drugset / Trial / NCT06676319

Study of Lunsekimig (SAR443765) Compared With Placebo in Adults With High-risk Asthma

NCT06676319

Phase 2 Active not recruiting 556 enrolled Sanofi
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a parallel-group, Phase 2, randomized, double-blind, placebo-controlled, 2-arm study for the treatment of asthma. The purpose of this study is to assess the efficacy, safety, and tolerability of add-on therapy with subcutaneous (SC) lunsekimig compared with placebo in male and female participants (aged 18 to 80 years, inclusive) with asthma, who are not currently eligible for biologic treatments. Study details include: * The study duration will be approximately 64 weeks for participants not transitioning into the LTS study and approximately 60 weeks for participants transitioning into the LTS study. * The investigational treatment duration will be up to approximately 52 weeks. * The number of visits will be 18.

Timeline

Start
2024-11-07
Primary completion
2027-06-21
Completion
2027-07-19

Drugs

EvaluationDrugModalityDoseRoute
Subject Lunsekimig Monoclonal antibody Subcutaneous
Background Budesonide Small molecule Inhaled
Background Fluticasone Other / unclassified Inhaled
Background Formoterol Other / unclassified Inhaled
Background Salbutamol Unknown Inhaled
Background Salmeterol Other / unclassified Inhaled

Indications