : 8400030
    Los Angeles, California 90048, United States
  • Antelope Valley Clinical Trials Site Number : 8400003
    Northridge, California 91325, United States
  • ~Alpine Clinical Research Center Site Number : 8400180
    Boulder, Colorado 80301, United States
  • Innovative Clinical Research Site Number : 8400017
    Lafayette, Colorado 80026, United States
  • Clin Research W Florida Site Number : 8400004
    Clearwater, Florida 33765, United States
  • Beautiful Minds Clinical Research Center Site Number : 8400037
    Cutler Bay, Florida 33157, United States
  • Indago Research and Health Center Site Number : 8400187
    Hialeah, Florida 33012, United States
  • Advanced Clinical Research Site Number : 8400409
    Kendall, Florida 33156, United States
  • Advanced Pulmonary Research Institute Site Number : 8400455
    Loxahatchee Groves, Florida 33470, United States
  • University of Miami/Miami VA Medical Center Site Number : 8400026
    Miami, Florida 33125, United States
  • DL Research Solutions Inc Site Number : 8400033
    Miami, Florida 33155, United States
  • Reliant Medical Research Site Number : 8400397
    Miami, Florida 33165, United States
  • Research Institute of South Florida,Inc Site Number : 8400006
    Miami, Florida 33173, United States
  • PROLIVE MEDICAL RESEARCH Site Number : 8400420
    Miami, Florida 33175, United States
  • Reed Medical Research Site Number : 8400032
    Miami, Florida 33176, United States
  • High Quality Research Site Number : 8400406
    Miami, Florida 33184, United States
  • Deluxe Health Center Site Number : 8400188
    Miami Lakes, Florida 33014, United States
  • Florida Institute for Clinical Research Site Number : 8400013
    Orlando, Florida 32825-4454, United States
  • Tellabio International Research Services Site Number : 8400411
    Pembroke Pines, Florida 33025, United States
  • Avanza Medical Research Center Site Number : 8400376
    Pensacola, Florida 32503, United States
  • Broward Pulmonary and Sleep Specialists Site Number : 8400031
    Plantation, Florida 33324, United States
  • Coastal Medical Research Institute Site Number : 8400044
    St. Petersburg, Florida 33707, United States
  • Pasadena Center for Medical Research Site Number : 8400043
    St. Petersburg, Florida 33710, United States
  • AdtreMed Site Number : 8400442
    Tampa, Florida 33607, United States
  • Premier Medical Associates Site Number : 8400388
    The Villages, Florida 32159, United States
  • Appalachian Clinical Research Site Number : 8400024
    Adairsville, Georgia 30103, United States
  • Covenant Pulmonary Critical Care Site Number : 8400183
    Atlanta, Georgia 30344, United States
  • David Kavtaradze MD, Inc. Site Number : 8400029
    Cordele, Georgia 31015, United States
  • Alpha Clinical Research Georgia Site Number : 8400190
    Dunwoody, Georgia 30350, United States
  • Gwinnett Biomedical Research Site Number : 8400007
    Lawrenceville, Georgia 30046, United States
  • Benchmark Research Site Number : 8400193
    Covington, Louisiana 70433, United States
  • Paul Shapero, PC Site Number : 8400016
    Bangor, Maine 04401, United States
  • Care Access Site Number : 8400276
    Boston, Massachusetts 02110, United States
  • Care Access Site Number : 8400277
    Boston, Massachusetts 02110, United States
  • Care Access Site Number : 8400278
    Boston, Massachusetts 02110, United States
  • Care Access Site Number : 8400280
    Boston, Massachusetts 02110, United States
  • Care Access Site Number : 8400281
    Boston, Massachusetts 02110, United States
  • Revival Research Institute, LLC Site Number : 8400191
    Dearborn, Michigan 48126, United States
  • Advanced Pulmonary Research Institute of Michigan Site Number : 8400403
    Warren, Michigan 48088, United States
  • Hannibal Clinic Site Number : 8400383
    Hannibal, Missouri 63401, United States
  • Midwest Chest Consultants, P.C. Site Number : 8400002
    Saint Charles, Missouri 63301, United States
  • Hendeson Clinical Trials Site Number : 8400365
    Henderson, Nevada 89052, United States
  • Northwell Health Site Number : 8400019
    Mount Kisco, New York 10549, United States
  • Gastonia Pharmaceutical Research Site Number : 8400010
