A Phase 2 interventional study of Amlitelimab and Placebo in Asthma, sponsored by Sanofi. Completed at 113 sites in 14 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-03-30.
Sponsored by Sanofi · Phase 2, Interventional, and Treatment
This was a parallel, Phase 2, global, multicenter, randomized, double-blind, placebo-controlled, dose-ranging, four-arms study for treatment.
The purpose of this study was to assess the efficacy, safety, and tolerability of add-on therapy with amlitelimab in adult participants with moderate-to-severe asthma.
Study details include:
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 437 is above the median of 83 across 2,752 interventional studies indexed under Asthma.
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Exclusion Criteria:
Participants were excluded from the study if any of the following criteria apply:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Participants received amlitelimab SC injection at an initial loading dose of 125 mg on Day 1 followed by amlitelimab 62.5 mg SC injection Q4W until Week 20 (inclusive) and Q12W starting from Week 24 until Week 48.
Drug: Amlitelimab
Participants received amlitelimab SC injection at an initial loading dose of 250 mg on Day 1 followed by amlitelimab 125 mg SC injection Q4W until Week 20 (inclusive) and Q12W starting from Week 24 until Week 48.
Drug: Amlitelimab
Participants received amlitelimab SC injection at an initial loading dose of 500 mg on Day 1 followed by amlitelimab 250 mg SC injection Q4W until Week 20 (inclusive) and Q12W starting from Week 24 until Week 48.
Drug: Amlitelimab
Participants received amlitelimab matching placebo SC injection on Day 1 followed by Q4W until Week 20 (inclusive) and Q12W starting from Week 24 until Week 48.
Drug: Placebo
Injection solution Subcutaneous injection
Also known as: SAR445229
Injection solution Subcutaneous injection
Annualized Rate of Severe Asthma Exacerbation Events Over 48 Weeks
Severe asthma exacerbation event was 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 (OCS) 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 was the total number of severe asthma exacerbation events divided by the total observation duration and was estimated based on negative binomial regression.
Time frame: Baseline (Day 1) to Week 48
Change From Baseline in Pre-Bronchodilator (BD) Forced Expiratory Volume in One Second (FEV1) at Week 48
The FEV1 was the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. The pre-BD spirometry was performed after a wash out period of BDs according to their action duration. Baseline was defined as the last available value before the first dose of double-blind study treatment.
Time frame: Baseline (Day 1) and Week 48
Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score at Week 48
The ACQ was a questionnaire that measured the adequacy of asthma control and any changes in asthma control that occurred spontaneously or as a result of treatment. The ACQ-5 had five questions on the asthma symptoms and participants were asked to recall how their asthma had been during the previous week. Each item of the ACQ was measured on a 7-point response scale (0=no impairment, 6=maximum impairment). The ACQ score was the mean of the item responses and ranged from 0 (totally controlled) and 6 (severely uncontrolled). A high score indicated low asthma control. Baseline was defined as the last available value before the first dose of double-blind study treatment.
Time frame: Baseline (Day 1) and Week 48
Change From Baseline in Asthma Quality of Life Questionnaire With Standardized Activities [AQLQ(S)] Self-administered Score at Week 48
The AQLQ(S) was a self-administered participant reported outcome (PRO) to measure the functional impairments that were most troublesome to adolescents and adults \>=12 years of age as a result of their asthma over the past two weeks. The instrument comprised of 32 items, each rated on a 7-point Likert scales from 1 (severely impaired) to 7 (not impaired). The AQLQ(S) had 4 domains: symptoms (12 items), activity limitation (11 items, 5 of which were individualized), emotional function (5 items), and environmental exposure (4 items). The global score was the mean of response to each of the 32 questions and ranged from 1 (severe impairment) to 7 (no impairment). Higher scores indicated better quality of life. Baseline was defined as the last available value before the first dose of double-blind study treatment.
Time frame: Baseline (Day 1) and Week 48
Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in One Second at Week 48
The FEV1 was the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. The post-BD spirometry was performed within 30 minutes after administration of BD. Baseline was defined as the last available value before the first dose of double-blind study treatment.
Time frame: Baseline (Day 1) and Week 48
Change From Baseline in Pre-Bronchodilator and Post-Bronchodilator Percent Predicted Forced Expiratory Volume in One Second at Week 48
The FEV1 was the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. The pre-BD spirometry was performed after a wash out period of BDs according to their action duration. The post-BD spirometry was performed within 30 minutes after administration of BD. Baseline was defined as the last available value before the first dose of double-blind study treatment.
Time frame: Baseline (Day 1) and Week 48
Change From Baseline in Asthma Control Questionnaire-5 Score at Weeks 2, 4, 8, 12, 24, 36, and 60
The ACQ was a questionnaire that measured the adequacy of asthma control and any changes in asthma control that occurred spontaneously or as a result of treatment. The ACQ-5 had five questions on the asthma symptoms and participants were asked to recall how their asthma had been during the previous week. Each item of the ACQ was measured on a 7-point response scale (0=no impairment, 6=maximum impairment). The ACQ score was the mean of the item responses and ranged from 0 (totally controlled) and 6 (severely uncontrolled). A high score indicated low asthma control. Baseline was defined as the last available value before the first dose of double-blind study treatment.
Time frame: Baseline (Day 1) and Weeks 2, 4, 8, 12, 24, 36, and 60
Time to First Severe Asthma Exacerbation Event Over 48 Weeks
Time to first severe asthma exacerbation event was defined as the onset date of the first severe asthma exacerbation minus randomization date + 1. Severe asthma exacerbation event was defined as worsening of asthma requiring the use of systemic corticosteroids for \>=3 days or, in the case of a stable maintenance regimen of OCS 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: Baseline (Day 1) to Week 48
Change From Baseline in Pre-Bronchodilator and Post-Bronchodilator Forced Expiratory Volume in One Second at Each Spirometry Timepoint
The FEV1 was the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. The pre-BD spirometry was performed after a wash out period of BDs according to their action duration. The post-BD spirometry was performed within 30 minutes after administration of BD. Baseline was defined as the last available value before the first dose of double-blind study treatment.
Time frame: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 36, and 60 for pre-BD; baseline (Day 1) and Weeks 4, 12, 24, 36, and 60 for post-BD
Change From Baseline in Pre-Bronchodilator and Post-Bronchodilator Peak Expiratory Flow (PEF) at Each Spirometry Timepoint
The PEF was a participant's maximum speed of expiration as measured with a peak flow meter. The pre-BD spirometry was performed after a wash out period of BDs according to their action duration. The post-BD spirometry was performed within 30 minutes after administration of BD. Baseline was defined as the last available value before the first dose of double-blind study treatment.
Time frame: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, and 60 for pre-BD; baseline (Day 1) and Weeks 4, 12, 24, 36, 48, and 60 for post-BD
Change From Baseline in Pre-Bronchodilator and Post-Bronchodilator Forced Vital Capacity (FVC) at Each Spirometry Timepoint
The FVC was defined as the volume of air that can be forcibly blown out after full inspiration in the upright position as measured by spirometer. The pre-BD spirometry was performed after a wash out period of BDs according to their action duration. The post-BD spirometry was performed within 30 minutes after administration of BD. Baseline was defined as the last available value before the first dose of double-blind study treatment.
Time frame: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, and 60 for pre-BD; baseline (Day 1) and Weeks 4, 12, 24, 36, 48, and 60 for post-BD
Change From Baseline in Pre-Bronchodilator and Post-Bronchodilator Forced Expiratory Flow (FEF) 25-75% at Each Spirometry Timepoint
The FEF was the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. The FEF 25-75% was defined as the FEF at 25% to 75% of FVC, where FVC was defined as the volume of air that can be forcibly blown out after full inspiration in the upright position. The pre-BD spirometry was performed after a wash out period of BDs according to their action duration. The post-BD spirometry was performed within 30 minutes after administration of BD. Baseline was defined as the last available value before the first dose of double-blind study treatment.
Time frame: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, and 60 for pre-BD; baseline (Day 1) and Weeks 4, 12, 24, 36, 48, and 60 for post-BD
Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) at Weeks 2, 4, 8, 12, 16, 24, 36, 48, and 60
FeNO was a measure of nitric oxide in exhaled breath produced by epithelial cells in the lung and considered as a biomarker of Type-2 inflammation in asthma. FeNO levels were collected on site with a dedicated medical device. The FeNO test was completed prior to impulse oscillometry and spirometry. Baseline was defined as the last available value before the first dose of double-blind study treatment.
