Phase 2 trial tests amlitelimab add-on therapy in adults with moderate-to-severe asthma
Photo by CDC / Unsplash
Key Takeaway
Await full results from this phase 2 trial of amlitelimab in asthma.
A phase 2, global, multicenter, randomized controlled trial investigated the novel add-on therapy amlitelimab in 437 adult participants with moderate-to-severe asthma. The study compared amlitelimab to placebo over 48 weeks, with the primary outcome being the annualized rate of severe asthma exacerbation events. No efficacy results, including the primary outcome or any secondary outcomes, were reported in the provided data. Safety and tolerability data, including adverse events, serious adverse events, and discontinuation rates, were also not reported. The study was funded by Sanofi, the lead sponsor. Key limitations include the absence of reported results, which prevents any assessment of efficacy or safety. The practice relevance is currently minimal, as this represents incomplete data from an early-phase trial. Clinicians should await the full publication of results, including safety profiles and efficacy endpoints, before considering any clinical implications.
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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
Budesonide-glycopyrronium-formoterol fumarate dihydrate improved lung function and reduced severe exacerbations versus budesonide-formoterol in inadequately controlled asthma.
New Asthma Drug Cuts Attacks Without Recent Crisis
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