    Gastonia, North Carolina 28054, United States
  • East Carolina University Brody School Of Medicine Site Number : 8400022
    Greenville, North Carolina 27834, United States
  • Carolina Research Center Site Number : 8400005
    Shelby, North Carolina 28150, United States
  • Accellacare Site Number : 8400001
    Wilmington, North Carolina 28401, United States
  • Southeastern Research Center Site Number : 8400011
    Winston-Salem, North Carolina 27103, United States
  • Bernstein Clinical Research Center Site Number : 8400014
    Cincinnati, Ohio 45236, United States
  • WellNow Urgent Care and Research Site Number : 8400039
    Springdale, Ohio 45215, United States
  • Clinical Research of Central PA Site Number : 8400023
    DuBois, Pennsylvania 15801, United States
  • Bogan Sleep Consultants Site Number : 8400181
    Columbia, South Carolina 29201, United States
  • Clinical Research of Rock Hill Site Number : 8400008
    Rock Hill, South Carolina 29732, United States
  • REX Clinical Trials Site Number : 8400371
    Beaumont, Texas 77701, United States
  • Clinrx Research Site Number : 8400021
    Carrollton, Texas 75007, United States
  • Corsicana Medical Research, LLC Site Number : 8400018
    Corsicana, Texas 75110, United States
  • Texas Tech University Health Sciences Center Site Number : 8400189
    El Paso, Texas 79911, United States
  • The Methodist Hospital Research Institute Site Number : 8400194
    Houston, Texas 77030, United States
  • Biopharma Informatic - Cardiff Avenue - PPDS Site Number : 8400038
    Houston, Texas 77043-2742, United States
  • Santa Clara Family Clinic Site Number : 8400398
    Houston, Texas 77087, United States
  • Metroplex Pulmonary and Sleep Center Site Number : 8400015
    McKinney, Texas 75069, United States
  • Advance Lung and Sleep Center Site Number : 8400040
    Sherman, Texas 75092, United States
  • Sherman Clinical Research Site Number : 8400009
    Sherman, Texas 75092, United States
  • DM Clinical Research Site Number : 8400179
    Tomball, Texas 77375, United States
  • Clearlake Specialties Site Number : 8400025
    Webster, Texas 77598, United States
  • Investigational Site Number : 0320001
    CABA, Buenos Aires C1425BEN, Argentina
  • Investigational Site Number : 0320002
    CABA, Buenos Aires C1425FVH, Argentina
  • Investigational Site Number : 0320005
    La Plata, Buenos Aires B1900BNN, Argentina
  • Investigational Site Number : 0320003
    Rosario, Santa Fe Province S2000DEJ, Argentina
  • Investigational Site Number : 0320004
    Mendoza, 5500, Argentina
  • Investigational Site Number : 1000005
    Dimitrovgrad, 6400, Bulgaria
  • Investigational Site Number : 1000001
    Sofia, 1233, Bulgaria
  • Investigational Site Number : 1000004
    Sofia, 1233, Bulgaria
  • Investigational Site Number : 1000002
    Sofia, 1407, Bulgaria
  • Investigational Site Number : 1000009
    Sofia, 1756, Bulgaria
  • Investigational Site Number : 1000006
    Stara Zagora, 6000, Bulgaria
  • Investigational Site Number : 1000003
    Stara Zagora, 6001, Bulgaria
  • Investigational Site Number : 1000007
    Veliko Tarnovo, 5000, Bulgaria
  • Investigational Site Number : 1000008
    Vidin, 3700, Bulgaria
  • Investigational Site Number : 1520008
    Temuco, La Araucanía 4781173, Chile
  • Investigational Site Number : 1520007
    Curicó, Maule Region 3341643, Chile
  • Investigational Site Number : 1520002
    Talca, Maule Region, Chile
  • Investigational Site Number : 1520009
    Santiago, Reg Metropolitana de Santiago 7500010, Chile
  • Investigational Site Number : 1520003
    Santiago, Reg Metropolitana de Santiago 7500571, Chile
  • Investigational Site Number : 1520001
    Santiago, Reg Metropolitana de Santiago 7500692, Chile
  • Investigational Site Number : 1520006
    Santiago, Reg Metropolitana de Santiago 7500698, Chile
  • Investigational Site Number : 1520004
    Santiago, Reg Metropolitana de Santiago 7750495, Chile
  • Investigational Site Number : 1520005
    Quillota, Valparaiso 2260877, Chile
  • Investigational Site Number : 1560003
    Baotou, 014010, China
  • Investigational Site Number : 1560004
    Beijing, 100020, China

