A Randomized, Phase 2, Double-blind, Placebo-controlled, Parallel-group, 2-arm Study to Investigate the Efficacy, Safety, and Tolerability of Subcutaneous Lunsekimig (SAR443765) in Adult Participants With High-risk Asthma Who Are Not Currently Eligible for Biologic Treatment

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.

Eligibility

Age range

18–80 years

Sex

All

Healthy volunteers

No

Interventions

• Drug
  Lunsekimig

  Pharmaceutical form: Solution for injection in vial; Route of administration: Subcutaneous injection

• Drug
  Short-Acting Beta Agonists (SABA)

  Pharmaceutical form: Varies and depends on pharmaceutical presentation; Route of administration: Oral Inhalation

• Drug
  Placebo

  Pharmaceutical form: Solution for injection in vial; Route of administration: Subcutaneous injection

• Drug
  Fluticasone/Salmeterol

  Pharmaceutical form: Varies and depends on pharmaceutical presentation; Route of administration:Oral Inhalation

• Drug
  Budesonide/Formoterol

  Pharmaceutical form: Varies and depends on pharmaceutical presentation; Route of administration: Oral Inhalation

• Drug
  Budesonide/Albuterol

  Pharmaceutical form: Aerosol for inhalation; Route of administration: Oral Inhalation

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