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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1272-2612 | Registry Identifier | ICTRP | |
| 2024-510641-33 | Registry Identifier | CTIS | |
| 2022-000065-41 | EudraCT Number |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amlitelimab 62.5 mg With 125 mg Loading Dose | Experimental | 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. |
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| Amlitelimab 125 mg With 250 mg Loading Dose | Experimental | 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. |
|
| Amlitelimab 250 mg With 500 mg Loading Dose | Experimental | 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. |
|
| Placebo | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amlitelimab | Drug | Injection solution Subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (Day 1) to Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Diego Health Site Number : 8400026 | La Jolla | California | 92093-0990 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39393433 | Derived | Seluk L, Davis AE, Rhoads S, Wechsler ME. Novel asthma treatments: Advancing beyond approved novel step-up therapies for asthma. Ann Allergy Asthma Immunol. 2025 Jan;134(1):9-18. doi: 10.1016/j.anai.2024.09.016. Epub 2024 Oct 10. |
| Label | URL |
|---|---|
| DRI17509 Plain Language Results Summary | View source |
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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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A total of 437 participants were randomized in a ratio of 2:1:2:2 to one of the following groups: placebo, amlitelimab 62.5 milligrams (mg) with 125 mg loading dose, amlitelimab 125 mg with 250 mg loading dose, or amlitelimab 250 mg with 500 mg loading dose. Randomization was stratified by region, screening blood eosinophil count (<300 cells per [/] microliter [mcL] and >=300 cells/mcL), and number of severe asthma exacerbations in the previous 12 months (=1 or >1 exacerbations).
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received amlitelimab matching placebo subcutaneous (SC) injection on Day 1 followed by every 4 weeks (Q4W) until Week 20 (inclusive) and every 12 weeks (Q12W) starting from Week 24 until Week 48. |
| FG001 | Amlitelimab 62.5 mg With 125 mg Loading Dose |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 14, 2023 | Mar 9, 2026 |
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|
| Placebo | Drug | Injection solution Subcutaneous injection |
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline (Day 1) and Weeks 2, 4, 8, 12, 24, 36, 48, and 60 |
| California Allergy and Asthma Medical Group, Inc. Site Number : 8400002 |
| Los Angeles |
| California |
| 90025 |
| United States |
| Allergy Asthma Associates of Santa Clara Valley Site Number : 8400019 | San Jose | California | 95117 | United States |
| Bensch Clinical Research LLC Site Number : 8400004 | Stockton | California | 95207 | United States |
| Allianz Research Institute Site Number : 8400023 | Westminster | California | 92683 | United States |
| Helix Biomedics, LLC Site Number : 8400029 | Boynton Beach | Florida | 33435 | United States |
| Renaissance Research and Medical Group, Inc Site Number : 8400030 | Cape Coral | Florida | 33991 | United States |
| Beautiful Minds Clinical Research Center Site Number : 8400027 | Cutler Bay | Florida | 33157 | United States |
| Reliable Clinical Research, LLC Site Number : 8400020 | Hialeah | Florida | 33012-5853 | United States |
| Savin Medical Group, LLC Site Number : 8400015 | Miami | Florida | 33126 | United States |
| Pines Care Research Center LLC Site Number : 8400028 | Pembroke Pines | Florida | 33023 | United States |
| Treasure Valley Medical Research Site Number : 8400031 | Boise | Idaho | 83706 | United States |
| The South Bend Clinic, LLC Site Number : 8400033 | South Bend | Indiana | 46617 | United States |
| University of Kansas Medical Center Site Number : 8400016 | Kansas City | Kansas | 66103 | United States |
| Johns Hopkins University School of Medicine Site Number : 8400012 | Baltimore | Maryland | 21224 | United States |
| Headlands Research Detroit Site Number : 8400032 | Southfield | Michigan | 48034 | United States |
| Henderson Clinical Trials Site Number : 8400037 | Henderson | Nevada | 89052 | United States |
| Asthma and Allergy Center Site Number : 8400005 | Toledo | Ohio | 43617 | United States |
| OK Clinical Research, LLC Site Number : 8400001 | Edmond | Oklahoma | 73034 | United States |
| Allergy, Asthma and Clinical Research Center Site Number : 8400035 | Oklahoma City | Oklahoma | 73120 | United States |
