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Monoclonal Antibodies
dupilumab for Asthma
Phase 3
Waitlist Available
Led By Parameswaran Nair, MD, PhD
Research Sponsored by McMaster University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up between screening (week -4) and week 16.
Awards & highlights
Study Summary
This study is evaluating whether a drug called Dupilumab can improve asthma control and reduce airway inflammation in people with asthma and a "T2 immune signature".
Eligible Conditions
- Asthma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ between screening (week -4) and week 16.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~between screening (week -4) and week 16.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of patients that achieve at least one doubling dose improvement in PC20 methacholine and/or a 50% reduction in FEV1 reversibility after bronchodilator.
Secondary outcome measures
Change in Asthma Control Questionnaire-5 (ACQ-5)
Change in Asthma Control Questionnaire-5 (AQLQ)
Change in Asthma Control Test (ACT)
+6 moreOther outcome measures
Change in CT airway remodeling and airway mucus scores (n=12 in each arm).
Change in MRI ventilation heterogeneity (n=12 in each arm).
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: dupilumabActive Control1 Intervention
Dupilumab 300 mg subcutaneously (SC) every 2 weeks as an investigational drug. For those randomized to dupilumab, a loading dose of 600 mg will be given only at randomization/Visit 2.
Sterile dupilumab of will be provided in 150 mg/mL in glass prefilled syringes (2.25 mL total volume) to deliver 300 mg in 2 mL.
Group II: matched placeboPlacebo Group1 Intervention
Sterile placebo for dupilumab will be provided in identically matched glass prefilled syringes to deliver 2 mL.
Find a Location
Who is running the clinical trial?
McMaster UniversityLead Sponsor
881 Previous Clinical Trials
2,597,866 Total Patients Enrolled
19 Trials studying Asthma
895 Patients Enrolled for Asthma
SanofiIndustry Sponsor
2,164 Previous Clinical Trials
3,514,956 Total Patients Enrolled
46 Trials studying Asthma
27,314 Patients Enrolled for Asthma
Parameswaran Nair, MD, PhDPrincipal InvestigatorMcMaster University
7 Previous Clinical Trials
233 Total Patients Enrolled
4 Trials studying Asthma
87 Patients Enrolled for Asthma
Frequently Asked Questions
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