EValuating trEatment RESponses of Dupilumab Versus Omalizumab in Type 2 Patients (EVEREST)

  • STATUS
    Recruiting
  • End date
    Feb 7, 2024
  • participants needed
    422
  • sponsor
    Sanofi
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Updated on 12 May 2023
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Summary

Primary Objective

-To evaluate the efficacy of dupilumab compared to omalizumab in reducing the polyp size and improving sense of smell

Secondary Objectives

  • To evaluate the efficacy of dupilumab in improving CRSwNP symptoms at Week 24 compared to omalizumab
  • To evaluate the efficacy of dupilumab in improving lung function at Week 24 compared to omalizumab
  • To evaluate the efficacy of dupilumab in improving CRSwNP total symptom score (TSS) at Week 24 compared to omalizumab
  • To evaluate the effect of dupilumab on health related quality of life (HRQoL) at week 24 compared to omalizumab
  • To evaluate the efficacy of dupilumab in improving nasal peak inspiratory flow at Week 24 compared to omalizumab
  • To evaluate the effect of dupilumab on CRSwNP overall disease severity at Week 24 compared to omalizumab
  • To evaluate the effect of dupilumab on asthma control at Week 24 compared to omalizumab
  • To evaluate the safety of dupilumab and omalizumab

Description

Study duration per participant will be 38 weeks. The study will comprise 3 periods: 28 days ± 3 days screening and run-in period; 24 weeks Randomized investigational medicinal product (IMP) intervention period; up to 12 weeks follow-up period.

Details
Condition Chronic Rhinosinusitis With Nasal Polyps, Asthma
Treatment Placebo, omalizumab, Dupilumab
Clinical Study IdentifierNCT04998604
SponsorSanofi
Last Modified on12 May 2023

Eligibility

 Yes No Not Sure

Inclusion Criteria

Participant must be at least 18 (or the legal age of consent in the jurisdiction in which the study is taking place) years of age inclusive, at the time of signing the informed consent
Participants with bilateral sino-nasal polyposis, that despite prior treatment with Systemic corticosteroids (SCS) anytime within the past 2 years; and/or medical contraindication/intolerance to SCS; and/or prior surgery for NP have
An endoscopic bilateral NPS of at least 5 out of a maximum score of 8 (with a minimum score of 2 in each nasal cavity) at visit 1; AND
Ongoing symptoms of Nasal congestion/blockade/obstruction and loss of smell for at least 8 weeks before screening (Visit 1), AND
Nasal congestion/blockade/obstruction and a weekly average severity greater than 1 in the 7 days before randomization (Visit 2) AND
loss of smell symptom severity score 2 or 3 at screening (Visit 1) and a weekly average severity of greater than 1 in the 7 days before randomization (Visit 2)
Participants with a physician diagnosis of asthma based on the Global Initiative for
Asthma (GINA) 2020 treated with low, medium or high dose inhaled
corticosteroids (ICS) and a second controller (ie, LABA), a third controller
is allowed but not mandatory. The dose regimen should be stable for at least 1
month before Visit 1 (screening visit) and during the screening and run-in
period
Asthma Control Questionnaire 5-question version (ACQ-5) score ≥1.5 at Visits 1 or 2
Treatment with intranasal mometasone ≥200 μg once daily (QD) (or equivalent of another INCS) for 1 month prior to Visit 1 and during the run-in period (for CRSwNP)
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

Exclusion Criteria

Participants are excluded from the study if any of the following criteria
apply
Participants who have undergone any sinus intranasal surgery (including polypectomy) within 6 months before Visit 1
Participants who have had a sino-nasal surgery changing the lateral wall structure of the nose, making impossible the evaluation of NPS
Participants with conditions/concomitant diseases making them non evaluable at Visit 1 or for the primary efficacy endpoint such as: Antrochoanal polyps, Nasal septal deviation that would occlude at least one nostril, Acute sinusitis, nasal infection, or upper respiratory infection
Severe asthma exacerbation requiring treatment with SCS in the last 4 weeks prior to Visit 1 and during screening
Severe concomitant illness(es) that, in the Investigator's judgment, would adversely affect the participant's participation in the study
Diagnosed with, suspected of, or at high risk of endoparasitic infection, and/or use of antiparasitic drugs within 2 weeks before Visit 1 (screening visit) or during the screening and run-in period
History of human immunodeficiency virus (HIV) infection or positive HIV 1/2 serology at Visit 1 (screening visit)
Known or suspected immunodeficiency, including history of invasive opportunistic infections
Active malignancy or history of malignancy within 5 years before Visit 1 (screening visit), except completely treated in situ carcinoma of the cervix and completely treated and resolved non metastatic squamous or basal cell carcinoma of the skin
History of systemic hypersensitivity or anaphylaxis to dupilumab and omalizumab, including any excipient
Treatment with a live (attenuated) vaccine within 4 weeks before Visit 1 (screening visit)
The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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