| TTS Research Site Number : 8400011 | Boerne | Texas | 78006 | United States |
| Investigational Site Number : 0320001 | CABA | Buenos Aires | C1425BEN | Argentina |
| Investigational Site Number : 0320002 | CABA | Buenos Aires | C1425FVH | Argentina |
| Investigational Site Number : 0320008 | La Plata | Buenos Aires | B1900BNN | Argentina |
| Investigational Site Number : 0320009 | Buenos Aires | Buenos Aires F.D. | 1060 | Argentina |
| Investigational Site Number : 0320006 | Rosario | Santa Fe Province | 2000 | Argentina |
| Investigational Site Number : 0320007 | Rosario | Santa Fe Province | S2000DEJ | Argentina |
| Investigational Site Number : 0320005 | Rosario | Santa Fe Province | S2000JKR | Argentina |
| Investigational Site Number : 0320004 | Buenos Aires | C1121ABE | Argentina |
| Investigational Site Number : 0320003 | Ciudad Autonoma Buenos Aires | C1414AIF | Argentina |
| CEDOES - Centro de Diagnostico e Pesquisa de Osteoporose do ES Site Number : 0760002 | Vitória | Espírito Santo | 29055 450 | Brazil |
| Proar Site Number : 0760004 | Salvador | Estado de Bahia | 40060-330 | Brazil |
| Centro Avancado de Oncologia CECAN - Liga Contra o Cancer Site Number : 0760010 | Natal | Rio Grande do Norte | 59062-000 | Brazil |
| Instituto Mederi de Pesquisa e Saude Site Number : 0760001 | Passo Fundo | Rio Grande do Sul | 99010-120 | Brazil |
| Irmandade da Santa Casa de Misericordia de Porto Alegre Site Number : 0760007 | Porto Alegre | Rio Grande do Sul | 90020-090 | Brazil |
| Hospital Sao Lucas da PUCRS Site Number : 0760006 | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Hospital das Clinicas de Sao Paulo Site Number : 0760008 | São Paulo | São Paulo | 05403-000 | Brazil |
| Clinica de Alergia Martti Antila Site Number : 0760003 | Sorocaba | São Paulo | 18040-425 | Brazil |
| Investigational Site Number : 1240006 | Brampton | Ontario | L6T 0G1 | Canada |
| Investigational Site Number : 1240008 | Ottawa | Ontario | K1H 1E4 | Canada |
| Investigational Site Number : 1240005 | Toronto | Ontario | M5T 3A9 | Canada |
| Investigational Site Number : 1240007 | Trois-Rivières | Quebec | G8T 7A1 | Canada |
| Investigational Site Number : 1240003 | Québec | G1V 4G5 | Canada |
| Investigational Site Number : 1520006 | Talca | Maule Region | Chile |
| Investigational Site Number : 1520007 | Santiago | Reg Metropolitana de Santiago | 7500010 | Chile |
| Investigational Site Number : 1520001 | Santiago | Reg Metropolitana de Santiago | 7500692 | Chile |
| Investigational Site Number : 1520002 | Santiago | Reg Metropolitana de Santiago | 7500698 | Chile |
| Investigational Site Number : 1520009 | Santiago | Reg Metropolitana de Santiago | 7640881 | Chile |
| Investigational Site Number : 1520008 | Santiago | Reg Metropolitana de Santiago | 8380465 | Chile |
| Investigational Site Number : 1520003 | Santiago | Reg Metropolitana de Santiago | 8910131 | Chile |
| Investigational Site Number : 1520005 | Quillota | Valparaiso | 2260877 | Chile |
| Investigational Site Number : 3480007 | Budapest | 1033 | Hungary |
| Investigational Site Number : 3480009 | Edelény | 3780 | Hungary |
| Investigational Site Number : 3480011 | Gödöllö | 2100 | Hungary |
| Investigational Site Number : 3480002 | Hajdunánás | 4080 | Hungary |
| Investigational Site Number : 3480004 | Mosonmagyaróvár | 9200 | Hungary |
| Investigational Site Number : 3480006 | Püspökladány | 4150 | Hungary |
| Investigational Site Number : 3480012 | Százhalombatta | 2440 | Hungary |
| Investigational Site Number : 3480003 | Szombathely | 9700 | Hungary |
| Investigational Site Number : 3800002 | Cona (FE) | Emilia-Romagna | 44124 | Italy |
| Investigational Site Number : 3800003 | Rome | Lazio | 00168 | Italy |
| Investigational Site Number : 3800004 | Naples | 80131 | Italy |
| Investigational Site Number : 3800001 | Verona | 37134 | Italy |
| Investigational Site Number : 3920014 | Narita-shi | Chiba | 286-8520 | Japan |
| Investigational Site Number : 3920002 | Kamakura-shi | Kanagawa | 247-0072 | Japan |
| Investigational Site Number : 3920016 | Yokohama | Kanagawa | 223-0059 | Japan |
| Investigational Site Number : 3920006 | Yokohama | Kanagawa | 245-8575 | Japan |
| Investigational Site Number : 3920013 | Nankoku-shi | Kochi | 783-8509 | Japan |
| Investigational Site Number : 3920015 | Kumamoto | Kumamoto | 860-8556 | Japan |
| Investigational Site Number : 3920010 | Sakai-shi | Osaka | 591-8555 | Japan |
| Investigational Site Number : 3920017 | Chuo-ku | Tokyo | 103-0022 | Japan |
| Investigational Site Number : 3920005 | Chuo-ku | Tokyo | 103-0027 | Japan |
| Investigational Site Number : 3920004 | Chuo-ku | Tokyo | 104-0031 | Japan |
| Investigational Site Number : 3920020 | Kiyose-shi | Tokyo | 204-8585 | Japan |