Time frame: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 24, 36, 48, and 60
Annualized Rate of Loss of Asthma Control (LOAC) Events Over 48 Weeks
LOAC events were defined by one or several of the following criteria: a 30% or greater reduction from baseline in morning PEF on 2 consecutive days; \>=6 additional reliever puffs of short-acting beta 2-agonists (SABA) or \>=4 additional puffs of low-dose ICS/formoterol in a 24-hour period (compared to baseline) on 2 consecutive days; increase in ICS \>=4 times than the Visit 2 dose; worsening of asthma requiring the use of systemic corticosteroids for \>=3 days or, in the case of a stable maintenance regimen of OCS 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 severe exacerbation event. Annualized rate was the total number of severe asthma exacerbation events divided by the total observation duration and was estimated based on negative binomial regression.
Time frame: Baseline (Day 1) to Week 48
Time to First Loss of Asthma Control Event Over 48 Weeks
Time to first LOAC event was defined as the onset date of the first LOAC minus randomization date + 1. LOAC events were defined by one or several of the following criteria: a 30% or greater reduction from baseline in morning PEF on 2 consecutive days; \>=6 additional reliever puffs of SABA or \>=4 additional puffs of low-dose ICS/formoterol in a 24-hour period (compared to baseline) on 2 consecutive days; increase in ICS \>=4 times than the Visit 2 dose; worsening of asthma requiring the use of systemic corticosteroids for \>=3 days or, in the case of a stable maintenance regimen of OCS 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 severe exacerbation event.
Time frame: Baseline (Day 1) to Week 48
Change From Baseline in the Asthma Daytime Symptom Diary (ADSD) 6-Item Daily Morning Score and in the Asthma Nighttime Symptom Diary (ANSD) 6-Item Daily Evening Score at Weeks 2, 4, 8, 12, 24, 36, 48, and 60
ADSD and ANSD were PRO measures designed to measure asthma symptoms in adult and adolescent (\>=12 years of age) participants diagnosed with mild-to-severe asthma. Both scales assessed asthma severity based on participant self-report of asthma core symptoms, i.e., difficulty of breathing; wheezing; shortness of breath; chest tightness; chest pain; and cough. Participants were asked to complete ADSD every night before they go to bed, thinking about their asthma symptoms today, from when they got up this morning until now; ANSD when getting up, thinking about their asthma symptoms last night from when they went to bed until now. Both scales consisted 6 items rated using an 11-point numerical rating scale that ranged from 0 (none) to 10 (as bad as you can imagine). Total score was an average of all 6 items for ADSD and ANSD each and therefore ranged from 0 to 10. Higher scores indicated worse outcomes. Baseline: last available value before first dose of double-blind study treatment.
Time frame: Baseline (Day 1) and Weeks 2, 4, 8, 12, 24, 36, 48, and 60
Annualized Rate of Severe Asthma Exacerbations Requiring Hospitalization or Emergency Room or Urgent Care Visit Over 48 Weeks
Severe asthma exacerbation event was defined as worsening of asthma requiring the use of systemic corticosteroids for \>=3 days or, in the case of a stable maintenance regimen of OCS 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. Severe asthma exacerbation events requiring hospitalization or emergency room or urgent care visit during the 48-week treatment period were recorded. Annualized rate was the total number of severe asthma exacerbation events divided by the total observation duration and was estimated based on negative binomial regression.
Time frame: Baseline (Day 1) to Week 48
Change From Baseline in the Numbers of Inhalations Per Day of Short-Acting Beta 2-Agonists or Low-Dose Inhaled Corticosteroid/Formoterol for Symptom Relief at Weeks 2, 4, 8, 12, 24, 36, 48, and 60
Participants were administered SABA or low-dose ICS/formoterol via oral inhalation as reliever medication as needed during the study and the number of inhalations/day were recorded. Baseline was defined as last available value before first dose of double-blind study treatment.
Time frame: Baseline (Day 1) and Weeks 2, 4, 8, 12, 24, 36, 48, and 60
Serum Amlitelimab Concentrations
Blood samples were collected at the specified timepoints for measurement of serum concentrations of amlitelimab.
Time frame: Weeks 4, 8, 12, 16, 24, 36, 48, and 60
Number of Participants With Anti-Drug Antibodies (ADA) to Amlitelimab
Serum samples were collected to evaluate antibodies to amlitelimab. Participants with treatment-emergent ADAs were participants with at least one treatment-induced/boosted ADA. Participants with treatment-induced ADAs were participants with ADAs that developed during the treatment-emergent (TE) period and without pre-existing ADA (including participants without pre-treatment samples). Participants with treatment-boosted ADAs were participants with pre-existing ADAs that were boosted during the TE period to a significant higher titer than the baseline. Number of participants with treatment-emergent ADAs are reported.
Time frame: From first dose of study treatment (Day 1) up to end of study visit (Week 72)
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Adverse Events of Special Interest (TEAESIs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Adverse event (AE): any untoward medical occurrence in participant or clinical study participant, temporally associated with use of study treatment, whether or not considered related to study treatment. TEAEs: AEs that developed, worsened or became serious during TE period. Serious AE: any untoward medical occurrence that at any dose, met one or more of criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was congenital anomaly/birth defect or was significant medical event that jeopardized the participant or required medical or surgical intervention to prevent one of above outcomes. AESI: AE (serious or non-serious) of scientific and medical concern specific to Sponsor's product or program, for which ongoing monitoring and immediate notification by Investigator to Sponsor was required. Percentages are rounded off to tenth decimal place.
Time frame: From first dose of study treatment (Day 1) up to last dose of study treatment + 168 days, approximately 88 weeks
Change From Baseline in Asthma Quality of Life Questionnaire With Standardized Activities Self-administered Score at Weeks 2, 4, 8, 12, 24, 36, and 60
The AQLQ(S) was a self-administered PRO to measure the functional impairments that were most troublesome to adolescents and adults \>=12 years of age as a result of their asthma over the past two weeks. The instrument comprised of 32 items, each rated on a 7-point Likert scales from 1 to (severely impaired) to 7 (not impaired). The AQLQ(S) had 4 domains: symptoms (12 items), activity limitation (11 items, 5 of which were individualized), emotional function (5 items), and environmental exposure (4 items). The global score was the mean of response to each of the 32 questions and ranged from 1 (severe impairment) to 7 (no impairment). Higher scores indicated better quality of life. Baseline was defined as the last available value before the first dose of double-blind study treatment.
Time frame: Baseline (Day 1) and Weeks 2, 4, 8, 12, 24, 36, and 60
Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at Weeks 2, 4, 8, 12, 24, 36, 48, and 60
SGRQ was 50-item questionnaire to measure and quantify health status in adult participants with chronic airflow limitation and consisted of three domains: symptoms (8 items \[covered symptomatology, frequency and severity of cough, sputum production, wheeze, breathlessness, duration and frequency of attacks of breathlessness/wheeze\]), activity (16 items \[covered disturbances to participants' daily physical activities\]), impacts (26 items \[covered effects that chest troubles had on participants' daily life and psycho-social functions\]). Global score was calculated by summing all positive responses in questionnaire and expressing result as percentage of total weight for questionnaire. Global and domain scores ranged from 0 to 100 with 100=worst possible health status and 0=best possible health status. Higher score=worse health status/heath related quality of life. Baseline: last available value before first dose of double-blind study treatment.
Time frame: Baseline (Day 1) and Weeks 2, 4, 8, 12, 24, 36, 48, and 60
Percentage of Participants With a Decrease From Baseline of at Least 4 Points in St. George's Respiratory Questionnaire Total Score at Week 48
SGRQ was 50-item questionnaire to measure and quantify health status in adult participants with chronic airflow limitation and consisted of three domains: symptoms (8 items\[covered symptomatology, frequency and severity of cough, sputum production, wheeze, breathlessness, duration and frequency of attacks of breathlessness/wheeze\]), activity (16 items\[covered disturbances to participants' daily physical activities\]), impacts (26 items\[covered effects that chest troubles had on participants' daily life and psycho-social functions\]). Global score was calculated by summing all positive responses in questionnaire and expressing result as percentage of total weight for questionnaire. Global and domain scores ranged from 0 to 100; 100=worst possible health status and 0=best possible health status. Higher score=worse health status/heath related quality of life. Baseline:last available value before first dose of double-blind study treatment. Percentages are rounded off to tenth decimal place.
