Mechanistic Study of the Effect of Itepekimab on Airway Inflammation in Patients With COPD (AERIFY-3)

August 26, 2026 updated by: Sanofi

A Phase 2a, Open-label, Two-part Study to Evaluate the Mechanism of Action of Itepekimab (Anti-IL-33 mAb) on Airway Inflammation in Patients With Chronic Obstructive Pulmonary Disease (COPD)

This study was an exploratory, two-part, 12-week, Phase 2a study evaluated the mechanism of action of Itepekimab (anti-IL-33-mAb) and its impact on airway inflammation in former and current smokers with COPD, aged 40 to 70 years.

This study consisted of participants who had been on a standard-of-care (SoC) mono (long-acting β2-agonist [LABA]) or long-acting muscarinic antagonist [LAMA]), double (inhaled corticosteroid [ICS] + LABA, LABA + LAMA or ICS + LAMA), or triple (ICS + LABA + LAMA) controller therapy for COPD for at least 3 months prior to Screening (Visit 1) with stable dose and regimen for controller therapy for ≥1 month prior to Screening (Visit 1) and during the screening period. Participants would stay on their established controller medications for COPD throughout the duration of the study, with the exception of systemic corticosteroids and/or antibiotics used for acute exacerbation of COPD (AECOPD).

Part A would consist of participants who were former smokers with COPD; Part B would consist of participants who were current smokers with COPD.

The total study duration for each part (Part A and Part B) was approximately 36 weeks:

  • 4-week screening period
  • 12-week treatment period
  • 20-week followup period

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
49

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Trial Transparency email recommended (Toll free number for US & Canada)
  • Phone Number: option 6 800-633-1610
  • Email: Contact-US@sanofi.com

Study Locations

  • Belgium
      • Edegem, Belgium, 2650
        • Investigational Site Number : 0560001
  • Brazil
      • São Paulo, Brazil, 01323-900
        • Hospital Beneficência Portuguesa de São Paulo- Site Number : 0760005
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
        • Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760003
    • São Paulo
      • Campinas, São Paulo, Brazil, 13059-900
        • Hospital e Maternidade Celso Pierro - PUC-Campinas- Site Number : 0760004
      • Votuporanga, São Paulo, Brazil, 15501-405
        • Integral Pesquisa e Ensino- Site Number : 0760006
  • Denmark
      • Aalborg, Denmark, 9000
        • Investigational Site Number : 2080003
      • Copenhagen, Denmark, 2400
        • Investigational Site Number : 2080001
      • Hvidovre, Denmark, 2650
        • Investigational Site Number : 2080002
  • Germany
      • Freiburg im Breisgau, Germany, 79106
        • Investigational Site Number : 2760005
      • Großhansdorf, Germany, 22926
        • Investigational Site Number : 2760001
      • Peine, Germany, 31224
        • Investigational Site Number : 2760004
  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • Investigational Site Number : 5280001
  • United Kingdom
      • Liverpool, United Kingdom, L9 7AL
        • Investigational Site Number : 8260002
    • Cheshire West And Chester
      • Wythenshawe, Cheshire West And Chester, United Kingdom, M23 9QZ
        • Investigational Site Number : 8260003
    • London, City of
      • London, London, City of, United Kingdom, W2 1NY
        • Investigational Site Number : 8260004
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
        • Investigational Site Number : 8260001
  • United States
    • California
      • Torrance, California, United States, 90509
        • UCLA Medical Center - Harbor- Site Number : 8400006
    • Colorado
      • Denver, Colorado, United States, 80206
        • National Jewish Health Medical Center- Site Number : 8400012
    • Florida
      • Miami, Florida, United States, 33125
        • University of Miami UHealth Tower- Site Number : 8400015
    • Missouri
      • Kansas City, Missouri, United States, 66160
        • University of Kansas Medical Center- Site Number : 8400004
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Allergy, Asthma and Clinical Research- Site Number : 8400010
    • Pennsylvania
      • DuBois, Pennsylvania, United States, 15801
        • Clinical Research Associates of Central PA - Dubois- Site Number : 8400011
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas - Southwestern Medical Center- Site Number : 8400014

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participant must be 40 to 70 years of age inclusive
  • Physician diagnosis of COPD for at least 1 year (based on the Global Initiative for Chronic Obstructive Lung Disease [GOLD] definition).