| Investigational Site Number : 3920001 | Shinagawa-ku | Tokyo | 140-8522 | Japan |
| Investigational Site Number : 3920011 | Shinjuku-ku | Tokyo | 162-8655 | Japan |
| Investigational Site Number : 3920009 | Tachikawa-shi | Tokyo | 190-0014 | Japan |
| Investigational Site Number : 3920018 | Toshima-ku | Tokyo | 170-0003 | Japan |
| Investigational Site Number : 3920008 | Fukuoka | 811-1394 | Japan |
| Investigational Site Number : 3920019 | Hiroshima | 730-0013 | Japan |
| Investigational Site Number : 4840001 | Guadalajara | Jalisco | 44100 | Mexico |
| Investigational Site Number : 4840005 | Guadalajara | Jalisco | 44670 | Mexico |
| Investigational Site Number : 4840002 | Chihuahua City | 31000 | Mexico |
| Investigational Site Number : 4840004 | Durango, Durango | 34080 | Mexico |
| Investigational Site Number : 4840006 | Tlalnepantla | 54055 | Mexico |
| Investigational Site Number : 4840008 | Yucatán | 97070 | Mexico |
| Investigational Site Number : 6160001 | Poznan | Greater Poland Voivodeship | 60-693 | Poland |
| Investigational Site Number : 6160006 | Krakow | Lesser Poland Voivodeship | 31-559 | Poland |
| Investigational Site Number : 6160004 | Bialystok | Podlaskie Voivodeship | 15-044 | Poland |
| Investigational Site Number : 6160003 | Elblag | 82-300 | Poland |
| Investigational Site Number : 6160002 | Gdansk | 80344 | Poland |
| Investigational Site Number : 6160007 | Tarnów | 33-100 | Poland |
| Investigational Site Number : 7100007 | Benoni | 1501 | South Africa |
| Investigational Site Number : 7100002 | Cape Town | 7530 | South Africa |
| Investigational Site Number : 7100005 | Cape Town | 7530 | South Africa |
| Investigational Site Number : 7100001 | Cape Town | 7937 | South Africa |
| Investigational Site Number : 7100003 | Durban | 4071 | South Africa |
| Investigational Site Number : 7100006 | George | 6530 | South Africa |
| Investigational Site Number : 7100008 | Johannesburg | 1401 | South Africa |
| Investigational Site Number : 7100004 | Middelburg | 1055 | South Africa |
| Investigational Site Number : 4100004 | Daegu | Daegu | 42415 | South Korea |
| Investigational Site Number : 4100003 | Seoul | Seoul-teukbyeolsi | 03312 | South Korea |
| Investigational Site Number : 4100001 | Seoul | Seoul-teukbyeolsi | 03722 | South Korea |
| Investigational Site Number : 4100005 | Seoul | Seoul-teukbyeolsi | 05030 | South Korea |
| Investigational Site Number : 4100002 | Seoul | Seoul-teukbyeolsi | 138-878 | South Korea |
| Investigational Site Number : 4100006 | Seoul | Seoul-teukbyeolsi | South Korea |
| Investigational Site Number : 4100007 | Seongnam-si, Gyeonggi-do | 13620 | South Korea |
| Investigational Site Number : 7920001 | Istanbul | 34303 | Turkey (Türkiye) |
| Investigational Site Number : 7920003 | Izmir | 35100 | Turkey (Türkiye) |
| Investigational Site Number : 7920008 | Kayseri | 38039 | Turkey (Türkiye) |
| Investigational Site Number : 7920005 | Kocaeli | 41100 | Turkey (Türkiye) |
| Investigational Site Number : 7920002 | Mersin | 33070 | Turkey (Türkiye) |
| Investigational Site Number : 8260001 | Bradford | BD9 6RJ | United Kingdom |
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. |
| FG002 | Amlitelimab 125 mg With 250 mg Loading Dose | 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. |
| FG003 | Amlitelimab 250 mg With 500 mg Loading Dose | 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. |
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| NOT COMPLETED |
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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.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | 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. |
| BG001 | Amlitelimab 62.5 mg With 125 mg Loading Dose | 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. |
| BG002 | Amlitelimab 125 mg With 250 mg Loading Dose | 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. |
| BG003 | Amlitelimab 250 mg With 500 mg Loading Dose | 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. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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. | Intent-to-treat (ITT) population included all randomized participants. | Posted | Number | 95% Confidence Interval | exacerbation/participant-year | Baseline (Day 1) to Week 48 |
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| Secondary | 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. | ITT population included all randomized participants. Only participants with data collected are reported. | Posted | Least Squares Mean | Standard Error | liters | Baseline (Day 1) and Week 48 |
