Dupilumab 300 MG/2 ML Subcutaneous Solution for Allergic Fungal Rhinosinusitis (AFRS)

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Emory Hospital Midtown-Otolaryngology, Atlanta, GA
Allergic Fungal Rhinosinusitis (AFRS)+1 More
Dupilumab 300 MG/2 ML Subcutaneous Solution - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The purpose of this study is to find a more effective treatment for allergic fungal rhinosinusitis (AFRS). Most people suffering from nasal polyps have elevated levels of white blood cells called eosinophils that are involved in inflammation of the air passages. Despite appropriate treatment with oral/topical corticosteroids, saline irrigations, and surgery, nasal polyps return frequently within months of surgery. Certain proteins made by the body called interleukins, appear to play a major role in the survival and activation of eosinophils. Antibodies are proteins naturally produced by your body that find foreign substances such as bacteria, fungi, viruses, and other substances that enter your body and make them inactive. Dupilumab is an antibody made in the laboratory that has been made to block specific interleukins from activating the eosinophils. This research is being done to find out if the medication dupilumab is effective and safe when used to treat patients with AFRS following recommended sinus surgery. Dupilumab is already approved for the treatment of atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyposis (CRSwNP); however, it is not approved to treat AFRS. Therefore its use in this study is considered experimental.

Eligible Conditions

  • Allergic Fungal Rhinosinusitis (AFRS)

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Allergic Fungal Rhinosinusitis (AFRS)

Study Objectives

2 Primary · 13 Secondary · Reporting Duration: 52 weeks and 64 weeks

Week 64
Change in the 22-item sinonasal outcomes test (SNOT-22)
Change in the RhinoSinusitis Disability Index (RSDI)
Change in the asthma Control Test (ACT)
Change in the endoscopic nasal polyp score (NPS)
Change in the modified Lund-Kennedy (mLK) radiologic score
Incidence of oral/topical antibiotic utilization per subject
Prevalence of oral corticosteroid utilization per treatment cohort
Prevalence of oral/topical antibiotic utilization per treatment cohort
Baseline and 52 weeks
Change in 1 second (FEV1) following sinus surgery in the subgroup of subjects with asthma (~25%)
Change in forced vital capacity (FVC) following sinus surgery in the subgroup of subjects with asthma (~25%)
Change in the FEV1/FVC ratio following sinus surgery in the subgroup of subjects with asthma (~25%)
Change in vital capacity (VC) following sinus surgery in the subgroup of subjects with asthma (~25%)
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 corticosteroid utilization per participant
Prevalence of revision sinus surgery for recurrent nasal polyps, and comparison of survival curves

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Allergic Fungal Rhinosinusitis (AFRS)

Trial Design

2 Treatment Groups

Dupilumab
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

132 Total Participants · 2 Treatment Groups

Primary Treatment: Dupilumab 300 MG/2 ML Subcutaneous Solution · Has Placebo Group · Phase 3

Dupilumab
Drug
Experimental Group · 1 Intervention: Dupilumab 300 MG/2 ML Subcutaneous Solution · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 52 weeks and 64 weeks
Closest Location: Emory Hospital Midtown-Otolaryngology · Atlanta, GA
Photo of Atlanta 1Photo of Atlanta 2Photo of Atlanta 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Allergic Fungal Rhinosinusitis (AFRS)
0 CompletedClinical Trials

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,494 Previous Clinical Trials
2,665,831 Total Patients Enrolled
SanofiIndustry Sponsor
2,021 Previous Clinical Trials
1,807,947 Total Patients Enrolled
1 Trials studying Allergic Fungal Rhinosinusitis (AFRS)
120 Patients Enrolled for Allergic Fungal Rhinosinusitis (AFRS)
Joshua M Levy, MD, MPH, MScPrincipal InvestigatorEmory University

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Failure of appropriate medical therapy, including topical intranasal corticosteroid (spray or irrigation) > 8 weeks duration, systemic corticosteroid trial of 1-3 weeks duration, and nasal saline irrigation of > 4 weeks duration.
You have a minimum score of 20 on the SNOT-22 questionnaire.
The patient has a suspected atrial fibrillation.
You are capable of giving informed consent as listed in the ICF and this protocol.
You are aged >18 years at the time of signing the ICF.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.