  • Smoking history of ≥10 pack-years

    • For former smokers: Participants who reported that they were not currently smoking, and smoking cessation must had occurred ≥6 months prior to Screening (Visit 1) with an intention to quit permanently.
    • For current smokers (not eligible for Part A): Participants who reported that they are currently smoking tobacco (participant smoked at least 5 cigarettes per day on average during the past 7 days) at Screening (Visit 1) and at Baseline, and who were not currently participating in, or planning to initiate, a smoking cessation intervention at Screening (Visit 1) or during the screening period.
  • Participant-reported history of signs and symptoms of chronic bronchitis (chronic productive cough for at least 3 months in the year before screening in a participant in whom other causes of chronic cough [eg, inadequately treated gastroesophageal reflux or chronic rhinosinusitis; or clinical diagnosis of bronchiectasis] had been excluded).

  • Documented or self-reported history of exacerbation having had ≥1 moderate or severe exacerbation within the 5 years prior to Screening (Visit 1), with at least 1 exacerbation treated with systemic corticosteroids:

    • Moderate exacerbations were defined as an acute worsening of respiratory symptoms that required either systemic corticosteroids (intramuscular [IM], intravenous [IV], or oral) and/or antibiotics.
    • Severe exacerbations were defined as AECOPD that required hospitalization or observation for >24 hours in emergency department/urgent care facility.
  • Participants treated with SoC controller therapy for ≥3 months before Screening (Visit 1) and at a stable dose and regimen of controller therapy for at least 1 month before the screening visit AND during the screening period, including either: triple therapy with LAMA + LABA + ICS or double therapy with ICS + LABA or LABA + LAMA or ICS + LAMA, or monotherapy with LABA or LAMA.
  • Participants who had received appropriate vaccination according to local recommendations against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), administered a minimum of 1 week prior to Screening (Visit 1).
  • Body mass index (BMI) ≥18 kg/m2

  • A female participant was eligible to participate if she was not pregnant, not breastfed, and at least one of the following conditions applies:

    • Not a women of child-bearing potential (WOCBP) or
    • A WOCBP who agreed to follow the contraceptive guidance during the intervention period and for at least 20 weeks after the last dose of study intervention.

Exclusion Criteria:

