Comparing the effectiveness of two treatments for severe nasal polyps and asthma

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    What is this study about?

    This study is looking at two medications, called Dupilumab and Omalizumab, to see how well they work in people who have severe nose and sinus problems alongside asthma. The main goal is to see if Dupilumab is better at shrinking nasal polyps (small growths in the nose) and improving the sense of smell. Other goals include seeing if Dupilumab can improve symptoms, lung function, and overall health-related quality of life better than Omalizumab. The study also aims to understand how these drugs affect the severity of the disease and asthma control, and their safety. To assess all these, doctors will use various tests, like measuring the size of nasal polyps, testing the ability to smell, and how well one’s lungs are working. Participants in the study will be involved for 38 weeks.

    Learn more about this Trial

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      Locations

      Where does the clinical trial take place?

      Gent , Belgium

      Leuven , Belgium

      Sint-Lambrechts-Woluwe , Belgium

      Benesov , Czechia

      Hradec Kralove , Czechia

      Ostrava – Poruba , Czechia

      Pardubice , Czechia

      Plzen , Czechia

      Praha 10 , Czechia

      Praha 2 , Czechia

      Praha 4 , Czechia

      Praha 5 – Motol , Czechia

      Aarhus , Denmark

      Copenhagen , Denmark

      Helsinki , Finland

      Tampere , Finland

      Creteil , France

      Kremlin Bicetre , France

      La Roche sur Yon , France

      Lille , France

      Marseille , France

      Montpellier , France

      Nantes , France

      Toulouse , France

      Vandoeuvre-les-nancy , France

      Berlin , Germany

      Du00fcsseldorf , Germany

      Hamburg , Germany

      Mu00fcnchen , Germany

      Mu00fcnster , Germany

      Budapest , Hungary

      Budapest , Hungary

      Debrecen , Hungary

      Edelu00e9ny , Hungary

      Pu00e9cs , Hungary

      Szeged , Hungary

      Roma , Italy

      Rozzano , Italy

      Catania , Italy

      Firenze , Italy

      Milano , Italy

      Varese , Italy

      Warszawa , Poland

      Katowice , Poland

      Poznan , Poland

      Krakow , Poland

      Lodz , Poland

      Sroda Wielkopolska , Poland

      Almada , Portugal

      Aveiro , Portugal

      Guimaru00e3es , Portugal

      Matosinhos , Portugal

      Santa Maria da Feira , Portugal

      Brasov , Romania

      Cluj-Napoca , Romania

      Craiova , Romania

      Sevilla , Spain

      Barcelona , Spain

      Hospitalet de Llobregat , Spain

      Jerez de la Frontera , Spain

      Madrid / Madrid , Spain

      Majadahonda , Spain

      Pamplona , Spain

      Gu00f6teborg , Sweden

      Lund , Sweden

      Stockholm , Sweden

      Wigan , United Kingdom

      Manchester , United Kingdom

      Newcastle upon Tyne , United Kingdom


      Study Steps

      How Complex Will My Study Be and What Phases Will I Go Through?

      The steps a patient needs to take in this clinical trial include the following:

      1. A screening and run-in period of 28 days ± 3 days.
      2. A randomized investigational medicinal product (IMP) intervention period lasting 24 weeks.
      3. A follow-up period of up to 12 weeks.

      The total duration for each participant in the study will be 38 weeks.


      Diseases Under Investigation

      What Conditions Qualify Me for This Study?

      To join the study, you need to have one or more of the following diseases:

      1. Bilateral sino-nasal polyposis – This condition must be confirmed despite prior treatment with systemic corticosteroids (SCS) anytime within the past 2 years, or if there is a medical contraindication/intolerance to SCS, or if you have had prior surgery for nasal polyps (NP).
      2. Asthma – You must have a physician’s diagnosis of asthma based on the Global Initiative for Asthma (GINA) 2020. The asthma should be treated with low, medium, or high dose inhaled corticosteroids (ICS) and a second controller (such as a Long-Acting Beta-Agonist (LABA)), with a third controller being optional but not mandatory. Your dose regimen should be stable for at least 1 month before the screening visit and during the screening and run-in period.

      Please note, the inclusion criteria also specify certain disease-specific conditions that must be met for participation.


      Terms and conditions

      What Requirements I Have to Meet To Join This Study?

      When Am I Eligible to Join the Study?

      Here are the conditions you must meet to join the study, along with explanations of medical terms where necessary:

      Inclusion Criteria:

      1. Participant must be at least 18 years of age inclusive, at the time of signing the informed consent.
      2. Participants with bilateral sino-nasal polyposis (SNP), which means polyps present in both sides of the nasal cavity, should meet the following:
        1. An endoscopic bilateral Nasal Polyp Score (NPS) of at least 5 out of a maximum score of 8 (with a minimum score of 2 in each nasal cavity) at the first visit. The NPS is a score that assesses the size and extent of nasal polyps during an endoscopic examination.
        2. Ongoing symptoms of nasal congestion/blockade/obstruction and loss of smell for at least 8 weeks before screening (Visit 1).
        3. Nasal congestion/blockade/obstruction with a weekly average severity greater than 1 in the 7 days before randomization (Visit 2).
        4. Loss of smell symptom severity score of 2 or 3 at screening (Visit 1) and a weekly average severity greater than 1 in the 7 days before randomization (Visit 2).
      3. 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 (like LABA). A third controller medication is allowed but not mandatory. The dose regimen should be stable for at least 1 month before Visit 1 and during the screening and run-in period. Inhaled corticosteroids are medications that reduce inflammation in the airways, and LABA stands for long-acting beta-agonists, which are used to help keep airway muscles relaxed.
      4. Asthma Control Questionnaire 5-question version (ACQ-5) score ≥1.5 at Visits 1 or 2. The ACQ-5 score measures the control of asthma symptoms, with higher scores indicating less control.
      5. Treatment with intranasal mometasone ≥200 µg once daily (or equivalent of another inhaled nasal corticosteroids) for 1 month prior to Visit 1 and during the run-in period. This treatment is for chronic rhinosinusitis with nasal polyps (CRSwNP).
      6. Eligibility as per omalizumab drug-dosing table (serum IgE level ≥30 to ≤1500 IU/mL and body weight ≥30 to ≤150 kg) and the ability to be dosed per the dosing table. Omalizumab is an injectable medication used for certain allergic conditions, and dosing is typically based on the level of IgE antibodies and body weight.

      Please let me know if you need further clarification on any of these points.

      What Reasons Could Exclude Me from the Study?

      Exclusion Criteria: You can’t take part in the study if any of the following conditions apply:

      1. Having had any sinus intranasal surgery (like polypectomy) within the last 6 months before the first visit.
      2. Having had sino-nasal surgery that changed the lateral wall structure of the nose, which would make it impossible to evaluate Nasal Polyp Score (NPS).
      3. Having conditions or concomitant diseases making you non-evaluable at the first visit or for the primary efficacy endpoint, such as:
        • Antrochoanal polyps: A type of nasal polyp that originates in the maxillary sinuses and extends into the nasal cavity.
        • Nasal septal deviation: A condition where the nasal septum, the bone and cartilage that divide the nasal cavity of the nose in half, is significantly off-center or crooked, potentially blocking one nostril.
        • Acute sinusitis, nasal infection, or upper respiratory infection: Recent or active infections affecting the sinuses, nasal passages, or upper respiratory tract.
      4. Severe asthma exacerbation requiring treatment with Systemic corticosteroids (SCS) in the last 4 weeks before the initial visit and during screening.
      5. Severe concomitant illnesses that, according to the Investigator’s judgment, would negatively affect your participation in the study.
      6. Being diagnosed with, suspected of, or at high risk of endoparasitic infection, and/or use of antiparasitic drugs within 2 weeks before the initial screening visit or during the screening and run-in period.
      7. History of Human Immunodeficiency Virus (HIV) infection or positive HIV 1/2 serology at the initial screening visit.
      8. Known or suspected immunodeficiency, including a history of severe opportunistic infections.
      9. Active malignancy or a history of cancer in the last 5 years before the first visit, except for completely treated in situ carcinoma of the cervix, and non-metastatic squamous or basal cell carcinoma of the skin which have been resolved.
      10. History of systemic hypersensitivity or anaphylaxis to dupilumab and omalizumab, or any ingredient in these medications.
      11. Treatment with a live (attenuated) vaccine within 4 weeks before the initial screening visit.

      Please note, the medical terms have been explained in simpler language where possible.


      Investigational Medicinal Product

      What Products Are Being Used in This Study?

      The drugs involved in the study are:

      1. Dupilumab (active substance: Dupilumab)

        Dupilumab is a monoclonal antibody designed to inhibit the signaling of interleukin-4 and interleukin-13, two key proteins that play a central role in type 2 inflammation associated with diseases like asthma and chronic rhinosinusitis with nasal polyps (CRSwNP).

      2. Omalizumab (active substance: Omalizumab)

        Omalizumab is a monoclonal antibody that works by binding to immunoglobulin E (IgE), which plays a pivotal role in the allergic response. By blocking IgE, omalizumab helps reduce allergic reactions and is used in treating moderate to severe persistent asthma and CRSwNP.

      3. Placebo

        A placebo, which contains no active medication, is used as a control in clinical trials to compare the effects and side effects of the investigational drugs.

      These are the medications that participants in the clinical trial will be administered.

      Have the Medicinal Substances Used in the Trial Been Previously Studied in Medicine?

      The active substances that are participating in the clinical trial are:

      1. Dupilumab: This is a medication that is already known to medicine and is available on the market under the trade name Dupixent. It is used for subcutaneous injection and is typically administered every two weeks (Q2W).
      2. Omalizumab: This is another medication that is well-known in the medical literature and is marketed as Xolair. It is also used for subcutaneous injection. The dosing schedule for this trial is every two weeks (Q2W) or every four weeks (Q4W).
      3. Placebo: A placebo is a substance with no active therapeutic effect. It is often used in clinical trials as a control to test the efficacy of a drug.

      Both Dupilumab and Omalizumab are drugs that are approved for certain conditions and are being investigated further in this clinical trial.


      Study ID

      CT-EU-00057021

      Recruitment status

      Recruting new patients

      Start of the trial

      3 years ago

      Study phase

      Phase
      IV

      Medicinal Product