Showing the first 100 of 232 sites across 21 countries. Choose a country and city above to see the rest.

09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

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

10

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2020 to primary completion in Apr 2025, 51 months.

Results were first posted in Oct 2026, 1 year 6 months after primary completion. A results delay was requested in Apr 2026.

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 51 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.

Registered
Dec 30, 2020
First posted
Jan 8, 2021
StartActual
Dec 16, 2020
Primary completionActual
Apr 11, 2025
CompletionActual
Aug 27, 2025
Results delay requested
Apr 9, 2026
Results first posted
Oct 15, 2026
Last update
Oct 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Results
Results posted
posted Oct 15, 2026
Sites
16 sites removed
Show 16 removed
  • My Community Research Center Site Number : 8400347 · Miami, United States
  • GenHarp Clinical Solutions Site Number : 8400028 · Evergreen Park, United States
  • ASHA Clinical Research Site Number : 8400408 · Hammond, United States
  • Exordia Medical Research, Inc. Site Number : 8400041 · Fall River, United States
  • WellNow Urgent Care and Clinical Research Site Number : 8400378 · Schenectady, United States
  • Austin Pulmonary Consultants Site Number : 8400035 · Cedar Park, United States
  • Premier Pulmonary Critical Care and Sleep Medicine Site Number : 8400440 · Denison, United States
  • PRX Research Site Number : 8400380 · Mesquite, United States
  • The Lung and Sleep Research Institute of North Texas Site Number : 8400417 · North Richland Hills, United States
  • Clincove: Plano Primary Care Clinic Site Number : 8400424 · Plano, United States
  • EPW Curesearch Dallas (Advanced Family Medical Care) Site Number : 8400414 · Plano, United States
  • Investigational Site Number : 3000007 · Larissa, Greece
  • Investigational Site Number : 4840016 · Oaxaca City, Mexico
  • Investigational Site Number : 4840013 · Aguascalientes, Mexico
  • Investigational Site Number : 8260015 · Ashton-under-Lyne, United Kingdom
  • Investigational Site Number : 8260016 · Salford, United Kingdom
Oct 15, 2026
Eligibility
4 inclusion criteria edited; 2 exclusion criteria edited
What changed in the criteria
Inclusion criteria
  • EditedSmoking history of ≥10 pack-years, but who arewere not currently smoking, and smoking cessation must have occurred ≥6 months prior to Screening (Visit 1A) with an intention to quit permanently.
  • EditedModerate exacerbations will bewere recorded by the Investigator and arewere defined as acute worsening of respiratory symptoms that requires either systemic corticosteroids (IM, IV, or oral) and/or antibiotics.
  • EditedSevere exacerbations will bewere recorded by the Investigator and arewere defined as AECOPD that require hospitalization or observation for >24 hours in emergency department/urgent care facility.
  • EditedFemale participant iswas not pregnant, not breastfeeding, and at least one of the following conditions applies:
Exclusion criteria
  • EditedParticipants with active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection (TBI), or who arewere at high risk of contracting TB (such as close contact with individuals with active or latent TB) or received Bacillus Calmette-Guérin (BCG)-vaccination within 12 weeks prior to Screening (Visit 1A).
  • EditedThe above information iswas not intended to contain all considerations relevant to a patientparticipant's potential participation in a clinical trial.
Oct 15, 2026
Primary outcomes
1 edited
What changed in the outcomes
  • EditedAnnualized rateRate of moderateAdjudicated Moderate or severe acute exacerbationSevere Acute Exacerbation of COPDChronic Obstructive Pulmonary Disease (AECOPD) Events Over the Placebo-Controlled Treatment PeriodTime frame: Baseline up to End Of Treatment (EOT) (Week 52 for initial randomized participants, Week 24 to 52 for potential additional randomized participants) → Baseline (Day 1) up to Week 52 for initial randomized participants; Baseline (Day 1) up to Week 24 to 52 for additional randomized participants