  • Current diagnosis or previously confirmed diagnosis of asthma according to the Global Initiative for Asthma (GINA) guidelines unless asthma resolved before 18 years of age and has not recurred.
  • For former smokers (Parts A): Active smoking or vaping of any products (eg, nicotine, tetrahydrocannabinol [THC]) within 6 months prior to Screening (Visit 1) or during the screening period. For current smokers (Part B): vaping of any products (eg, nicotine, THC) within 6 months prior to Screening (Visit 1) or during the screening period.
  • Participants who were expected to be regularly exposed to environmental (ie, 'second hand') tobacco smoke in an indoor setting during the screening or treatment periods (former smokers only).
  • Clinically significant new abnormal electrocardiogram (ECG) within 6 months before or at Screening (Visit 1) that might affect the participant's participation in the study.
  • Clinically significant and current pulmonary disease other than COPD, eg, sarcoidosis, interstitial lung disease, bronchiectasis (clinical diagnosis), diagnosis of α1 anti-trypsin deficiency, or another diagnosed pulmonary disease.
  • Diagnosis of cor pulmonale, evidence of right cardiac failure, or moderate-to-severe pulmonary hypertension.
  • Participants who required more than 2 L/min of long-term treatment with oxygen at rest. Participants who used up to 4L/min of supplemental oxygen during exercise might enroll. Oxygen during sleep was allowed.
  • Hypercapnia that required bi-level positive airway pressure (BiPAP).
  • Moderate or severe exacerbation of COPD (AECOPD) within 8 weeks prior to Screening (Visit 1) or during the screening period.
  • Prior history of pneumonectomy, lobectomy, segmentectomy, or therapeutic bronchoscopy procedure (including bronchoscopic volume reduction). Note: Prior history of surgical lung biopsy or wedge resection were not exclusion criteria.
  • Any surgery or major procedures (including those requiring conscious sedation) planned to occur during the study. Minor skin procedures were allowed.
  • Unstable ischemic heart disease, including acute myocardial infarction within 1 year before Screening (Visit 1), or unstable angina within 6 months before Screening (Visit 1) or during the screening period.
  • Cardiac arrhythmias, including paroxysmal (eg, intermittent) atrial fibrillation. Participants with isolated premature ventricular contractions (PVCs) or premature atrial contractions (PACs) might be considered for inclusion.
  • Cardiomyopathy, as defined by Stage III-IV (New York Heart Association) cardiac failure, or other relevant cardiovascular disorder that that might affect the participant's participation in the study.
  • Any underlying disease required the use of prophylaxis for endocarditis.
  • Uncontrolled hypertension (ie, systolic blood pressure [BP] >180 mm Hg or diastolic BP >110 mm Hg with or without use of antihypertensive 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 before Screening (Visit 1).
  • History of human immunodeficiency virus (HIV) infection or positive HIV 1/2 serology at Screening (Visit 1).
  • Suspicion of, or confirmed, coronavirus disease 2019 (COVID-19) infection or contact with known exposure to COVID19 at Screening (Visit 1) or during the screening period; known history of COVID19 infection within 6 weeks before Screening (Visit 1); history of requiring mechanical ventilation or extracorporeal membrane oxygenation (ECMO) secondary to COVID-19 within 12 months before Screening (Visit 1); participants who had a COVID-19 infection before Screening (Visit 1) who had 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 6 weeks before Screening (Visit 1) or during the screening period, significant viral infections within 6 weeks before Screening (Visit 1) or during the screening period that might not have been treated with antiviral treatment (eg, influenza receiving only symptomatic treatment).
  • Participants with active autoimmune disease or participants taking immunosuppressive therapy for autoimmune disease (eg, rheumato arthritis, inflammatory bowel disease, primary biliary cirrhosis, systemic lupus erythematosus, multiple sclerosis).
  • History of malignancy within 5 years before Screening (Visit 1), or during the screening period, except completely treated in situ carcinoma of the cervix, completely treated and resolved nonmetastatic squamous or basal cell carcinoma of the skin.
  • Symptomatic herpes zoster within 3 months prior to screening.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Itepekimab

This arm includes participants from 2 populations: Part A-former smokers and Part B-current smokers.

Subcutaneous (SC) administration of Itepekimab every 2 weeks (Q2W) for 12 weeks
Drug: Itepekimab SAR440340
Pharmaceutical form: solution for injection in pre-filled syringe; Route of administration: subcutaneous
Other Names:
  • REGN3500