Time frame: Baseline (Day 1) to Week 48
Change From Baseline in Asthma Control Questionnaire-6 (ACQ-6) and Asthma Control Questionnaire-7 Scores at Weeks 2, 4, 8, 12, 24, 36, 48, and 60
The ACQ was a questionnaire that measured the adequacy of asthma control and any changes in asthma control that occurred spontaneously or as a result of treatment. The ACQ-5 had five questions on the asthma symptoms and participants were asked to recall how their asthma had been during the previous week. The ACQ-6 included an additional item that scored the average number of daily puffs needed from a SABA BD during the past week and the ACQ-7 included this SABA item, plus a final clinic-assessed item scoring FEV1% predicted. Each item of the ACQ was measured on a 7-point response scale (0=no impairment, 6=maximum impairment). The ACQ-6 and ACQ-7 scores were the mean of the item responses in the respective scales and ranged from 0 (totally controlled) and 6 (severely uncontrolled). A high score indicated low asthma control. Baseline was defined as the last available value before the first dose of double-blind study treatment.
Time frame: Baseline (Day 1) and Weeks 2, 4, 8, 12, 24, 36, 48, and 60
The study was conducted at 112 centers in 14 countries. A total of 910 participants were screened from 30 June 2022 to 31 October 2023, of which 473 were screen failures. Screen failures were mainly due to not meeting the eligibility criteria.
| Milestone | Placebo | Amlitelimab 62.5 mg With 125 mg Loading Dose | Amlitelimab 125 mg With 250 mg Loading Dose | Amlitelimab 250 mg With 500 mg Loading Dose |
|---|---|---|---|---|
| Started | 127 | 61 | 125 | 124 |
| Completed | 110 | 57 | 107 | 112 |
| Not completed | 17 | 4 | 18 | 12 |
| Withdrew: Adverse event: not related to coronavirus disease 2019 (covid-19) | 1 | 2 | 2 | 0 |
| Withdrew: Withdrawal by subject | 8 | 0 | 12 | 6 |
| Withdrew: Non-compliance with study schedule | 2 | 0 | 1 | 3 |
| Withdrew: Other: not related to covid-19 | 6 | 2 | 3 | 3 |
Severe asthma exacerbation event was 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 (OCS) 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 was the total number of severe asthma exacerbation events divided by the total observation duration and was estimated based on negative binomial regression.
| exacerbation/participant-year | Placebo | Amlitelimab 62.5 mg With 125 mg Loading Dose | Amlitelimab 125 mg With 250 mg Loading Dose | Amlitelimab 250 mg With 500 mg Loading Dose |
|---|---|---|---|---|
| Annualized Rate of Severe Asthma Exacerbation Events Over 48 Weeks | 0.598 (0.410 to 0.874) | 0.463 (0.281 to 0.763) | 0.312 (0.202 to 0.482) | 0.450 (0.300 to 0.674) |
The FEV1 was the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. The pre-BD spirometry was performed after a wash out period of BDs according to their action duration. Baseline was defined as the last available value before the first dose of double-blind study treatment.
| liters | Placebo | Amlitelimab 62.5 mg With 125 mg Loading Dose | Amlitelimab 125 mg With 250 mg Loading Dose | Amlitelimab 250 mg With 500 mg Loading Dose |
|---|---|---|---|---|
| Change From Baseline in Pre-Bronchodilator (BD) Forced Expiratory Volume in One Second (FEV1) at Week 48 | 0.09 ± 0.04 | 0.14 ± 0.05 | 0.19 ± 0.04 | 0.18 ± 0.04 |
The ACQ was a questionnaire that measured the adequacy of asthma control and any changes in asthma control that occurred spontaneously or as a result of treatment. The ACQ-5 had five questions on the asthma symptoms and participants were asked to recall how their asthma had been during the previous week. Each item of the ACQ was measured on a 7-point response scale (0=no impairment, 6=maximum impairment). The ACQ score was the mean of the item responses and ranged from 0 (totally controlled) and 6 (severely uncontrolled). A high score indicated low asthma control. Baseline was defined as the last available value before the first dose of double-blind study treatment.
| score on a scale | Placebo | Amlitelimab 62.5 mg With 125 mg Loading Dose | Amlitelimab 125 mg With 250 mg Loading Dose | Amlitelimab 250 mg With 500 mg Loading Dose |
|---|---|---|---|---|
| Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score at Week 48 | -0.83 ± 0.11 | -1.07 ± 0.15 | -1.07 ± 0.11 | -1.25 ± 0.12 |
The AQLQ(S) was a self-administered participant reported outcome (PRO) to measure the functional impairments that were most troublesome to adolescents and adults \>=12 years of age as a result of their asthma over the past two weeks. The instrument comprised of 32 items, each rated on a 7-point Likert scales from 1 (severely impaired) to 7 (not impaired). The AQLQ(S) had 4 domains: symptoms (12 items), activity limitation (11 items, 5 of which were individualized), emotional function (5 items), and environmental exposure (4 items). The global score was the mean of response to each of the 32 questions and ranged from 1 (severe impairment) to 7 (no impairment). Higher scores indicated better quality of life. Baseline was defined as the last available value before the first dose of double-blind study treatment.
| score on a scale | Placebo | Amlitelimab 62.5 mg With 125 mg Loading Dose | Amlitelimab 125 mg With 250 mg Loading Dose | Amlitelimab 250 mg With 500 mg Loading Dose |
|---|---|---|---|---|
| Change From Baseline in Asthma Quality of Life Questionnaire With Standardized Activities [AQLQ(S)] Self-administered Score at Week 48 | 0.72 ± 0.12 | 1.11 ± 0.16 | 0.89 ± 0.12 | 1.14 ± 0.12 |
The FEV1 was the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. The post-BD spirometry was performed within 30 minutes after administration of BD. Baseline was defined as the last available value before the first dose of double-blind study treatment.
| liters | Placebo | Amlitelimab 62.5 mg With 125 mg Loading Dose | Amlitelimab 125 mg With 250 mg Loading Dose | Amlitelimab 250 mg With 500 mg Loading Dose |
|---|---|---|---|---|
| Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in One Second at Week 48 | 0.04 ± 0.04 | 0.08 ± 0.04 | 0.14 ± 0.03 | 0.13 ± 0.03 |
The FEV1 was the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. The pre-BD spirometry was performed after a wash out period of BDs according to their action duration. The post-BD spirometry was performed within 30 minutes after administration of BD. Baseline was defined as the last available value before the first dose of double-blind study treatment.
| percent predicted FEV1 | Placebo | Amlitelimab 62.5 mg With 125 mg Loading Dose | Amlitelimab 125 mg With 250 mg Loading Dose | Amlitelimab 250 mg With 500 mg Loading Dose |
|---|---|---|---|---|
| Pre-BD percent predicted FEV1 | 2.39 ± 1.29 | 4.36 ± 1.66 | 6.13 ± 1.25 | 5.55 ± 1.30 |
| Post-BD percent predicted FEV1 | 0.37 ± 1.19 | 1.87 ± 1.51 | 4.24 ± 1.15 | 3.77 ± 1.16 |
The ACQ was a questionnaire that measured the adequacy of asthma control and any changes in asthma control that occurred spontaneously or as a result of treatment. The ACQ-5 had five questions on the asthma symptoms and participants were asked to recall how their asthma had been during the previous week. Each item of the ACQ was measured on a 7-point response scale (0=no impairment, 6=maximum impairment). The ACQ score was the mean of the item responses and ranged from 0 (totally controlled) and 6 (severely uncontrolled). A high score indicated low asthma control. Baseline was defined as the last available value before the first dose of double-blind study treatment.
