A clinical study to evaluate lunsekimig compared with placebo in adults with asthma

Study of an Investigational Medication for Asthma: A Condition Affecting the Airways

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

Study Overview

  • Are you between 18-80 years of age? 
  • Have you been diagnosed with asthma for at least 12 months? 
  • Are you taking daily treatment for your asthma? 
  • Have you had at least one (1) asthma attack in the past year?  

If you answered yes to these questions, you may be eligible to participate in a clinical study testing an investigational medication (lunsekimig) to see if it can improve breathing and symptoms of asthma while reducing future asthma attacks when taken with standard asthma medications. The investigational medication is not yet approved for treating asthma and can only be used in a clinical study like this one. 

Sanofi believes that everyone should have the opportunity to take part in clinical trials.  It is important to include people who have been historically under-represented in clinical trials. Sanofi is committed to inclusivity in our studies.

If you are interested in learning more about this clinical study, we encourage you to complete a brief questionnaire to help determine if you may qualify to participate and be referred to a study site in your area for further evaluation.

Study Details

This clinical study will include approximately 1000 participants in 22 countries. 

All study participants will have 50% (1 in 2) chance of receiving the investigational medication or placebo (a placebo is an inactive substance that looks like the investigational medicine but does not contain any medicine).  Lunsekimig or placebo will be provided and administered by injection under the skin every 4 weeks at the study site.

The clinical study will last up to 64 weeks (about 15 months) and include 18 study visits to the study site. Participants may have the possibility to continue treatment with the investigational medication following this clinical study, which could be an additional 40 weeks (about 9 months).  Study assessments include:  

  • Medical history and physical exam
  • Electrocardiogram (ECG): A recording of the electrical activity of your heart over a period of time using electrodes placed on your skin
  • Breathing tests:
    • Spirometry: A test in which you blow into a device to measure lung function
    • Oscillometry: A test that measures lung function in the very small airways of the lung where asthma sometimes occurs
    • Fractional Exhaled Nitric Oxide (FeNO): A test that measures inflammation in the lungs by sampling your exhaled breath tests
  • Blood and urine tests
  • Participants will complete daily, electronic questionnaires (ediary) and remote spirometry while at home

There is no cost to participate.  All study-related exams, study-related medications and study-related medical care is provided.  There is no insurance required to take part in this study.  You may be compensated for time and travel. 

Eligibility Criteria

 
Updated on 28 Mar 2025. Study ID: NCT06676319

This study investigates an investigational medication to see if it can improve breathing and symptoms of asthma while reducing future asthma attacks. Asthma is a condition that affects the airways in the lungs, causing them to become narrow and inflamed, which makes it difficult to breathe. The investigational medication is not yet approved for treating asthma and is being tested in this study to see how well it works when taken with standard asthma treatments.

Participants in the study 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. The medication or placebo will be given by injection under the skin every four weeks at the study site. Study procedures include medical history review, physical exams, heart activity recording, breathing tests, and blood and urine tests. Participants will also complete daily electronic questionnaires and perform remote spirometry tests at home.

  • Who can participate: Adults aged 18 to 80 years who have been diagnosed with asthma for at least 12 months and are taking daily asthma treatment may participate. Participants should have had at least one asthma attack in the past year.
  • Study details: Participants will be randomly assigned to receive either the investigational medication or a placebo, which is an inactive substance that looks like the investigational medication but does not contain any medicine. The medication or placebo will be administered by injection under the skin every four weeks at the study site.
  • Study Timelines and Visits: The study will last up to 64 weeks. The study requires 18 visits.

Pre-Screener

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