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| Secondary | 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. | ITT population included all randomized participants. Only participants with data collected are reported. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline (Day 1) and Week 48 |
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| Secondary | 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. | ITT population included all randomized participants. Only participants with data collected are reported. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline (Day 1) and Week 48 |
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| Secondary | 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. | ITT population included all randomized participants. Only participants with data collected are reported. | Posted | Least Squares Mean | Standard Error | liters | Baseline (Day 1) and Week 48 |
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| Secondary | 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. | ITT population included all randomized participants. Only participants with data collected for the specified categories are reported. | Posted | Least Squares Mean | Standard Error | percent predicted FEV1 | Baseline (Day 1) and Week 48 |
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| Secondary | 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. | ITT population included all randomized participants. During the study, participants missed few scheduled site visits for data collection, and only participants with data collected at specified timepoints are reported. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline (Day 1) and Weeks 2, 4, 8, 12, 24, 36, and 60 |
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| Secondary | 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. | ITT population included all randomized participants. | Posted | Median | 95% Confidence Interval | days | Baseline (Day 1) to Week 48 |
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| Secondary | 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. | ITT population included all randomized participants. During the study, participants missed few scheduled site visits for data collection, and only participants with data collected at specified timepoints for the specified categories are reported. | Posted | Least Squares Mean | Standard Error | liters | 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 |
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| Secondary | 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. | ITT population included all randomized participants. During the study, participants missed few scheduled site visits for data collection, and only participants with data collected at specified timepoints for the specified categories are reported. | Posted | Least Squares Mean | Standard Error | liters/second | 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 |
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| Secondary | 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. | ITT population included all randomized participants. During the study, participants missed few scheduled site visits for data collection, and only participants with data collected at specified timepoints for the specified categories are reported. | Posted | Least Squares Mean | Standard Error | liters | 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 |
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| Secondary | 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. | ITT population included all randomized participants. During the study, participants missed few scheduled site visits for data collection, and only participants with data collected at specified timepoints for the specified categories are reported. | Posted | Least Squares Mean | Standard Error | liters/second | 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 |
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| Secondary | 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. | ITT population included all randomized participants. During the study, participants missed few scheduled site visits for data collection, and only participants with data collected at specified timepoints are reported. | Posted | Least Squares Mean | Standard Error | parts/billion | Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 24, 36, 48, and 60 |
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| Secondary | 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. | ITT population included all randomized participants. | Posted | Number | 95% Confidence Interval | LOAC event/participant-year | Baseline (Day 1) to Week 48 |
