A study to find out how well Benralizumab works and how safe it is when administered in addition to standard asthma treatments in people with eosinophilic asthma

Descrizione riassuntiva dello studio

Researchers are looking for a better way to treat eosinophilic asthma. Eosinophilic asthma is a type of asthma caused by a high number of white blood cells called eosinophils. High eosinophil levels in the blood mean that people with asthma are likely to have more severe inflammation in the airways and worse asthma attacks. People with eosinophilic asthma typically take medications known as inhaled corticosteroids (ICS) and long-acting beta-agonists (LABA). When asthma symptoms worsen, the standard treatment is to increase the ICS dose (usually from a medium to a high dosage). However, higher doses of ICS increase the risk of unwanted side effects and may not lead to an improvement in asthma symptoms. The medication Benralizumab is intended to reduce the number of eosinophils in the blood and help control asthma symptoms. Researchers believe that adding Benralizumab to a medium dose of ICS and LABA can better control asthma symptoms than simply increasing the ICS dose to a high ICS dose along with LABA. For this reason, researchers want to find out how well Benralizumab works in addition to a medium dose of ICS with LABA and how safe it is in people with eosinophilic asthma compared to increasing the ICS dose.

(BASEC)

Intervento studiato

Does Benralizumab help reduce the number of participants' asthma attacks?

Researchers will record each asthma attack of a participant during the 48-week (11-month) treatment period of the study. An asthma attack occurs when asthma symptoms are worse than normal and require more medication, medical emergency care, or overnight hospital care. Researchers will calculate how often asthma attacks occur and compare participants receiving Benralizumab with a medium dosage of ICS and LABA to participants receiving a high dosage of ICS and LABA.

Does Benralizumab improve the participants' quality of life?

Participants will fill out a questionnaire about their quality of life before, during, and after treatment. Researchers will then compare the results at the end of treatment (week 48) of those receiving Benralizumab along with a medium dose of ICS and LABA with those receiving a high dose of ICS and LABA.

Does Benralizumab help treat the participants' eosinophilic asthma?

Researchers will evaluate and compare the following data between the two participant groups during the treatment period and at the end of treatment (week 48):

• Change in participants' lung function during the study

• Change in asthma control of participants during the study, based on questionnaire scores

• Change in participants' quality of life during the treatment period based on questionnaire results

• Change in the frequency with which participants need to take emergency medications for their asthma during the study

• Changes during the study regarding the time participants missed from work and/or school due to asthma

• Time until participants have their first asthma attack

• Frequency with which participants experience asthma attacks requiring medical emergency care or overnight hospitalization

• Number of participants whose asthma has significantly improved at week 24 and at the end of treatment (also known as remission)

How does the overall health status of participants change during the study?

Researchers will document all medical problems (adverse events) that occur during the study. They will also look at the results of various tests and measurements to determine if the health status of participants has changed since starting the investigational treatment.

Study design: This is a randomized, double-blind Phase IIIb study. Randomized means that a computer program assigns the treatment that individual participants receive randomly. Double-blind means that none of the participants, researchers, investigators, or other study staff know which treatment individual participants receive. To ensure that the study is double-blind, 50% of participants will receive a placebo instead of Benralizumab. The placebo looks like Benralizumab but contains no active ingredient. Participants will receive the investigational treatment for up to 48 weeks (11 months). The total duration of a participant's involvement in the study may be about 1 year and 1 month.

Study population: Up to 400 participants will take part in this study. To participate in this study, participants must be between 12 and 75 years old and have eosinophilic asthma. Potential participants must have been taking a medium dose of ICS and LABA for at least 3 months prior to participating in this study. They must also have uncontrolled asthma, meaning they had at least two asthma attacks in the past year and their symptoms regularly interfere with their daily life, even when treated.

Treatments and procedures: The study begins with an approximately 5-week screening and run-in period. During screening, study doctors will assess participants' health and conduct tests to ensure they can participate in the study. During the run-in period, participants will receive a medium dose of ICS and LABA medications for at least 4 weeks. Participants will then begin the treatment period by being assigned to one of two groups as described in the table below:

Group 1

200 participants

30 mg Benralizumab once every 4 weeks for 3 doses, then once every 8 weeks + Medium dosage ICS and LABA twice daily

Group 2

200 participants

Placebo once every 4 weeks for 3 doses, then once every 8 weeks + High dosage ICS and LABA twice daily

For both groups:

Benralizumab or the placebo will be administered as an injection directly under the skin (subcutaneous injection). ICS and LABA will be taken as inhalers.

Treatment period: For 48 weeks (11 months)

To monitor the health status of participants throughout the study, doctors will:

► Test participants' blood and urine

► Conduct physical examinations

► Ask participants to fill out an electronic diary ► Ask participants to complete questionnaires

► Test participants' lung function

► Inquire about participants' medications and any medical problems

Four weeks after the end of the treatment period, participants will have a follow-up appointment to check their health status while they resume the standard treatment for their asthma.

Ethical aspects: All participants will contribute to researchers learning more about Benralizumab.

The potential benefit of treatment with Benralizumab is the improvement of participants' eosinophilic asthma.

The potential risks of treatment with Benralizumab include:

► A potentially life-threatening overreaction of the immune system in response to the treatment (hypersensitivity)

► Cancer

► Antibodies formed against Benralizumab

► An infection with a parasitic worm, known as helminths, due to a low number of eosinophils

The procedures performed in this study as well as ICS and LABA also carry risks. The investigator or study staff will provide you with more information about these risks.

The tests, procedures, and measures with participants are necessary to ensure that the test results are accurate.

(BASEC)

Malattie studiate

Eosinophilic Asthma

(BASEC)

Sponsor

Fortrea Switzerland AG

(BASEC)

Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)

Commissione d'etica svizzera nord-ovest/centrale EKNZ

(BASEC)

Data di approvazione del comitato etico

03.04.2025

(BASEC)

Risultati dello studio