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Itepekimab Pharmacodynamic Normalized Enrichment Score Derived From Former Smokers in Endobronchial Biopsies in Current Smokers With Chronic Obstructive Pulmonary Disease at Week 12
Time Frame: Baseline (Week 0) and Week 12
The NES provides an indication of the difference in gene expression levels for a particular individual before and after treatment for a defined set of genes (or signature). The gene signatures are derived from the genes differentially expressed in endobronchial biopsies, bronchial brushings, and nasal brushings of former smokers. The NES in current smokers, at baseline and at Week 12, are calculated based on the gene signatures of former smokers. Change in NES from baseline indicates that the gene signature is differentially regulated in response to itepekimab, with up- and down-regulated genes changing in their expected directions. No predetermined directionality has been established for this score; therefore, a higher or lower NES does not indicate a better or worse outcome. Baseline was defined as the last available value before first dose of study treatment.
Baseline (Week 0) and Week 12
Change From Baseline in Itepekimab Pharmacodynamic Normalized Enrichment Score Derived From Former Smokers in Bronchial Brushings in Current Smokers With Chronic Obstructive Pulmonary Disease at Week 12
Time Frame: Baseline (Week 0) and Week 12
The NES provides an indication of the difference in gene expression levels for a particular individual before and after treatment for a defined set of genes (or signature). The gene signatures are derived from the genes differentially expressed in endobronchial biopsies, bronchial brushings, and nasal brushings of former smokers. The NES in current smokers, at baseline and at Week 12, are calculated based on the gene signatures of former smokers. Change in NES from baseline indicates that the gene signature is differentially regulated in response to itepekimab, with up- and down-regulated genes changing in their expected directions. No predetermined directionality has been established for this score; therefore, a higher or lower NES does not indicate a better or worse outcome. Baseline was defined as the last available value before first dose of study treatment.
Baseline (Week 0) and Week 12
Change From Baseline in Itepekimab Pharmacodynamic Normalized Enrichment Score Derived From Former Smokers in Nasal Brushings in Current Smokers With Chronic Obstructive Pulmonary Disease at Week 12
Time Frame: Baseline (Week 0) and Week 12
The NES provides an indication of the difference in gene expression levels for a particular individual before and after treatment for a defined set of genes (or signature). The gene signatures are derived from the genes differentially expressed in endobronchial biopsies, bronchial brushings, and nasal brushings of former smokers. The NES in current smokers, at baseline and at Week 12, are calculated based on the gene signatures of former smokers. Change in NES from baseline indicates that the gene signature is differentially regulated in response to itepekimab, with up- and down-regulated genes changing in their expected directions. No predetermined directionality has been established for this score; therefore, a higher or lower NES does not indicate a better or worse outcome. Baseline was defined as the last available value before first dose of study treatment.
Baseline (Week 0) and Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Interleukin-33 (IL-33) Treated Eosinophil-associated Normalized Enrichment Score in Endobronchial Biopsies at Week 12
Time Frame: Baseline (Week 0) and Week 12
The NES provides an indication of the difference in gene expression levels for a particular individual before and after treatment for a defined set of genes (or signature). IL-33 treated eosinophil-associated gene signature is used to evaluate NES of endobronchial biopsies of former and current smokers, at baseline and Week 12. Change in NES from baseline indicates that the gene signature is differentially regulated in response to itepekimab, with up- and down-regulated genes changing in their expected directions. No predetermined directionality has been established for this score; therefore, a higher or lower NES does not indicate a better or worse outcome. Baseline was defined as the last available value before first dose of study treatment.
Baseline (Week 0) and Week 12
Change From Baseline in Interleukin-33 Treated Mast Cell-associated Normalized Enrichment Score in Endobronchial Biopsies at Week 12
Time Frame: Baseline (Week 0) and Week 12
The NES provides an indication of the difference in gene expression levels for a particular individual before and after treatment for a defined set of genes (or signature). IL-33 treated mast cell-associated gene signature is used to evaluate NES of endobronchial biopsies of former and current smokers, at baseline and Week 12. Change in NES from baseline indicates that the gene signature is differentially regulated in response to itepekimab, with up- and down-regulated genes changing in their expected directions. No predetermined directionality has been established for this score; therefore, a higher or lower NES does not indicate a better or worse outcome. Baseline was defined as the last available value before first dose of study treatment.
Baseline (Week 0) and Week 12
Change From Baseline to Week 12 in Blood Eosinophil Count
Time Frame: Baseline (Week 0) and Week 12
Blood samples were collected at specified timepoints to assess change in blood eosinophil count. Baseline was defined as the last available value before first dose of study treatment.
