xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06033833</url>
    </required_header>
    <id_info>
      <org_study_id>LTS17510</org_study_id>
      <secondary_id>U1111-1280-5321</secondary_id>
      <nct_id>NCT06033833</nct_id>
    </id_info>
    <brief_title>Long-term Safety and Efficacy Evaluation of Subcutaneous Amlitelimab in Adult Participants With Moderatetosevere Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study</brief_title>
    <acronym>RIVER-ASTHMA</acronym>
    <official_title>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</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sanofi</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sanofi</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a study of amlitelimab for the treatment of participants with moderatetosevere&#xD;
        asthma. The study will have a double-blind treatment period until Week 24 for each&#xD;
        participant and an open-label treatment period where each participant will receive open-label&#xD;
        amlitelimab from Week 24 onwards. The purpose of this study is to evaluate long-term safety,&#xD;
        tolerability, and efficacy of amlitelimab for the treatment of adult participants with&#xD;
        moderate-to-severe asthma who have previously been enrolled and completed the treatment&#xD;
        period of the parent study. The study duration will be up to 156 weeks. The treatment&#xD;
        duration will be up to 144 weeks. The number of visits will be 18.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The duration of the study for each participant will be up to 156 weeks.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 6, 2023</start_date>
    <completion_date type="Anticipated">June 25, 2030</completion_date>
    <primary_completion_date type="Anticipated">June 25, 2030</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>This study will have a double-blind treatment period and an open-label treatment period</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Triple (Participant, Care Provider, Investigator)</masking>
      <masking_description>This study will have a double-blind treatment period and an open-label treatment period after week 24</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Percentage of participants with treatment-emergent adverse events</measure>
      <time_frame>From baseline up to Week 156 (EOS of LTS17510)</time_frame>
      <description>Percentage of participants with treatment emergent Adverse Events.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Percentage of participants who experienced adverse events.</measure>
      <time_frame>From baseline up to Week 156 (End of Study [EOS] of LTS17510)</time_frame>
      <description>Data reported for participants who experienced adverse events of special interest (AESI) and serious adverse events (SAEs)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Annualized rate of severe exacerbation events over treatment period from parent study baseline</measure>
      <time_frame>From baseline of the parent study up to Week 144 (End of Treatment [EOT] of LTS17510)</time_frame>
      <description>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, 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 because of asthma, requiring systemic corticosteroids</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Annualized rate of severe exacerbation events over treatment period from LTS17510 study baseline</measure>
      <time_frame>From baseline of the LTE17510 study Up to Week 144 (EOT of LTS17510)</time_frame>
      <description>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, 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 because of asthma, requiring systemic corticosteroids</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to first exacerbation event from LTS17510 study baseline</measure>
      <time_frame>From baseline of the LTE17510 study Up to Week 144 (EOT of LTS17510)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Annualized rate of severe asthma exacerbations requiring hospitalization or emergency room or urgent care visit over treatment period from parent study baseline</measure>
      <time_frame>From baseline of the parent study up to Week 144 (EOT of LTS17510)</time_frame>
      <description>Severe asthma exacerbations are defined as: Worsening of asthma requiring the use of systemic corticosteroids for ≥3 days 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&#xD;
  • Hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Annualized rate of severe asthma exacerbations requiring hospitalization or emergency room or urgent care visit over treatment period from LTS17510 study baseline</measure>
      <time_frame>From baseline of the LTE17510 study up to Week 144 (EOT of LTS17510)</time_frame>
      <description>Severe asthma exacerbations are defined as: Worsening of asthma requiring the use of systemic corticosteroids for ≥3 days 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&#xD;
  • Hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from parent study baseline in prebronchodilator (BD) and post-BD forced expiratory volume in 1 second (FEV1) at each spirometry endpoint</measure>
      <time_frame>From baseline of parent study up to week 144 (EOT of LTS17510)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from LTS17510 study baseline in pre bronchodilator (BD) and post-BD forced expiratory volume in 1 second (FEV1) at each spirometry endpoint</measure>
      <time_frame>From baseline of LTS17510 study up to week 144 (EOT of LTS17510)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from parent study baseline in pre-BD and post-BD peak expiratory flow [PEF] at each spirometry endpoint</measure>
      <time_frame>From baseline of parent study up to Week 144 (EOT of LTS17510)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from LTS17510 study baseline in pre-BD and post-BD peak expiratory flow [PEF] at each spirometry endpoint</measure>
      <time_frame>From baseline of LTS17510 study up to Week 144 (EOT of LTS17510)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from parent study baseline in Pre-BD and post-BD forced vital capacity [FVC] at each spirometry endpoint</measure>
      <time_frame>From baseline of parent study up to Week 144 (EOT of LTS17510)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from LTS17510 study Baseline in Pre-BD and post-BD forced vital capacity [FVC] at each spirometry endpoint</measure>
      <time_frame>From baseline of lTS17510 study up to Week 144 (EOT of LTS17510)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from parent study baseline in pre-BD and post-BD forced expiratory flow [FEF] 25% to 75%) at each spirometry endpoint</measure>
      <time_frame>From baseline of parent study up to Week 144 (EOT of LTS17510)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from LTS17510 study baseline in pre-BD and post-BD forced expiratory flow [FEF] 25% to 75%) at each spirometry endpoint</measure>
