Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study on Reducing Biologic Treatments Mepolizumab and Dupilumab for Patients with Severe Chronic Rhinosinusitis with Nasal Polyps

Verified siteRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on a condition known as chronic rhinosinusitis with nasal polyps (CRSwNP). This is a long-term inflammation of the sinuses that leads to the growth of polyps in the nasal passages, causing symptoms like nasal blockage, runny nose, facial pain, and a reduced sense of smell. The study involves two medications: Dupilumab and Mepolizumab. Dupilumab, also known by its code names REGN668 and SAR231893, and Mepolizumab, also known as SB240563, are both used to help control the symptoms of CRSwNP.

The purpose of this study is to evaluate the effects of reducing the frequency of these medications in patients who have shown stable, partly controlled symptoms. Participants in the study will have been receiving either Dupilumab or Mepolizumab for at least 18 months, with their symptoms being partly controlled for at least 12 months. The study will last for 52 weeks, during which the dosing intervals of the medications will be gradually extended. The main goal is to determine how many patients can maintain partly controlled symptoms with less frequent dosing.

Throughout the study, participants will be monitored to assess changes in their symptoms and overall disease control. This will involve regular check-ups to evaluate nasal blockage, runny nose, facial pain, sense of smell, and the need for additional treatments. The study aims to provide insights into whether patients with CRSwNP can maintain symptom control with less frequent medication, potentially leading to more convenient treatment options in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Beginning of the trial

    Upon joining the study, the patient will continue their current treatment with either dupilumab or mepolizumab. These medications are solutions for injection provided in pre-filled syringes.

    The patient will receive dupilumab at a dose of 300 mg or mepolizumab at a dose of 100 mg every four weeks. This treatment schedule will be maintained for at least three months before any changes are made.

  2. Step 2

    Assessment of disease control

    The patient's condition will be evaluated to ensure it is partly controlled. This means that the patient may experience 1-2 of the following symptoms: nasal blockage, runny nose or postnasal drip, facial pain or pressure, impaired sense of smell, sleep disturbance or fatigue, diseased mucosa observed during nasal endoscopy, or the need for rescue treatment such as corticosteroids, surgery, or antibiotics.

    The assessment will be based on the patient's condition over the past year while receiving biologic treatment.

  3. Step 3

    Tapering of medication

    After confirming that the disease is partly controlled, the dosing intervals of the biologic therapy will be gradually extended. This means the patient will receive the medication less frequently over time.

    The goal is to evaluate the impact of these prolonged dosing intervals on the patient's condition over a period of 52 weeks.

  4. Step 4

    Monitoring and evaluation

    Throughout the trial, the patient's condition will be closely monitored. This includes regular assessments of symptoms and overall disease control.

    The primary focus will be on maintaining partly controlled disease status, with evaluations at the start and end of the 52-week period.

  5. Step 5

    Completion of the trial

    At the end of the 52 weeks, the patient's condition will be thoroughly evaluated to determine the success of the tapering strategy.

    The study aims to find the percentage of patients who achieve sustained partly controlled disease after the tapering of biologics.

Who can join the trial?

17 criteria

  • Must be at least 18 years old.
  • Currently receiving treatment with either Dupilumab (300 mg) or Mepolizumab (100 mg) every four weeks.
  • Have been on the same dosing schedule for at least three months.
  • For at least one year during treatment with these medications, the patient's condition must be categorized as either A or B:
    • Partly controlled (A): This means having 1-2 of the following symptoms:
      • Nasal blockage: present on most days of the week.
      • Runny nose or postnasal drip: thick mucus on most days of the week.
      • Facial pain or pressure: present on most days of the week.
      • Sense of smell: impaired.
      • Sleep disturbance or fatigue: present.
      • Nasal endoscopy: shows diseased tissue.
      • Need for rescue treatment (like steroids, surgery, or antibiotics): required at least once.
      • Controlled (B): This means having all of the following:
        • Nasal blockage: not present or not bothersome.
        • Runny nose or postnasal drip: little and clear mucus.
        • Facial pain or pressure: not present or not bothersome.
        • Sense of smell: normal or only slightly impaired.
        • Sleep disturbance or fatigue: not present.
        • Nasal endoscopy: shows healthy or almost healthy tissue.
        • No need for rescue treatment (like steroids, surgery, or antibiotics).

Who cannot join the trial?

4 criteria

  • Patients who have not been treated with either **Mepolizumab** or **Dupilumab** for at least 18 months cannot participate. These are medications used to treat certain conditions.
  • Patients who have not had a **partly controlled disease** for at least 12 months cannot participate. This means their condition has not been stable enough.
  • Patients who are not between the ages of 18 and 65 cannot participate.
  • Patients who are part of a vulnerable population, such as those unable to give consent, cannot participate.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Mepolizumab

    is a medication used in this clinical trial to help manage severe chronic rhinosinusitis with nasal polyps. It works by targeting and reducing the activity of certain cells in the immune system that can cause inflammation. In this study, patients who have been on Mepolizumab for at least 18 months and have shown stable disease for at least 12 months will have their dosing intervals extended to see if they can maintain control of their symptoms with less frequent doses.

  • Dupilumab

    is another medication being tested in this trial for patients with severe chronic rhinosinusitis with nasal polyps. It helps by blocking specific proteins in the body that contribute to inflammation and nasal polyps. Similar to Mepolizumab, patients who have been using Dupilumab for at least 18 months and have had stable disease for at least 12 months will have their dosing intervals extended. The goal is to determine if they can continue to manage their symptoms effectively with less frequent dosing.

What is already known about the treatment

  • Mepolizumab

    Mepolizumab is administered as an injection under the skin, typically in a healthcare setting. It is currently used in medicine to help manage severe chronic rhinosinusitis with nasal polyps (CRSwNP) and is well-documented in medical literature. The main therapeutic indication for Mepolizumab is to reduce inflammation and control symptoms in patients with CRSwNP. At the molecular level, Mepolizumab works by targeting and blocking a protein called interleukin-5 (IL-5), which plays a key role in the inflammation process. It is classified as a biologic medication, specifically an anti-IL-5 monoclonal antibody.

  • Dupilumab

    Dupilumab is administered as an injection under the skin, often in a clinical setting. It is recognized in the medical community for its role in treating severe chronic rhinosinusitis with nasal polyps (CRSwNP) and is supported by extensive medical literature. The primary therapeutic use of Dupilumab is to alleviate inflammation and manage symptoms in patients with CRSwNP. On a molecular level, Dupilumab works by inhibiting the signaling of proteins called interleukin-4 (IL-4) and interleukin-13 (IL-13), which are involved in the inflammatory response. It is classified as a biologic medication, specifically an interleukin inhibitor.

Investigated diseases

Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) – This condition is characterized by inflammation of the nasal passages and sinuses lasting more than 12 weeks, accompanied by the growth of polyps in the nasal cavity. These polyps are non-cancerous, soft, and painless, but they can cause significant nasal blockage. Symptoms often include persistent nasal congestion, runny nose, facial pain or pressure, and a reduced sense of smell. The disease progresses with periods of worsening symptoms, often triggered by infections or allergens. Over time, the polyps can grow larger, leading to more severe nasal obstruction and breathing difficulties. The condition can also cause sleep disturbances and fatigue due to impaired airflow.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-519758-35-01Estimated enrolment135 patientsSponsorRigshospitalet

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).