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Study on Tozorakimab for Adults with Uncontrolled Asthma Using Medium-to-High Dose Inhaled Corticosteroids

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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 asthma, a condition where the airways in the lungs become inflamed and narrow, making it difficult to breathe. The study will test a new treatment called Tozorakimab, also known by its code name MEDI3506. Tozorakimab is a type of medication known as a monoclonal antibody, which is designed to target specific proteins in the body that may contribute to asthma symptoms. The trial will also involve a comparison with a placebo to evaluate the effectiveness of Tozorakimab.

The purpose of this study is to assess how well Tozorakimab works in reducing severe asthma attacks in adults who have uncontrolled asthma despite using medium-to-high doses of inhaled corticosteroids, which are common medications used to manage asthma. Participants in the study will receive either Tozorakimab or a placebo through a subcutaneous injection, which means the medication is injected under the skin. The study will last for up to 52 weeks, during which participants will be monitored for any changes in their asthma symptoms and overall health.

Throughout the study, participants will continue using their regular asthma medications, such as Salbutamol, which is often used as a quick-relief inhaler to help open the airways. The trial aims to find the most effective dose of Tozorakimab and to ensure its safety for people with asthma. By the end of the study, researchers hope to gather valuable information on how Tozorakimab can help manage asthma symptoms and improve the quality of life for those affected by this condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, participants provide signed and dated written informed consent. This is a document that confirms understanding of the study and agreement to participate.
Women of childbearing potential must undergo a serum pregnancy test to ensure they are not pregnant before starting the study.
Step 2
Initial assessments
Participants undergo initial assessments to confirm eligibility. This includes checking asthma history, current treatment with medium or high dose inhaled corticosteroids, and a specific score on the asthma control questionnaire.
Lung function tests are conducted to measure the forced expiratory volume, which helps assess the severity of asthma.
Step 3
Randomization and treatment
Participants are randomly assigned to receive either the study medication tozorakimab, a placebo, or continue with their current asthma treatment.
The study medication tozorakimab is administered as a subcutaneous injection. The exact dosage and frequency are determined by the study protocol.
Step 4
Ongoing treatment and monitoring
Participants continue their assigned treatment for a period of 52 weeks. Regular monitoring is conducted to assess the effect of the treatment on asthma symptoms.
Participants are required to maintain a daily asthma diary to track symptoms and medication use, ensuring compliance with the study requirements.
Step 5
Follow-up assessments
Throughout the study, follow-up assessments are conducted to evaluate lung function and asthma control. These assessments occur at specified intervals, such as weeks 20-26 and week 26.
Blood samples may be collected to measure the concentration of tozorakimab in the body and to check for any immune response to the medication.
Step 6
Completion of the study
At the end of the study period, participants undergo final assessments to evaluate the overall effect of the treatment on asthma exacerbations and lung function.
Participants may be asked to provide feedback on their experience during the study, which helps in understanding the impact of the treatment.

Who can join the trial?

12 criteria

Provide signed and dated written informed consent before any study-specific procedures.
Women who can have children must have a negative pregnancy test at the Screening Visit and before starting the study.
Use of birth control by both males and females should follow local rules for those taking part in clinical studies.
Be an adult aged between 18 and 75 years old when signing the informed consent.
Have a documented diagnosis of asthma by a doctor for at least 12 months before the first visit.
Be treated with medium or high dose ICS (inhaled corticosteroids) along with LABA (long-acting beta-agonists) as per guidelines.
Show signs of uncontrolled asthma with an ACQ-6 score of 1.5 or higher at screening and before starting the study. (ACQ-6 is a questionnaire that measures asthma control.)
Have a pre-bronchodilator FEV1 (forced expiratory volume in 1 second) between 40% and 90% of the predicted normal value at both screening and before starting the study.
Have a history of asthma worsening in the last 12 months before screening, with either:
- 2 severe asthma worsening episodes, or
- 1 severe asthma worsening episode and either:
  - Eosinophils (a type of white blood cell) count of 150 cells/μl or more at screening, or
  - FeNo (fractional exhaled nitric oxide) level of 25 parts per billion or more at screening and before starting the study.
  - Show at least 70% compliance in completing the Asthma Daily Diary.

Who cannot join the trial?

8 criteria

Patients with any other serious health conditions that could interfere with the study.
Patients who have had a recent infection that required treatment with antibiotics.
Patients who have been diagnosed with cancer in the past five years.
Patients who are currently pregnant or breastfeeding.
Patients who have a history of drug or alcohol abuse.
Patients who have participated in another clinical trial within the last 30 days.
Patients who have a known allergy to the study medication or its ingredients.
Patients who are unable to comply with the study procedures.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Assistance Publique Hopitaux De Marseille
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Marseille, France
Athens Medical Center S.A.
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Thessaloniki, Greece
Azienda Ospedaliero Universitaria Ospedali Riuniti
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Foggia, Italy

Trial locations

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Investigated drugs

Tozorakimab is a medication being studied for its potential to help people with asthma who are already using medium-to-high doses of inhaled corticosteroids but still have uncontrolled symptoms. This medication is designed to reduce the number of severe asthma attacks that a person experiences. It works by targeting specific pathways in the body that are involved in the inflammation and narrowing of the airways, which are common problems in asthma. By doing so, it aims to improve breathing and reduce the frequency of asthma exacerbations, making it easier for patients to manage their condition. The study is focused on understanding how effective and safe this medication is for people with asthma.

What is already known about the treatment

Tozorakimab – Tozorakimab is administered as an injection and is currently being studied in clinical trials for its potential to help people with asthma who do not respond well to standard treatments. It is in the research phase, specifically in a Phase IIb trial, which means it is being tested for its effectiveness and safety. The main goal of this medication is to reduce the number of severe asthma attacks in patients who are already using medium-to-high doses of inhaled corticosteroids. Tozorakimab works by targeting specific molecules in the body that are involved in the inflammation process, which is a key factor in asthma. It is classified as an anti-inflammatory agent.

Investigated diseases

Asthma – Asthma is a chronic respiratory condition characterized by inflammation and narrowing of the airways, leading to difficulty in breathing. It often presents with symptoms such as wheezing, coughing, shortness of breath, and chest tightness. The disease can vary in severity and may be triggered by allergens, exercise, cold air, or stress. During an asthma attack, the muscles around the airways tighten, and the lining of the airways becomes swollen, further restricting airflow. Over time, repeated asthma attacks can lead to changes in the airways, making them more sensitive and reactive. Asthma is a long-term condition that requires ongoing management to control symptoms and prevent exacerbations.