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Dupilumab for Sinus Infection

Phase 3
Recruiting
Led By Joshua Levy, M.D.
Research Sponsored by National Institute on Deafness and Other Communication Disorders (NIDCD)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants aged >=18 years at the time of signing the ICF.
All study participants will have met criteria for sinus surgery and undergo a comprehensive procedure prior to randomization.
Must not have
Scheduled systemic corticosteroid treatment during the study period.
Participants with conditions or comorbid disease findings that preclude nasal endoscopy for evaluation of primary outcome.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline at 52 weeks
Awards & highlights

Summary

"This trial is testing a drug called Dupilumab in people with a severe sinus infection called allergic fungal rhinosinusitis (AFRS). Participants will undergo surgery to remove nasal polyps and then

Who is the study for?
Adults aged 18+ with suspected Allergic Fungal Rhinosinusitis (AFRS) who are planning to have surgery for nasal polyps. They must be willing to self-administer injections every two weeks for a year after surgery and participate in follow-ups.
What is being tested?
The trial is testing Dupilumab, an approved drug believed to help AFRS patients. Participants will either receive Dupilumab or a placebo without active medicine, administered as under-the-skin injections every other week for one year post-surgery.
What are the potential side effects?
Dupilumab may cause side effects such as allergic reactions at the injection site, eye inflammation, headache, sore throat, and potentially more serious conditions like joint pain or inflammation of blood vessels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am eligible for and will have sinus surgery before joining the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am scheduled to receive corticosteroid treatment during the study.
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I cannot have a nasal endoscopy due to my health condition.
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I have not taken antibiotics for an infection in the last 4 weeks.
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I cannot take dupilumab due to health reasons.
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I have used dupilumab before.
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I haven't taken immunosuppressive drugs in the last 3 months.
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I started allergy shots less than 3 months ago or plan to start or change the dose during the study.
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I've had a severe asthma attack needing steroids or a hospital stay in the last month.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline at 52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline at 52 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy of Dupilumab
Secondary outcome measures
Effect of Dupilumab on Oral Corticosteroid Utilization
Health-Related Quality of Life
Lower Airway Dysfunction in Participants with Asthma
+3 more

Side effects data

From 2021 Phase 4 trial • 188 Patients • NCT04033367
9%
Conjunctivitis
7%
Headache
3%
Dermatitis Atopic
2%
Nasopharyngitis
1%
Accidental Overdose
1%
Drug Hypersensitivity
1%
Polyarthritis
100%
80%
60%
40%
20%
0%
Study treatment Arm
DB Period: Placebo
DB Period: Dupilumab
OLE Period: Placebo/Dupilumab
OLE Period: Dupilumab/Dupilumab

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm A:Experimental Treatment1 Intervention
Treatment: Dupilumab 300 mg administered subcutaneously every two weeks for 52 weeks.
Group II: Arm B:Placebo Group1 Intervention
Control: Placebo administered subcutaneously every two weeks for 52 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dupilumab
2017
Completed Phase 4
~11960

Find a Location

Who is running the clinical trial?

National Institute on Deafness and Other Communication Disorders (NIDCD)Lead Sponsor
339 Previous Clinical Trials
179,613 Total Patients Enrolled
Joshua Levy, M.D.Principal InvestigatorNational Institute on Deafness and Other Communication Disorders (NIDCD)
4 Previous Clinical Trials
5,744 Total Patients Enrolled
~88 spots leftby Dec 2025
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