EValuating trEatment RESponses of Dupilumab Versus Omalizumab in Type 2 Patients

Study on Investigational Medications for Nasal Polyps and Smell Improvement

Not Recruiting
18 years or above
All
Phase 4
320 participants needed

Study Overview

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 chronic rhinosinusitis with nasal polyps (CRSwNP) symptoms 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 safety of dupilumab and omalizumab

Study Details

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.

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Chronic Rhinosinusitis With Nasal Polyps, Asthma
  • Age: 18 years or above
  • Gender: All

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.

Updated on 03 Apr 2025. Study ID: NCT04998604

This study investigates the effectiveness of investigational medications in reducing the size of nasal polyps and improving the sense of smell. Nasal polyps are non-cancerous growths in the lining of the nasal passage or sinuses that can lead to breathing problems, loss of smell, and frequent infections. The study compares two investigational medications to see which one is more effective in treating these symptoms.

Participants will undergo several procedures during the study. They will be randomly assigned to receive one of the investigational medications and will have regular check-ups to monitor their symptoms. The study will also assess the overall quality of life and safety of the treatments. Participants will be required to take specific medications and attend scheduled visits to track their progress.

  • Who can participate: Adults 18 years and older with bilateral sino-nasal polyposis and symptoms like nasal congestion or loss of smell can participate. A history of treatment with systemic corticosteroids or surgery is required, and those with asthma treated with inhaled corticosteroids and other controllers are eligible.
  • Study details: Participants will receive one of the investigational medications and be monitored for changes in nasal polyps and smell. A placebo is not used. Participants must maintain stable asthma medication doses and avoid certain medications and procedures during the study.
  • Study timelines: The study will last 38 weeks.