Oct 15, 2026
Documents
Oct 15, 2026
Secondary outcomes
10 edited, 8 added, 5 removed
What changed in the outcomes
  • EditedChange from baselineFrom Baseline in prePre-bronchodilator (BD) forced expiratory volumeBronchodilator Forced Expiratory Volume in 1 second (FEV1)One Second at Week 24Time frame: Baseline to Week 24 → Baseline (Day 1) to Week 24
  • EditedChange from baselineFrom Baseline in postPost-BD FEV1Bronchodilator Forced Expiratory Volume in One Second at Week 24Time frame: Baseline to Week 24 and Week 52 → Baseline (Day 1) to Week 24
  • EditedChange from baselineFrom Baseline in prePre-BD FEV1Bronchodilator Forced Expiratory Volume in One Second at Week 52Time frame: Baseline to Week 52 → Baseline (Day 1) to Week 52
  • EditedChange from baselineFrom Baseline in Evaluating Respiratory Symptoms in COPDChronic Obstructive Pulmonary Disease (E-RS: COPD) total scoreTotal Score at Week 24Time frame: Baseline to Week 24 and Week 52 → Baseline (Day 1) to Week 24
  • EditedRate of changeChange in postPost-BD FEV1Bronchodilator Forced Expiratory Volume in One Second From Baseline (LPost-Bronchodilator Forced Expiratory Volume in One Second Slope) from baseline (post-BD FEV1 slope)After Week 4Time frame: Baseline up to EOT (Week 52 for initial randomized participants, Week 24 to 52 for potential additional randomized participants) → Baseline (Day 1) and from Week 8 up to Week 52 for initial randomized participants; Baseline (Day 1) and from Week 8 up to a variable study treatment period (i.e., 24 weeks minimum and 52 weeks maximum) for additional randomized participants
  • EditedChange from baselineFrom Baseline in St. George''s Respiratory Questionnaire (SGRQ) total scoreTotal Score at Week 24Time frame: Baseline to Week 24 and Week 52 → Baseline (Day 1) to Week 24
  • EditedProportionPercentage of participants withParticipants With a decrease from baselineDecrease From Baseline of at leastLeast 4 pointsPoints in SGRQ total scoreSt. George's Respiratory Questionnaire Total Score at Week 24Time frame: Baseline to Week 24 and Week 52 → Baseline (Day 1) and Week 24
  • EditedIncidenceNumber of treatmentParticipants With Treatment-emergent adverse eventsEmergent Adverse Events (TEAEs), adverse eventTreatment-Emergent Serious Adverse Events (TESAEs), TEAEs of special interestsSpecial Interest (AESIsTEAESIs), serious adverse events (SAEs), and adverse events (AEs) leadingTEAEs Leading to permanent treatment discontinuationPermanent Treatment DiscontinuationTime 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) → 1st dose (Day 1) up to 22 weeks post last dose (considering maximum treatment exposure) for who did not enter LTS18133 (approximately 78 weeks); up to EOT (considering maximum treatment exposure) for who entered LTS18133 (approximately 58 weeks)
  • EditedFunctional itepekimab concentrationsItepekimab Concentrations in serumSerumTime 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) → Baseline (Day 1), Weeks 2, 4, 8, 12, 24, 36, 52 (EOT), 58 and 72 (EOS) (Weeks 58 and 72 applicable for participants not transitioning to the LTS18133 study)
  • EditedIncidenceNumber of treatmentParticipants With Treatment-emergent antiEmergent Anti-itepekimab antibodies responsesItepekimab Antibodies ResponseTime 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) → 1st dose (Day 1) up to 22 weeks post last dose (considering maximum treatment exposure) for who did not enter LTS18133 (approximately 78 weeks); up to EOT (considering maximum treatment exposure) for who entered LTS18133 (approximately 58 weeks)
  • AddedAnnualized Rate of Adjudicated Severe Acute Exacerbation of Chronic Obstructive Pulmonary Disease Events Over the Placebo-Controlled Treatment PeriodTime frame: Baseline (Day 1) up to Week 52 for initial randomized participants; Baseline (Day 1) up to Week 24 to 52 for additional randomized participants
  • AddedChange From Baseline in Post-Bronchodilator Forced Expiratory Volume in One Second at Week 52Time frame: Baseline (Day 1) to Week 52
  • AddedProbability of Participants With First Adjudicated Moderate or Severe Acute Exacerbation of Chronic Obstructive Pulmonary Disease in Weeks 12, 24, 36 and 52 Over the Placebo-Controlled Treatment PeriodTime frame: Baseline (Day 1) up to Weeks 12, 24, 36 and 52