| score on a scale | Placebo | Amlitelimab 62.5 mg With 125 mg Loading Dose | Amlitelimab 125 mg With 250 mg Loading Dose | Amlitelimab 250 mg With 500 mg Loading Dose |
|---|---|---|---|---|
| Week 2 | -0.45 ± 0.10 | -0.47 ± 0.13 | -0.32 ± 0.10 | -0.55 ± 0.10 |
| Week 4 | -0.68 ± 0.10 | -0.80 ± 0.14 | -0.53 ± 0.10 | -0.75 ± 0.11 |
| Week 8 | -0.63 ± 0.10 | -1.03 ± 0.13 | -0.80 ± 0.10 | -0.99 ± 0.10 |
| Week 12 | -0.71 ± 0.10 | -1.09 ± 0.14 | -0.94 ± 0.10 | -1.02 ± 0.11 |
| Week 24 | -0.98 ± 0.10 | -1.24 ± 0.14 | -1.06 ± 0.11 | -1.28 ± 0.11 |
| Week 36 | -0.94 ± 0.11 | -1.11 ± 0.15 | -1.07 ± 0.11 | -1.25 ± 0.11 |
| Week 60 | -0.80 ± 0.12 | -1.27 ± 0.15 | -1.07 ± 0.12 | -1.19 ± 0.12 |
Time to first severe asthma exacerbation event was defined as the onset date of the first severe asthma exacerbation minus randomization date + 1. Severe asthma exacerbation event was defined as worsening of asthma requiring the use of systemic corticosteroids for \>=3 days or, in the case of a stable maintenance regimen of OCS 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.
| days | Placebo | Amlitelimab 62.5 mg With 125 mg Loading Dose | Amlitelimab 125 mg With 250 mg Loading Dose | Amlitelimab 250 mg With 500 mg Loading Dose |
|---|---|---|---|---|
| Time to First Severe Asthma Exacerbation Event Over 48 Weeks | NA (338.00 to NA) | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) |
The FEV1 was the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. The pre-BD spirometry was performed after a wash out period of BDs according to their action duration. The post-BD spirometry was performed within 30 minutes after administration of BD. Baseline was defined as the last available value before the first dose of double-blind study treatment.
| liters | Placebo | Amlitelimab 62.5 mg With 125 mg Loading Dose | Amlitelimab 125 mg With 250 mg Loading Dose | Amlitelimab 250 mg With 500 mg Loading Dose |
|---|---|---|---|---|
| Pre-BD FEV1: Week 2 | 0.08 ± 0.03 | 0.12 ± 0.04 | 0.07 ± 0.03 | 0.14 ± 0.03 |
| Pre-BD FEV1: Week 4 | 0.06 ± 0.03 | 0.07 ± 0.04 | 0.05 ± 0.03 | 0.10 ± 0.03 |
| Pre-BD FEV1: Week 8 | 0.11 ± 0.03 | 0.17 ± 0.04 | 0.16 ± 0.03 | 0.16 ± 0.03 |
| Pre-BD FEV1: Week 12 | 0.11 ± 0.03 | 0.18 ± 0.05 | 0.18 ± 0.03 | 0.14 ± 0.03 |
| Pre-BD FEV1: Week 16 | 0.08 ± 0.03 | 0.13 ± 0.04 | 0.19 ± 0.03 | 0.18 ± 0.03 |
| Pre-BD FEV1: Week 20 | 0.11 ± 0.03 | 0.19 ± 0.05 | 0.19 ± 0.03 | 0.19 ± 0.04 |
| Pre-BD FEV1: Week 24 | 0.13 ± 0.03 | 0.18 ± 0.05 | 0.19 ± 0.03 | 0.17 ± 0.04 |
| Pre-BD FEV1: Week 36 | 0.10 ± 0.04 | 0.18 ± 0.05 | 0.19 ± 0.04 | 0.20 ± 0.04 |
| Pre-BD FEV1: Week 60 | 0.10 ± 0.04 | 0.13 ± 0.05 | 0.16 ± 0.04 | 0.25 ± 0.04 |
| Post-BD FEV1: Week 4 | 0.02 ± 0.02 | 0.02 ± 0.03 | 0.04 ± 0.02 | 0.06 ± 0.02 |
| Post-BD FEV1: Week 12 | 0.06 ± 0.03 | 0.11 ± 0.04 | 0.14 ± 0.03 | 0.10 ± 0.03 |
| Post-BD FEV1: Week 24 | 0.05 ± 0.03 | 0.10 ± 0.04 | 0.18 ± 0.03 | 0.11 ± 0.03 |
| Post-BD FEV1: Week 36 | 0.04 ± 0.03 | 0.10 ± 0.04 | 0.17 ± 0.03 | 0.14 ± 0.03 |
| Post-BD FEV1: Week 60 | 0.02 ± 0.04 | 0.03 ± 0.05 | 0.14 ± 0.03 | 0.17 ± 0.04 |
The PEF was a participant's maximum speed of expiration as measured with a peak flow meter. The pre-BD spirometry was performed after a wash out period of BDs according to their action duration. The post-BD spirometry was performed within 30 minutes after administration of BD. Baseline was defined as the last available value before the first dose of double-blind study treatment.
| liters/second | Placebo | Amlitelimab 62.5 mg With 125 mg Loading Dose | Amlitelimab 125 mg With 250 mg Loading Dose | Amlitelimab 250 mg With 500 mg Loading Dose |
|---|---|---|---|---|
| Pre-BD PEF: Week 2 | 0.33 ± 0.08 | 0.49 ± 0.10 | 0.32 ± 0.08 | 0.40 ± 0.08 |
| Pre-BD PEF: Week 4 | 0.25 ± 0.08 | 0.27 ± 0.11 | 0.24 ± 0.08 | 0.24 ± 0.09 |
| Pre-BD PEF: Week 8 | 0.37 ± 0.09 | 0.61 ± 0.13 | 0.54 ± 0.09 | 0.49 ± 0.10 |
| Pre-BD PEF: Week 12 | 0.44 ± 0.10 | 0.55 ± 0.13 | 0.59 ± 0.10 | 0.51 ± 0.10 |
| Pre-BD PEF: Week 16 | 0.37 ± 0.10 | 0.60 ± 0.13 | 0.60 ± 0.10 | 0.53 ± 0.10 |
| Pre-BD PEF: Week 20 | 0.50 ± 0.10 | 0.71 ± 0.13 | 0.62 ± 0.10 | 0.61 ± 0.10 |
| Pre-BD PEF: Week 24 | 0.50 ± 0.10 | 0.62 ± 0.14 | 0.58 ± 0.10 | 0.48 ± 0.10 |
| Pre-BD PEF: Week 36 | 0.53 ± 0.11 | 0.68 ± 0.14 | 0.58 ± 0.11 | 0.59 ± 0.11 |
| Pre-BD PEF: Week 48 | 0.46 ± 0.11 | 0.57 ± 0.14 | 0.63 ± 0.11 | 0.60 ± 0.11 |
| Pre-BD PEF: Week 60 | 0.52 ± 0.12 | 0.50 ± 0.16 | 0.45 ± 0.12 | 0.67 ± 0.12 |
| Post-BD PEF: Week 4 | 0.11 ± 0.07 | 0.24 ± 0.10 | 0.09 ± 0.07 | 0.11 ± 0.08 |
| Post-BD PEF: Week 12 | 0.23 ± 0.09 | 0.43 ± 0.12 | 0.42 ± 0.09 | 0.30 ± 0.09 |
| Post-BD PEF: Week 24 | 0.24 ± 0.09 | 0.42 ± 0.12 | 0.42 ± 0.09 | 0.25 ± 0.09 |
| Post-BD PEF: Week 36 | 0.29 ± 0.10 | 0.46 ± 0.13 | 0.45 ± 0.09 | 0.35 ± 0.10 |
| Post-BD PEF: Week 48 | 0.22 ± 0.10 | 0.40 ± 0.13 | 0.40 ± 0.10 | 0.37 ± 0.10 |
| Post-BD PEF: Week 60 | 0.29 ± 0.11 | 0.32 ± 0.14 | 0.42 ± 0.11 | 0.46 ± 0.11 |
The FVC was defined as the volume of air that can be forcibly blown out after full inspiration in the upright position as measured by spirometer. The pre-BD spirometry was performed after a wash out period of BDs according to their action duration. The post-BD spirometry was performed within 30 minutes after administration of BD. Baseline was defined as the last available value before the first dose of double-blind study treatment.
