Dupilumab vs Omalizumab for Nasal Polyps

(EVEREST Trial)

Recruiting at 193 trial locations

Overseen By Trial Transparency email recommended (Toll free number for US & Canada)

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Sanofi

Must be taking: Inhaled corticosteroids, Intranasal mometasone

Must not be taking: Antiparasitic drugs

Disqualifiers: Sinus surgery, Severe asthma, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 15

Duration: 24 weeks

320 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial compares Dupilumab and Omalizumab to see which is better at reducing nasal polyps and improving symptoms in patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP). Both medications work by reducing inflammation but target different parts of the immune system. Omalizumab is a biologic agent that blocks the action of immunoglobulin E and has been shown to be effective in treating severe allergic asthma and chronic rhinosinusitis with nasal polyps (CRSwNP).

Eligibility Criteria

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

I have been diagnosed with asthma by a doctor.

My IgE levels and weight match the criteria for omalizumab treatment.

I have nasal polyps and treatments like steroids or surgery haven't worked for me.

Exclusion Criteria

I've needed strong asthma medication in the last 4 weeks.

Participants with conditions/concomitant diseases making them non evaluable at Visit 1 or for the primary efficacy endpoint.

I might have a parasite infection or have taken antiparasitic drugs recently.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Treatment

Participants receive either dupilumab or omalizumab with dosing every 2 weeks or every 4 weeks for 24 weeks

24 weeks

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

2 visits (in-person)

Treatment Details

Interventions

• Dupilumab
• Omalizumab
• Placebo

Trial Overview The study compares Dupilumab against Omalizumab in reducing nasal polyp size and improving sense of smell by week 24. It also looks at how these drugs affect other symptoms, lung function, quality of life, asthma control, and overall disease severity. Participants are randomly assigned to receive either drug or a placebo.

Participant Groups

Group I: Omalizumab Experimental Treatment 2 Interventions

Dosing Q2W or every 4 weeks (Q4W)

Group II: Dupilumab Experimental Treatment 2 Interventions

Dosing every 2 weeks (Q2W)

Dupilumab is already approved in United States, European Union for the following indications:

Approved in United States as Dupixent for:

• Atopic dermatitis
• Asthma
• Chronic rhinosinusitis with nasal polyps
• Eosinophilic esophagitis

Approved in European Union as Dupixent for:

• Atopic dermatitis
• Asthma
• Chronic rhinosinusitis with nasal polyps
• Eosinophilic esophagitis

Who Is Running the Clinical Trial?

Sanofi

Lead Sponsor

Trials

2,246

Recruited

4,085,000+

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

Trials

690

Recruited

948,000+

Founded

1988

Headquarters

Tarrytown, USA

Known For

Precision medicine

Top Products

Dupixent, EYLEA, Libtayo, Praluent

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