Long-term Safety and Efficacy Evaluation of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study (RIVER-ASTHMA)

May 18, 2026 updated by: Sanofi

A Long-term Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study

This is a study of amlitelimab for the treatment of participants with moderate-to-severe asthma. The study will have a double-blind treatment period until Week 24 for each participant and an open-label treatment period where each participant will receive open-label amlitelimab from Week 24 onwards. The purpose of this study is to evaluate long-term safety, tolerability, and efficacy of amlitelimab for the treatment of adult participants with moderate-to-severe asthma who have previously been enrolled and completed the treatment period of the parent study. The study duration will be up to 156 weeks. The treatment duration will be up to 144 weeks. The number of visits will be 18.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

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.

Detailed Description

The duration of the study for each participant will be up to 156 weeks.

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.
335

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

  • Argentina
      • Buenos Aires, Argentina, 1425
        • Investigational Site Number : 0320001
      • Buenos Aires, Argentina, 1121
        • Investigational Site Number : 0320004
      • Buenos Aires, Argentina, 1414
        • Investigational Site Number : 0320003
      • Buenos Aires, Argentina, 1425
        • Investigational Site Number : 0320002
      • Buenos Aires, Argentina, 1650
        • Investigational Site Number : 0320009
    • Buenos Aires
      • La Plata, Buenos Aires, Argentina, 1900
        • Investigational Site Number : 0320008
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, 2000
        • Investigational Site Number : 0320006
      • Rosario, Santa Fe Province, Argentina, 2000
        • Investigational Site Number : 0320007
      • Rosario, Santa Fe Province, Argentina, 2000
        • Investigational Site Number : 0320005
  • Brazil
      • São Paulo, Brazil, 05403-000
        • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo- Site Number : 0760008
    • Espírito Santo
      • Vitória, Espírito Santo, Brazil, 29055-450
        • Centro de Diagnostico e Pesquisa da Osteoporose do Espirito Santo- Site Number : 0760002
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brazil, 40060-330
        • Associacao Proar- Site Number : 0760004
    • Rio Grande do Sul
      • Passo Fundo, Rio Grande do Sul, Brazil, 99010-170
        • Instituto Méderi de Pesquisa e Saúde- Site Number : 0760001
      • Porto Alegre, Rio Grande do Sul, Brazil, 90020-090
        • Irmandade da Santa Casa de Misericórdia de Porto Alegre- Site Number : 0760007
      • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
        • Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760006
    • São Paulo
      • Sorocaba, São Paulo, Brazil, 18040-425
        • Clinica de Alergia Martti Antila- Site Number : 0760003
  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1G 6C6
        • Investigational Site Number : 1240008
    • Quebec
      • Trois-Rivières, Quebec, Canada, G8T 7A1
        • Investigational Site Number : 1240007
  • Chile
    • Maule Region
      • Talca, Maule Region, Chile, 3465584
        • Investigational Site Number : 1520006
    • Reg Metropolitana de Santiago
      • Santiago, Reg Metropolitana de Santiago, Chile, 7500692
        • Investigational Site Number : 1520001
      • Santiago, Reg Metropolitana de Santiago, Chile, 7750495
        • Investigational Site Number : 1520003
      • Santiago, Reg Metropolitana de Santiago, Chile, 8380465
        • Investigational Site Number : 1520008
    • Valparaiso
      • Quillota, Valparaiso, Chile, 2260877
        • Investigational Site Number : 1520005
  • Hungary
      • Edelény, Hungary, 3780
        • Investigational Site Number : 3480009
      • Gödöllő, Hungary, 2100
        • Investigational Site Number : 3480011
      • Püspökladány, Hungary, 4150
        • Investigational Site Number : 3480006
      • Százhalombatta, Hungary, 2440
        • Investigational Site Number : 3480012
  • Italy
      • Verona, Italy, 37134
        • Investigational Site Number : 3800001
    • Napoli
      • Naples, Napoli, Italy, 80131
        • Investigational Site Number : 3800004
    • Roma
      • Rome, Roma, Italy, 00168
        • Investigational Site Number : 3800003
  • Japan
      • Hiroshima, Japan, 732-0052
        • Investigational Site Number : 3920019
      • Tokyo, Japan, 140-8522
        • Investigational Site Number : 3920001
      • Tokyo, Japan, 103-0027
        • Investigational Site Number : 3920005
    • Osaka
      • Sakai, Osaka, Japan, 591-8555
        • Investigational Site Number : 3920010
    • Tokyo
      • Chūō, Tokyo, Japan, 104-0031
        • Investigational Site Number : 3920004
  • Mexico
      • Chihuahua City, Mexico, 31000
        • Investigational Site Number : 4840002
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44100
        • Investigational Site Number : 4840001
      • Guadalajara, Jalisco, Mexico, 44670
        • Investigational Site Number : 4840005
    • Yucatán
      • Mérida, Yucatán, Mexico, 97070
        • Investigational Site Number : 4840008
  • Poland
      • Elblag, Poland, 82-300
        • Investigational Site Number : 6160003
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Poland, 60-693
        • Investigational Site Number : 6160001
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Poland, 31-209
        • Investigational Site Number : 6160006
      • Tarnów, Lesser Poland Voivodeship, Poland, 33-100
        • Investigational Site Number : 6160007
    • Podlaskie Voivodeship
      • Bialystok, Podlaskie Voivodeship, Poland, 15-044
        • Investigational Site Number : 6160004
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Poland, 80-405
        • Investigational Site Number : 6160002
  • South Africa
      • Benoni, South Africa, 1500
        • Investigational Site Number : 7100007
      • Cape Town, South Africa, 7530
        • Investigational Site Number : 7100002
      • Cape Town, South Africa, 7700
        • Investigational Site Number : 7100001
      • Middelburg, South Africa, 1055
        • Investigational Site Number : 7100004
  • South Korea
    • Gyeongsangbuk-do
      • Daegu, Gyeongsangbuk-do, South Korea, 42415
        • Investigational Site Number : 4100004
    • Seoul-teukbyeolsi
      • Seoul, Seoul-teukbyeolsi, South Korea, 05505
        • Investigational Site Number : 4100002
      • Seoul, Seoul-teukbyeolsi, South Korea, 03722
        • Investigational Site Number : 4100001
      • Seoul, Seoul-teukbyeolsi, South Korea, 05030
        • Investigational Site Number : 4100005
      • Seoul, Seoul-teukbyeolsi, South Korea, 06591
        • Investigational Site Number : 4100006
  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye), 34098
        • Investigational Site Number : 7920001
      • Izmir, Turkey (Türkiye), 35100
        • Investigational Site Number : 7920003
      • Kayseri, Turkey (Türkiye), 38039
        • Investigational Site Number : 7920008
      • Mersin, Turkey (Türkiye), 33070
        • Investigational Site Number : 7920002
      • İzmit, Turkey (Türkiye), 41001
        • Investigational Site Number : 7920005
  • United Kingdom
      • Bradford, United Kingdom, BD9 6RJ
        • Investigational Site Number : 8260001
  • United States
    • California
      • Stockton, California, United States, 95207
        • Bensch Research Associates- Site Number : 8400004
    • Florida
      • Boynton Beach, Florida, United States, 33435
        • Helix Biomedics- Site Number : 8400029
      • Miami Lakes, Florida, United States, 33014
        • Savin Medical Group - Miami Lakes- Site Number : 8400015
      • Pembroke Pines, Florida, United States, 33025
        • Pines Care Research Center- Site Number : 8400028
    • Idaho
      • Boise, Idaho, United States, 83706
        • Treasure Valley Medical Research- Site Number : 8400031
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Johns Hopkins Bayview Medical Center- Site Number : 8400012
    • Oklahoma
      • Edmond, Oklahoma, United States, 73034
        • OK Clinical Research- Site Number : 8400001
    • Texas
      • Boerne, Texas, United States, 78006
        • South Texas Medical Research Institute - TTS Research- Site Number : 8400011

