Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study on Stopping Mepolizumab or Dupilumab in Patients with Severe Chronic Rhinosinusitis with Nasal Polyps After 12 Months Symptom-Free

Verified siteRegistered drugNo placebo
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 is focused on studying a condition known as Chronic Rhinosinusitis with Nasal Polyps. This is a long-term condition where the sinuses become inflamed and develop growths called polyps. The study involves two treatments: Mepolizumab, also known by its code name SB240563, and Dupilumab, which is also referred to as REGN668 or SAR231893. Both medications are given as injections under the skin and are used to help manage symptoms in patients with this condition.

The purpose of the study is to determine if patients who have been symptom-free for at least 12 months can safely stop their treatment without their symptoms returning. Participants in the study will have been receiving either Mepolizumab or Dupilumab regularly and will be monitored to see if they can maintain their symptom-free status after discontinuing the medication. The study will compare the outcomes of patients who stop treatment with those who continue, to see if there are any differences based on the medication used.

Throughout the study, participants will be closely observed to ensure their condition remains stable. The main goal is to find out what percentage of patients can stop their biologic treatment and still remain in complete remission, meaning they have no symptoms. The study will also look at whether there are any differences in outcomes based on which drug the patients were treated with. This research aims to provide valuable insights into the long-term management of Chronic Rhinosinusitis with Nasal Polyps.

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

    Initial assessment

    The study begins with an initial assessment to confirm eligibility. This involves reviewing the criteria for participation, such as age, current treatment with either Dupilumab or Mepolizumab, and stability of treatment for at least three months.

    The assessment ensures that the condition, chronic rhinosinusitis with nasal polyps, has been controlled for the past year, with symptoms rated five or below on a scale from 0 to 10.

  2. Step 2

    Treatment continuation

    Participants continue their current treatment regimen. This involves receiving Dupilumab 300 mg or Mepolizumab 100 mg via subcutaneous injection every four weeks.

    This phase ensures that the treatment remains stable and unchanged, maintaining symptom control.

  3. Step 3

    Monitoring phase

    During this phase, regular monitoring occurs to assess the control of symptoms and the presence of nasal polyps.

    Participants are evaluated to ensure no significant changes in their condition, such as the need for additional treatments or surgery.

  4. Step 4

    Treatment discontinuation

    After at least 12 months without symptoms, the study evaluates the possibility of discontinuing the biologic treatment.

    The main objective is to determine if treatment can be stopped without the recurrence of symptoms.

  5. Step 5

    Follow-up

    Participants are followed up to monitor their condition after discontinuation of treatment.

    The study aims to identify the percentage of patients who remain in complete remission and to assess any differences based on the specific medication used.

Who can join the trial?

15 criteria

  • The patient must have been diagnosed with **chronic rhinosinusitis with nasal polyps**. This is a long-term condition where the sinuses are inflamed and have growths called polyps.
  • The patient must have had **bilateral polyps**, meaning polyps on both sides of the nose.
  • The patient must have undergone **ESS (endoscopic sinus surgery)**, which is a type of surgery to clear blocked sinuses.
  • The patient must meet at least three of the following five criteria:
    • Evidence of **type 2 inflammation**, which is a specific kind of immune response.
    • Need for and treatment with **systemic corticosteroids**, or a reason why they cannot take these medications. Corticosteroids are medicines that reduce inflammation.
    • A **SNOT-22 score** of 40 or above. This is a questionnaire that measures the impact of sinus problems on quality of life.
    • Significant loss of smell.
    • Having **asthma** that requires regular use of inhaled corticosteroids.
    • The patient must be over 18 years old.
    • The patient must currently be receiving treatment with either **Dupilumab (300 mg)** or **Mepolizumab (100 mg)** every four weeks. This treatment should have been stable for at least three months.
    • In the past year, the patient must have always considered their **CRS (chronic rhinosinusitis)** as controlled.
    • In the past year, the patient must have rated their CRS symptoms as five or below on a scale from 0 to 10. Symptoms include nasal blockage, runny nose, facial pain, loss of smell, sleep problems, or tiredness.
    • In the past year, a **nasal endoscopy** must not have shown a polyp score of more than 1+1 out of 4+4, and there should be no thick secretions or general swelling.
    • In the past year, the patient must not have had ESS or needed rescue treatment for their CRSwNP, such as antibiotics or systemic steroids.
    • The patient must be able to understand Danish and sign an informed consent form.

Who cannot join the trial?

1 criterion

  • There are no specific reasons listed that would prevent a patient from participating in this study.
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.

Not 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 to treat patients with severe chronic rhinosinusitis with nasal polyps. It works by targeting and reducing the activity of certain immune cells that contribute to inflammation, helping to decrease the size of the polyps and relieve symptoms.

  • Dupilumab

    is another treatment option for severe chronic rhinosinusitis with nasal polyps. It helps by blocking specific proteins in the body that cause inflammation, which can reduce the size of the polyps and improve breathing and other symptoms.

What is already known about the treatment

  • Mepolizumab

    Mepolizumab is administered as an injection under the skin. It is currently used in medicine to treat conditions like severe asthma and chronic rhinosinusitis with nasal polyps. The main therapeutic indication is to reduce inflammation and prevent the recurrence of nasal polyps. At the molecular level, Mepolizumab works by targeting and inhibiting interleukin-5 (IL-5), a protein that plays a key role in the growth and activation of eosinophils, which are cells involved in inflammation. It is classified as a monoclonal antibody.

  • Dupilumab

    Dupilumab is administered as an injection under the skin. It is widely recognized in medical literature for its use in treating conditions such as eczema, asthma, and chronic rhinosinusitis with nasal polyps. The main therapeutic indication is to reduce inflammation and improve symptoms associated with these conditions. Dupilumab works by blocking the signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13), which are proteins involved in the inflammatory response. It is classified as a monoclonal antibody.

Investigated diseases

Chronic Rhinosinusitis with Nasal Polyps – This condition involves long-term inflammation of the nasal passages and sinuses, often accompanied by the growth of soft, painless polyps inside the nose. These polyps can block nasal passages, leading to breathing difficulties, a reduced sense of smell, and frequent sinus infections. The inflammation is persistent and can cause symptoms such as nasal congestion, facial pain, and a runny nose. Over time, the polyps may grow larger, worsening the blockage and symptoms. The condition is often associated with other respiratory issues, such as asthma. It tends to be a chronic issue, requiring ongoing management to control symptoms and prevent complications.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-519628-25-00Estimated enrolment66 patientsSponsorRegion Hovedstaden

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.