Study of Lebrikizumab and Mometasone Furoate for Adults with Perennial Allergic Rhinitis

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What is this study about?

This clinical trial is focused on studying Perennial Allergic Rhinitis, a condition where individuals experience year-round allergy symptoms such as a runny nose, nasal congestion, itching, and sneezing. The study will evaluate the effectiveness and safety of a medication called Lebrikizumab, which is given as a solution for injection. Participants in the study will receive either Lebrikizumab or a placebo, which is a substance with no active medication.

The purpose of the study is to assess how well Lebrikizumab can reduce the total nasal symptoms in adults with perennial allergic rhinitis over a period of 16 weeks. Participants will be randomly assigned to receive either the medication or the placebo, and neither the participants nor the researchers will know who is receiving which treatment. This is known as a double-blind study, which helps ensure the results are unbiased.

Throughout the study, participants will attend regular visits to monitor their symptoms and overall health. The main focus will be on changes in the severity of nasal symptoms from the start of the study to the end of the 16-week period. The study aims to provide valuable information on the potential benefits of Lebrikizumab for individuals suffering from perennial allergic rhinitis.

1 joining the study

Upon joining the study, the participant is confirmed to have a physician-diagnosed condition known as perennial allergic rhinitis.

Eligibility is further confirmed through a positive skin prick test with indoor allergens or a positive antigen-specific serum immunoglobulin E (IgE) test.

2 initial assessment

An initial assessment is conducted to establish a baseline for the total nasal symptom score (TNSS).

The TNSS is a composite score of four symptoms: rhinorrhea (runny nose), nasal congestion, nasal itching, and sneezing. Each symptom is scored from 0 (none) to 3 (severe), with a total score range of 0 to 12.

3 treatment phase

Participants are randomly assigned to receive either lebrikizumab or a placebo.

Lebrikizumab is administered as a subcutaneous injection.

The treatment phase lasts up to 16 weeks, during which the efficacy of lebrikizumab is evaluated.

4 nasal spray administration

Participants may also use a nasal spray containing mometasone furoate as part of their treatment regimen.

The nasal spray is used to help manage symptoms of perennial allergic rhinitis.

5 evaluation of treatment efficacy

The primary objective is to evaluate the change in the total nasal symptom score from baseline to week 16.

The effectiveness of lebrikizumab is compared to the placebo based on the reduction in symptom severity.

6 completion of the study

The study is estimated to conclude by August 3, 2026.

Participants’ progress and any changes in symptoms are documented throughout the study duration.

Who Can Join the Study?

The patient must have been diagnosed by a doctor with Perennial Allergic Rhinitis (PAR), which is a type of allergy that occurs all year round.
The patient must have a positive result on a skin prick test (SPT) for indoor allergens. This test checks for allergic reactions by placing a small amount of allergen on the skin and pricking it.
The patient can also have a positive result on a blood test for immunoglobulin E (IgE), which is a type of antibody that the body makes in response to allergens. The level must be 0.70 kU/L or higher.
If the patient has dermatographism, which is a condition where the skin becomes raised and inflamed when scratched, they can still participate if they have a positive IgE blood test.
If the patient has asthma, it must be stable for at least 3 months before the study starts, and they must be using regular asthma treatment that is allowed in the study.
The study is open to both male and female patients.
The study includes patients who are considered part of a vulnerable population, which means they might need extra protection or care.

Who Cannot Join the Study?

Having a different condition than Perennial Allergic Rhinitis (PAR), which is a type of allergy that happens all year round.
Being outside the age range specified for the study.
Having any health issues that the study doctors think might make it unsafe to participate.
Being pregnant or planning to become pregnant during the study period.
Currently participating in another clinical trial.
Having a history of severe allergic reactions to medications.
Using certain medications that might interfere with the study treatment.
Having a history of drug or alcohol abuse.
Having any other medical condition that the study doctors think might affect the study results.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Technische Universitaet Dresden	Dresden	Germany
Alergo Med Osrodek Badan Klinicznych Sp. z o.o.	Tarnow	Poland
Katholieke Universiteit te Leuven	Leuven	Belgium
Université Libre de Bruxelles – Hôpital Erasme	Brussels	Belgium

Other Sites

Site Name	City	Country
Etg Neuroscience Sp. z o.o.	Warsaw	Poland
Universitair Ziekenhuis Gent	Gent	Belgium
Centre Hospitalier Regional De La Citadelle	Liege	Belgium
Santa Sp. z o.o.	Lodz	Poland
Specjalistyczna Przychodnia Lekarska Alergo Med Sp. z o.o.	Poznan	Poland
Pneumocare	Namur	Belgium
IKF Pneumologie GmbH & Co. KG	Frankfurt	Germany
Malopolskie Centrum Alergologii Sp. z o.o.	Cracow	Poland
Siteworks GmbH	Hanover	Germany
Clinmedica Research sp. z o.o.	Skierniewice	Poland
Santa Sp. z o.o. sp. K.Polimedica PTG Kielce	Kielce	Poland
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Philipps-Universitaet Marburg	Marburg	Germany
Promed P.Lach R.Glowacki Sp. j.	Cracow	Poland
ALL-MED – Specjalistyczna Opieka Medyczna – Medyczny Instytut Badawczy	Wroclaw	Poland
EMed Centrum Uslug Medycznych Ewa Śmiałek	Rzeszow	Poland
Gzoj Glmdrpohdcih fwkn Elmljmmsbuzjzu uwd Kkzhujida Ahtcfrdsqpuxcvojp mda	Wiesbaden	Germany
Cgvvldw Auieovjidcm Skn z othi	Poznan	Poland
Pfebwz fas Hls uxv Aumfjaxkrzeh Doj Yzsk Ytrcj	Dresden	Germany
Ptncijs Magckw Sqv z Oupc Eqk Pwamwhwdn	Poniatowa	Poland

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	20.09.2024
Germany	Not recruiting	20.09.2024
Poland	Not recruiting	20.09.2024

Trial locations

Investigated drugs:

Lebrikizumab: This medication is being studied for its effectiveness in treating perennial allergic rhinitis, which is a type of allergy that causes symptoms like a runny or stuffy nose throughout the year. The trial aims to see how well lebrikizumab can reduce these nasal symptoms over a period of 16 weeks.

Investigated diseases:

Rhinitis allergic

Perennial Allergic Rhinitis – This is a condition characterized by inflammation of the nasal passages due to allergens present throughout the year, such as dust mites, pet dander, or mold. Symptoms include a runny nose, nasal congestion, sneezing, and itching, which can persist continuously or intermittently. The condition is triggered by an immune response to allergens, leading to the release of histamines and other chemicals that cause inflammation. Over time, the persistent symptoms can affect daily activities and quality of life. The severity of symptoms can vary, with some individuals experiencing mild discomfort and others facing more significant challenges.

Trial ID:

2023-508817-18-00

Protocol code:

J2T-MC-KGBT

NCT ID:

NCT06339008

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of Lebrikizumab and Mometasone Furoate for Adults with Perennial Allergic Rhinitis

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