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Monoclonal Antibodies

Lunsekimig for Asthma

Phase 2
Recruiting
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least 1 asthma exacerbation in the year prior to Screening (Visit 1)
Physician-diagnosed mild-to-moderate asthma for more than 12 months based on GINA guidelines
Must not have
Severe concomitant illness that would inhibit the participant's participation in the study, including hypertension, renal disease, neurological conditions, heart failure, and pulmonary disease
Other severe lung diseases (eg, chronic obstructive pulmonary disease [COPD], bronchiectasis, idiopathic pulmonary fibrosis, etc) which may impair lung function
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to week 52

Summary

This trial is testing a new medication called SC lunsekimig as an add-on therapy for asthma treatment. It will involve male and female participants with asthma who are not eligible for other biologic treatments

Who is the study for?
This trial is for adults aged 18 to 80 with high-risk asthma who aren't eligible for biologic treatments. Participants will be involved in the study for about a year, with up to 18 visits.
What is being tested?
The trial is testing Lunsekimig as an add-on therapy compared to a placebo. It's double-blind, meaning neither participants nor researchers know who gets the real treatment or placebo during the study.
What are the potential side effects?
While specific side effects are not listed here, common ones associated with new asthma treatments may include injection site reactions, headaches, and potential worsening of asthma symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I had at least one asthma attack in the last year.
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I have had asthma diagnosed by a doctor for over a year.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have severe illnesses like heart failure or kidney disease that would stop me from joining the study.
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I do not have severe lung diseases like COPD that could affect my breathing.
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I've needed emergency care or steroids for asthma in the last month.
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I haven't taken any antibiotics or antivirals for an infection in the last 2 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Annualized rate of asthma exacerbation events
Secondary study objectives
Annualized rate of loss of asthma control events (LOAC) events
Change from baseline in Asthma Control Questionnaire5 (ACQ-5) score

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: LunsekimigExperimental Treatment4 Interventions
Participants will receive lunsekimig (SC injection) every 4 weeks
Group II: PlaceboPlacebo Group4 Interventions
Participants will receive placebo (SC injection) every 4 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Budesonide/formoterol
2016
Completed Phase 2
~460
Fluticasone/salmeterol
2012
Completed Phase 3
~750

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor
2,201 Previous Clinical Trials
4,035,426 Total Patients Enrolled
51 Trials studying Asthma
28,718 Patients Enrolled for Asthma
~667 spots leftby Oct 2027
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
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