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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 belowSelect...
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:Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline to week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to week 52
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
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Who is running the clinical trial?
SanofiLead Sponsor
2,209 Previous Clinical Trials
4,038,766 Total Patients Enrolled
51 Trials studying Asthma
28,718 Patients Enrolled for Asthma
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