RIVER-ASTHMA: 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
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
The duration of the study for each participant will be up to 156 weeks.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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)
|
Outcome Measures
Primary Outcome Measures
- Percentage of participants with treatment-emergent adverse events [From baseline up to Week 156 (EOS of LTS17510)]
Percentage of participants with treatment emergent Adverse Events.
Secondary Outcome Measures
- Percentage of participants who experienced adverse events. [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)
- Annualized rate of severe exacerbation events over treatment period from parent study baseline [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, 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
- Annualized rate of severe exacerbation events over treatment period from LTS17510 study baseline [From baseline of the LTE17510 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, 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
- Time to first exacerbation event from LTS17510 study baseline [From baseline of the LTE17510 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 [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, 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
- Annualized rate of severe asthma exacerbations requiring hospitalization or emergency room or urgent care visit over treatment period from LTS17510 study baseline [From baseline of the LTE17510 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, 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
- Change from parent study baseline in prebronchodilator (BD) and post-BD forced expiratory volume in 1 second (FEV1) at each spirometry endpoint [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 [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 [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 [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 [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 [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 [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 [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 [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).
- Change from LTS17510 study baseline in Asthma Control Questionnaire (ACQ)-5, ACQ-6, and ACQ-7 scores [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).
- Change from parent study baseline in Fractional Exhaled Nitric Oxide (FeNO) [From parent study baseline up to Week 144 (EOT of LTS17510)]
- Change from LTS17510 study baseline in Fractional Exhaled Nitric Oxide (FeNO) [From LTS17510 study baseline up to Week 144 (EOT of LTS17510)]
- Serum amlitelimab concentrations [From baseline up to Week156 (EOS of LTS17510)]
- Incidence of anti- amlitelimab antibody positive response [From baseline up to Week 156 (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 [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
Eligibility Criteria
Criteria
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 - Participants who received prohibited concomitant medications and prohibited rescue medications - 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."
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Sanofi
Investigators
- Study Director: Clinical Sciences & Operations, Sanofi
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LTS17510
- U1111-1280-5321