| liters | Placebo | Amlitelimab 62.5 mg With 125 mg Loading Dose | Amlitelimab 125 mg With 250 mg Loading Dose | Amlitelimab 250 mg With 500 mg Loading Dose |
|---|---|---|---|---|
| Pre-BD FVC: Week 2 | 0.10 ± 0.03 | 0.11 ± 0.04 | 0.09 ± 0.03 | 0.14 ± 0.03 |
| Pre-BD FVC: Week 4 | 0.07 ± 0.03 | 0.07 ± 0.04 | 0.09 ± 0.03 | 0.11 ± 0.03 |
| Pre-BD FVC: Week 8 | 0.11 ± 0.04 | 0.17 ± 0.05 | 0.18 ± 0.04 | 0.17 ± 0.04 |
| Pre-BD FVC: Week 12 | 0.09 ± 0.04 | 0.13 ± 0.05 | 0.16 ± 0.04 | 0.13 ± 0.04 |
| Pre-BD FVC: Week 16 | 0.09 ± 0.04 | 0.13 ± 0.05 | 0.21 ± 0.04 | 0.19 ± 0.04 |
| Pre-BD FVC: Week 20 | 0.09 ± 0.04 | 0.13 ± 0.06 | 0.21 ± 0.04 | 0.19 ± 0.04 |
| Pre-BD FVC: Week 24 | 0.11 ± 0.04 | 0.14 ± 0.06 | 0.18 ± 0.04 | 0.17 ± 0.04 |
| Pre-BD FVC: Week 36 | 0.07 ± 0.04 | 0.11 ± 0.06 | 0.15 ± 0.04 | 0.17 ± 0.04 |
| Pre-BD FVC: Week 48 | 0.06 ± 0.04 | 0.08 ± 0.06 | 0.15 ± 0.04 | 0.16 ± 0.04 |
| Pre-BD FVC: Week 60 | 0.10 ± 0.05 | 0.08 ± 0.06 | 0.16 ± 0.05 | 0.23 ± 0.05 |
| Post-BD FVC: Week 4 | 0.04 ± 0.03 | 0.03 ± 0.04 | 0.05 ± 0.03 | 0.09 ± 0.03 |
| Post-BD FVC: Week 12 | 0.05 ± 0.03 | 0.07 ± 0.04 | 0.13 ± 0.03 | 0.08 ± 0.03 |
| Post-BD FVC: Week 24 | 0.03 ± 0.04 | 0.05 ± 0.05 | 0.14 ± 0.03 | 0.08 ± 0.04 |
| Post-BD FVC: Week 36 | 0.02 ± 0.04 | 0.04 ± 0.05 | 0.10 ± 0.04 | 0.09 ± 0.04 |
| Post-BD FVC: Week 48 | 0.02 ± 0.04 | 0.02 ± 0.05 | 0.09 ± 0.04 | 0.10 ± 0.04 |
| Post-BD FVC: Week 60 | 0.02 ± 0.04 | -0.01 ± 0.05 | 0.09 ± 0.04 | 0.14 ± 0.04 |
The FEF was the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. The FEF 25-75% was defined as the FEF at 25% to 75% of FVC, where FVC was defined as the volume of air that can be forcibly blown out after full inspiration in the upright position. The pre-BD spirometry was performed after a wash out period of BDs according to their action duration. The post-BD spirometry was performed within 30 minutes after administration of BD. Baseline was defined as the last available value before the first dose of double-blind study treatment.
| liters/second | Placebo | Amlitelimab 62.5 mg With 125 mg Loading Dose | Amlitelimab 125 mg With 250 mg Loading Dose | Amlitelimab 250 mg With 500 mg Loading Dose |
|---|---|---|---|---|
| Pre-BD FEF 25-75%: Week 2 | 0.04 ± 0.03 | 0.13 ± 0.04 | 0.03 ± 0.03 | 0.11 ± 0.03 |
| Pre-BD FEF 25-75%: Week 4 | 0.04 ± 0.03 | 0.09 ± 0.05 | -0.03 ± 0.03 | 0.04 ± 0.04 |
| Pre-BD FEF 25-75%: Week 8 | 0.07 ± 0.04 | 0.17 ± 0.06 | 0.11 ± 0.04 | 0.13 ± 0.04 |
| Pre-BD FEF 25-75%: Week 12 | 0.12 ± 0.05 | 0.25 ± 0.06 | 0.16 ± 0.05 | 0.12 ± 0.05 |
| Pre-BD FEF 25-75%: Week 16 | 0.07 ± 0.04 | 0.13 ± 0.06 | 0.13 ± 0.04 | 0.15 ± 0.04 |
| Pre-BD FEF 25-75%: Week 20 | 0.12 ± 0.05 | 0.25 ± 0.06 | 0.13 ± 0.05 | 0.18 ± 0.05 |
| Pre-BD FEF 25-75%: Week 24 | 0.16 ± 0.04 | 0.22 ± 0.06 | 0.21 ± 0.04 | 0.16 ± 0.05 |
| Pre-BD FEF 25-75%: Week 36 | 0.14 ± 0.05 | 0.26 ± 0.07 | 0.20 ± 0.05 | 0.19 ± 0.05 |
| Pre-BD FEF 25-75%: Week 48 | 0.13 ± 0.05 | 0.19 ± 0.07 | 0.21 ± 0.05 | 0.21 ± 0.05 |
| Pre-BD FEF 25-75%: Week 60 | 0.07 ± 0.05 | 0.15 ± 0.06 | 0.15 ± 0.05 | 0.20 ± 0.05 |
| Post-BD FEF 25-75%: Week 4 | 0.01 ± 0.04 | 0.06 ± 0.06 | 0.01 ± 0.04 | 0.05 ± 0.04 |
| Post-BD FEF 25-75%: Week 12 | 0.06 ± 0.05 | 0.19 ± 0.06 | 0.15 ± 0.05 | 0.12 ± 0.05 |
| Post-BD FEF 25-75%: Week 24 | 0.06 ± 0.05 | 0.16 ± 0.06 | 0.22 ± 0.05 | 0.15 ± 0.05 |
| Post-BD FEF 25-75%: Week 36 | 0.08 ± 0.06 | 0.19 ± 0.08 | 0.24 ± 0.06 | 0.18 ± 0.06 |
| Post-BD FEF 25-75%: Week 48 | 0.11 ± 0.05 | 0.17 ± 0.07 | 0.20 ± 0.05 | 0.20 ± 0.05 |
| Post-BD FEF 25-75%: Week 60 | 0.02 ± 0.05 | 0.06 ± 0.07 | 0.16 ± 0.05 | 0.21 ± 0.06 |
FeNO was a measure of nitric oxide in exhaled breath produced by epithelial cells in the lung and considered as a biomarker of Type-2 inflammation in asthma. FeNO levels were collected on site with a dedicated medical device. The FeNO test was completed prior to impulse oscillometry and spirometry. Baseline was defined as the last available value before the first dose of double-blind study treatment.
| parts/billion | Placebo | Amlitelimab 62.5 mg With 125 mg Loading Dose | Amlitelimab 125 mg With 250 mg Loading Dose | Amlitelimab 250 mg With 500 mg Loading Dose |
|---|---|---|---|---|
| Week 2 | 4.77 ± 2.05 | 3.19 ± 2.80 | 1.53 ± 2.05 | 2.71 ± 2.10 |
| Week 4 | 1.10 ± 1.81 | 3.65 ± 2.52 | -0.67 ± 1.84 | -2.37 ± 1.89 |
| Week 8 | 1.15 ± 2.06 | 2.11 ± 2.87 | -4.82 ± 2.09 | -2.52 ± 2.19 |
| Week 12 | 2.01 ± 2.20 | 0.87 ± 3.09 | -1.29 ± 2.24 | -5.52 ± 2.30 |
| Week 16 | 1.38 ± 2.48 | 0.16 ± 3.42 | -2.47 ± 2.47 | -4.28 ± 2.53 |
| Week 24 | -1.60 ± 2.25 | -2.77 ± 3.12 | -3.36 ± 2.28 | -6.52 ± 2.35 |
| Week 36 | -2.75 ± 2.36 | -4.09 ± 3.23 | -1.18 ± 2.37 | -6.23 ± 2.39 |
| Week 48 | -0.42 ± 2.61 | 0.45 ± 3.53 | -0.95 ± 2.64 | -5.73 ± 2.69 |
| Week 60 | 0.13 ± 2.28 | -2.89 ± 3.10 | -0.69 ± 2.31 | -6.80 ± 2.34 |
LOAC events were defined by one or several of the following criteria: a 30% or greater reduction from baseline in morning PEF on 2 consecutive days; \>=6 additional reliever puffs of short-acting beta 2-agonists (SABA) or \>=4 additional puffs of low-dose ICS/formoterol in a 24-hour period (compared to baseline) on 2 consecutive days; increase in ICS \>=4 times than the Visit 2 dose; worsening of asthma requiring the use of systemic corticosteroids for \>=3 days or, in the case of a stable maintenance regimen of OCS 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 severe exacerbation event. Annualized rate was the total number of severe asthma exacerbation events divided by the total observation duration and was estimated based on negative binomial regression.
