Dupilumab vs Omalizumab for Nasal Polyps
(EVEREST Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial compares two treatments, dupilumab and omalizumab, to determine which better reduces nasal polyps and improves the sense of smell in people with chronic rhinosinusitis. It also examines other benefits, such as symptom relief, breathing improvement, and overall quality of life over 24 weeks. Suitable participants are those with nasal polyps causing ongoing nasal congestion and loss of smell, who have not found success with treatments like steroids or surgery. Participants must also have asthma managed with inhalers. As a Phase 4 trial, this research aims to understand how these FDA-approved treatments can benefit more patients.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that asthma medications should be stable for at least 1 month before the trial and during the screening period.
What is the safety track record for dupilumab and omalizumab?
Research has shown that both dupilumab and omalizumab have undergone safety testing in people with nasal polyps. Studies found that dupilumab is generally well-tolerated by patients with chronic rhinosinusitis with nasal polyps (CRSwNP). Some reported mild side effects, such as injection site reactions, but serious side effects were rare.
Omalizumab also maintains a good safety record in similar studies. It has been used to treat nasal polyps and has improved symptoms for many. Mild side effects, like headaches and injection site reactions, have been noted, but serious issues were uncommon.
Both treatments have approval for other conditions, which increases confidence in their safety. However, discussing personal health concerns with a doctor before joining a trial is important.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about these treatments for nasal polyps because they target the condition in novel ways. Unlike traditional treatments that often involve steroids or surgery, Dupilumab works by inhibiting the signaling of interleukin-4 and interleukin-13, which are key drivers of inflammation in nasal polyps. On the other hand, Omalizumab targets IgE, an antibody involved in allergic responses, and its dosing is tailored based on a patient's IgE levels and weight, offering a personalized approach. These mechanisms provide alternative pathways for managing nasal polyps, potentially reducing symptoms and improving quality of life without the need for invasive procedures.
What evidence suggests that this trial's treatments could be effective for nasal polyps?
This trial will compare the effectiveness of Dupilumab and Omalizumab for treating chronic rhinosinusitis with nasal polyps (CRSwNP). Research has shown that both Dupilumab and Omalizumab effectively treat CRSwNP. Studies indicate that Dupilumab can significantly reduce nasal polyp size and improve CT scan results, with patients also reporting improved overall health. Similarly, Omalizumab decreases nasal polyp scores and improves CRSwNP symptoms over time, enhancing quality of life related to sinus health. Several studies have shown that Dupilumab is more effective than Omalizumab in improving CRSwNP symptoms and reducing polyp size.56789
Are You a Good Fit for This Trial?
This trial is for adults with chronic rhinosinusitis and nasal polyps who've had symptoms like nasal blockage or loss of smell for at least 8 weeks, despite previous treatments. They should have used mometasone before and meet specific criteria for asthma control and body weight/IgE levels. People can't join if they've had recent sinus surgery, certain infections including HIV, severe allergies to the drugs being tested, or a history of cancer within the last 5 years.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either dupilumab or omalizumab with dosing every 2 weeks or every 4 weeks for 24 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Dupilumab
- Omalizumab
- Placebo
Dupilumab is already approved in United States, European Union for the following indications:
- Atopic dermatitis
- Asthma
- Chronic rhinosinusitis with nasal polyps
- Eosinophilic esophagitis
- Atopic dermatitis
- Asthma
- Chronic rhinosinusitis with nasal polyps
- Eosinophilic esophagitis
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