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Trial record 1 of 1 for:    LPS16747
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EValuating trEatment RESponses of Dupilumab Versus Omalizumab in Type 2 Patients (EVEREST)

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ClinicalTrials.gov Identifier: NCT04998604
Recruitment Status : Recruiting
First Posted : August 10, 2021
Last Update Posted : July 12, 2023
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi

Study Description
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Brief 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

Condition or disease Intervention/treatment Phase
Chronic Rhinosinusitis With Nasal Polyps Asthma Drug: Dupilumab Drug: Omalizumab Drug: Placebo Phase 4

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 422 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Placebo injections will be administered as needed to blind the number of active dupilumab and omalizumab injections
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Head-to-head Comparison of Dupilumab Versus Omalizumab in Severe Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) and Comorbid Asthma Patients
Actual Study Start Date : September 27, 2021
Estimated Primary Completion Date : October 17, 2023
Estimated Study Completion Date : February 7, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Dupilumab
Dosing every 2 weeks (Q2W)
 Drug: Dupilumab
solution for injection subcutaneous
Other Name: SAR231893 Dupixent

Drug: Placebo
solution for injection subcutaneous
Experimental: Omalizumab
Dosing Q2W or every 4 weeks (Q4W)
 Drug: Omalizumab
solution for injection subcutaneous
Other Name: Xolair

Drug: Placebo
solution for injection subcutaneous


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline to Week 24 in Nasal Polyp Score (NPS) [ Time Frame: Baseline to Week 24 ]
    The total nasal polyps score (NPS) is the sum of the right and left nostrils, ranging from 0 (no polyps) to 8 (large polyps causing complete obstruction).

  2. Change from baseline to Week 24 in University of Pennsylvania Smell Identification Test (UPSIT) [ Time Frame: Baseline to Week 24 ]
    The UPSIT score ranges from 0 to 40, with 40 being the best possible score.


Secondary Outcome Measures :
  1. Change from baseline to Week 24 in the loss of smell score of the CRSwNP Nasal Symptom Diary [ Time Frame: Baseline to Week 24 ]
    Loss of smell scores are scored from 0 ('No symptoms') to 3 ('Severe symptoms').

  2. Change from baseline to Week 24 in the nasal congestion (NC) score of the CRSwNP Nasal Symptom Diary [ Time Frame: Baseline to week 24 ]
    NC scores are scored from 0 ('No symptoms') to 3 ('Severe symptoms').

  3. Change from baseline to Week 24 in pre--bronchodilator forced expiratory volume in 1 second (FEV1) [ Time Frame: Baseline to Week 24 ]
    Pre-bronchodilator forced expiratory volume in 1 second (volume of air in liters).

  4. Change from baseline to Week 24 in Total Symptom Score (TSS) derived from the CRSwNP Nasal Symptom Diary [ Time Frame: Baseline to Week 24 ]
    TSS ranges from 0 to 9. Higher scores on the TSS indicate greater symptom severity.

  5. Change from baseline to Week 24 in 22-Item Sino-nasal Outcome Test (SNOT-22) and [ Time Frame: Baseline to Week 24 ]
    SNOT-22 is a patient-reported outcome (PRO) questionnaire. Score ranges from 0 to 110 with higher score indicating greater rhinosinusitis related health burden.

  6. Change from baseline to Week 24 in SNOT-22 nasal domain score [ Time Frame: Baseline to Week 24 ]
    SNOT-22 is a patient-reported outcome (PRO) questionnaire. Nasal domain score ranges from 0-40 with high score representing higher disease burden.

  7. Change from baseline to Week 24 in Nasal Peak Inspiratory Flow (NPIF) [ Time Frame: Baseline to Week 24 ]
    Nasal Peak Inspiratory flow (nasal flow in liter per minute).

  8. Change from baseline to Week 24 in rhinosinusitis visual analogue scale (VAS) [ Time Frame: Baseline to Week 24 ]
    Severity of the rhinosinusitis from 0 to 10. Higher scores indicate more severe symptom.

  9. Change from baseline to Week 24 in 7-item Asthma Control Questionnaire (ACQ-7) [ Time Frame: Baseline to Week 24 ]
    Asthma control with 6 questions plus FEV1 measure. Score ranges from 0 (totally controlled) and 6 (severely uncontrolled). Higher score indicates lower asthma control.

  10. Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) [ Time Frame: Baseline to Week 36 ]
    Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).

  11. Incidence of adverse events of special interest (AESIs) [ Time Frame: Baseline to Week 36 ]
    Incidence of adverse events of special interest (AESIs).


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04998604


Contacts
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Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext option 6 Contact-US@sanofi.com

Locations
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Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT04998604    
Other Study ID Numbers: LPS16747
2021-000829-27 ( EudraCT Number )
U1111-1255-4713 ( Registry Identifier: ICTRP )
First Posted: August 10, 2021    Key Record Dates
Last Update Posted: July 12, 2023
Last Verified: July 10, 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Asthma
Nasal Polyps
Polyps
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
 Hypersensitivity
Immune System Diseases
Pathological Conditions, Anatomical
Nose Diseases
Otorhinolaryngologic Diseases
Omalizumab
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents