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

Study on Investigational Medication and Placebo in High-risk Asthma

Recruiting
18 years - 80 years
All
Phase 2
1147 participants needed
5 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 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 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.

This study investigates the effects of an investigational medication compared to a placebo in adults with high-risk asthma. The purpose is to evaluate the safety and effectiveness of this add-on therapy in participants who are not eligible for biologic treatments. Participants will be involved in the study for about 64 weeks if they do not transition into an additional study, and about 60 weeks if they do. The investigational treatment itself will last up to 52 weeks.

Participants will undergo various procedures during the study. They will receive either the investigational medication or a placebo, which is an inactive substance that looks like the investigational medicine but does not contain any medicine. The study includes 18 visits where participants' health and response to the treatment will be closely monitored.

  • Who can participate: Adults aged 18 to 80 years with physician-diagnosed mild-to-moderate asthma for more than 12 months can participate. They must have had at least one asthma exacerbation in the past year and meet specific lung function criteria. Individuals with severe lung diseases or recent severe asthma issues are excluded.
  • Study details: Participants will receive either the investigational medication or a placebo. They will attend 18 visits where their health and asthma management will be assessed. The study will not alter participants' existing asthma treatments beyond the investigational add-on therapy.
  • Study visits: The study requires 18 visits.
Updated on 03 Mar 2026. Study ID: NCT06676319

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