| LOAC event/participant-year | Placebo | Amlitelimab 62.5 mg With 125 mg Loading Dose | Amlitelimab 125 mg With 250 mg Loading Dose | Amlitelimab 250 mg With 500 mg Loading Dose |
|---|---|---|---|---|
| Annualized Rate of Loss of Asthma Control (LOAC) Events Over 48 Weeks | 1.452 (0.958 to 2.198) | 1.103 (0.640 to 1.903) | 0.791 (0.511 to 1.226) | 1.079 (0.692 to 1.681) |
Time to first LOAC event was defined as the onset date of the first LOAC minus randomization date + 1. LOAC events were defined by one or several of the following criteria: a 30% or greater reduction from baseline in morning PEF on 2 consecutive days; \>=6 additional reliever puffs of SABA or \>=4 additional puffs of low-dose ICS/formoterol in a 24-hour period (compared to baseline) on 2 consecutive days; increase in ICS \>=4 times than the Visit 2 dose; worsening of asthma requiring the use of systemic corticosteroids for \>=3 days or, in the case of a stable maintenance regimen of OCS 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 severe exacerbation event.
| days | Placebo | Amlitelimab 62.5 mg With 125 mg Loading Dose | Amlitelimab 125 mg With 250 mg Loading Dose | Amlitelimab 250 mg With 500 mg Loading Dose |
|---|---|---|---|---|
| Time to First Loss of Asthma Control Event Over 48 Weeks | NA (225.00 to NA) | NA (250.00 to NA) | NA (NA to NA) | NA (251.00 to NA) |
ADSD and ANSD were PRO measures designed to measure asthma symptoms in adult and adolescent (\>=12 years of age) participants diagnosed with mild-to-severe asthma. Both scales assessed asthma severity based on participant self-report of asthma core symptoms, i.e., difficulty of breathing; wheezing; shortness of breath; chest tightness; chest pain; and cough. Participants were asked to complete ADSD every night before they go to bed, thinking about their asthma symptoms today, from when they got up this morning until now; ANSD when getting up, thinking about their asthma symptoms last night from when they went to bed until now. Both scales consisted 6 items rated using an 11-point numerical rating scale that ranged from 0 (none) to 10 (as bad as you can imagine). Total score was an average of all 6 items for ADSD and ANSD each and therefore ranged from 0 to 10. Higher scores indicated worse outcomes. Baseline: last available value before first dose of double-blind study treatment.
| score on a scale | Placebo | Amlitelimab 62.5 mg With 125 mg Loading Dose | Amlitelimab 125 mg With 250 mg Loading Dose | Amlitelimab 250 mg With 500 mg Loading Dose |
|---|---|---|---|---|
| ADSD Score: Week 2 | -0.23 ± 0.11 | -0.42 ± 0.14 | -0.32 ± 0.11 | -0.36 ± 0.11 |
| ADSD Score: Week 4 | -0.46 ± 0.11 | -0.41 ± 0.15 | -0.51 ± 0.12 | -0.53 ± 0.12 |
| ADSD Score: Week 8 | -0.65 ± 0.12 | -0.92 ± 0.17 | -0.82 ± 0.13 | -0.79 ± 0.13 |
| ADSD Score: Week 12 | -0.56 ± 0.13 | -0.88 ± 0.18 | -0.91 ± 0.13 | -0.78 ± 0.14 |
| ADSD Score: Week 24 | -0.67 ± 0.16 | -1.06 ± 0.20 | -0.88 ± 0.15 | -0.88 ± 0.16 |
| ADSD Score: Week 36 | -0.71 ± 0.17 | -1.07 ± 0.21 | -0.92 ± 0.17 | -0.91 ± 0.17 |
| ADSD Score: Week 48 | -0.67 ± 0.17 | -1.10 ± 0.22 | -0.99 ± 0.17 | -0.91 ± 0.17 |
| ADSD Score: Week 60 | -0.80 ± 0.17 | -1.11 ± 0.22 | -0.98 ± 0.17 | -0.94 ± 0.17 |
| ANSD Score: Week 2 | -0.17 ± 0.11 | -0.40 ± 0.14 | -0.17 ± 0.11 | -0.26 ± 0.11 |
| ANSD Score: Week 4 | -0.36 ± 0.12 | -0.40 ± 0.15 | -0.39 ± 0.12 | -0.40 ± 0.12 |
| ANSD Score: Week 8 | -0.54 ± 0.12 | -0.88 ± 0.17 | -0.73 ± 0.12 | -0.66 ± 0.13 |
| ANSD Score: Week 12 | -0.51 ± 0.13 | -0.81 ± 0.17 | -0.87 ± 0.13 | -0.69 ± 0.13 |
| ANSD Score: Week 24 | -0.61 ± 0.16 | -1.17 ± 0.20 | -0.81 ± 0.15 | -0.77 ± 0.16 |
| ANSD Score: Week 36 | -0.67 ± 0.17 | -1.06 ± 0.22 | -0.88 ± 0.17 | -0.86 ± 0.17 |
| ANSD Score: Week 48 | -0.62 ± 0.17 | -1.06 ± 0.22 | -0.92 ± 0.17 | -0.89 ± 0.17 |
| ANSD Score: Week 60 | -0.64 ± 0.17 | -1.07 ± 0.22 | -0.87 ± 0.17 | -0.84 ± 0.17 |
Severe asthma exacerbation event was defined as worsening of asthma requiring the use of systemic corticosteroids for \>=3 days or, in the case of a stable maintenance regimen of OCS 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. Severe asthma exacerbation events requiring hospitalization or emergency room or urgent care visit during the 48-week treatment period were recorded. Annualized rate was the total number of severe asthma exacerbation events divided by the total observation duration and was estimated based on negative binomial regression.
| exacerbation/participant-year | Placebo | Amlitelimab 62.5 mg With 125 mg Loading Dose | Amlitelimab 125 mg With 250 mg Loading Dose | Amlitelimab 250 mg With 500 mg Loading Dose |
|---|---|---|---|---|
| Annualized Rate of Severe Asthma Exacerbations Requiring Hospitalization or Emergency Room or Urgent Care Visit Over 48 Weeks | 0.000 (0.000 to NA) | 0.000 (0.000 to NA) | 0.000 (0.000 to NA) | 0.000 (0.000 to NA) |
Participants were administered SABA or low-dose ICS/formoterol via oral inhalation as reliever medication as needed during the study and the number of inhalations/day were recorded. Baseline was defined as last available value before first dose of double-blind study treatment.
| inhalations/day | Placebo | Amlitelimab 62.5 mg With 125 mg Loading Dose | Amlitelimab 125 mg With 250 mg Loading Dose | Amlitelimab 250 mg With 500 mg Loading Dose |
|---|---|---|---|---|
| Week 2 | 0.28 ± 0.21 | -0.06 ± 0.28 | 0.37 ± 0.21 | 0.05 ± 0.21 |
| Week 4 | 0.09 ± 0.19 | -0.21 ± 0.26 | -0.06 ± 0.19 | -0.23 ± 0.20 |
| Week 8 | -0.35 ± 0.19 | -0.31 ± 0.25 | -0.21 ± 0.19 | -0.52 ± 0.19 |
| Week 12 | -0.13 ± 0.20 | -0.24 ± 0.27 | -0.41 ± 0.20 | -0.64 ± 0.21 |
| Week 24 | -0.33 ± 0.24 | -0.01 ± 0.31 | -0.46 ± 0.24 | -0.44 ± 0.24 |
| Week 36 | -0.10 ± 0.26 | -0.12 ± 0.32 | -0.55 ± 0.24 | -0.62 ± 0.24 |
| Week 48 | -0.26 ± 0.25 | -0.10 ± 0.32 | -0.63 ± 0.25 | -0.68 ± 0.24 |
| Week 60 | -0.27 ± 0.30 | -0.29 ± 0.38 | -0.45 ± 0.30 | -0.54 ± 0.29 |
Blood samples were collected at the specified timepoints for measurement of serum concentrations of amlitelimab.