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| Secondary | 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. | ITT population included all randomized participants. | Posted | Median | 95% Confidence Interval | days | Baseline (Day 1) to Week 48 |
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| Secondary | 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. | ITT population included all randomized participants. During the study, participants missed few scheduled site visits for data collection, and only participants with data collected at specified timepoints for the specified categories are reported. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline (Day 1) and Weeks 2, 4, 8, 12, 24, 36, 48, and 60 |
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| Secondary | 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. | ITT population included all randomized participants. | Posted | Number | 95% Confidence Interval | exacerbation/participant-year | Baseline (Day 1) to Week 48 |
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| Secondary | 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. | ITT population included all randomized participants. During the study, participants missed few scheduled site visits for data collection, and only participants with data collected at specified timepoints are reported. | Posted | Least Squares Mean | Standard Error | inhalations/day | Baseline (Day 1) and Weeks 2, 4, 8, 12, 24, 36, 48, and 60 |
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| Secondary | Serum Amlitelimab Concentrations | Blood samples were collected at the specified timepoints for measurement of serum concentrations of amlitelimab. | Pharmacokinetic (PK) population included all participants from the safety population with at least one post-baseline PK result with adequate documentation of dosing and sampling dates and times. During the study, participants missed few scheduled site visits for data collection, and only participants with data collected at specified timepoints are reported. | Posted | Mean | Standard Deviation | microgram per milliliter | Weeks 4, 8, 12, 16, 24, 36, 48, and 60 |
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| Secondary | 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. | ADA population included all participants from the safety population treated with amlitelimab with at least one post-baseline ADA result (positive, negative or inconclusive). | Posted | Count of Participants | Participants | From first dose of study treatment (Day 1) up to end of study visit (Week 72) |
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| Secondary | 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. | Safety population included all randomized participants who took at least one dose of study treatment, regardless of the amount of treatment administered. | Posted | Number | percentage of participants | From first dose of study treatment (Day 1) up to last dose of study treatment + 168 days, approximately 88 weeks |
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| Secondary | 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. | ITT population included all randomized participants. During the study, participants missed few scheduled site visits for data collection, and only participants with data collected at specified timepoints are reported. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline (Day 1) and Weeks 2, 4, 8, 12, 24, 36, and 60 |
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| Secondary | 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. | ITT population included all randomized participants. During the study, participants missed few scheduled site visits for data collection, and only participants with data collected at specified timepoints are reported. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline (Day 1) and Weeks 2, 4, 8, 12, 24, 36, 48, and 60 |
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| Secondary | 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. | ITT population included all randomized participants. | Posted | Number | percentage of participants | Baseline (Day 1) to Week 48 |
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| Secondary | 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. | ITT population included all randomized participants. During the study, participants missed few scheduled site visits for data collection, and only participants with data collected at specified timepoints for specified categories are reported. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline (Day 1) and Weeks 2, 4, 8, 12, 24, 36, 48, and 60 |
|
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.
