Ongoing Clinical Trials for Asthmatic Crisis
Currently, there are 2 ongoing clinical trials investigating new treatments for asthmatic crisis and severe asthma in adults. These studies are evaluating Verekitug (UPB-101), an investigational monoclonal antibody therapy, across multiple European countries. The trials aim to assess the long-term safety and effectiveness of this new medication in reducing asthma attacks and improving symptom control in patients with severe forms of the disease.
Clinical trial locations
- Bulgaria
- Czechia
- Germany
- Italy
- Poland
- Spain
Long-term safety and effectiveness study of verekitug injections in adults with severe asthma who completed the VALIANT trial
This study is designed for adults with severe asthma who have already completed a previous research study called VALIANT. The trial will investigate whether Verekitug, also known as UPB-101, can safely and effectively control severe asthma symptoms when used over an extended period of approximately 60 weeks.
Main inclusion criteria: To participate in this study, you must have successfully completed the VALIANT trial without meeting any reasons for early stopping and attended your final study visit. You need to be at least 18 years old and have been diagnosed with severe asthma, a condition where breathing is significantly impaired and regular medications may not provide adequate control. You must be willing to sign an informed consent form that explains all the study details and your rights as a participant. Additionally, you must agree to use appropriate birth control methods as required by local regulations throughout the study period.
Main exclusion criteria: You cannot participate if you have had previous severe allergic reactions to similar medications that caused breathing difficulties, severe rash, or required emergency treatment. The study excludes people who are currently in other clinical trials or have been in one within the last 30 days. You will not be eligible if you have had cancer in the past 5 years, except for successfully treated skin cancer. Other conditions that prevent participation include severe heart problems, lung diseases other than asthma such as chronic bronchitis or emphysema, serious liver or kidney problems, uncontrolled high blood pressure, or active infections requiring treatment. The study also excludes anyone with a history of drug or alcohol abuse within the past year, pregnant women, those planning pregnancy during the study, breastfeeding women, and people unable to follow study procedures or attend scheduled visits.
Study focus: The trial aims to monitor how well participants’ asthma is controlled and how their breathing functions over time with long-term Verekitug treatment. Researchers will track how often asthma flare-ups occur that require treatment with steroids. Throughout the study, participants will have regular check-ups that include breathing tests to measure how much air they can forcefully exhale in one second, measurements of nitric oxide in their breath to assess airway inflammation, blood samples to check medication levels and the body’s immune response, and questionnaires about asthma symptoms and treatment.
Investigational drug: Verekitug, also known as UPB-101, is a monoclonal antibody given as an injection under the skin. It is a protein designed to target specific substances in the body that contribute to asthma symptoms. This medication represents a new approach to treating severe asthma in patients who don’t respond adequately to conventional treatments.
Study on the Effects of Verekitug (UPB-101) for Adults with Severe Asthma
This clinical trial evaluates how Verekitug affects asthma flare-ups in adults with severe asthma. Participants will receive either the active treatment or a placebo through injections under the skin over approximately 60 weeks. The study will closely monitor asthma symptoms and overall health to determine the safety and effectiveness of this potential new treatment.
Main inclusion criteria: To join this study, you must be between 18 and 75 years old with a body mass index between 18 and 40. You need to have been diagnosed with asthma by a doctor for at least 12 months and show that your lung function improves after using medications that open the airways. You must have been taking stable doses of asthma medication for at least 12 weeks, including medium or high doses of inhaled corticosteroids. Your asthma history should include at least two episodes of worsening symptoms within the past 12 months, or one episode with elevated exhaled nitric oxide levels. You should score 1.5 or higher on the Asthma Control Questionnaire-6, indicating that your asthma is not fully controlled. During the run-in period before treatment starts, you must demonstrate that you can keep a daily diary of symptoms and comply with your medication regimen for at least 12 out of 15 days. You also need to show proper technique when using inhalers and other lung function measurement tools.
Main exclusion criteria: You cannot participate if you have a different type of asthma that is not considered severe, are outside the specified age range, or have medical conditions that could interfere with study results. Pregnant women or those planning to become pregnant during the study are excluded. You cannot be currently participating in another clinical trial or have a history of allergic reactions to the study medication. Using medications that could affect study outcomes, having a recent history of smoking or substance abuse, being unable to follow study procedures, or having a serious illness that could affect participation will also prevent you from joining.
Study focus: The primary goal is to assess the annualized asthma exacerbation rate over the treatment period, measuring how often severe asthma attacks occur. Throughout the study, participants will attend regular monitoring visits that include lung function tests measuring forced expiratory volume, checks of nitric oxide levels in breath, and evaluations of asthma control using standardized questionnaires. Participants will continue recording their asthma symptoms and medication use in a daily diary throughout the 60-week treatment period.
Investigational drug: Verekitug (UPB-101) is a monoclonal antibody medication being studied for its potential to reduce asthma attacks in adults with severe asthma. It works by modulating specific pathways involved in the inflammatory response associated with asthma. The medication is administered as a subcutaneous injection under the skin and is classified as an anti-inflammatory agent.
Summary
Both ongoing clinical trials focus exclusively on Verekitug (UPB-101), a novel monoclonal antibody therapy for severe asthma in adults. The studies are being conducted across six European countries: Poland, Bulgaria, Czechia, Spain, Germany, and Italy. Notably, one trial is a continuation study specifically designed for patients who have already completed the earlier VALIANT trial, allowing researchers to gather long-term safety and effectiveness data. Both studies share similar designs, with approximately 60-week treatment periods and regular monitoring of lung function, asthma exacerbations, and quality of life. The trials reflect a targeted approach to developing new treatment options for patients whose severe asthma is not adequately controlled by conventional therapies. The concentration of trials in Central and Southern Europe suggests a coordinated research effort to evaluate this investigational medication across diverse patient populations.