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants with moderate-to-severe asthma who completed the treatment period of the parent study per protocol
  • Participants on background dose with medium-to-high doses of ICS therapy (≥500 µg of fluticasone propionate daily or comparable ICS dosage up to a maximum of 2000 µg/day of fluticasone propionate or clinically comparable) in combination with a second or third controller (eg, LABA, LTRA, LAMA, methylxanthines), with or without OCS (up to a maximum of 15 mg prednisone or equivalent daily or 30 mg every other day) as maintained during the parent study in which they participated Note for Japan: participants must be on ≥400 μg of fluticasone propionate daily or equivalent.
  • Contraception for male and female participants;

For female participants:

  • incapable of becoming pregnant
  • not pregnant or breast feeding
  • not to donate or cryopreserve eggs for female participants For male participants
  • No sperm donation or cryopreserving sperms

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

  • Chronic lung disease other than asthma
  • Participants who developed a new medical condition or a change in status of an established medical condition or require a new treatment or medication prior to enrollment, which (per Investigator's medical judgment) would adversely affect the participation in this study or would require permanent IMP discontinuation
  • Current smoker or active vaping of any products and/or marijuana smoking
  • Prescription drug or substance abuse, including alcohol, considered significant by the Investigator
  • Any new development with the participant's disease or condition or any significant laboratory test abnormality during the parent study that, in the opinion of the Investigator, may present an unreasonable risk for the participant
  • Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study
  • Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized
  • Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures
  • Participants are employees of the investigative site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals

