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NCT Number: NCT06033833

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Investigational Site Number : 0320008, La Plata, Buenos Aires, Argentina

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Amlitelimab

Drug

Injection Solution: by subcutaneous injection (SCI)

Placebo

Drug

Injection Solution: by subcutaneous injection (SCI)

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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.

  3. 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.

  4. Time to first exacerbation event from LTS17510 study baseline

    Time frame: From baseline of the LTS17510 study Up to Week 144 (EOT of LTS17510)

  5. 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.

  6. 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.

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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)

  12. 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)

  13. 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)

  14. 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)

  15. 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).

  16. 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).

  17. Change from parent study baseline in Fractional Exhaled Nitric Oxide (FeNO)

    Time frame: From parent study baseline up to Week 144 (EOT of LTS17510)

  18. Change from LTS17510 study baseline in Fractional Exhaled Nitric Oxide (FeNO)

    Time frame: From LTS17510 study baseline up to Week 144 (EOT of LTS17510)

  19. Serum amlitelimab concentrations

    Time frame: From baseline up to Week156 (EOS of LTS17510)

  20. Incidence of anti- amlitelimab antibody positive response

    Time frame: From baseline up to Week 156 (EOS of LTS17510)

  21. 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.

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Acronym: RIVER-ASTHMA

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 13, 2023
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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