  • AddedProbability of Participants With First Adjudicated Severe Acute Exacerbation of Chronic Obstructive Pulmonary Disease in Weeks 12, 24, 36 and 52 Over the Placebo-Controlled Treatment PeriodTime frame: Baseline (Day 1) up to Weeks 12, 24, 36 and 52
  • AddedAnnualized Rate of Corticosteroid-Treated Acute Exacerbation of Chronic Obstructive Pulmonary Disease Events Over Placebo-Controlled Treatment PeriodTime frame: Baseline (Day 1) up to Week 52 for initial randomized participants; Baseline (Day 1) up to Week 24 to 52 for additional randomized participants
  • AddedChange From Baseline in Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease Total Score at Week 52Time frame: Baseline (Day 1) to Week 52
  • AddedChange From Baseline in St. George's Respiratory Questionnaire Total Score at Week 52Time frame: Baseline (Day 1) to Week 52
  • AddedPercentage of Participants With a Decrease From Baseline of at Least 4 Points in St. George's Respiratory Questionnaire Total Score at Week 52Time frame: Baseline (Day 1) and Week 52
  • RemovedTime to first moderate or severe AECOPDTime frame: Baseline through EOT (Week 52 for initial randomized participants, Week 24 to 52 for potential additional randomized participants)
  • RemovedAnnualized rate of severe AECOPDTime frame: Baseline up to EOT (Week 52 for initial randomized participants, Week 24 to 52 for potential additional randomized participants)
  • RemovedTime to first severe AECOPDTime frame: Baseline through EOT (Week 52 for initial randomized participants, Week 24 to 52 for potential additional randomized participants)
  • RemovedAnnualized rate of corticosteroid-treated AECOPDTime frame: Baseline up to EOT (Week 52 for initial randomized participants, Week 24 to 52 for potential additional randomized participants)
  • RemovedIncidence of potentially clinically significant laboratory test, vital signs, and electrocardiogram (ECGs) abnormalitiesTime 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)
Oct 15, 2026
Show all 1 update
  1. Oct 15, 2026
    Results posted
    Documents Study protocol ↗ posted · Statistical analysis plan ↗ posted
    16 sites removed
    Show 16 removed
    • My Community Research Center Site Number : 8400347 · Miami, United States
    • GenHarp Clinical Solutions Site Number : 8400028 · Evergreen Park, United States
    • ASHA Clinical Research Site Number : 8400408 · Hammond, United States
    • Exordia Medical Research, Inc. Site Number : 8400041 · Fall River, United States
    • WellNow Urgent Care and Clinical Research Site Number : 8400378 · Schenectady, United States
    • Austin Pulmonary Consultants Site Number : 8400035 · Cedar Park, United States
    • Premier Pulmonary Critical Care and Sleep Medicine Site Number : 8400440 · Denison, United States
    • PRX Research Site Number : 8400380 · Mesquite, United States
    • The Lung and Sleep Research Institute of North Texas Site Number : 8400417 · North Richland Hills, United States
    • Clincove: Plano Primary Care Clinic Site Number : 8400424 · Plano, United States
    • EPW Curesearch Dallas (Advanced Family Medical Care) Site Number : 8400414 · Plano, United States
    • Investigational Site Number : 3000007 · Larissa, Greece
    • Investigational Site Number : 4840016 · Oaxaca City, Mexico
    • Investigational Site Number : 4840013 · Aguascalientes, Mexico
    • Investigational Site Number : 8260015 · Ashton-under-Lyne, United Kingdom
    • Investigational Site Number : 8260016 · Salford, United Kingdom
    Eligibility 4 inclusion criteria edited; 2 exclusion criteria edited
    What changed in the criteria
    Inclusion criteria
    • EditedSmoking history of ≥10 pack-years, but who arewere not currently smoking, and smoking cessation must have occurred ≥6 months prior to Screening (Visit 1A) with an intention to quit permanently.
    • EditedModerate exacerbations will bewere recorded by the Investigator and arewere defined as acute worsening of respiratory symptoms that requires either systemic corticosteroids (IM, IV, or oral) and/or antibiotics.
