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Monoclonal Antibodies
Dupilumab for Respiratory Diseases
Phase 2
Recruiting
Research Sponsored by Scripps Clinic
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 aspirin challenge = 6 weeks after starting dupilumab/placebo. aspirin challenge day = up to 8 hours
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to study the impact of a new respiratory biologic called dupilumab on patients with Aspirin-Exacerbated Respiratory Disease (AERD) undergoing aspirin des
Who is the study for?
This trial is for adults over 18 with Aspirin-Exacerbated Respiratory Disease (AERD), diagnosed through specific tests or a history of reactions to aspirin. Participants must be on dupilumab treatment for at least 12 weeks and have a confirmed history of nasal polyposis.
What is being tested?
The study investigates the effect of dupilumab, a medication approved for certain respiratory conditions, on the process and reactions during aspirin desensitization in AERD patients. This involves observing how well patients tolerate increasing doses of aspirin.
What are the potential side effects?
Potential side effects may include hypersensitivity reactions like worsening nasal-ocular symptoms or asthma during the desensitization procedure. Dupilumab itself can cause injection site reactions, eye issues, and allergic responses.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ aspirin challenge = 6 weeks after starting dupilumab/placebo. aspirin challenge day = up to 8 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~aspirin challenge = 6 weeks after starting dupilumab/placebo. aspirin challenge day = up to 8 hours
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Rate of positive challenges to aspirin challenge
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Aspirin ChallengeExperimental Treatment1 Intervention
All subjects will undergo a standardized aspirin challenge
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aspirin Challenge
2003
Completed Early Phase 1
~200
Find a Location
Who is running the clinical trial?
Regeneron PharmaceuticalsIndustry Sponsor
671 Previous Clinical Trials
385,808 Total Patients Enrolled
Scripps ClinicLead Sponsor
14 Previous Clinical Trials
28,497 Total Patients Enrolled
University of California, San DiegoOTHER
1,189 Previous Clinical Trials
1,587,725 Total Patients Enrolled