      <time_frame>From baseline of LTS17510 study up to Week 144 (EOT of LTS17510)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from parent study baseline in Asthma Control Questionnaire (ACQ)-5, ACQ-6, and ACQ-7 scores</measure>
      <time_frame>From parent study baseline up to Week 144 (EOT of LTS17510)</time_frame>
      <description>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).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from LTS17510 study baseline in Asthma Control Questionnaire (ACQ)-5, ACQ-6, and ACQ-7 scores</measure>
      <time_frame>From LTS17510 study baseline up to Week 144 (EOT of LTS17510)</time_frame>
      <description>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).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from parent study baseline in Fractional Exhaled Nitric Oxide (FeNO)</measure>
      <time_frame>From parent study baseline up to Week 144 (EOT of LTS17510)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from LTS17510 study baseline in Fractional Exhaled Nitric Oxide (FeNO)</measure>
      <time_frame>From LTS17510 study baseline up to Week 144 (EOT of LTS17510)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Serum amlitelimab concentrations</measure>
      <time_frame>From baseline up to Week156 (EOS of LTS17510)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of anti- amlitelimab antibody positive response</measure>
      <time_frame>From baseline up to Week 156 (EOS of LTS17510)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from parent study baseline and from LTS17510 in Asthma Quality of Life Questionnaire with Standardized Activities (AQLQ [S]) Self-Administered Score</measure>
      <time_frame>From baseline up to Weeks 144 (EOT of LTS17510)</time_frame>
      <description>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</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">380</enrollment>
    <condition>Asthma</condition>
    <arm_group>
      <arm_group_label>Treatment group 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Subcutaneous Injection as per protocol</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Treatment group 2</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Subcutaneous injection as per protocol</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Amlitelimab</intervention_name>
      <description>Injection Solution: by subcutaneous injection (SCI)</description>
      <arm_group_label>Treatment group 1</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Injection Solution: by subcutaneous injection (SCI)</description>
      <arm_group_label>Treatment group 2</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          - Participants with moderate-to-severe asthma who completed the treatment period of the&#xD;
          parent study per protocol - Participants on background dose with medium-to-high doses of&#xD;
          ICS therapy (≥500 µg of fluticasone propionate daily or comparable ICS dosage up to a&#xD;
          maximum of 2000 µg/day of fluticasone propionate or clinically comparable) in combination&#xD;
          with a second or third controller (eg, LABA, LTRA, LAMA, methylxanthines), with or without&#xD;
          OCS (up to a maximum of 15 mg prednisone or equivalent daily or 30 mg every other day) as&#xD;
          maintained during the parent study in which they participated Note for Japan: participants&#xD;
          must be on ≥400&amp;nbsp;μg of fluticasone propionate daily or equivalent. - Contraception for&#xD;
          male and female participants; For female participants: - incapable of becoming pregnant -&#xD;
          not pregnant or breast feeding - not to donate or cryopreserve eggs for female participants&#xD;
          For male participants - No sperm donation or cryopreserving sperms&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Participants are excluded from the study if any of the following criteria apply: - Chronic&#xD;
          lung disease other than asthma - Participants who developed a new medical condition or a&#xD;
          change in status of an established medical condition or require a new treatment or&#xD;
          medication prior to enrollment, which (per Investigator's medical judgment) would adversely&#xD;
          affect the participation in this study or would require permanent IMP discontinuation -&#xD;
          Current smoker or active vaping of any products and/or marijuana smoking - Prescription&#xD;
          drug or substance abuse, including alcohol, considered significant by the Investigator -&#xD;
          Participants who received prohibited concomitant medications and prohibited rescue&#xD;
          medications - Any new development with the participant's disease or condition or any&#xD;
          significant laboratory test abnormality during the parent study that, in the opinion of the&#xD;
          Investigator, may present an unreasonable risk for the participant - Sensitivity to any of&#xD;
          the study interventions, or components thereof, or drug or other allergy that, in the&#xD;
          opinion of the Investigator, contraindicates participation in the study - Individuals&#xD;
          accommodated in an institution because of regulatory or legal order; prisoners or&#xD;
          participants who are legally institutionalized - Participant not suitable for&#xD;
          participation, whatever the reason, as judged by the Investigator, including medical or&#xD;
          clinical conditions, or participants potentially at risk of noncompliance to study&#xD;
          procedures - Participants are employees of the investigative site or other individuals&#xD;
          directly involved in the conduct of the study, or immediate family members of such&#xD;
          individuals &quot;The above information is not intended to contain all considerations relevant&#xD;
          to a potential participation in a clinical trial.&quot;&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Clinical Sciences &amp;amp; Operations</last_name>
      <role>Study Director</role>
      <affiliation>Sanofi</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Trial transparency Contact-US@sanofi.com</last_name>
      <phone>1800633 1610</phone>
      <phone_ext>option 6</phone_ext>
      <email>Contact-US@sanofi.com</email>
    </overall_contact>
    <verification_date>September 4, 2023</verification_date>
    <study_first_submitted>September 5, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Asthma</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_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</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06033833
  org study id: LTS17510
  secondary id: U1111-1280-5321
  nct id: NCT06033833
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  This is a study of amlitelimab for the treatment of participants with moderatetosevere
        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.