| microgram per milliliter | Amlitelimab 62.5 mg With 125 mg Loading Dose | Amlitelimab 125 mg With 250 mg Loading Dose | Amlitelimab 250 mg With 500 mg Loading Dose |
|---|---|---|---|
| Week 4 | 8.26 ± 3.57 | 18.14 ± 7.69 | 27.91 ± 10.35 |
| Week 8 | 8.26 ± 5.77 | 17.91 ± 6.44 | 29.97 ± 13.34 |
| Week 12 | 7.84 ± 3.42 | 18.41 ± 7.37 | 30.52 ± 13.63 |
| Week 16 | 8.41 ± 4.65 | 18.68 ± 7.06 | 30.60 ± 13.66 |
| Week 24 | 8.23 ± 3.42 | 19.97 ± 7.49 | 33.41 ± 19.97 |
| Week 36 | 1.79 ± 1.48 | 5.88 ± 3.87 | 9.31 ± 6.43 |
| Week 48 | 1.12 ± 0.85 | 3.88 ± 4.17 | 6.68 ± 4.87 |
| Week 60 | 0.99 ± 0.80 | 3.29 ± 2.16 | 6.31 ± 6.41 |
Serum samples were collected to evaluate antibodies to amlitelimab. Participants with treatment-emergent ADAs were participants with at least one treatment-induced/boosted ADA. Participants with treatment-induced ADAs were participants with ADAs that developed during the treatment-emergent (TE) period and without pre-existing ADA (including participants without pre-treatment samples). Participants with treatment-boosted ADAs were participants with pre-existing ADAs that were boosted during the TE period to a significant higher titer than the baseline. Number of participants with treatment-emergent ADAs are reported.
| Participants | Amlitelimab 62.5 mg With 125 mg Loading Dose | Amlitelimab 125 mg With 250 mg Loading Dose | Amlitelimab 250 mg With 500 mg Loading Dose |
|---|---|---|---|
| Number of Participants With Anti-Drug Antibodies (ADA) to Amlitelimab | 8 | 8 | 7 |
Adverse event (AE): any untoward medical occurrence in participant or clinical study participant, temporally associated with use of study treatment, whether or not considered related to study treatment. TEAEs: AEs that developed, worsened or became serious during TE period. Serious AE: any untoward medical occurrence that at any dose, met one or more of criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was congenital anomaly/birth defect or was significant medical event that jeopardized the participant or required medical or surgical intervention to prevent one of above outcomes. AESI: AE (serious or non-serious) of scientific and medical concern specific to Sponsor's product or program, for which ongoing monitoring and immediate notification by Investigator to Sponsor was required. Percentages are rounded off to tenth decimal place.
| percentage of participants | Placebo | Amlitelimab 62.5 mg With 125 mg Loading Dose | Amlitelimab 125 mg With 250 mg Loading Dose | Amlitelimab 250 mg With 500 mg Loading Dose |
|---|---|---|---|---|
| Any TEAE | 74.8 | 78.7 | 76.0 | 75.8 |
| Any TEAESI | 6.3 | 6.6 | 3.2 | 4.0 |
| Any TESAE | 8.7 | 9.8 | 8.0 | 9.7 |
The AQLQ(S) was a self-administered PRO to measure the functional impairments that were most troublesome to adolescents and adults \>=12 years of age as a result of their asthma over the past two weeks. The instrument comprised of 32 items, each rated on a 7-point Likert scales from 1 to (severely impaired) to 7 (not impaired). The AQLQ(S) had 4 domains: symptoms (12 items), activity limitation (11 items, 5 of which were individualized), emotional function (5 items), and environmental exposure (4 items). The global score was the mean of response to each of the 32 questions and ranged from 1 (severe impairment) to 7 (no impairment). Higher scores indicated better quality of life. Baseline was defined as the last available value before the first dose of double-blind study treatment.
| score on a scale | Placebo | Amlitelimab 62.5 mg With 125 mg Loading Dose | Amlitelimab 125 mg With 250 mg Loading Dose | Amlitelimab 250 mg With 500 mg Loading Dose |
|---|---|---|---|---|
| Week 2 | 0.40 ± 0.08 | 0.55 ± 0.11 | 0.34 ± 0.09 | 0.54 ± 0.09 |
| Week 4 | 0.57 ± 0.09 | 0.80 ± 0.13 | 0.43 ± 0.10 | 0.63 ± 0.10 |
| Week 8 | 0.61 ± 0.09 | 1.03 ± 0.13 | 0.67 ± 0.10 | 0.88 ± 0.10 |
| Week 12 | 0.62 ± 0.10 | 1.01 ± 0.14 | 0.75 ± 0.10 | 0.94 ± 0.10 |
| Week 24 | 0.83 ± 0.11 | 1.18 ± 0.14 | 0.93 ± 0.11 | 1.04 ± 0.11 |
| Week 36 | 0.84 ± 0.11 | 1.26 ± 0.15 | 0.93 ± 0.11 | 1.12 ± 0.11 |
| Week 60 | 0.76 ± 0.12 | 1.16 ± 0.15 | 0.98 ± 0.12 | 1.11 ± 0.12 |
SGRQ was 50-item questionnaire to measure and quantify health status in adult participants with chronic airflow limitation and consisted of three domains: symptoms (8 items \[covered symptomatology, frequency and severity of cough, sputum production, wheeze, breathlessness, duration and frequency of attacks of breathlessness/wheeze\]), activity (16 items \[covered disturbances to participants' daily physical activities\]), impacts (26 items \[covered effects that chest troubles had on participants' daily life and psycho-social functions\]). Global score was calculated by summing all positive responses in questionnaire and expressing result as percentage of total weight for questionnaire. Global and domain scores ranged from 0 to 100 with 100=worst possible health status and 0=best possible health status. Higher score=worse health status/heath related quality of life. Baseline: last available value before first dose of double-blind study treatment.
| score on a scale | Placebo | Amlitelimab 62.5 mg With 125 mg Loading Dose | Amlitelimab 125 mg With 250 mg Loading Dose | Amlitelimab 250 mg With 500 mg Loading Dose |
|---|---|---|---|---|
| Week 2 | -4.06 ± 1.33 | -5.01 ± 1.72 | -4.14 ± 1.34 | -5.36 ± 1.39 |
| Week 4 | -6.08 ± 1.54 | -9.31 ± 2.07 | -4.95 ± 1.55 | -9.87 ± 1.60 |
| Week 8 | -7.53 ± 1.54 | -13.03 ± 2.06 | -9.48 ± 1.56 | -13.47 ± 1.61 |
| Week 12 | -8.37 ± 1.65 | -13.73 ± 2.18 | -11.64 ± 1.66 | -14.86 ± 1.69 |
| Week 24 | -12.94 ± 1.77 | -17.89 ± 2.33 | -14.01 ± 1.80 | -17.31 ± 1.81 |
| Week 36 | -13.36 ± 1.89 | -17.37 ± 2.51 | -16.84 ± 1.92 | -18.20 ± 1.92 |
| Week 48 | -12.21 ± 1.99 | -17.23 ± 2.61 | -14.75 ± 2.00 | -19.82 ± 2.02 |
| Week 60 | -11.97 ± 1.96 | -18.08 ± 2.56 | -16.23 ± 2.01 | -20.04 ± 1.97 |
SGRQ was 50-item questionnaire to measure and quantify health status in adult participants with chronic airflow limitation and consisted of three domains: symptoms (8 items\[covered symptomatology, frequency and severity of cough, sputum production, wheeze, breathlessness, duration and frequency of attacks of breathlessness/wheeze\]), activity (16 items\[covered disturbances to participants' daily physical activities\]), impacts (26 items\[covered effects that chest troubles had on participants' daily life and psycho-social functions\]). Global score was calculated by summing all positive responses in questionnaire and expressing result as percentage of total weight for questionnaire. Global and domain scores ranged from 0 to 100; 100=worst possible health status and 0=best possible health status. Higher score=worse health status/heath related quality of life. Baseline:last available value before first dose of double-blind study treatment. Percentages are rounded off to tenth decimal place.
| percentage of participants | Placebo | Amlitelimab 62.5 mg With 125 mg Loading Dose | Amlitelimab 125 mg With 250 mg Loading Dose | Amlitelimab 250 mg With 500 mg Loading Dose |
|---|---|---|---|---|
| Percentage of Participants With a Decrease From Baseline of at Least 4 Points in St. George's Respiratory Questionnaire Total Score at Week 48 | 48.8 | 65.6 | 58.4 | 66.1 |
The ACQ was a questionnaire that measured the adequacy of asthma control and any changes in asthma control that occurred spontaneously or as a result of treatment. The ACQ-5 had five questions on the asthma symptoms and participants were asked to recall how their asthma had been during the previous week. The ACQ-6 included an additional item that scored the average number of daily puffs needed from a SABA BD during the past week and the ACQ-7 included this SABA item, plus a final clinic-assessed item scoring FEV1% predicted. Each item of the ACQ was measured on a 7-point response scale (0=no impairment, 6=maximum impairment). The ACQ-6 and ACQ-7 scores were the mean of the item responses in the respective scales and ranged from 0 (totally controlled) and 6 (severely uncontrolled). A high score indicated low asthma control. Baseline was defined as the last available value before the first dose of double-blind study treatment.
