Dupilumab for Allergic Fungal Rhinosinusitis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests dupilumab, a medication that might help people with allergic fungal rhinosinusitis (AFRS), a condition causing sinus problems due to a reaction to fungus. The main goal is to determine if dupilumab can reduce sinus blockages and improve symptoms like nasal polyps (small growths in the nose) and sense of smell. People diagnosed with AFRS who experience frequent sinus issues, such as nasal blockages and polyps, might be suitable candidates. The trial will compare dupilumab to a placebo (a treatment with no active medication) to evaluate its effectiveness and safety. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.
Do I have to stop taking my current medications for the trial?
The trial requires that you stop certain medications before participating. For example, you must not have taken biologic therapy or systemic immunosuppressants within 5 half-lives before the trial, and you need to be on a stable dose of intranasal corticosteroids for at least 4 weeks before starting. Check with the trial team for specific guidance on your current medications.
Is there any evidence suggesting that dupilumab is likely to be safe for humans?
Research has shown that dupilumab, a treatment under study for allergic fungal rhinosinusitis (AFRS), is safe for use. Studies have found that patients generally tolerate dupilumab well. In trials for other conditions, such as chronic rhinosinusitis with nasal polyps, the FDA approved dupilumab, indicating it meets safety standards for those uses.
In earlier studies, few patients experienced serious side effects. Common side effects included mild reactions at the injection site, such as redness or swelling. These effects were not severe and usually did not last long. Overall, the safety of dupilumab appears promising, making it a viable option for those considering participation in a clinical trial.12345Why do researchers think this study treatment might be promising for allergic fungal rhinosinusitis?
Dupilumab is unique because it targets interleukin-4 and interleukin-13 pathways, which are key players in the inflammatory process of allergic fungal rhinosinusitis. Unlike traditional treatments that often involve steroids or surgery, dupilumab offers a targeted biological approach, potentially reducing inflammation without the side effects of steroids. Researchers are excited about dupilumab because it promises a more precise treatment option that could lead to better symptom control and improved quality of life for patients with this challenging condition.
What evidence suggests that dupilumab might be an effective treatment for allergic fungal rhinosinusitis?
Research has shown that dupilumab, which participants in this trial may receive, may help treat allergic fungal rhinosinusitis (AFRS). Studies have found that it can clear up the sinuses, as seen in scans. Patients have reported fewer symptoms, such as a stuffy nose, and an improved sense of smell. A case series noted that dupilumab reduced the frequency of symptom recurrence, suggesting it could make symptoms less likely to return. Overall, early evidence suggests that dupilumab could be an effective option for managing AFRS.12367
Who Is on the Research Team?
Clinical Sciences & Operations
Principal Investigator
Sanofi
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive dupilumab or placebo every 2 or 4 weeks based on weight for 52 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Dupilumab SAR231893
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sanofi
Lead Sponsor
Paul Hudson
Sanofi
Chief Executive Officer since 2019
Degree in Economics from Manchester Metropolitan University
Christopher Corsico
Sanofi
Chief Medical Officer
MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University
Regeneron Pharmaceuticals
Industry Sponsor
Leonard Schleifer
Regeneron Pharmaceuticals
Chief Executive Officer since 1988
MD and PhD in Medicine
George Yancopoulos
Regeneron Pharmaceuticals
Chief Medical Officer since 1997
MD from Harvard Medical School