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

Investigating an Asthma Treatment with an Investigational Medication

Recruiting
18 years - 80 years
All
Phase 2
1000 participants needed
24 Locations

Study Overview

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 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 Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Asthma
  • Age: 18 years - 80 years
  • Gender: All

Inclusion Criteria:

  • Physician-diagnosed mild-to-moderate asthma for more than 12 months based on GINA guidelines.
  • At least 1 asthma exacerbation in the year prior to Screening (Visit 1).
  • Pre-BD FEV1 of equal or more than 40% of predicted normal (by Global Lung Function Initiative [GLI] standards) at Screening (Visit 1).

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

  • Other severe lung diseases (eg, chronic obstructive pulmonary disease [COPD]. bronchiectasis, idiopathic pulmonary fibrosis, etc) which may impair lung function.
  • Participants who experience a deterioration of asthma that results in emergency treatment or hospitalization, or treatment with systemic steroids within 1 month prior to the Screening (Visit 1) (counting from the date of completion of treatment for asthma exacerbation).
  • Participants who have experienced an upper or lower respiratory tract infection within the 4 weeks prior to Screening (Visit 1).
  • Known history of, or suspected, significant current immunosuppression, including history of invasive opportunistic or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration.
  • Evidence of any infection requiring systemic anti-infective treatment within 2 weeks before Screening (Visit 1) or during the screening period. Significant viral infections within 2 weeks before Screening (Visit 1) or during the screening period even if the participant has not received systemic antiviral treatment (eg, influenza receiving only symptomatic treatment).
  • Participants with active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, or who are at high risk of contracting TB (such as close contact with individuals with active TB), or received Bacillus Calmette-Guérin (BCG)-vaccination within 12 weeks prior to Screening (Visit 1).
  • Severe concomitant illness that would in the Investigator's opinion inhibit the participant's participation in the study, including for example, but not limited to, hypertension, renal disease, neurological conditions, heart failure, and pulmonary disease.

NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical study.

Updated on 28 Mar 2025. Study ID: NCT06676319

This study investigates an investigational medication for the treatment of asthma. Asthma is a condition where the airways in the lungs become inflamed and narrow, making it hard to breathe. The purpose of this study is to assess how effective and safe the investigational medication is when added to the current treatment of people with asthma who cannot use biologic treatments. Participants in this study will be randomly assigned to one of two study arms: one receiving the investigational medication and the other receiving a placebo.

Participants in the study will undergo various procedures to assess the effects of the investigational medication. A placebo is an inactive substance that looks like the investigational medication but does not contain any medicine. Participants will have regular check-ups and assessments to monitor their asthma symptoms and overall health. These procedures will help researchers determine the safety and effectiveness of the treatment.

  • Who can participate: Adults aged 18 to 80 years with mild-to-moderate asthma diagnosed for more than 12 months can participate. Participants must have had at least one asthma exacerbation in the year before the study and meet specific lung function criteria at screening.
  • Study details: Participants will be randomly assigned to receive either the investigational medication or a placebo. A placebo is an inactive substance that looks like the investigational medication but does not contain any medicine. Participants will attend regular visits for health assessments and monitoring.
  • Study Timelines and Visits: The study will last 64 weeks. The study requires 18 visits.

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