Study on Symptom Changes in Adults with Chronic Rhinosinusitis with Nasal Polyps Using Tezepelumab

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What is this study about?

This clinical trial is focused on studying a condition known as Chronic Rhinosinusitis with Nasal Polyposis. This is a long-term inflammation of the sinuses that leads to the growth of polyps in the nasal passages, causing symptoms like nasal congestion, loss of smell, and sleep disturbances. The treatment being investigated in this study is a medication called Tezepelumab, which is administered as a solution for injection.

The purpose of the study is to observe changes in symptoms experienced by participants after starting treatment with Tezepelumab. Participants will report on their nasal congestion and other sinus-related symptoms over the course of the study. The study will last for 24 weeks, during which participants will receive regular injections of Tezepelumab and will be asked to keep a diary of their symptoms.

Throughout the study, changes in nasal congestion and other symptoms will be measured to assess the effectiveness of Tezepelumab. Participants will be monitored for any improvements in their condition, such as reduced nasal congestion and better sleep quality. The study aims to provide valuable information on how Tezepelumab can help manage symptoms of Chronic Rhinosinusitis with Nasal Polyposis.

1 joining the study

Upon joining the study, you will be required to provide signed and dated written informed consent. This document confirms your understanding of the study and your agreement to participate.

You must be 18 years of age or older and have been diagnosed with chronic rhinosinusitis with nasal polyposis for at least 12 months prior to the first visit.

2 initial assessment

An initial assessment will be conducted to evaluate your symptoms and medical history. This includes a nasal congestion score and a sino-nasal outcome test.

You must have ongoing nasal polyposis symptoms for more than 8 weeks prior to screening, such as runny nose, reduced or lost sense of smell, and/or poor quality of sleep.

3 treatment initiation

You will begin treatment with tezepelumab, administered as a subcutaneous injection using a pre-filled syringe. The dosage is 210 mg.

The treatment will be administered at regular intervals as specified by the study protocol.

4 ongoing assessments

Throughout the study, you will undergo regular assessments to monitor changes in your symptoms. This includes measuring nasal congestion and sino-nasal symptoms.

These assessments will help determine the effectiveness of the treatment over time.

5 completion of study

The study is expected to last until January 2027. Upon completion, a final assessment will be conducted to evaluate the overall changes in your symptoms.

Your participation will contribute to understanding the effectiveness of tezepelumab in treating chronic rhinosinusitis with nasal polyposis.

Who Can Join the Study?

Participants must be 18 years of age or older at the time of signing the informed consent.
Participants must have been diagnosed by a doctor with Chronic Rhinosinusitis with Nasal Polyposis (CRSwNP) for at least 12 months before the first visit.
The condition must be severe enough to potentially require surgery, with a total Nasal Polyp Score (NPS) of 4 or more at screening, as determined by a central reader. The NPS is a measure of the size and extent of nasal polyps.
Participants must have a mean Nasal Congestion Score (NCS) of 2 or more in the two weeks before the second visit. The NCS measures the level of nasal congestion.
Participants must have ongoing nasal polyp symptoms for more than 8 weeks before screening, such as a runny nose, reduced or lost sense of smell, and/or poor quality or loss of sleep.
The Sino-Nasal Outcome Test (SNOT-22) total score must be 30 or more at screening. This test measures the impact of sinus and nasal issues on quality of life.
Participants must be on a stable treatment plan for CRSwNP, which includes using intranasal corticosteroids (a type of medication sprayed into the nose to reduce inflammation) for at least 30 days before the first visit.
Participants must have either been treated for nasal polyp flare-ups with systemic corticosteroids (SCS) for at least 3 consecutive days or received one injectable dose in the past 12 months, but not in the last 3 months before the first visit. Alternatively, they must have a history of nasal polyp surgery.
Participants must have a body weight of 40 kg or more at the first visit.
Female participants must follow local regulations for contraception during the study. Women who cannot have children or are postmenopausal (no menstrual periods for 12 months without another medical reason) have specific criteria to meet.
Participants must provide a signed and dated written Informed Consent Form (ICF) before any study-specific procedures, sampling, and analyses.
Participants must be capable of giving signed informed consent, which includes agreeing to follow the study’s requirements and restrictions.

Who Cannot Join the Study?

Patients who do not have Chronic Rhinosinusitis with Nasal Polyposis 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 and requirements 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 are currently participating in another clinical trial cannot participate.
Patients who have had recent surgery or plan to have surgery during the study period cannot participate.
Patients who have a history of severe allergic reactions cannot participate.
Patients who are unable to provide informed consent cannot participate. This means they must understand the study and agree to take part.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Hospital Universitario De Salamanca	Salamanca	Spain
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
Centre Hospitalier Universitaire De Lille	Lille	France
Oncopole Claudius Regaud	Toulouse	France
Hospital Jerez de la Frontera	Jerez De La Frontera	Spain
IRCCS Humanitas Research Hospital	Rozzano	Italy

Other Sites

Site Name	City	Country
University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov	Sofia	Bulgaria
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania	Catania	Italy
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Del Mar	Barcelona	Spain
Santa Sp. z o.o.	Lodz	Poland
Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j.	Bydgoszcz	Poland
Medical Institute Ministry Of Interior	Sofia	Bulgaria
Azienda Ospedaliera di Padova	Padua	Italy
CENTRUM MEDYCZNE LUCYNA ANDRZEJ DYMEK	Zawadzkie	Poland
Diagnostic-consultative center “Aleksandrovska” EOOD	Sofia	Bulgaria
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Azienda Unita Sanitaria Locale Di Bologna	Bologna	Italy
Philipps-Universitaet Marburg	Marburg	Germany
Semmelweis University	Budapest	Hungary
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz	Nyiregyhaza	Hungary
Centre Hospitalier Universitaire De Nantes	Nantes	France
Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH	Villingen-Schwenningen	Germany
University Of Pecs	Pecs	Hungary
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
MeDoc Egeszsegkoezpont Zrt.	Budapest	Hungary
Azienda Ospedaliero Universitaria Pisana	Pisa	Italy
Osrodek Medycyny Estetycznej Medica	Bialystok	Poland
Gqyu Gfytvypbijda ffjm Emgvslgzkfryhz uww Kkxyttdty Aabqxmfrchlcrohbz mgt	Wiesbaden	Germany
Aisinqyjkn Pwztoeex Hbjyvqib Dn Mdiloapie	Marseille	France
Mscyutj Cluuws Psjacy Cbpnom Envh	Lovech	Bulgaria
Hkbdfjnr Vuke dnhjyfud	Barcelona	Spain
Ukeutxrqwqmmladfrvkac Dwabycckzqx Aud	Duesseldorf	Germany

Trial status

Country	Status	Recruitment Start
Bulgaria	Recruiting	30.03.2025
France	Recruiting	30.03.2025
Germany	Recruiting	30.03.2025
Hungary	Recruiting	30.03.2025
Italy	Recruiting	30.03.2025
Poland	Recruiting	30.03.2025
Spain	Recruiting	30.03.2025

Trial locations

Investigated drugs:

Tezepelumab

Tezepelumab is a medication being studied for its potential to help people with chronic rhinosinusitis with nasal polyps. This condition causes swelling in the nose and sinuses, leading to symptoms like nasal congestion and difficulty breathing. Tezepelumab works by blocking a specific protein in the body that can cause inflammation. By reducing this inflammation, the medication aims to improve symptoms such as nasal congestion and other sinus-related issues. Participants in the trial will receive this treatment to see if it helps alleviate their symptoms and improve their quality of life.

Investigated diseases:

Chronic rhinosinusitis with nasal polyps

Chronic Rhinosinusitis with Nasal Polyposis – This condition involves long-term inflammation of the sinuses and nasal passages, often accompanied by the growth of polyps. These polyps are non-cancerous swellings that can obstruct nasal passages, leading to difficulty breathing through the nose. Symptoms typically include nasal congestion, facial pain or pressure, reduced sense of smell, and nasal discharge. The disease progresses with persistent symptoms that can fluctuate in severity over time. The presence of polyps can exacerbate symptoms and contribute to further nasal obstruction. Chronic inflammation is a key feature, often requiring ongoing management to alleviate symptoms.

Trial ID:

2024-513862-20-00

Protocol code:

D5242C00002

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Symptom Changes in Adults with Chronic Rhinosinusitis with Nasal Polyps Using Tezepelumab

What is this study about?

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