Trial · NCT05421598
Dose Ranging Study of Amlitelimab in Adult Participants With Moderate-to-severe Asthma
NCT05421598, Phase 2, Completed, Sanofi
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. Dose Ranging Study of Amlitelimab in Adult Participants With Moderate-to-severe Asthma. Trials, record NCT05421598. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05421598
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dose Ranging Study of Amlitelimab in Adult Participants With Moderate-to-severe Asthma
- NCT number
- NCT05421598
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 437 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Asthma
- Interventions
- Amlitelimab, Placebo
- First posted
- 2022-06-16
- Last updated
- 2026-03-30
- Other registries' IDs
- eudract:2022-000065-41
Source ClinicalTrials.gov
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39393433 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- 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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05421598
GET https://conductscience.org/api/trials/v1/NCT05421598/registered?page=2