| score on a scale | Placebo | Amlitelimab 62.5 mg With 125 mg Loading Dose | Amlitelimab 125 mg With 250 mg Loading Dose | Amlitelimab 250 mg With 500 mg Loading Dose |
|---|---|---|---|---|
| ACQ-6: Week 2 | -0.42 ± 0.09 | -0.46 ± 0.12 | -0.33 ± 0.09 | -0.52 ± 0.09 |
| ACQ-6: Week 4 | -0.65 ± 0.10 | -0.74 ± 0.13 | -0.51 ± 0.10 | -0.69 ± 0.10 |
| ACQ-6: Week 8 | -0.59 ± 0.09 | -0.95 ± 0.12 | -0.75 ± 0.09 | -0.91 ± 0.10 |
| ACQ-6: Week 12 | -0.66 ± 0.09 | -1.00 ± 0.13 | -0.87 ± 0.10 | -0.93 ± 0.10 |
| ACQ-6: Week 24 | -0.90 ± 0.10 | -1.14 ± 0.13 | -0.98 ± 0.10 | -1.17 ± 0.10 |
| ACQ-6: Week 36 | -0.87 ± 0.10 | -1.04 ± 0.14 | -1.00 ± 0.10 | -1.16 ± 0.11 |
| ACQ-6: Week 48 | -0.77 ± 0.11 | -1.01 ± 0.14 | -1.01 ± 0.11 | -1.18 ± 0.11 |
| ACQ-6: Week 60 | -0.74 ± 0.11 | -1.14 ± 0.14 | -0.98 ± 0.11 | -1.09 ± 0.11 |
| ACQ-7: Week 2 | -0.40 ± 0.08 | -0.48 ± 0.11 | -0.30 ± 0.08 | -0.52 ± 0.08 |
| ACQ-7: Week 4 | -0.59 ± 0.09 | -0.71 ± 0.12 | -0.48 ± 0.09 | -0.64 ± 0.09 |
| ACQ-7: Week 8 | -0.55 ± 0.08 | -0.93 ± 0.11 | -0.72 ± 0.09 | -0.87 ± 0.09 |
| ACQ-7: Week 12 | -0.61 ± 0.09 | -0.95 ± 0.12 | -0.83 ± 0.09 | -0.86 ± 0.09 |
| ACQ-7: Week 24 | -0.83 ± 0.09 | -1.07 ± 0.12 | -0.92 ± 0.09 | -1.11 ± 0.09 |
| ACQ-7: Week 36 | -0.80 ± 0.10 | -1.00 ± 0.13 | -0.93 ± 0.10 | -1.08 ± 0.10 |
| ACQ-7: Week 48 | -0.72 ± 0.10 | -0.93 ± 0.13 | -0.94 ± 0.10 | -1.09 ± 0.10 |
| ACQ-7: Week 60 | -0.68 ± 0.10 | -1.07 ± 0.14 | -0.93 ± 0.10 | -1.06 ± 0.11 |
Collected over Adverse events and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 168 days, approximately 88 weeks.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/127 (0%) | 11/127 (8.7%) | 76/127 (59.8%) |
| Amlitelimab 62.5 mg With 125 mg Loading Dose | 1/61 (1.6%) | 6/61 (9.8%) | 32/61 (52.5%) |
| Amlitelimab 125 mg With 250 mg Loading Dose | 2/125 (1.6%) | 10/125 (8%) | 63/125 (50.4%) |
| Amlitelimab 250 mg With 500 mg Loading Dose | 0/124 (0%) | 12/124 (9.7%) | 75/124 (60.5%) |
| Event | Placebo | Amlitelimab 62.5 mg With 125 mg Loading Dose | Amlitelimab 125 mg With 250 mg Loading Dose | Amlitelimab 250 mg With 500 mg Loading Dose |
|---|---|---|---|---|
| AsthmaRespiratory, thoracic and mediastinal disorders | 4/127 | 0/61 | 1/125 | 1/124 |
| InfluenzaInfections and infestations | 0/127 | 1/61 | 0/125 | 0/124 |
| PneumoniaInfections and infestations | 2/127 | 1/61 | 1/125 | 0/124 |
| Pyelonephritis AcuteInfections and infestations | 0/127 | 1/61 | 0/125 | 1/124 |
| Acute Left Ventricular FailureCardiac disorders | 0/127 | 1/61 | 0/125 | 0/124 |
| Renovascular HypertensionVascular disorders | 0/127 | 1/61 | 0/125 | 0/124 |
| CholelithiasisHepatobiliary disorders | 0/127 | 1/61 | 0/125 | 1/124 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 0/127 | 1/61 | 0/125 | 0/124 |
| Strangulated Incisional HerniaInjury, poisoning and procedural complications | 0/127 | 1/61 | 0/125 | 0/124 |
| Acute Myocardial InfarctionCardiac disorders | 0/127 | 0/61 | 2/125 | 0/124 |
| Event | Placebo | Amlitelimab 62.5 mg With 125 mg Loading Dose | Amlitelimab 125 mg With 250 mg Loading Dose | Amlitelimab 250 mg With 500 mg Loading Dose |
|---|---|---|---|---|
| AsthmaRespiratory, thoracic and mediastinal disorders | 53/127 | 21/61 | 36/125 | 48/124 |
| Covid-19Infections and infestations | 8/127 | 5/61 | 12/125 | 13/124 |
| BronchitisInfections and infestations | 8/127 | 5/61 | 13/125 | 12/124 |
| NasopharyngitisInfections and infestations | 13/127 | 6/61 | 8/125 | 9/124 |
| Upper Respiratory Tract InfectionInfections and infestations | 11/127 | 5/61 | 8/125 | 9/124 |
| Acute SinusitisInfections and infestations | 2/127 | 5/61 | 3/125 | 7/124 |
| HeadacheNervous system disorders | 4/127 | 5/61 | 3/125 | 7/124 |
| Urinary Tract InfectionInfections and infestations | 8/127 | 1/61 | 3/125 | 5/124 |
| PharyngitisInfections and infestations | 7/127 | 1/61 | 3/125 | 7/124 |
| InfluenzaInfections and infestations | 7/127 | 2/61 | 7/125 | 4/124 |
Randomized population included all participants from screened population who had been allocated to a randomized treatment by interactive voice/web response system regardless of whether the treatment was received or not.
| Age, Continuous(years) | Placebo | Amlitelimab 62.5 mg With 125 mg Loading Dose | Amlitelimab 125 mg With 250 mg Loading Dose | Amlitelimab 250 mg With 500 mg Loading Dose | Total |
|---|---|---|---|---|---|
| Mean | 52.1 ± 13.1 | 55.4 ± 12.5 | 52.8 ± 13.0 | 54.4 ± 12.8 | 53.4 ± 12.9 |
| Sex: Female, Male(Participants) | Placebo | Amlitelimab 62.5 mg With 125 mg Loading Dose | Amlitelimab 125 mg With 250 mg Loading Dose | Amlitelimab 250 mg With 500 mg Loading Dose | Total |
|---|---|---|---|---|---|
| Female | 97 | 47 | 74 | 84 | 302 |
| Male | 30 | 14 | 51 | 40 | 135 |
| Race (NIH/OMB)(Participants) | Placebo | Amlitelimab 62.5 mg With 125 mg Loading Dose | Amlitelimab 125 mg With 250 mg Loading Dose | Amlitelimab 250 mg With 500 mg Loading Dose | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 2 | 1 | 4 |
| Asian | 11 | 6 | 8 | 7 | 32 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 3 | 5 | 11 | 9 | 28 |
| White | 106 | 48 | 101 | 103 | 358 |
| More than one race | 2 | 1 | 0 | 2 | 5 |
| Unknown or Not Reported | 4 | 1 | 3 | 2 | 10 |
Showing the first 100 of 113 sites across 14 countries.
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Plan to share: Yes — 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
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