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Study on the Effects of Verekitug (UPB-101) for Adults with Severe Asthma

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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 Severe Asthma, a condition where the airways in the lungs become inflamed and narrowed, making it difficult to breathe. The study will evaluate a treatment called Verekitug (UPB-101), which is a type of medication known as a monoclonal antibody. Monoclonal antibodies are proteins made in a lab that can bind to specific targets in the body. In this case, Verekitug (UPB-101) targets a protein involved in asthma symptoms. The trial will compare the effects of this treatment to a placebo, which is a substance with no active treatment.

The purpose of the study is to assess how Verekitug (UPB-101) affects asthma flare-ups, also known as exacerbations, in adults with severe asthma. Participants in the study will receive either the active treatment or a placebo through an injection under the skin, known as a subcutaneous injection. The study will last for about 60 weeks, during which participants will have regular check-ups to monitor their asthma symptoms and overall health.

Throughout the study, researchers will collect information on how often asthma exacerbations occur and any changes in lung function. This will help determine the safety and effectiveness of Verekitug (UPB-101) as a potential treatment for severe asthma. Participants will be closely monitored to ensure their safety and well-being during the trial.

The research process

The trial runs in 5 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, the participant will have signed and dated the informed consent form, confirming understanding and agreement to participate.
The participant must be between 18 and 75 years old, with a body mass index between 18 and 40 kg/m².
Step 2
Screening and run-in period
The participant will undergo a screening process to confirm eligibility, including a review of asthma history and current medication use.
The participant must have a physician-diagnosed asthma for at least 12 months and demonstrate bronchodilator reversibility.
During this period, the participant will maintain a stable dose of background asthma medication and demonstrate compliance with daily diary entries.
Step 3
Randomization and treatment
Participants will be randomly assigned to receive either Verekitug (UPB-101) or a placebo.
The medication is administered as a subcutaneous injection, which means it is injected under the skin.
The treatment will last for 60 weeks, during which the participant will continue to record asthma symptoms and medication use in a daily diary.
Step 4
Monitoring and assessments
Throughout the study, the participant will attend regular visits to monitor asthma symptoms and overall health.
Assessments will include lung function tests, such as measuring the forced expiratory volume (FEV1), and checking the level of nitric oxide in the breath (FeNO).
The participant's asthma control will be evaluated using the Asthma Control Questionnaire-6 (ACQ-6).
Step 5
End of treatment
At the end of the 60-week treatment period, the participant will undergo final assessments to evaluate the effect of the treatment on asthma exacerbations and overall asthma control.
The primary goal is to assess the annualized asthma exacerbation rate (AAER) over the treatment period.

Who can join the trial?

17 criteria

The participant must have signed, dated, and received a copy of the approved written informed consent form. This means they agree to take part in the study and understand what it involves.
The participant should be between 18 and 75 years old at the time of signing the consent form.
The participant's body mass index (BMI) should be between 18 and 40. BMI is a measure of body fat based on height and weight.
The participant must have been diagnosed with asthma by a doctor for at least 12 months before the study starts.
The participant should show evidence of bronchodilator (BD) reversibility. This means their lung function improves after using a medication that opens the airways. This can be shown by a past test or a test done during the study.
The participant must have been taking asthma medication for at least 12 weeks before the study starts, with a stable dose for at least 4 weeks. This includes medium or high doses of inhaled corticosteroids (ICS) and possibly other asthma medications.
The participant should have a history of asthma worsening (exacerbations) within 12 months before the study. This could be two or more events, or one event with a specific test result (FeNO) of 50 or more.
The participant must have a score of 1.5 or higher on the Asthma Control Questionnaire-6 (ACQ-6) at specific visits. This questionnaire measures how well asthma is controlled.
The participant must meet at least one of the following conditions between specific visits:
- Asthma symptoms during the day or night for at least 2 days.
- Use of reliever medication for at least 3 days to treat increased asthma symptoms.
- At least one night-time awakening due to asthma.
- The participant must have a morning pre-BD FEV1 value between 30% and 80% predicted at a specific visit. FEV1 is a measure of how much air a person can forcefully exhale in one second.
- The participant must comply with keeping a daily diary during the Run-In Period, with at least 12 fully compliant days out of 15.
- The participant must have at least 4 days with complete daily diary entries (evening and next morning) in the 7 days before a specific visit.
- The participant must comply with taking their background asthma medication as recorded in the diary during the Run-In Period, with at least 12 fully compliant dosing days out of 15.
- The participant must demonstrate acceptable techniques for using an inhaler, peak flow meter, and spirometry. These are tools used to manage and measure lung function.
- The participant must use contraception methods that are consistent with local regulations for those participating in clinical studies.

Who cannot join the trial?

10 criteria

Having a different type of asthma that is not considered severe.
Being outside the age range specified for the study.
Having a medical condition that could interfere with the study results.
Being pregnant or planning to become pregnant during the study.
Currently participating in another clinical trial.
Having a history of allergic reactions to the study medication.
Using medications that could affect the study outcomes.
Having a recent history of smoking or substance abuse.
Being unable to follow the study procedures or instructions.
Having a serious illness that could affect participation in the study.

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Verified sites

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

Azienda Ospedaliera Universitaria Federico II Di Napoli
Verified
Naples, Italy
Diagnostics And Consultation Center Convex Ltd.
Verified
Sofia, Bulgaria
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
Responsive
Plovdiv, Bulgaria

Trial locations

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Investigated drugs

Verekitug (UPB-101) is a medication being studied for its potential to reduce asthma attacks in adults with severe asthma. The trial aims to evaluate how effective and safe this medication is when compared to not taking any active treatment. Participants in the study will receive this medication to see if it can help manage their asthma symptoms better.

Human Igg1 Kappa Monoclonal Antibody Against Crlf2

What is already known about the treatment

Verekitug – Verekitug is administered orally in the form of tablets. It is currently being studied in clinical trials for its potential use in treating severe asthma. The main therapeutic indication for Verekitug is to reduce asthma exacerbations in adults with severe asthma. At the molecular level, it works by modulating specific pathways involved in the inflammatory response associated with asthma. Verekitug is classified pharmacologically as an anti-inflammatory agent.

Investigated diseases

Severe Asthma – Severe asthma is a chronic respiratory condition characterized by frequent and intense episodes of airway inflammation and constriction, leading to difficulty in breathing. It often involves persistent symptoms such as wheezing, coughing, shortness of breath, and chest tightness. Unlike mild or moderate asthma, severe asthma does not respond well to standard treatments and can significantly impact daily activities. The condition may be triggered by allergens, respiratory infections, exercise, or stress. Over time, severe asthma can lead to structural changes in the airways, known as airway remodeling, which can further exacerbate symptoms. Managing severe asthma typically requires a comprehensive approach to control symptoms and prevent exacerbations.