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Long-term Safety and Efficacy Evaluation of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study
StoppedTrial terminatedSponsor's reason: Sponsor decision; the decision is not related to any safety concern.Show 4 more changesShow less
Primary and study completion dates changed from estimate of Sep 29, 2026 to Sep 22, 2026
Eligibility criteria expanded, about 16 words
Secondary endpoints: details revised at 3 of 21 entries
Publications: details revised at 1 of 1 entry
NotablePrimary and study completion dates: Jun 25, 2029 to Sep 29, 2026
Study sites revised (68)
v23
MinorSecondary endpoints: details revised at 4 of 21 entries
Study sites revised (68)
v22
MinorTrial status: Recruiting to Active, Not Recruiting
Enrollment target: estimated 380 to confirmed 335
Site details revised at 68 of 68 sites
v21
MinorStudy sites: 67 to 68v20
Show 18 earlier versionsHide 18 earlier versions
MinorSite details revised at 7 of 67 sitesv19
MinorStudy sites: 66 to 67v18
MinorStudy sites revised (66)v17
MinorStudy sites: 65 to 66v16
MinorStudy sites: 62 to 65v15
MinorStudy sites: 59 to 62v14
MinorStudy sites: 37 to 59v13
MinorStudy sites: 31 to 37v12
MinorSecondary endpoints: details revised at 3 of 21 entriesv11
MinorStudy sites: 20 to 31v10
MinorStudy sites: 15 to 20v9
MinorStudy sites: 13 to 15v8
MinorStudy sites: 11 to 13v7
MinorStudy sites: 7 to 11
Eligibility criteria shortened, about 10 words
Secondary endpoints: details revised at 4 of 21 entries
Study title revised
v6
MinorStudy sites: 3 to 7v5
NotablePrimary and study completion dates: Jun 25, 2030 to Jun 25, 2029
Study sites: 2 to 3
v4
MinorStudy sites: 1 to 2
Eligibility criteria shortened, about 16 words
Secondary endpoints: details revised at 2 of 21 entries
v3
NotableTrial status: Not Yet Recruiting to Recruiting
Study sites: 0 to 1
Start date changed from estimate of Sep 6, 2023 to Sep 5, 2023
v2
MinorStudy First Submitted
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a study of amlitelimab for the treatment of participants with moderate-to-severe asthma. The study will have a double-blind treatment period until Week 24 for each participant and an open-label treatment period where each participant will receive open-label amlitelimab from Week 24 onwards. The purpose of this study is to evaluate long-term safety, tolerability, and efficacy of amlitelimab for the treatment of adult participants with moderate-to-severe asthma who have previously been enrolled and completed the treatment period of the parent study. The study duration will be up to 156 weeks. The treatment duration will be up to 144 weeks. The number of visits will be 18.