Actively Recruiting
A Randomized, Double-blind, Placebo-controlled, Phase 2 Study to Assess Subcutaneous Lunsekimig in Adults With High-risk Asthma Not Eligible for Biologic Treatment
Led by Sanofi · Updated on 2026-05-27
1147
Participants Needed
230
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy, safety, and tolerability of adding subcutaneous lunsekimig compared with a placebo in adults aged 18 to 80 years who have high-risk asthma and are not currently eligible for biologic treatments. This is a Phase 2, randomized, double-blind, placebo-controlled study with two groups. Participants must have a diagnosis of mild-to-moderate asthma for over 12 months and at least one asthma exacerbation in the previous year. Participants will be randomly assigned to receive either lunsekimig or placebo by subcutaneous injection every 4 weeks. The investigational treatment will last up to approximately 52 weeks. The study includes 18 visits in total and may last about 64 weeks for those not entering the long-term safety study or about 60 weeks for those who do. During the study, participants will have regular assessments including lung function tests, asthma control questionnaires, and measurements of biomarkers like FeNO. Researchers will track asthma exacerbation rates, lung function changes, asthma symptom scores, quality of life, and the presence of antibodies against the study drug. Safety will be monitored through adverse event reporting up to 56 weeks. Participants usual asthma treatments such as inhalers may continue under supervision.
CONDITIONS
Brief Title
Study of Lunsekimig (SAR443765) Compared With Placebo in Adults With High-risk Asthma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 80 years
- 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
- Pre-bronchodilator FEV1 equal to or greater than 40% of predicted normal at screening
You will not qualify if you...
- Presence of other severe lung diseases such as COPD, bronchiectasis, or idiopathic pulmonary fibrosis
- Recent asthma deterioration requiring emergency treatment, hospitalization, or systemic steroids within 1 month prior to screening
- Upper or lower respiratory tract infection within 4 weeks prior to screening
- Known or suspected significant immunosuppression or history of invasive infections
- Any infection requiring systemic anti-infective treatment within 2 weeks before or during screening
- Active, latent, or incompletely treated tuberculosis, or high risk of TB exposure
- Severe illnesses that may prevent participation, including hypertension, renal disease, neurological conditions, heart failure, or pulmonary disease as judged by the investigator
Research Team
T
Trial Transparency email recommended (Toll free for US & Canada)
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here