  The duration of the study for each participant will be up to 156 weeks.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  intervention model description: This study will have a double-blind treatment period and an open-label treatment period
  primary purpose: Treatment
  masking: Triple (Participant, Care Provider, Investigator)
  masking description: This study will have a double-blind treatment period and an open-label treatment period after week 24
  measure: Percentage of participants with treatment-emergent adverse events
  time frame: From baseline up to Week 156 (EOS of LTS17510)
  description: Percentage of participants with treatment emergent Adverse Events.
  measure: Percentage of participants who experienced adverse events.
  time frame: From baseline up to Week 156 (End of Study [EOS] of LTS17510)
  description: Data reported for participants who experienced adverse events of special interest (AESI) and serious adverse events (SAEs)
  measure: 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)
  description: 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, 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 because of asthma, requiring systemic corticosteroids
  measure: Annualized rate of severe exacerbation events over treatment period from LTS17510 study baseline
  time frame: From baseline of the LTE17510 study Up to Week 144 (EOT of LTS17510)
  description: 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, 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 because of asthma, requiring systemic corticosteroids
  measure: Time to first exacerbation event from LTS17510 study baseline
  time frame: From baseline of the LTE17510 study Up to Week 144 (EOT of LTS17510)
  measure: 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)
  description: Severe asthma exacerbations are defined as: Worsening of asthma requiring the use of systemic corticosteroids for ≥3 days 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 because of asthma, requiring systemic corticosteroids
  measure: 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 LTE17510 study up to Week 144 (EOT of LTS17510)
  description: Severe asthma exacerbations are defined as: Worsening of asthma requiring the use of systemic corticosteroids for ≥3 days 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 because of asthma, requiring systemic corticosteroids
  measure: 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)
  measure: 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)
  measure: 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)
  measure: 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)
  measure: 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)
  measure: 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)
  measure: 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)
  measure: 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)
  measure: 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)
  description: 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).
  measure: 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)
  description: 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).
  measure: Change from parent study baseline in Fractional Exhaled Nitric Oxide (FeNO)
  time frame: From parent study baseline up to Week 144 (EOT of LTS17510)
  measure: Change from LTS17510 study baseline in Fractional Exhaled Nitric Oxide (FeNO)
  time frame: From LTS17510 study baseline up to Week 144 (EOT of LTS17510)
  measure: Serum amlitelimab concentrations
  time frame: From baseline up to Week156 (EOS of LTS17510)
  measure: Incidence of anti- amlitelimab antibody positive response
  time frame: From baseline up to Week 156 (EOS of LTS17510)
  measure: 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)
  description: 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
  arm group label: Treatment group 1
  arm group type: Experimental
  description: Subcutaneous Injection as per protocol
  arm group label: Treatment group 2
  arm group type: Experimental
  description: Subcutaneous injection as per protocol
  intervention type: Drug
  intervention name: Amlitelimab
  description: Injection Solution: by subcutaneous injection (SCI)
  arm group label: Treatment group 1
  intervention type: Drug
  intervention name: Placebo
  description: Injection Solution: by subcutaneous injection (SCI)
  arm group label: Treatment group 2
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Clinical Sciences &amp; Operations
  role: Study Director
  affiliation: Sanofi
  last name: Trial transparency Contact-US@sanofi.com
  phone: 1800633 1610
  phone ext: option 6
  email: Contact-US@sanofi.com
  responsible party type: Sponsor
  mesh term: Asthma
  sharing ipd: Yes
  ipd 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