Pulmonology & Critical Care
PHASE2
● Phase II
Phase 2 trial of amlitelimab add-on therapy in adults with moderate-to-severe asthma reports no results
ClinicalTrials.gov
Published March 30, 2026
Sanofi
NCT05421598 ↗
This was a global, multicenter, phase 2 randomized controlled trial involving 437 adult participants with moderate-to-severe asthma. The study compared the investigational add-on therapy amlitelimab against a placebo control. The primary efficacy endpoint was the annualized rate of severe asthma exacerbation events over a 48-week period.
No efficacy results for the primary or any secondary outcomes have been reported. Similarly, no safety or tolerability data—including rates of adverse events, serious adverse events, or treatment discontinuations—are available from this trial.
The study was a dose-ranging phase 2 trial, which is designed to explore preliminary signals and inform future research. The lead sponsor was Sanofi. In the absence of reported efficacy and safety outcomes, no conclusions regarding the clinical utility of amlitelimab in this population can be drawn. Further data from this and subsequent trials are required.
Imagine living with asthma so severe that a sudden flare-up could send you to the hospital. For adults with moderate-to-severe asthma, standard treatments don't always work, and the search for new options is constant. That's why researchers are testing a new add-on drug called amlitelimab in a global study involving 437 people. The main goal was to see if it could lower the yearly rate of these dangerous, severe asthma attacks over 48 weeks.
This was a Phase 2 trial, which is an early stage of testing designed to find the right dose and get initial signals about whether a drug might work. The study compared amlitelimab against a placebo, a treatment with no active medicine, to see if there was a real difference. The trial was sponsored by the drug company Sanofi.
It's important to know that this is just one study, and a relatively early one. We don't have the results yet on whether the drug actually reduced asthma attacks, or what side effects people might have experienced. The findings from this dose-ranging study will help decide if amlitelimab is promising enough to move into larger, longer trials that could give clearer answers for patients.
What this means for you: An early study tests a new add-on drug for severe asthma; results are pending.
View Original Abstract ↓
Status: COMPLETED | Phase: PHASE2
Condition(s): Asthma
Intervention(s): Amlitelimab (DRUG), Placebo (DRUG)
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:
* The study duration (per participant) was up to approximately 76 weeks for participants not going into LTS study and will be up to approximately 64 weeks for participants going into LTS study.
* The randomized treatment duration was up to approximately 60 weeks.
* The scheduled number of visits was 13.
Primary Outcome(s): Annualized Rate of Severe Asthma Exacerbation Events Over 48 Weeks
Enrollment: 437 (ACTUAL)
Lead Sponsor: Sanofi
Start: 2022-06-30 | Primary Completion: 2024-10-11
Results posted: 2026-03-30
