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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 24 and week 52
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
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.
Select...
I have been diagnosed with AFRS based on specific criteria.
Select...
I have bone damage in my sinus area.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in sinus opacifications assessed by computerized tomography (CT) scans using the Lund Mackay (LMK) score at Week 52
Secondary outcome measures
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
+13 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

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
~2070

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor
2,164 Previous Clinical Trials
3,514,918 Total Patients Enrolled
Regeneron PharmaceuticalsIndustry Sponsor
622 Previous Clinical Trials
380,669 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi
862 Previous Clinical Trials
2,019,776 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

Frequently Asked Questions

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

How many participants are being accepted into this trial?

"The sponsor, Sanofi, needs to enroll 120 eligible patients from multiple clinical trial sites across North America. For example, one location is at Investigational Site Number: 1240001 in Vancouver while another site is Children's Healthcare of Atlanta (CHOA)-Site Number: 8400016."

Answered by AI

How many different research facilities are conducting this trial?

"Currently, there are 24 patients enrolled in this trial. This includes locations such as Investigational Site Number: 1240001 in Vancouver, Children's Healthcare of Atlanta (CHOA)-Site Number: 8400016 in Atlanta, and Eastern Virginia Medical School (EVMS) Medical Group - Otola-Site Number: 8400008 in Norfolk."

Answered by AI

To your knowledge, does a similar study exist?

"Dupilumab SAR231893 has been under research since 2015. The very first trial was conducted in 2015 by Sanofi and it included 880 patients. After the success of this initial study, Dupilumab SAR231893 received Phase 3 approval in 2015. Now, 52 different trials are underway involving 455 cities and 43 countries."

Answered by AI

Has Dupilumab's efficacy been verified by the FDA?

"Dupilumab SAR231893 is a medication that has completed Phase 3 clinical trials. This means that there is both supporting efficacy data as well as multiple rounds of safety data, leading our team to believe it is safe for use and award it a score of 3."

Answered by AI

Do we have room for new test subjects in this clinical trial?

"That is correct. The clinical trial was first posted on December 1st, 2020 and is actively recruiting 120 patients from 24 sites across the nation."

Answered by AI

What are the primary indications for Dupilumab SAR231893?

"Dupilumab SAR231893, a medication used to treat dermatitis and atopic, can also be employed when corticosteroid therapy fails, for eosinophil patients, and in certain asthma cases."

Answered by AI

Are there other scientific investigations that have used Dupilumab SAR231893?

"Dupilumab SAR231893 is being studied in 52 different ongoing clinical trials, with 14 of those studies currently in Phase 3. Although several of the Louisville, Kentucky based trials are for Dupilumab SAR231893, there are a total of 2662 locations conducting research on this medication."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
Investigational Site Number :8400010
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Dupilumab in Allergic Fungal Rhinosinusitis (AFRS) (LIBERTY-AFRS-AI)
2020. "Dupilumab in Allergic Fungal Rhinosinusitis (AFRS) (LIBERTY-AFRS-AI)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04684524.
~9 spots leftby Dec 2024
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