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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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

Where you can join this trial?

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Other Sites

Site Name	City	Country
Odense University Hospital	Odense	Denmark
Sygehus Lillebaelt Vejle Sygehus	Vejle	Denmark
Rigshospitalet	Copenhagen	Denmark
Sjællands Universitetshospital	Koege	Denmark
Rejafy Mjezpjjvkhl	Herning	Denmark
Hldwqwau Hifgccgp	Hillerød	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	02.12.2024

Trial locations

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.

Investigated diseases:

Chronic rhinosinusitis with nasal polyps

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 ID:

2024-519628-25-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

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