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

NCT06676319 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1147

Last updated 2026-04-16

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-07
Primary Completion
2027-09-17
Completion
2027-10-15
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Belgium
  • Brazil
  • Canada
  • Chile
  • China
  • Denmark
  • France
  • Germany
  • Hungary
  • India
  • Israel
  • Italy
  • Japan
  • Mexico
  • Poland
  • Romania
  • South Africa
  • Spain
  • Sweden
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06676319 on ClinicalTrials.gov