    • EditedSevere exacerbations will bewere recorded by the Investigator and arewere defined as AECOPD that require hospitalization or observation for >24 hours in emergency department/urgent care facility.
    • EditedFemale participant iswas not pregnant, not breastfeeding, and at least one of the following conditions applies:
    Exclusion criteria
    • EditedParticipants with active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection (TBI), or who arewere at high risk of contracting TB (such as close contact with individuals with active or latent TB) or received Bacillus Calmette-Guérin (BCG)-vaccination within 12 weeks prior to Screening (Visit 1A).
    • EditedThe above information iswas not intended to contain all considerations relevant to a patientparticipant's potential participation in a clinical trial.
    Primary outcomes 1 edited
    What changed in the outcomes
    • EditedAnnualized rateRate of moderateAdjudicated Moderate or severe acute exacerbationSevere Acute Exacerbation of COPDChronic Obstructive Pulmonary Disease (AECOPD) Events Over the Placebo-Controlled Treatment PeriodTime frame: Baseline up to End Of Treatment (EOT) (Week 52 for initial randomized participants, Week 24 to 52 for potential additional randomized participants) → Baseline (Day 1) up to Week 52 for initial randomized participants; Baseline (Day 1) up to Week 24 to 52 for additional randomized participants
    Secondary outcomes 10 edited, 8 added, 5 removed
    What changed in the outcomes
    • EditedChange from baselineFrom Baseline in prePre-bronchodilator (BD) forced expiratory volumeBronchodilator Forced Expiratory Volume in 1 second (FEV1)One Second at Week 24Time frame: Baseline to Week 24 → Baseline (Day 1) to Week 24
    • EditedChange from baselineFrom Baseline in postPost-BD FEV1Bronchodilator Forced Expiratory Volume in One Second at Week 24Time frame: Baseline to Week 24 and Week 52 → Baseline (Day 1) to Week 24
    • EditedChange from baselineFrom Baseline in prePre-BD FEV1Bronchodilator Forced Expiratory Volume in One Second at Week 52Time frame: Baseline to Week 52 → Baseline (Day 1) to Week 52
    • EditedChange from baselineFrom Baseline in Evaluating Respiratory Symptoms in COPDChronic Obstructive Pulmonary Disease (E-RS: COPD) total scoreTotal Score at Week 24Time frame: Baseline to Week 24 and Week 52 → Baseline (Day 1) to Week 24
    • EditedRate of changeChange in postPost-BD FEV1Bronchodilator Forced Expiratory Volume in One Second From Baseline (LPost-Bronchodilator Forced Expiratory Volume in One Second Slope) from baseline (post-BD FEV1 slope)After Week 4Time frame: Baseline up to EOT (Week 52 for initial randomized participants, Week 24 to 52 for potential additional randomized participants) → Baseline (Day 1) and from Week 8 up to Week 52 for initial randomized participants; Baseline (Day 1) and from Week 8 up to a variable study treatment period (i.e., 24 weeks minimum and 52 weeks maximum) for additional randomized participants
    • EditedChange from baselineFrom Baseline in St. George''s Respiratory Questionnaire (SGRQ) total scoreTotal Score at Week 24Time frame: Baseline to Week 24 and Week 52 → Baseline (Day 1) to Week 24
    • EditedProportionPercentage of participants withParticipants With a decrease from baselineDecrease From Baseline of at leastLeast 4 pointsPoints in SGRQ total scoreSt. George's Respiratory Questionnaire Total Score at Week 24Time frame: Baseline to Week 24 and Week 52 → Baseline (Day 1) and Week 24
    • EditedIncidenceNumber of treatmentParticipants With Treatment-emergent adverse eventsEmergent Adverse Events (TEAEs), adverse eventTreatment-Emergent Serious Adverse Events (TESAEs), TEAEs of special interestsSpecial Interest (AESIsTEAESIs), serious adverse events (SAEs), and adverse events (AEs) leadingTEAEs Leading to permanent treatment discontinuationPermanent Treatment DiscontinuationTime 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) → 1st dose (Day 1) up to 22 weeks post last dose (considering maximum treatment exposure) for who did not enter LTS18133 (approximately 78 weeks); up to EOT (considering maximum treatment exposure) for who entered LTS18133 (approximately 58 weeks)
