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Study on Secukinumab for Treating Chronic Rhinosinusitis with Nasal Polyps in Non-Type 2 Patients

Verified siteRegistered drugNo placebo

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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 (CRSwNP). This condition involves long-term inflammation of the sinuses and the growth of polyps in the nasal passages, which can lead to symptoms like nasal congestion, loss of smell, and facial pain. The treatment being tested in this study is a medication called secukinumab, which is also known by its code name AIN457. Secukinumab is a type of protein that works by targeting and blocking a specific substance in the body called interleukin-17A, which is involved in inflammation.

The purpose of this study is to evaluate how effective secukinumab is in reducing symptoms for patients with a specific type of CRSwNP, known as non-type 2 CRSwNP. Participants in the study will receive secukinumab as an injection under the skin, using a pre-filled syringe. The study will last for a period of 16 weeks, during which the effects of the treatment on symptoms will be monitored. Participants will be assessed on changes in their symptoms and any improvements in their condition.

Throughout the study, researchers will also look at changes in certain markers in the body that are associated with inflammation. This will help to understand how secukinumab affects the underlying inflammation in CRSwNP. The study aims to provide valuable information on whether secukinumab can be a beneficial treatment option for people with this challenging condition.

The research process

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

Step 1
Initial visit
Upon joining the study, an initial visit is scheduled. During this visit, eligibility is confirmed based on specific criteria, such as age and previous treatments.
A detailed explanation of the study procedures, potential risks, and benefits is provided. Consent is obtained before proceeding.
Step 2
Baseline assessment
A baseline assessment is conducted to evaluate the current state of the condition. This includes measuring the SNOT-22 and NPS scores, which are tools used to assess symptoms and nasal polyp size.
Blood samples may be taken to measure inflammatory markers associated with the condition.
Step 3
Treatment phase
The treatment phase involves receiving the medication secukinumab, which is administered as a 150 mg solution for injection under the skin (subcutaneous injection).
Injections are given at regular intervals as specified by the study protocol. The duration of this phase is up to 16 weeks.
Step 4
Follow-up visits
Regular follow-up visits are scheduled to monitor progress and any side effects. These visits include repeating the assessments of SNOT-22 and NPS scores.
Adjustments to the treatment plan may be made based on the results of these assessments.
Step 5
Final assessment
At the end of the 16-week treatment period, a final assessment is conducted. This includes a comprehensive evaluation of the condition using the same tools as the baseline assessment.
The results are compared to the baseline to determine the effectiveness of the treatment.

Who can join the trial?

4 criteria

Must have been diagnosed with Chronic rhinosinusitis with nasal polyps (CRSwNP) according to the EPOS2020 criteria.
Must be between the ages of 18 and 64.
Previous treatment with glucocorticosteroids (a type of medication that reduces inflammation) and/or surgery must have resulted in unacceptable disease control.
Must not have responded to treatment with IL-4/IL-13 antibody (dupilumab), which is a type of medication used to treat certain inflammatory conditions.

Who cannot join the trial?

8 criteria

Patients who do not have **chronic rhinosinusitis with nasal polyps** cannot participate. This is a condition where the spaces inside your nose and head (sinuses) are swollen for a long time, and you have growths called polyps in your nose.
Patients who are not between the ages of 18 and 65 cannot participate.
Patients who are not willing to follow the study procedures cannot participate.
Patients who have other medical conditions that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have participated in another clinical trial recently cannot participate.
Patients who have a history of severe allergic reactions cannot participate.
Patients who are using certain medications that might interfere with the study cannot participate.

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Verified sites

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Verified
Tartu University Hospital
Tartu, Estonia

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Investigated drugs

Secukinumab is a medication used in this clinical trial to help treat a condition called chronic rhinosinusitis with nasal polyps (CRSwNP) that is not related to type 2 inflammation. This medication works by targeting a specific protein in the body known as IL-17, which is involved in inflammation. By blocking this protein, secukinumab can help reduce the symptoms of CRSwNP, such as nasal congestion and sinus pressure, and improve the overall quality of life for patients. The trial aims to see how effective secukinumab is in reducing symptoms and improving nasal health in patients with this condition.

Secukinumab

What is already known about the treatment

Secukinumab – Secukinumab is administered as an injection under the skin, typically in the form of a pre-filled syringe or auto-injector. It is currently being studied for its effectiveness in treating chronic rhinosinusitis with nasal polyps, particularly in patients who do not have type 2 inflammation. The main therapeutic use of secukinumab is to reduce symptoms like nasal congestion and sinus pressure in these patients. At the molecular level, secukinumab works by blocking a protein called interleukin-17 (IL-17), which plays a role in inflammation. It is classified as a monoclonal antibody, a type of medication that targets specific proteins in the body to reduce inflammation and improve symptoms.

Investigated diseases

Chronic rhinosinusitis with nasal polyps – This condition involves long-term inflammation of the sinuses and nasal passages, often accompanied by the growth of soft, painless polyps inside the nose. These polyps can block nasal passages, leading to breathing difficulties, reduced sense of smell, and frequent sinus infections. The inflammation is persistent and can cause symptoms such as nasal congestion, facial pain or pressure, and nasal discharge. Over time, the condition can lead to a thickening of the sinus linings and further polyp growth. The disease is often associated with other respiratory conditions, such as asthma, and can significantly impact quality of life.