Analysis was performed on the safety population.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | 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. | 0 | 127 | 11 | 127 | 76 | 127 |
| EG001 | Amlitelimab 62.5 mg With 125 mg Loading Dose | 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. | 1 | 61 | 6 | 61 | 32 | 61 |
| EG002 | Amlitelimab 125 mg With 250 mg Loading Dose | 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. | 2 | 125 | 10 | 125 | 63 | 125 |
| EG003 | Amlitelimab 250 mg With 500 mg Loading Dose | 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. | 0 | 124 | 12 | 124 | 75 | 124 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Influenza | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Oral Fungal Infection | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Pneumonia Bacterial | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Pneumonia Pseudomonal | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Pyelonephritis Acute | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Tracheobronchitis | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Papillary Cystadenoma Lymphomatosum | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 27.1 | Systematic Assessment |
| |
| Anaphylactic Reaction | Immune system disorders | MedDra 27.1 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDra 27.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDra 27.1 | Systematic Assessment |
| |
| Temporal Lobe Epilepsy | Nervous system disorders | MedDra 27.1 | Systematic Assessment |
| |
| Acute Left Ventricular Failure | Cardiac disorders | MedDra 27.1 | Systematic Assessment |
| |
| Acute Myocardial Infarction | Cardiac disorders | MedDra 27.1 | Systematic Assessment |
| |
| Angina Pectoris | Cardiac disorders | MedDra 27.1 | Systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDra 27.1 | Systematic Assessment |
| |
| Hypertensive Emergency | Vascular disorders | MedDra 27.1 | Systematic Assessment |
| |
| Renovascular Hypertension | Vascular disorders | MedDra 27.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Pulmonary Hypertension | Respiratory, thoracic and mediastinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Enterovesical Fistula | Gastrointestinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Inguinal Hernia | Gastrointestinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Upper Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDra 27.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDra 27.1 | Systematic Assessment |
| |
| Spinal Stenosis | Musculoskeletal and connective tissue disorders | MedDra 27.1 | Systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDra 27.1 | Systematic Assessment |
| |
| Humerus Fracture | Injury, poisoning and procedural complications | MedDra 27.1 | Systematic Assessment |
| |
| Joint Injury | Injury, poisoning and procedural complications | MedDra 27.1 | Systematic Assessment |
| |
| Patella Fracture | Injury, poisoning and procedural complications | MedDra 27.1 | Systematic Assessment |
| |
| Radius Fracture | Injury, poisoning and procedural complications | MedDra 27.1 | Systematic Assessment |
| |
| Strangulated Incisional Hernia | Injury, poisoning and procedural complications | MedDra 27.1 | Systematic Assessment |
| |
| Tendon Rupture | Injury, poisoning and procedural complications | MedDra 27.1 | Systematic Assessment |
| |
| Wound Evisceration | Injury, poisoning and procedural complications | MedDra 27.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Sinusitis | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDra 27.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDra 27.1 | Systematic Assessment |
|
The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi aventis recherche & développement | 800-633-1610 | 6# | Contact-US@sanofi.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 11, 2024 | Mar 9, 2026 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially (till outcome measure 4) in order the outcome measures are reported and continued when previous outcome measure was statistically significant at a 2-sided 5% significant level.
| Analysis was performed using negative binomial regression model with the total number of events occurring during the observation duration as response variable, treatment group, region (pooled country), screening eosinophil strata (<300 cells/mcL or >=300 cells/mcL) and number of asthma exacerbations in the previous 12 months strata (=1 or >1) and baseline ICS dose level as covariates, and the log-transformed observation duration as the offset variable. | Negative binomial regression model | 0.0075 | Rate ratio | 0.522 | 2-Sided | 95 | 0.324 | 0.840 | Superiority | A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially (till outcome measure 4) in order the outcome measures are reported and continued when previous outcome measure was statistically significant at a 2-sided 5% significant level. |
| Analysis was performed using negative binomial regression model with the total number of events occurring during the observation duration as response variable, treatment group, region (pooled country), screening eosinophil strata (<300 cells/mcL or >=300 cells/mcL) and number of asthma exacerbations in the previous 12 months strata (=1 or >1) and baseline ICS dose level as covariates, and the log-transformed observation duration as the offset variable. | Negative binomial regression model | 0.2161 | Rate ratio | 0.752 | 2-Sided | 95 | 0.479 | 1.182 | Superiority | A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially (till outcome measure 4) in order the outcome measures are reported and continued when previous outcome measure was statistically significant at a 2-sided 5% significant level. |
| OG003 | Amlitelimab 250 mg With 500 mg Loading Dose | 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. |
|
|
|
| OG002 | Amlitelimab 125 mg With 250 mg Loading Dose | 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. |
| OG003 | Amlitelimab 250 mg With 500 mg Loading Dose | 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. |
|
|
|
| OG002 | Amlitelimab 125 mg With 250 mg Loading Dose | 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. |
| OG003 | Amlitelimab 250 mg With 500 mg Loading Dose | 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. |
|
|
|
| OG003 | Amlitelimab 250 mg With 500 mg Loading Dose | 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. |
|
|
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. |
| OG003 | Amlitelimab 250 mg With 500 mg Loading Dose | 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. |
|
|
| OG002 | Amlitelimab 125 mg With 250 mg Loading Dose | 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. |
| OG003 | Amlitelimab 250 mg With 500 mg Loading Dose | 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. |
|
|
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.
