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Monoclonal Antibodies

Dupilumab vs Omalizumab for Nasal Polyps (EVEREST Trial)

Phase 4

Recruiting

Research Sponsored by Sanofi

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eligibility as per omalizumab drug-dosing table (serum IgE level ≥30 to ≤1500 IU/mL and body weight ≥30 to ≤150 kg) and ability to be dosed per the dosing table.

Participants with bilateral sino-nasal polyposis, meeting specific endoscopic and symptom criteria

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to week 36

Awards & highlights

EVEREST Trial Summary

This trial is comparing the efficacy of two drugs, dupilumab and omalizumab, in reducing polyp size, improving sense of smell, and reducing symptoms of CRSwNP. The trial will also evaluate the effect of the drugs on quality of life, asthma control, and safety.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects include allergic reactions to the medications such as rash or itching; possible injection site reactions like pain or swelling; headache; eye irritation; joint pain; nausea; fatigue. The exact side effects will be monitored throughout the trial.

EVEREST Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I have polyps in both sides of my nose confirmed by a special nose exam.

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I have had severe nasal congestion for over a week.

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I have been using mometasone nasal spray daily for at least a month.

Select...

I am at least 18 years old or the legal age of consent where the study is conducted.

EVEREST Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 36

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week 36

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 36 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 to Week 24 in Nasal Polyp Score (NPS)

Change from baseline to Week 24 in University of Pennsylvania Smell Identification Test (UPSIT)

Secondary outcome measures

Change from baseline to Week 24 in 22-Item Sino-nasal Outcome Test (SNOT-22)

Change from baseline to Week 24 in 7-item Asthma Control Questionnaire (ACQ-7)

Change from baseline to Week 24 in Nasal Peak Inspiratory Flow (NPIF)

+8 more

Side effects data

From 2016 Phase 4 trial • 17 Patients • NCT02023151

77%

Infections

100%

80%

60%

40%

20%

Study treatment Arm

Omalizumab

EVEREST Trial Design

2Treatment groups

Experimental Treatment

Group I: OmalizumabExperimental Treatment2 Interventions

Dosing Q2W or every 4 weeks (Q4W)

Group II: DupilumabExperimental Treatment2 Interventions

Dosing every 2 weeks (Q2W)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dupilumab

2017

Completed Phase 4

~12230

Omalizumab

2006

Completed Phase 4

~2350

Placebo

1995

Completed Phase 3

~2670

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor

2,164 Previous Clinical Trials

3,514,558 Total Patients Enrolled

Regeneron PharmaceuticalsIndustry Sponsor

617 Previous Clinical Trials

379,783 Total Patients Enrolled

Media Library

Dupilumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04998604 — Phase 4

Chronic Rhinosinusitis Research Study Groups: Dupilumab, Omalizumab

Chronic Rhinosinusitis Clinical Trial 2023: Dupilumab Highlights & Side Effects. Trial Name: NCT04998604 — Phase 4

Dupilumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04998604 — Phase 4

Frequently Asked Questions

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

Is Omalizumab currently being studied in any other medical experiments?

"Omalizumab's clinical trials began in 2010 at the London Chest Hospital. To date, 18421 tests have been closed and 69 are still ongoing; many of these sites are based out of Norfolk, Virginia."

Answered by AI

What conditions can Omalizumab be utilized to address?

"Omalizumab is a non-sedating histamine H1 antagonist prescribed to treat dermatitis, atopic conditions, chronic idiopathic urticaria and eosinophil."

Answered by AI

What is the ultimate goal of this medical trial?

"According to information released by Regeneron Pharmaceuticals, the primary outcome of this study will be a comparison in University of Pennsylvania Smell Identification Test (UPSIT) results from baseline to Week 24. Secondary outcomes being measured include Total Symptom Score (TSS), Incidence of adverse events of special interest (AESIs), and pre-bronchodilator forced expiratory volume in 1 second (FEV1)."

Answered by AI

In what number of venues is this investigation taking place?

"Currently, 23 medical centres are recruiting for this trial. These include Eastern Virginia Medical School-Site Number:8400010 in Norfolk, Cedars Sinai Medical Center-Site Number:8400026 in Los Angeles, and Investigational Site Number : 8400028 in Cincinnati alongside 20 other study sites."

Answered by AI

Is recruitment open for this scientific trial?

"The clinical trial is presently in a recruitment phase, as evidenced on the clinicaltrials.gov website. It was originally posted on September 27th 2021 and subsequently revised October 26th 2022."

Answered by AI

How many subjects are involved in the current clinical trial?

"Affirmative. The information hosted on the clinicaltrials website supports that this trial is currently recruiting participants. It was first published on September 27th 2021 and has since been updated, with 422 patients sought from 23 sites nationwide."

Answered by AI