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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Sydvestjysk Sygehus	Esbjerg	Denmark

Other Sites

Site Name	City	Country
Odense University Hospital	Odense	Denmark
Sygehus Lillebaelt Vejle Sygehus	Vejle	Denmark
Aalborg University Hospital	Aalborg	Denmark
Rigshospitalet	Copenhagen	Denmark
Sjællands Universitetshospital	Koege	Denmark
Alhbmt Uaembdqgio Hbgbufmk	Aarhus	Denmark
Rxjjak Mhuhatqmhzt	Herning	Denmark
Hvfxdtzh Hmgobyga	Hillerød	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	01.03.2025

Trial locations

Investigated drugs:

Dupilumab

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.

Investigated diseases:

Chronic rhinosinusitis with nasal polyps

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 ID:

2024-519758-35-01

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?