    • EditedFunctional itepekimab concentrationsItepekimab Concentrations in serumSerumTime 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) → Baseline (Day 1), Weeks 2, 4, 8, 12, 24, 36, 52 (EOT), 58 and 72 (EOS) (Weeks 58 and 72 applicable for participants not transitioning to the LTS18133 study)
    • EditedIncidenceNumber of treatmentParticipants With Treatment-emergent antiEmergent Anti-itepekimab antibodies responsesItepekimab Antibodies ResponseTime 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) → 1st dose (Day 1) up to 22 weeks post last dose (considering maximum treatment exposure) for who did not enter LTS18133 (approximately 78 weeks); up to EOT (considering maximum treatment exposure) for who entered LTS18133 (approximately 58 weeks)
    • AddedAnnualized Rate of Adjudicated Severe Acute Exacerbation of Chronic Obstructive Pulmonary Disease Events Over the Placebo-Controlled Treatment PeriodTime frame: Baseline (Day 1) up to Week 52 for initial randomized participants; Baseline (Day 1) up to Week 24 to 52 for additional randomized participants
    • AddedChange From Baseline in Post-Bronchodilator Forced Expiratory Volume in One Second at Week 52Time frame: Baseline (Day 1) to Week 52
    • AddedProbability of Participants With First Adjudicated Moderate or Severe Acute Exacerbation of Chronic Obstructive Pulmonary Disease in Weeks 12, 24, 36 and 52 Over the Placebo-Controlled Treatment PeriodTime frame: Baseline (Day 1) up to Weeks 12, 24, 36 and 52
    • AddedProbability of Participants With First Adjudicated Severe Acute Exacerbation of Chronic Obstructive Pulmonary Disease in Weeks 12, 24, 36 and 52 Over the Placebo-Controlled Treatment PeriodTime frame: Baseline (Day 1) up to Weeks 12, 24, 36 and 52
    • AddedAnnualized Rate of Corticosteroid-Treated Acute Exacerbation of Chronic Obstructive Pulmonary Disease Events Over Placebo-Controlled Treatment PeriodTime frame: Baseline (Day 1) up to Week 52 for initial randomized participants; Baseline (Day 1) up to Week 24 to 52 for additional randomized participants
    • AddedChange From Baseline in Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease Total Score at Week 52Time frame: Baseline (Day 1) to Week 52
    • AddedChange From Baseline in St. George's Respiratory Questionnaire Total Score at Week 52Time frame: Baseline (Day 1) to Week 52
    • AddedPercentage of Participants With a Decrease From Baseline of at Least 4 Points in St. George's Respiratory Questionnaire Total Score at Week 52Time frame: Baseline (Day 1) and Week 52
    • RemovedTime to first moderate or severe AECOPDTime frame: Baseline through EOT (Week 52 for initial randomized participants, Week 24 to 52 for potential additional randomized participants)
    • RemovedAnnualized rate of severe AECOPDTime frame: Baseline up to EOT (Week 52 for initial randomized participants, Week 24 to 52 for potential additional randomized participants)
    • RemovedTime to first severe AECOPDTime frame: Baseline through EOT (Week 52 for initial randomized participants, Week 24 to 52 for potential additional randomized participants)
    • RemovedAnnualized rate of corticosteroid-treated AECOPDTime frame: Baseline up to EOT (Week 52 for initial randomized participants, Week 24 to 52 for potential additional randomized participants)
    • RemovedIncidence of potentially clinically significant laboratory test, vital signs, and electrocardiogram (ECGs) abnormalitiesTime 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)
    + 6 other changes: index terms, verification date, registry dates, description, arm descriptions and references

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 ↗

11

Registry details

Key details

Study ID
NCT04701983
Lead sponsor
Sanofi
Collaborators
Regeneron Pharmaceuticals
Responsible party
Sponsor
First posted
Jan 8, 2021
Start date
Dec 16, 2020
Primary completion
Apr 11, 2025
Completion
Aug 27, 2025
Results posted
Oct 15, 2026
Last update
Oct 15, 2026

Study contacts

Clinical Sciences & Operations
study director · Sanofi

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Discussion

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