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Long-term safety and effectiveness study of verekitug injections in adults with severe asthma who completed the VALIANT trial

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on people with severe asthma, a condition where breathing becomes difficult due to inflammation and narrowing of the airways. The study will test a medication called Verekitug (also known as UPB-101), which is given as an injection under the skin. This medicine is a type of monoclonal antibody, which is a protein designed to target specific substances in the body that contribute to asthma symptoms.

The purpose of this research is to evaluate the safety and effectiveness of long-term treatment with Verekitug in adults who have previously participated in another study called VALIANT. During the study, participants will receive either Verekitug or a placebo as an injection under the skin for approximately 60 weeks. The study will monitor how well participants' asthma is controlled and how their breathing functions over time.

Throughout the study, participants will have regular check-ups that include breathing tests, blood samples, and questionnaires about their asthma symptoms. The study will track how often participants experience asthma flare-ups that require treatment with steroids. Blood samples will be collected to measure the amount of medicine in the body and to check for the body's immune response to the treatment.

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
Initial study visit
During the first visit, after completing the VALIANT study, you will undergo initial assessments including physical examination, laboratory tests, vital signs measurement, and ECG (heart rhythm test).
Your ability to forcefully exhale air in 1 second will be measured, along with the amount of nitric oxide in your breath to check airway inflammation.
You will complete a questionnaire about your asthma symptoms and treatment.
Step 2
Treatment administration
Verekitug will be administered through subcutaneous injection (under the skin).
Blood samples will be collected to measure the amount of medication in your system.
Your blood will also be tested for antibodies against the medication.
Step 3
Ongoing monitoring
Regular visits will occur throughout the 60-week treatment period.
During each visit, you will undergo physical examinations, laboratory tests, vital signs measurements, and ECGs.
Any severe asthma attacks requiring steroid treatment will be recorded.
Your breathing capacity and exhaled nitric oxide levels will be measured regularly.
You will complete questionnaires about your asthma management.
Step 4
Safety monitoring
Throughout the study, you will be monitored for any side effects.
Any changes in your health will be documented and assessed.
Regular blood tests will continue to check medication levels and antibody development.
Step 5
Study completion
Final assessments will include physical examination, laboratory tests, and breathing measurements.
A final questionnaire about your asthma management will be completed.
The study will conclude with a final evaluation of your overall health status.

Who can join the trial?

6 criteria

Must have completed the VALIANT study according to protocol, without meeting any discontinuation criteria and attended the final study visit
Must be an adult (18 years or older)
Must sign and receive a copy of the approved informed consent form (a document that explains the study details and patient rights)
Must agree to use appropriate contraception methods as required by local regulations while participating in the study
Can be either male or female
Must have been diagnosed with severe asthma (a condition where breathing is significantly impaired and regular asthma medications may not provide adequate control)

Who cannot join the trial?

14 criteria

Previous severe allergic reactions to similar medications (causing difficulty breathing, severe rash, or requiring emergency treatment)
Currently participating in other clinical trials or within 30 days of the last study
History of cancer in the past 5 years (except successfully treated skin cancer)
Severe heart conditions (including heart attack or unstable heart disease)
Lung diseases other than asthma (such as chronic bronchitis or emphysema)
Serious liver problems or abnormal liver test results
Serious kidney problems or abnormal kidney function
Uncontrolled high blood pressure (blood pressure that remains high despite treatment)
Current active infections requiring treatment
History of drug or alcohol abuse within the past year
Pregnant women or women planning to become pregnant during the study
Breastfeeding women
Inability to follow study procedures or attend scheduled visits
Use of prohibited medications that might interfere with the study drug

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Verified sites

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

Diagnostics And Consultation Center Convex Ltd.
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Sofia, Bulgaria
Fondazione IRCCS Policlinico San Matteo
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Pavia, Italy
Hospital General Universitario Gregorio Maranon
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Madrid, Spain

Trial locations

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Investigated drugs

Verekitug (also known as UPB-101) is a new investigational medication being studied for treating severe asthma in adults. This medication is being tested to understand if it can be used safely over a long period and if it helps control severe asthma symptoms. The study is specifically designed for patients who have already participated in the VALIANT trial and will help researchers understand how well the medication works when used for an extended time.

Human Igg1 Kappa Monoclonal Antibody Against Crlf2

What is already known about the treatment

Verekitug – A novel investigational medication administered as an injectable treatment for severe asthma in adult patients. This drug, also known by its development code UPB-101, is currently being studied in clinical trials to evaluate its long-term safety and efficacy in patients with severe asthma who have completed the initial VALIANT trial. While the exact molecular mechanism is still under investigation, Verekitug belongs to a class of targeted biological therapies designed to help control severe asthma symptoms in patients who don't respond adequately to conventional treatments. The medication represents a potential new option in the therapeutic arsenal for managing severe asthma, with ongoing research focusing on its long-term safety profile and effectiveness.

Investigated diseases

Severe Asthma - A chronic respiratory condition characterized by significant inflammation and narrowing of the airways in the lungs. In this form of asthma, the airways are particularly sensitive to triggers, leading to frequent and intense symptoms such as wheezing, shortness of breath, chest tightness, and coughing. The condition involves recurring episodes of airway constriction, mucus production, and inflammation that make breathing difficult. People with severe asthma experience symptoms that are harder to control compared to mild or moderate asthma, with more frequent flare-ups or attacks. The condition often affects daily activities and can worsen at night or early morning.