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

Conditions

• Asthma

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Lunsekimig — DRUG
  Pharmaceutical form: Solution for injection in vial; Route of administration: Subcutaneous injection
• Short-Acting Beta Agonists (SABA) — DRUG
  Pharmaceutical form: Varies and depends on pharmaceutical presentation; Route of administration: Oral Inhalation
• Placebo — DRUG
  Pharmaceutical form: Solution for injection in vial; Route of administration: Subcutaneous injection
• Fluticasone/Salmeterol — DRUG
  Pharmaceutical form: Varies and depends on pharmaceutical presentation; Route of administration:Oral Inhalation
• Budesonide/Formoterol — DRUG
  Pharmaceutical form: Varies and depends on pharmaceutical presentation; Route of administration: Oral Inhalation
• Budesonide/Albuterol — DRUG
  Pharmaceutical form: Aerosol for inhalation; Route of administration: Oral Inhalation

Study Details

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.

Key Dates

Start date

Nov 7, 2024

Status verified

May 2026

Primary completion

Sep 17, 2027

Completion

Oct 15, 2027

Study Design

Enrollment

1,147 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Lunsekimig
  Participants will receive lunsekimig (SC injection) every 4 weeks
• Placebo Comparator: Placebo
  Participants will receive placebo (SC injection) every 4 weeks

Primary Outcome Measure

Annualized rate of asthma exacerbation events [ Time Frame: From baseline up to 52 weeks ]

Central Contacts

• Trial Transparency email recommended (Toll free for US & Canada)
  800-633-1610
  [email protected]

Locations (54)

Find similar trials in Saraland, AL

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