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Lunsekimig treatment for adults with high-risk asthma

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

Phase 2 Interventional Sanofi · NCT06676319

This study is testing a new asthma treatment called lunsekimig to see if it can help adults with mild-to-moderate asthma who can't use other biologic therapies.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment1147 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorSanofi Industry-sponsored
Locations236 sites (Saraland, Alabama and 235 other locations)
Trial IDNCT06676319 on ClinicalTrials.gov

What this trial studies

This Phase 2 clinical trial evaluates the efficacy, safety, and tolerability of lunsekimig as an add-on therapy for adults with mild-to-moderate asthma who are not eligible for biologic treatments. The study is designed as a randomized, double-blind, placebo-controlled trial with two arms, comparing lunsekimig to a placebo over a duration of approximately 52 weeks. Participants will undergo 18 visits throughout the study period to monitor their response to the treatment. The trial aims to provide insights into how lunsekimig can improve asthma management in this specific patient population.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 80 with physician-diagnosed mild-to-moderate asthma and a history of exacerbations.

Not a fit: Patients with severe lung diseases or recent respiratory infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for adults with high-risk asthma, potentially improving their quality of life and reducing exacerbations.

How similar studies have performed: Other studies have shown promise with similar approaches in asthma treatment, but the specific use of lunsekimig is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Saraland, Alabama and 235 other locations

+186 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Asthma
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.