Baseline (Week 0) and Week 12
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Adverse Event of Special Interests (TEAESIs), Treatment-emergent Serious Adverse Events (TESAEs), and TEAEs Leading to Permanent Treatment Discontinuation
Time Frame: From first dose of study treatment administration (Week 0) up to end of study, 32 weeks
An AE was defined as any untoward medical occurrence in participant or clinical study participant, temporally associated with use of study treatment, whether or not considered related to study treatment. An AE of special interest (AESI) was an AE (serious or nonserious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by Investigator to Sponsor was required. SAEs were defined as any AE that, at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was congenital anomaly/birth defect or was medically important event. TEAEs were defined as AEs that developed, worsened or became serious during TE period (from first study treatment administration up to end of study).
From first dose of study treatment administration (Week 0) up to end of study, 32 weeks
Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) in Hematology During the Treatment-emergent Period
Time Frame: From first dose of study treatment administration (Week 0) up to end of study, 32 weeks
Blood samples were collected to determine the PCSA in hematology during the TE period (from the first treatment administration up to the end of study). Here, Hb = hemoglobin; g/L = grams per liter; M = male; F = female; v/v= volume by volume; LC = leukocyte count; NB = non-black; B = black; ULN = upper limit of normal and EO = eosinophils. Only parameters in which any participant had abnormality are reported.
From first dose of study treatment administration (Week 0) up to end of study, 32 weeks
Number of Participants With Potentially Clinically Significant Abnormalities in Clinical Chemistry During the Treatment-emergent Period
Time Frame: From first dose of study treatment administration (Week 0) up to end of study, 32 weeks
Blood samples were collected to determine the PCSA in chemistry during the TE period (first treatment administration up to the end of study). Here, mmol/L = millimoles/liter; LLN = lower limit of normal; mg/L = milligrams/liter and mcmol/L = micromoles/liter. Only parameters in which any participant had abnormality are reported.
From first dose of study treatment administration (Week 0) up to end of study, 32 weeks
Number of Participants With Potentially Clinically Significant Abnormalities in Urinalysis During the Treatment-emergent Period
Time Frame: From first dose of study treatment administration (Week 0) up to end of study, 32 weeks
Urine samples were collected to determine the PCSA in urine during the TE period (from the first treatment administration up to the end of study).
From first dose of study treatment administration (Week 0) up to end of study, 32 weeks
Number of Participants With Potentially Clinically Significant Abnormalities in Vital Signs During the Treatment-emergent Period
Time Frame: From first dose of study treatment administration (Week 0) up to end of study, 32 weeks
Participants were examined to determine the PCSA in vital signs during the TE period (from the first treatment administration up to the end of study). Here, SSBP = sitting systolic blood pressure; mmHg = millimeters of mercury; DFB = decrease from baseline and IFB = increase from baseline. Only parameters in which any participant had abnormality are reported.
From first dose of study treatment administration (Week 0) up to end of study, 32 weeks
Number of Participants With Potentially Clinically Significant Abnormalities in Electrocardiogram (ECG) During the Treatment-emergent Period
Time Frame: From first dose of study treatment administration (Week 0) up to end of study, 32 weeks
Single 12-lead ECGs were obtained to determine PCSA during the TE period (from the first treatment administration up to the end of study). Here, QTcB= QT interval corrected by Bazett's formula and QTcF= QT interval corrected by Fridericia formula. Only parameters in which any participant had abnormality are reported.
From first dose of study treatment administration (Week 0) up to end of study, 32 weeks
Number of Participants With Treatment-emergent Antidrug Antibodies (ADA) to Itepekimab
Time Frame: From first dose of study treatment administration (Week 0) up to end of study, 32 weeks
Blood samples were collected to evaluate antibodies to itepekimab in serum. Treatment-emergent ADA response was defined as a positive response in the ADA assay post first dose when baseline results were negative or missing.
From first dose of study treatment administration (Week 0) up to end of study, 32 weeks
Serum Concentrations of Functional Itepekimab
Time Frame: Pre-dose at Weeks 0, 4, 12 and 32
Blood samples were collected at specified timepoints to obtain serum concentrations of itepekimab.
Pre-dose at Weeks 0, 4, 12 and 32

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sanofi

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Regeneron Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Sciences & Operations, Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 19, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 5, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 25, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 6, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 31, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PDY16967
  • 2021-001654-65 (EudraCT Number)
  • U1111-1255-5322 (Registry Identifier: ICTRP)
  • 2024-512007-39-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings