Study on the Effects of Itepekimab for Patients with Chronic Rhinosinusitis Without Nasal Polyps

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What is this study about?

This clinical trial is focused on studying a condition known as chronic rhinosinusitis without nasal polyps, which is a long-term inflammation of the sinuses that does not involve growths called polyps. The study will test a treatment called itepekimab, which is a type of medication known as a monoclonal antibody. Monoclonal antibodies are proteins made in a lab that can bind to specific substances in the body. Itepekimab is designed to target and block a protein called interleukin-33, which is involved in the inflammation process.

The purpose of this study is to evaluate how effective itepekimab is compared to a placebo in reducing sinus inflammation. Participants in the study will receive either itepekimab or a placebo through an injection under the skin. The study will last for a period of up to 24 weeks, during which participants will have regular check-ups to monitor their condition and any changes in their symptoms. The main focus will be on changes in the amount of sinus blockage, as seen on a CT scan, which is a type of imaging test that helps doctors see inside the body.

Throughout the study, participants will also be asked to keep track of their symptoms, such as nasal congestion, runny nose, facial pain, and loss of smell, using a daily electronic diary. The study will also monitor the safety and tolerability of itepekimab, looking for any side effects or reactions to the treatment. This research aims to provide more information on how well itepekimab works for people with chronic rhinosinusitis without nasal polyps and to ensure it is safe for use.

1 initial assessment

The trial begins with an initial assessment to confirm eligibility. This includes checking symptoms of nasal congestion and sinus issues, as well as reviewing medical history related to chronic rhinosinusitis.

A CT scan is performed to assess sinus opacification, ensuring at least 25% opacification in specific sinus areas.

2 baseline evaluation

Participants undergo a baseline evaluation to record initial symptoms and scores, such as the Sino-Nasal Outcome Test-22 (SNOT-22) and Total Symptom Score (sTSS).

The use of mometasone furoate nasal spray is confirmed to be stable for at least three weeks prior to this evaluation.

3 randomization and treatment

Participants are randomly assigned to receive either the study medication, itepekimab, or a placebo. Both are administered as a subcutaneous injection using a pre-filled syringe.

The treatment phase involves regular administration of the assigned injection, with the frequency and duration specified by the study protocol.

4 ongoing monitoring

Throughout the trial, participants are monitored for changes in symptoms and any side effects. This includes regular assessments of nasal congestion, rhinorrhea, facial pain, and loss of smell.

Participants maintain a daily electronic diary to record symptom severity and any adverse events.

5 final assessment

At the end of the treatment period, a final assessment is conducted to evaluate changes from baseline in sinus opacification and symptom scores.

The presence of any treatment-emergent adverse events and the concentration of itepekimab in the serum are also assessed.

Who Can Join the Study?

Participant must be 18 years of age or older.
Participants must have ongoing symptoms of nasal congestion or blockage for at least 12 consecutive weeks before the first visit and a Nasal Congestion Score (NCS) of 2 or more at the first and second visits. The NCS is a way to measure how blocked your nose feels.
Participants must have a sinus Total Symptom Score (sTSS) of 5 or more at the first and second visits. This score includes symptoms like nasal congestion, runny nose, and facial pain or pressure.
Participants must have at least one of the following:
- Previous sinus surgery for chronic rhinosinusitis (CRS), which is a long-term inflammation of the sinuses.
- Treatment with systemic corticosteroids (SCS) in the last 2 years before the first visit. SCS are medications that reduce inflammation throughout the body.
- Worsening symptoms of CRS in the past 2 years that would have needed treatment with SCS, but the participant cannot take SCS due to intolerance or other health reasons.
Participants must have inflammation in both sides of the paranasal sinuses, with at least 25% blockage in the ethmoid sinuses and at least one maxillary sinus as seen on a CT scan. The paranasal sinuses are air-filled spaces around the nose, and the ethmoid and maxillary sinuses are specific areas within them.
Participants must have a Sino-Nasal Outcome Test-22-Items (SNOT-22) score of 20 or more at the first and second visits. This test measures the impact of sinus problems on daily life.
Participants must have been using a stable dose of mometasone furoate nasal spray (MFNS) for at least 3 weeks before the second visit. This is a nasal spray used to reduce inflammation in the nose.
A female participant is eligible if she is not pregnant or breastfeeding and meets one of the following conditions:
- She is not a woman of childbearing potential (WOCBP).
- She is a WOCBP and agrees to use a highly effective contraceptive method with a failure rate of less than 1% during the study and for at least 20 weeks after the last dose of the study treatment.

