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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 (RIVER-ASTHMA)

Primary Purpose

Asthma

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Amlitelimab
Placebo
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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."

Sites / Locations

  • Site number 8400001Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Treatment group 1

Treatment group 2

Arm Description

Subcutaneous Injection as per protocol

Subcutaneous injection as per protocol

Outcomes

Primary Outcome Measures

Percentage of participants with treatment-emergent adverse events
Percentage of participants with treatment emergent Adverse Events.

Secondary Outcome Measures

Percentage of participants who experienced adverse events.
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
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
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
Annualized rate of severe asthma exacerbations requiring hospitalization or emergency room or urgent care visit over treatment period from parent study baseline
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
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
Change from LTS17510 study baseline in pre bronchodilator (BD) and post-BD forced expiratory volume in 1 second (FEV1) at each spirometry endpoint
Change from parent study baseline in pre-BD and post-BD peak expiratory flow [PEF] at each spirometry endpoint
Change from LTS17510 study baseline in pre-BD and post-BD peak expiratory flow [PEF] at each spirometry endpoint
Change from parent study baseline in Pre-BD and post-BD forced vital capacity [FVC] at each spirometry endpoint
Change from LTS17510 study Baseline in Pre-BD and post-BD forced vital capacity [FVC] at each spirometry endpoint
Change from parent study baseline in pre-BD and post-BD forced expiratory flow [FEF] 25% to 75%) at each spirometry endpoint
Change from LTS17510 study baseline in pre-BD and post-BD forced expiratory flow [FEF] 25% to 75%) at each spirometry endpoint
Change from parent study baseline in Asthma Control Questionnaire (ACQ)-5, ACQ-6, and ACQ-7 scores
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
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)
Change from LTS17510 study baseline in Fractional Exhaled Nitric Oxide (FeNO)
Serum amlitelimab concentrations
Incidence of anti- amlitelimab antibody positive response
Change from parent study baseline and from LTS17510 in Asthma Quality of Life Questionnaire with Standardized Activities (AQLQ [S]) Self-Administered Score
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

Full Information

First Posted
September 5, 2023
Last Updated
October 6, 2023
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT06033833
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
Acronym
RIVER-ASTHMA
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 5, 2023 (Actual)
Primary Completion Date
June 25, 2030 (Anticipated)
Study Completion Date
June 25, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
Detailed Description
The duration of the study for each participant will be up to 156 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
This study will have a double-blind treatment period and an open-label treatment period
Masking
ParticipantCare ProviderInvestigator
Masking Description
This study will have a double-blind treatment period and an open-label treatment period after week 24
Allocation
Non-Randomized
Enrollment
380 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment group 1
Arm Type
Experimental
Arm Description
Subcutaneous Injection as per protocol
Arm Title
Treatment group 2
Arm Type
Experimental
Arm Description
Subcutaneous injection as per protocol
Intervention Type
Drug
Intervention Name(s)
Amlitelimab
Intervention Description
Injection Solution: by subcutaneous injection (SCI)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Injection Solution: by subcutaneous injection (SCI)
Primary Outcome Measure Information:
Title
Percentage of participants with treatment-emergent adverse events
Description
Percentage of participants with treatment emergent Adverse Events.
Time Frame
From baseline up to Week 156 (EOS of LTS17510)
Secondary Outcome Measure Information:
Title
Percentage of participants who experienced adverse events.
Description
Data reported for participants who experienced adverse events of special interest (AESI) and serious adverse events (SAEs)
Time Frame
From baseline up to Week 156 (End of Study [EOS] of LTS17510)
Title
Annualized rate of severe exacerbation events over treatment period from parent study baseline
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
Time Frame
From baseline of the parent study up to Week 144 (End of Treatment [EOT] of LTS17510)
Title
Annualized rate of severe exacerbation events over treatment period from LTS17510 study baseline
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
Time Frame
From baseline of the LTE17510 study Up to Week 144 (EOT of LTS17510)
Title
Time to first exacerbation event from LTS17510 study baseline
Time Frame
From baseline of the LTE17510 study Up to Week 144 (EOT of LTS17510)
Title
Annualized rate of severe asthma exacerbations requiring hospitalization or emergency room or urgent care visit over treatment period from parent study baseline
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
Time Frame
From baseline of the parent study up to Week 144 (EOT of LTS17510)
Title
Annualized rate of severe asthma exacerbations requiring hospitalization or emergency room or urgent care visit over treatment period from LTS17510 study baseline
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
Time Frame
From baseline of the LTE17510 study up to Week 144 (EOT of LTS17510)
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
Change from parent study baseline in Asthma Control Questionnaire (ACQ)-5, ACQ-6, and ACQ-7 scores
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).
Time Frame
From parent study baseline up to Week 144 (EOT of LTS17510)
Title
Change from LTS17510 study baseline in Asthma Control Questionnaire (ACQ)-5, ACQ-6, and ACQ-7 scores
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).
Time Frame
From LTS17510 study baseline up to Week 144 (EOT of LTS17510)
Title
Change from parent study baseline in Fractional Exhaled Nitric Oxide (FeNO)
Time Frame
From parent study baseline up to Week 144 (EOT of LTS17510)
Title
Change from LTS17510 study baseline in Fractional Exhaled Nitric Oxide (FeNO)
Time Frame
From LTS17510 study baseline up to Week 144 (EOT of LTS17510)
Title
Serum amlitelimab concentrations
Time Frame
From baseline up to Week156 (EOS of LTS17510)
Title
Incidence of anti- amlitelimab antibody positive response
Time Frame
From baseline up to Week 156 (EOS of LTS17510)
Title
Change from parent study baseline and from LTS17510 in Asthma Quality of Life Questionnaire with Standardized Activities (AQLQ [S]) Self-Administered Score
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
Time Frame
From baseline up to Weeks 144 (EOT of LTS17510)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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."
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Trial transparency Contact-US@sanofi.com
Phone
1800633 1610
Ext
option 6
Email
Contact-US@sanofi.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Site number 8400001
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73034-3257
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

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

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