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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

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 weeks
Treatment ~ Varies
Follow Up ~aspirin challenge = 6 weeks after starting dupilumab/placebo. aspirin challenge day = up to 8 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and aspirin challenge = 6 weeks after starting dupilumab/placebo. aspirin challenge day = up to 8 hours for reporting.

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

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
647 Previous Clinical Trials
384,202 Total Patients Enrolled
Scripps ClinicLead Sponsor
14 Previous Clinical Trials
28,497 Total Patients Enrolled
University of California, San DiegoOTHER
1,157 Previous Clinical Trials
1,571,403 Total Patients Enrolled
~11 spots leftby Dec 2025
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