Who Cannot Join the Study?

Patients with certain respiratory tract diseases cannot participate. This refers to illnesses affecting the parts of the body involved in breathing, like the lungs and airways.
Individuals who do not fall within the specified age range for the study are excluded. This means only people of certain ages can join the trial.
Participants who are not part of the specified clinical trial groups are not eligible. This refers to specific categories or groups of people the study is focusing on.
People who are considered part of a vulnerable population are excluded. This term refers to groups of people who might be at a higher risk of harm or exploitation, such as children, pregnant women, or those with certain disabilities.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Bellvitge University Hospital	L'hospitalet De Llobregat	Spain
Katholieke Universiteit te Leuven	Leuven	Belgium
Hospital Universitario De Navarra	Pamplona	Spain
Hospital Jerez de la Frontera	Jerez De La Frontera	Spain

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Universitair Ziekenhuis Gent	Gent	Belgium
Hospital Del Mar	Barcelona	Spain
Alergologia Plus Sp. z o.o.	Poznan	Poland
Santa Sp. z o.o.	Lodz	Poland
Promed P.Lach R.Glowacki Sp. j.	Cracow	Poland
Centre Hospitalier Groupe Hospitalier De La Rochelle Re Aunis	La Rochelle	France
Unidade Local De Saude Do Alto Ave E.P.E.	Guimaraes	Portugal
Pneumocare	Namur	Belgium
Universita’ Campus Bio-medico Di Roma	Rome	Italy
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy	Warsaw	Poland
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Universita’ Di Pisa	Pisa	Italy
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Centro Hospitalar Do Baixo Vouga E.P.E. (CHBV E.P.E.)	Aveiro	Portugal
Cadresxii Uipnzjhrcrqcke Slimhmeuy	Woluwe-Saint-Lambert	Belgium
Cohmljs Myxfwsa Df Dqtwhkwmlf Sc Tyvjxibhl Acsotnthv Nwultv Sfdvkh	Brasov	Romania
Cybvmsb Dn Eoeyxbbqu Ie Rbttukfoq Sdmrbs	Craiova	Romania
Sgadozv Sinyzovy Lbvffah Syfk	Bielsko-Biala	Poland
Aokxywmneb Pvbklqzk Hbwxtkfl Dq Mezghcpgk	Marseille	France

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	15.01.2025
France	Not recruiting	15.01.2025
Italy	Not recruiting	15.01.2025
Poland	Not recruiting	15.01.2025
Portugal	Not recruiting	15.01.2025
Romania	Not recruiting	15.01.2025
Spain	Not recruiting	15.01.2025

Trial locations

Investigated drugs:

Itepekimab

Itepekimab is a medication being studied for its potential to help people with chronic rhinosinusitis who do not have nasal polyps. This condition involves inflammation of the sinuses, leading to symptoms like nasal congestion and facial pain. The trial aims to see if itepekimab can reduce the blockage in the sinuses, which is often seen in this condition.

Investigated diseases:

Chronic rhinosinusitis without nasal polyps

Chronic Rhinosinusitis – This condition involves inflammation of the sinuses and nasal passages, leading to symptoms such as nasal congestion, facial pain or pressure, and a reduced sense of smell. It can cause the sinuses to become blocked with fluid, resulting in sinus opacification visible on imaging tests like CT scans. Over time, the persistent inflammation can lead to the thickening of the sinus lining and the formation of nasal polyps. The condition is often chronic, meaning it can last for several weeks or longer, and may recur frequently. It can significantly impact quality of life due to ongoing discomfort and difficulty breathing through the nose.

Trial ID:

2024-515576-12-00

Protocol code:

ACT18421

NCT ID:

NCT06691113

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effects of Itepekimab for Patients with Chronic Rhinosinusitis Without Nasal Polyps

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