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Monoclonal Antibodies

Aspirin Challenge for Respiratory Disease

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

Study 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.Check my eligibility

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.See study design

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsIndustry Sponsor

622 Previous Clinical Trials

380,715 Total Patients Enrolled

Scripps ClinicLead Sponsor

13 Previous Clinical Trials

28,421 Total Patients Enrolled

University of California, San DiegoOTHER

1,123 Previous Clinical Trials

1,552,823 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research study currently open for enrollment of participants?

"According to clinicaltrials.gov, this investigation is presently enrolling volunteers. The trial was initially uploaded on March 25th, 2024, and the most recent revision occurred on April 3rd of the same year."

Answered by AI

What is the current number of individuals being recruited for participation in this clinical investigation?

"Indeed, information available on clinicaltrials.gov affirms that this investigation is presently seeking volunteers. The trial was initially posted on March 25th, 2024 and last revised on April 3rd, 2024. Enrollment targets to recruit a total of 16 participants from a single site."

Answered by AI

What is the safety profile of the Aspirin Provocation Test for individuals?

"The safety evaluation conducted by our team at Power rates the Aspirin Challenge with a score of 2, based on being in Phase 2 where there is existing safety data without confirmed efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Mechanisms of Dupilumab in AERD

Andrew White 2024. "Mechanisms of Dupilumab in AERD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05031455.

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