The above information is not intended to contain all considerations relevant to a 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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

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: Treatment group 1
Subcutaneous Injection as per protocol
Drug: Amlitelimab
Injection Solution: by subcutaneous injection (SCI)
Experimental: Treatment group 2
Subcutaneous injection as per protocol
Drug: Placebo
Injection Solution: by subcutaneous injection (SCI)

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
Percentage of participants with treatment-emergent adverse events
Time Frame: From baseline up to Week 156 (EOS of LTS17510)
Percentage of participants with treatment emergent Adverse Events.
From baseline up to Week 156 (EOS of LTS17510)

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 parent study baseline in prebronchodilator (BD) and post-BD forced expiratory volume in 1 second (FEV1) at each spirometry endpoint
Time Frame: From baseline of parent study up to week 144 (EOT of LTS17510)
From baseline of parent study up to week 144 (EOT of LTS17510)
Change from LTS17510 study baseline in pre bronchodilator (BD) and post-BD forced expiratory volume in 1 second (FEV1) at each spirometry endpoint
Time Frame: From baseline of LTS17510 study up to week 144 (EOT of LTS17510)
From baseline of LTS17510 study up to week 144 (EOT of LTS17510)
Change from parent study baseline in pre-BD and post-BD peak expiratory flow [PEF] at each spirometry endpoint
Time Frame: From baseline of parent study up to Week 144 (EOT of LTS17510)
From baseline of parent study up to Week 144 (EOT of LTS17510)
Change from LTS17510 study baseline in pre-BD and post-BD peak expiratory flow [PEF] at each spirometry endpoint
Time Frame: From baseline of LTS17510 study up to Week 144 (EOT of LTS17510)
From baseline of LTS17510 study up to Week 144 (EOT of LTS17510)
Change from parent study baseline in Pre-BD and post-BD forced vital capacity [FVC] at each spirometry endpoint
Time Frame: From baseline of parent study up to Week 144 (EOT of LTS17510)
From baseline of parent study up to Week 144 (EOT of LTS17510)
Change from LTS17510 study Baseline in Pre-BD and post-BD forced vital capacity [FVC] at each spirometry endpoint
Time Frame: From baseline of lTS17510 study up to Week 144 (EOT of LTS17510)
From baseline of lTS17510 study up to Week 144 (EOT of LTS17510)
Change from parent study baseline in pre-BD and post-BD forced expiratory flow [FEF] 25% to 75%) at each spirometry endpoint
Time Frame: From baseline of parent study up to Week 144 (EOT of LTS17510)
From baseline of parent study up to Week 144 (EOT of LTS17510)
Change from LTS17510 study baseline in pre-BD and post-BD forced expiratory flow [FEF] 25% to 75%) at each spirometry endpoint
Time Frame: From baseline of LTS17510 study up to Week 144 (EOT of LTS17510)
From baseline of LTS17510 study up to Week 144 (EOT of LTS17510)
Change from parent study baseline in Asthma Control Questionnaire (ACQ)-5, ACQ-6, and ACQ-7 scores
Time Frame: From parent study baseline up to Week 144 (EOT of LTS17510)
The ACQ is a validated questionnaire that measures the adequacy of asthma control and any changes in asthma control that may occur spontaneously or as a result of treatment. Each item of the ACQ is measured on a 7-point response scale (0=no impairment, 6=maximum impairment). The ACQ score is the mean of the item responses and ranges from 0 (totally controlled) and 6 (severely uncontrolled).
From parent study baseline up to Week 144 (EOT of LTS17510)
Change from LTS17510 study baseline in Asthma Control Questionnaire (ACQ)-5, ACQ-6, and ACQ-7 scores
Time Frame: From LTS17510 study baseline up to Week 144 (EOT of LTS17510)
The ACQ is a validated questionnaire that measures the adequacy of asthma control and any changes in asthma control that may occur spontaneously or as a result of treatment. Each item of the ACQ is measured on a 7-point response scale (0=no impairment, 6=maximum impairment). The ACQ score is the mean of the item responses and ranges from 0 (totally controlled) and 6 (severely uncontrolled).
From LTS17510 study baseline up to Week 144 (EOT of LTS17510)
Change from parent study baseline in Fractional Exhaled Nitric Oxide (FeNO)
Time Frame: From parent study baseline up to Week 144 (EOT of LTS17510)
From parent study baseline up to Week 144 (EOT of LTS17510)
Change from LTS17510 study baseline in Fractional Exhaled Nitric Oxide (FeNO)
Time Frame: From LTS17510 study baseline up to Week 144 (EOT of LTS17510)
From LTS17510 study baseline up to Week 144 (EOT of LTS17510)
Serum amlitelimab concentrations
Time Frame: From baseline up to Week156 (EOS of LTS17510)
From baseline up to Week156 (EOS of LTS17510)
Incidence of anti- amlitelimab antibody positive response
Time Frame: From baseline up to Week 156 (EOS of LTS17510)
From baseline up to Week 156 (EOS of LTS17510)
Percentage of participants who experienced adverse events.
Time Frame: From baseline up to Week 156 (End of Study [EOS] of LTS17510)
