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Dupilumab for Allergic Fungal Sinusitis (ADAPT Trial)

Phase 3
Recruiting
Led By Joshua M Levy, MD, MPH, MSc
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Capable of giving signed informed consent as listed in the informed consent form (ICF) and this protocol
Patients with nasal polyps in the setting of suspected AFRS and electing to undergo comprehensive sinus surgery per established criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52 weeks and 64 weeks
Awards & highlights

ADAPT Trial Summary

This trial will test whether dupilumab is an effective treatment for people with AFRS who have undergone sinus surgery.

Who is the study for?
Adults over 18 with Allergic Fungal Rhinosinusitis (AFRS) who've had sinus surgery and failed standard treatments like corticosteroids and saline irrigations. They must have a CT score indicating disease, signs of nasal polyps, and meet specific criteria for AFRS diagnosis. Excluded are those previously on dupilumab, with certain health conditions or recent surgeries, pregnant or not using contraception, and unable to tolerate nasal irrigations.Check my eligibility
What is being tested?
The trial is testing if Dupilumab—an antibody treatment already approved for other allergic conditions—can effectively treat AFRS after sinus surgery. Participants will either receive Dupilumab or a placebo in a randomized study to compare outcomes.See study design
What are the potential side effects?
Potential side effects of Dupilumab may include allergic reactions at the injection site, eye irritation or inflammation, headache, joint pain, gastrointestinal discomfort, and an increased risk of cold sores.

ADAPT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am able to understand and sign the consent form.
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I have nasal polyps and am choosing to have sinus surgery for suspected fungal sinusitis.
Select...
My condition didn't improve after using nasal sprays, oral steroids, and saline irrigation for the specified durations.
Select...
I have nasal polyps.
Select...
I am over 18 years old.

ADAPT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 weeks and 64 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks and 64 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 in controlling sinonasal inflammation and preventing nasal polyp recurrence after complete sinus surgery for allergic fungal rhinosinusitis (AFRS) by using the modified Lund-Kennedy score
Incidence of oral/topical corticosteroid utilization per participant
Secondary outcome measures
Change in 1 second (FEV1) following sinus surgery in the subgroup of participants with asthma (~25%)
Change in forced vital capacity (FVC) following sinus surgery in the subgroup of participants with asthma (~25%)
Change in the 22-item sinonasal outcomes test (SNOT-22)
+10 more

ADAPT Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: DupilumabExperimental Treatment1 Intervention
150 mg/mL in a pre-filled syringe to deliver 300 mg in 2 mL given subcutaneous every 2 weeks during the treatment period
Group II: PlaceboPlacebo Group1 Intervention
Pre-filled syringe to deliver 2 mL given subcutaneous every 2 weeks during the treatment period

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,632 Previous Clinical Trials
2,556,345 Total Patients Enrolled
SanofiIndustry Sponsor
2,160 Previous Clinical Trials
3,514,330 Total Patients Enrolled
Joshua M Levy, MD, MPH, MScPrincipal InvestigatorEmory University

Media Library

Dupilumab 300 MG/2 ML Subcutaneous Solution Clinical Trial Eligibility Overview. Trial Name: NCT05545072 — Phase 3
Allergic Fungal Rhinosinusitis Research Study Groups: Placebo, Dupilumab
Allergic Fungal Rhinosinusitis Clinical Trial 2023: Dupilumab 300 MG/2 ML Subcutaneous Solution Highlights & Side Effects. Trial Name: NCT05545072 — Phase 3
Dupilumab 300 MG/2 ML Subcutaneous Solution 2023 Treatment Timeline for Medical Study. Trial Name: NCT05545072 — Phase 3

Frequently Asked Questions

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

Are participants of this trial required to be a certain age?

"The age limit for this particular study is 18 to 99, as opposed to the 4 studies that only allow participants that are under 18 and the 51 studies for those over 65."

Answered by AI

Are there any specific requirements for participants in this research project?

"Eligibility criteria for this study include a diagnosis of allergic fungal rhinosinusitis and being between 18-99 years old. A total of 132 people will be accepted into the trial."

Answered by AI

Are there any harmful side-effects associated with Dupilumab 300 MG/2 ML Subcutaneous Solution?

"Dupilumab 300 MG/2 ML Subcutaneous Solution is considered safe. Because this is a Phase 3 trial, there is data supporting both efficacy and safety."

Answered by AI

What are we hoping to achieve with this research?

"The primary outcome of this trial is to evaluate the efficacy of dupilumab in controlling sinonasal inflammation and preventing nasal polyp recurrence after complete sinus surgery for allergic fungal rhinosinusitis (AFRS) by using the modified Lund-Kennedy score. Secondary outcomes include the prevalence of revision sinus surgery for recurrent nasal polyps and the comparison of survival curves, which is defined as the documentation of the number of revision sinus surgery per participant that are deemed clinically necessary for the treatment of an acute exacerbation of chronic rhinosinusitis (AECRS). The study will also assess the change"

Answered by AI

Are there any inclusion criteria for this research?

"Evidently, this trial is not looking for more patients as it was last updated on September 15th, 2022. This is according to the information provided on clinicaltrials.gov. Although this study is not currently recruiting, there are 56 other studies that are."

Answered by AI
~88 spots leftby Oct 2025