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Monoclonal Antibodies

Dupilumab for Allergic Fungal Rhinosinusitis

Phase 3
Waitlist Available
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
AFRS patients with specific endoscopic NPS and sinus opacification criteria, and body weight ≥15 kg.
Participant must be at least 6 years of age (or the minimum legal age for adolescents in the country of the investigational site) at the time of signing the informed consent.
Must not have
Active tuberculosis or non-tuberculous mycobacterial infection, or a history of incompletely treated tuberculosis unless documented adequately treated.
Diagnosed active endoparasitic infections; suspected or high risk of endoparasitic infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 24 and week 52
Awards & highlights
Pivotal Trial

Summary

This trial is looking at whether or not the drug dupilumab can reduce the need for rescue therapy or surgery in patients with allergic fungal rhinosinusitis.

Who is the study for?
This trial is for individuals at least 6 years old with Allergic Fungal Rhinosinusitis (AFRS), confirmed by specific allergy tests, nasal polyps seen in endoscopy, and characteristic CT scans. They must weigh over 15 kg and not have had sinus surgery or used certain nasal treatments recently. People with fungal invasion of sinus tissue, immune deficiencies, active infections requiring systemic treatment, hypersensitivity to dupilumab or its components are excluded.
What is being tested?
The study is testing the effectiveness of Dupilumab in reducing sinus blockage due to AFRS compared to a placebo. It will also assess if Dupilumab can lessen the need for other treatments, improve symptoms and quality of life, reduce nasal polyp formation, enhance smell sense and evaluate safety over a period up to Week 24.
What are the potential side effects?
Possible side effects include allergic reactions such as rash or itching at the injection site; eye problems like redness or irritation; joint pain; headache; cold sores in your mouth or throat.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have sinus issues, weigh at least 15 kg, and meet specific nasal and sinus criteria.
Select...
I am at least 6 years old or meet the minimum age requirement in my country.
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I have been diagnosed with AFRS based on specific criteria.
Select...
I have bone damage in my sinus area.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have active tuberculosis or a related infection, or if I had it, it's been fully treated.
Select...
I have or might have a parasite infection.
Select...
I am using specific nasal treatments like steroid drops or Xhance™.
Select...
I have a fungal infection in my sinus tissue.
Select...
I have used dupilumab in the last year or stopped it due to side effects.
Select...
I have a tumor in my nasal cavity, it could be cancerous or not.
Select...
My nasal condition doesn't affect my trial participation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 24 and week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 24 and week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline in sinus opacifications assessed by computerized tomography (CT) scans using the Lund Mackay (LMK) score at Week 52
Secondary study objectives
Change from Baseline in the monthly average anterior/posterior rhinorrhea score from the Nasal Symptom Diary at Week 24 and Week 52
Change from baseline in 22-item sino-nasal outcome test (SNOT-22) total score at Week 24 and Week 52
Change from baseline in University of Pennsylvania smell identification test (UPSIT) at Week 24 and Week 52
+7 more

Side effects data

From 2021 Phase 4 trial • 52 Patients • NCT04447417
12%
Ecchymosis
8%
Limb Injury
8%
Myalgia
8%
Medical Device Site Haemorrhage
4%
Abdominal Pain
4%
Upper Respiratory Tract Infection
4%
Medical Device Site Pain
4%
Anxiety
4%
Dental Restoration Failure
4%
Petechiae
4%
Medical Device Site Urticaria
4%
Back Pain
4%
Pain In Extremity
4%
Covid-19
4%
Food Poisoning
4%
Tooth Abscess
4%
Dermatitis
4%
Medical Device Site Erythema
4%
Blood Pressure Abnormal
100%
80%
60%
40%
20%
0%
Study treatment Arm
Healthy Volunteer
Atopic Dermatitis Patients

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: DupilumabExperimental Treatment1 Intervention
Dupilumab administered every 2 or 4 weeks based on weights
Group II: Matching placeboPlacebo Group1 Intervention
Placebo administered every 2 or 4 weeks based on weights
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dupilumab SAR231893
2021
Completed Phase 4
~3010

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor
2,204 Previous Clinical Trials
4,036,716 Total Patients Enrolled
Regeneron PharmaceuticalsIndustry Sponsor
668 Previous Clinical Trials
386,011 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi
873 Previous Clinical Trials
2,020,789 Total Patients Enrolled

Media Library

Dupilumab SAR231893 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04684524 — Phase 3
Allergic Fungal Rhinosinusitis Research Study Groups: Dupilumab, Matching placebo
Allergic Fungal Rhinosinusitis Clinical Trial 2023: Dupilumab SAR231893 Highlights & Side Effects. Trial Name: NCT04684524 — Phase 3
Dupilumab SAR231893 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04684524 — Phase 3
~0 spots leftby Dec 2024
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