Data reported for participants who experienced adverse events of special interest (AESI) and serious adverse events (SAEs).
From baseline up to Week 156 (End of Study [EOS] of LTS17510)
Change from parent study baseline and from LTS17510 in Asthma Quality of Life Questionnaire with Standardized Activities (AQLQ [S]) Self-Administered Score
Time Frame: From baseline up to Weeks 144 (EOT of LTS17510)
The AQLQ(S) was designed as a self-administered participant reported outcome to measure the functional impairments that are most troublesome to adolescents and adults ≥12 years of age as a result of their asthma over the past two weeks. The instrument is comprised of 32 items, each rated on a 7-point Likert scales from 1 to 7.
From baseline up to Weeks 144 (EOT of LTS17510)
Time to first exacerbation event from LTS17510 study baseline
Time Frame: From baseline of the LTS17510 study Up to Week 144 (EOT of LTS17510)
From baseline of the LTS17510 study Up to Week 144 (EOT of LTS17510)
Annualized rate of severe exacerbation events over treatment period from parent study baseline
Time Frame: From baseline of the parent study up to Week 144 (End of Treatment [EOT] of LTS17510)
Severe exacerbation events over treatment period from parent study baseline are defined as: Worsening of asthma requiring the use of systemic corticosteroids for ≥3 days (or a single IM or IV injection of corticosteroids) or, in the case of a stable maintenance regimen of oral corticosteroids for the treatment of asthma, a doubling of the dose for 3 or more days; or Hospitalization or emergency room visit or urgent care visit because of asthma, requiring systemic corticosteroids.
From baseline of the parent study up to Week 144 (End of Treatment [EOT] of LTS17510)
Annualized rate of severe exacerbation events over treatment period from LTS17510 study baseline
Time Frame: From baseline of the LTS17510 study Up to Week 144 (EOT of LTS17510)
Severe exacerbation events over treatment period from LTS17510 study baseline defined as: Worsening of asthma requiring the use of systemic corticosteroids for ≥3 days (or a single IM or IV injection of corticosteroids) or, in the case of a stable maintenance regimen of oral corticosteroids for the treatment of asthma, a doubling of the dose for 3 or more days; or Hospitalization or emergency room visit or urgent care visit because of asthma, requiring systemic corticosteroids.
From baseline of the LTS17510 study Up to Week 144 (EOT of LTS17510)
Annualized rate of severe asthma exacerbations requiring hospitalization or emergency room or urgent care visit over treatment period from parent study baseline
Time Frame: From baseline of the parent study up to Week 144 (EOT of LTS17510)
Severe asthma exacerbations are defined as: Worsening of asthma requiring the use of systemic corticosteroids for ≥3 days (or a single IM or IV injection of corticosteroids) or, in the case of a stable maintenance regimen of oral corticosteroids for the treatment of asthma, a doubling of the dose for 3 or more days; or Hospitalization or emergency room visit or urgent care visit because of asthma, requiring systemic corticosteroids.
From baseline of the parent study up to Week 144 (EOT of LTS17510)
Annualized rate of severe asthma exacerbations requiring hospitalization or emergency room or urgent care visit over treatment period from LTS17510 study baseline
Time Frame: From baseline of the LTS17510 study up to Week 144 (EOT of LTS17510)
Severe asthma exacerbations are defined as: Worsening of asthma requiring the use of systemic corticosteroids for ≥3 days (or a single IM or IV injection of corticosteroids) or, in the case of a stable maintenance regimen of oral corticosteroids for the treatment of asthma, a doubling of the dose for 3 or more days; or Hospitalization or emergency room visit or urgent care visit because of asthma, requiring systemic corticosteroids.
From baseline of the LTS17510 study up to Week 144 (EOT of LTS17510)

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

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.

General Publications

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.
September 5, 2023

Primary Completion (Estimated)

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.
September 29, 2026

Study Completion (Estimated)

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.
September 29, 2026

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).
September 5, 2023

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.
September 5, 2023

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.
September 13, 2023

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.
May 20, 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.
May 18, 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.
May 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.
  • LTS17510
  • U1111-1280-5321 (Registry Identifier: ICTRP)
  • 2023-503385-24 (Registry Identifier: 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

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.

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