| OG003 | Amlitelimab 250 mg With 500 mg Loading Dose | 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. |
|
|
| OG002 | Amlitelimab 125 mg With 250 mg Loading Dose | 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. |
| OG003 | Amlitelimab 250 mg With 500 mg Loading Dose | 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. |
|
|
| OG002 | Amlitelimab 125 mg With 250 mg Loading Dose | 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. |
| OG003 | Amlitelimab 250 mg With 500 mg Loading Dose | 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. |
|
|
| OG002 | Amlitelimab 125 mg With 250 mg Loading Dose | 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. |
| OG003 | Amlitelimab 250 mg With 500 mg Loading Dose | 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. |
|
|
| OG002 | Amlitelimab 125 mg With 250 mg Loading Dose | 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. |
| OG003 | Amlitelimab 250 mg With 500 mg Loading Dose | 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. |
|
|
| Amlitelimab 125 mg With 250 mg Loading Dose |
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. |
| OG003 | Amlitelimab 250 mg With 500 mg Loading Dose | 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. |
|
|
| OG002 | Amlitelimab 125 mg With 250 mg Loading Dose | 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. |
| OG003 | Amlitelimab 250 mg With 500 mg Loading Dose | 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. |
|
|
| OG002 | Amlitelimab 125 mg With 250 mg Loading Dose | 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. |
| OG003 | Amlitelimab 250 mg With 500 mg Loading Dose | 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. |
|
|
| OG001 | Amlitelimab 62.5 mg With 125 mg Loading Dose | 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. |
| OG002 | Amlitelimab 125 mg With 250 mg Loading Dose | 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. |
| OG003 | Amlitelimab 250 mg With 500 mg Loading Dose | 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. |
|
|
| OG002 | Amlitelimab 125 mg With 250 mg Loading Dose | 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. |
| OG003 | Amlitelimab 250 mg With 500 mg Loading Dose | 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. |
|
|
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. |
| OG003 | Amlitelimab 250 mg With 500 mg Loading Dose | 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. |
|
|
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.
|
|
| OG002 | Amlitelimab 250 mg With 500 mg Loading Dose | 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. |
|
|
| OG001 | Amlitelimab 62.5 mg With 125 mg Loading Dose | 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. |
| OG002 | Amlitelimab 125 mg With 250 mg Loading Dose | 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. |
| OG003 | Amlitelimab 250 mg With 500 mg Loading Dose | 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. |
|
|
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. |
| OG002 | Amlitelimab 125 mg With 250 mg Loading Dose | 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. |
| OG003 | Amlitelimab 250 mg With 500 mg Loading Dose | 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. |
|
|
| OG001 |
| Amlitelimab 62.5 mg With 125 mg Loading Dose |
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. |
| OG002 | Amlitelimab 125 mg With 250 mg Loading Dose | 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. |
| OG003 | Amlitelimab 250 mg With 500 mg Loading Dose | 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. |
|
|
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. |
| OG002 | Amlitelimab 125 mg With 250 mg Loading Dose | 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. |
| OG003 | Amlitelimab 250 mg With 500 mg Loading Dose | 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. |
|
|
| OG001 |
| Amlitelimab 62.5 mg With 125 mg Loading Dose |
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. |
| OG002 | Amlitelimab 125 mg With 250 mg Loading Dose | 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. |
| OG003 | Amlitelimab 250 mg With 500 mg Loading Dose | 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. |
|
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