Registered outcomes25

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 20 of 25

List	Outcome	Time frame	Description
Primary	Annualized Rate of Severe Asthma Exacerbation Events Over 48 Weeks	Baseline (Day 1) to Week 48	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.
Secondary	Change From Baseline in Pre-Bronchodilator (BD) Forced Expiratory Volume in One Second (FEV1) at Week 48	Baseline (Day 1) and 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.
Secondary	Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score at Week 48	Baseline (Day 1) and 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.
Secondary	Change From Baseline in Asthma Quality of Life Questionnaire With Standardized Activities [AQLQ(S)] Self-administered Score at Week 48	Baseline (Day 1) and 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.
Secondary	Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in One Second at Week 48	Baseline (Day 1) and 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.
Secondary	Change From Baseline in Pre-Bronchodilator and Post-Bronchodilator Percent Predicted Forced Expiratory Volume in One Second at Week 48	Baseline (Day 1) and 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.
Secondary	Change From Baseline in Asthma Control Questionnaire-5 Score at Weeks 2, 4, 8, 12, 24, 36, and 60	Baseline (Day 1) and 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.
Secondary	Time to First Severe Asthma Exacerbation Event Over 48 Weeks	Baseline (Day 1) to Week 48	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.
Secondary	Change From Baseline in Pre-Bronchodilator and Post-Bronchodilator Forced Expiratory Volume in One Second at Each Spirometry Timepoint	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	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.
Secondary	Change From Baseline in Pre-Bronchodilator and Post-Bronchodilator Peak Expiratory Flow (PEF) at Each Spirometry Timepoint	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	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.
Secondary	Change From Baseline in Pre-Bronchodilator and Post-Bronchodilator Forced Vital Capacity (FVC) at Each Spirometry Timepoint	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	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.
Secondary	Change From Baseline in Pre-Bronchodilator and Post-Bronchodilator Forced Expiratory Flow (FEF) 25-75% at Each Spirometry Timepoint	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	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.
Secondary	Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) at Weeks 2, 4, 8, 12, 16, 24, 36, 48, and 60	Baseline (Day 1) and 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.
Secondary	Annualized Rate of Loss of Asthma Control (LOAC) Events Over 48 Weeks	Baseline (Day 1) to Week 48	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.
Secondary	Time to First Loss of Asthma Control Event Over 48 Weeks	Baseline (Day 1) to Week 48	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.
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	Baseline (Day 1) and 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.
Secondary	Annualized Rate of Severe Asthma Exacerbations Requiring Hospitalization or Emergency Room or Urgent Care Visit Over 48 Weeks	Baseline (Day 1) to Week 48	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.
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	Baseline (Day 1) and 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.
Secondary	Serum Amlitelimab Concentrations	Weeks 4, 8, 12, 16, 24, 36, 48, and 60	Blood samples were collected at the specified timepoints for measurement of serum concentrations of amlitelimab.
Secondary	Number of Participants With Anti-Drug Antibodies (ADA) to Amlitelimab	From first dose of study treatment (Day 1) up to end of study visit (Week 72)	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.

Source ClinicalTrials.govtrials-2026-11-12-0.4.0

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

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ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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Registered outcomes25

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