Study on the Effects of Dupilumab for Patients with Chronic Rhinosinusitis with Nasal Polyps

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What is this study about?

This clinical trial is focused on studying the effects of a medication called Dupilumab on a condition known as chronic rhinosinusitis with nasal polyps (CRSwNP). CRSwNP is a long-term condition where the sinuses become inflamed, and small growths called polyps form in the nasal passages. The study will compare the effects of Dupilumab, which is given as a subcutaneous injection, to a placebo. Dupilumab is also known by its code names REGN668 and SAR231893.

The purpose of the study is to explore how Dupilumab can help restore the barrier function in the airways of patients with CRSwNP. Participants will receive either Dupilumab or a placebo in addition to their standard care for CRSwNP and/or asthma. The study will last for 24 weeks, during which time the effects of the treatment on nasal tissue and other health markers will be monitored. This includes looking at changes in certain proteins and genes in the nasal tissue, as well as other health indicators in the blood.

Throughout the study, participants will have regular check-ups to assess their condition and the impact of the treatment. The study aims to provide insights into how Dupilumab can improve the symptoms and quality of life for people with CRSwNP. Participants will be monitored for changes in their symptoms and overall health, with the goal of understanding the potential benefits of adding Dupilumab to their treatment plan.

1 joining the study

Upon joining the study, you will provide written consent to participate. This ensures that you understand the study and agree to take part in it.

You will be required to use effective birth control methods if you are a woman of childbearing potential or a fertile man, during the study and for three months after it ends.

2 initial assessment

An initial assessment will be conducted to confirm your eligibility. This includes checking your medical history and current health status.

You must have a condition called chronic rhinosinusitis with nasal polyps and meet specific criteria related to this condition.

3 treatment phase

You will be randomly assigned to receive either the medication Dupixent (dupilumab) or a placebo. A placebo looks like the real medication but does not contain the active ingredient.

The medication is administered as a subcutaneous injection, which means it is injected under the skin. The dosage is 300 mg, and it will be given according to the study schedule.

4 ongoing assessments

Throughout the study, you will have regular assessments to monitor your health and the effects of the treatment. These assessments will occur at baseline, 12 weeks, and 24 weeks.

The assessments will include tests to measure changes in your condition and overall health, such as blood tests and questionnaires about your symptoms and quality of life.

5 end of treatment

After 24 weeks, the treatment phase will end. You will have a final assessment to evaluate the overall effects of the treatment.

You will continue to be monitored for a short period after the treatment ends to ensure your safety and well-being.

Who Can Join the Study?

The patient must provide voluntary written consent to participate in the study.
Women who can have children and men who are fertile must use highly effective birth control methods during the study and for 3 months after the study ends. This includes methods like implants, injectables, some birth control pills, certain IUDs, or true sexual abstinence (not having heterosexual intercourse during the study period). Postmenopausal women (those who have not had a period for at least 12 months without another medical reason) do not need to use birth control.
The patient must be at least 18 years old.
The patient must be able to understand the study requirements and be available to participate in the study procedures.
The patient must have a condition called chronic rhinosinusitis with nasal polyps (CRSwNP) with a specific score on a nasal polyp and symptom questionnaire.
The patient must have been using a stable dose of intranasal corticosteroids (INCS) for at least 4 weeks before the study screening.
The patient may or may not have asthma, as defined by the Global Initiative for Asthma (GINA).
The patient must not have received any live vaccines within 4 weeks before the study screening and until the end of the study.
If the patient has asthma, they must be on a stable or as-needed dose of inhaled corticosteroids (ICS) for at least 12 weeks before the study screening and must follow the study’s washout periods. They may use additional asthma medications like long-acting beta agonists (LABA) or Leukotriene antagonists/modifiers if they have been on continuous treatment for at least 30 days before the study screening.

Who Cannot Join the Study?

Patients who do not have chronic rhinosinusitis with nasal polyps cannot participate. This is a condition where the sinuses are inflamed for a long time, and there are growths called polyps in the nose.
Patients who are not within the specified age range cannot participate. The study is open to certain age groups only.
Patients who are not willing to follow the study procedures or take the study medication as directed cannot participate.
Patients who have other medical conditions that might interfere with the study cannot participate. This includes conditions that the study doctors think could affect the results.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have participated in another clinical trial recently may not be eligible.
Patients who have allergies to the study medication or its ingredients cannot participate.
Patients who have a history of certain diseases or health issues that the study doctors think could affect the study cannot participate.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	01.06.2023

Trial locations

Investigated drugs:

Dupilumab

Dupilumab is a medication used in this clinical trial to help people with a type of airway disease that includes nasal polyps. It works by blocking certain proteins in the body that can cause inflammation. This inflammation is often seen in conditions like asthma and chronic rhinosinusitis with nasal polyps (CRSwNP). By reducing inflammation, Dupilumab may help improve symptoms and restore the natural barrier in the nasal passages. In this study, Dupilumab is being tested to see how well it can help repair the nasal tissue in patients with CRSwNP when added to their usual treatment.

Investigated diseases:

Chronic rhinosinusitis with nasal polyps

Chronic Rhinosinusitis with Nasal Polyps – Chronic rhinosinusitis with nasal polyps is a condition characterized by prolonged inflammation of the nasal and sinus linings, leading to the growth of soft, painless, noncancerous masses called polyps. These polyps can obstruct nasal passages, causing breathing difficulties, reduced sense of smell, and frequent sinus infections. The disease progresses as the inflammation persists, often resulting in a cycle of swelling and blockage. Over time, the polyps may increase in size and number, exacerbating symptoms. The condition is often associated with other respiratory issues, such as asthma, and can significantly impact quality of life.

Trial ID:

2023-504014-30-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effects of Dupilumab for Patients with Chronic Rhinosinusitis with Nasal Polyps

What is this study about?

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