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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Dr
Clinical
Trials
+41 616878333
global.trial_information@roche.com
More information about this study, what is involved and how to take part can be found on the study website.
Moderate to severe asthma
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Asthma is a common long-term lung condition caused by swelling (inflammation) of the airways that causes occasional breathing difficulties. Inflammation is the body’s normal reaction (immune response) to an injury, infection, or irritation – in people with asthma, the body overreacts. The current standard treatment for asthma is inhaled corticosteroids (ICS) and bronchodilators (medications that open the airways); however, many people have uncontrolled symptoms and asthma attacks (exacerbations), and new treatments are needed. The body produces a protein called NLRP3 that can amplify the immune response and inflammation. A drug called selnoflast blocks the activity of NLRP3 and could reduce inflammation in the lungs of people with asthma. Selnoflast is an experimental drug, which means that health authorities (like the U.S. Food and Drug Administration, Health Canada, Medicines and Healthcare Products Regulatory Agency, and European Medicines Agency) have not approved selnoflast for the treatment of asthma. Selnoflast has been tested in healthy people and in people with ulcerative colitis in other studies and is being tested in people with Parkinson’s disease and coronary artery disease.
This clinical trial aims to compare what happens to selnoflast once it is in the body and what selnoflast does to the body and the disease when compared with placebo – which looks like a drug but has no active ingredient – in people with asthma.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
Current inclusion criteria as of 30/09/2024:
1. Documented physician-diagnosed asthma for at least 12 months prior to Screening.
2. Treatment with non-biologic asthma controller therapy for ≥3 months prior to screening and no changes in controller dosing regimens within 4 weeks prior to screening or during the screening period, or anticipated need for changes throughout the study.
3. Morning pre-bronchodilator forced expiratory volume in 1 second (FEV1) of 40% - 90% of predicted at screening.
4. Demonstrated post-bronchodilator reversibility of FEV1 ≥12% and ≥200 millilitres (mL) at Screening, or at least one documented historic evidence of lung function variability within 5 years prior to screening
5. Non-smoker or former smoker. A former smoker is defined as someone with smoking history who has not used inhaled tobacco or cannabis products within 6 months prior to Screening. Current smoking is not permitted.
6. Asthma Control Questionnaire, 5-item version (ACQ-5) score ≥1.5 at screening
7. hs-CRP ≥1 milligrams per liter (mg/L) at screening.
8. Body mass index (BMI) within the range of 18 - 40 kilograms per square meter (kg/m2) (inclusive).
9. Ability to provide
You may not be able to take part if:
Current exclusion criteria as of 30/09/2024:1. History of malignancy within 5 years prior to screening.2. History of any clinically significant hepatic disease or cirrhosis.3. Known immunodeficiency including, but not limited to, human immunodeficiency virus (HIV) infection.4. Respiratory infection (including upper respiratory and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections) within 2 weeks prior to screening or during the Screening period.5. Other infection requiring oral or intravenous (IV) antibiotics, antivirals, or antimycotics within 2 weeks prior to screening or during the Screening period.6. History of tuberculosis or a positive Interferon-Gamma Release Assay (IGRA) test at screening.7. Presence of hepatitis B surface antigen (HBsAg) at Screening or within 3 months prior to dosing.8. Positive hepatitis C (HCV) antibody test result at Screening or within 3 months prior to starting study treatment.9. Vaccine(s) within 4 weeks prior to Screening
Previous exclusion criteria:1. History of malignancy within 5 years prior to screening.2. History of any clinically significant hepatic disease or cirrhosis.3. Known immunodeficiency including, but not limited to, human immunodeficiency virus (HIV) infection.4. Respiratory infection (including upper respiratory and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections) within 6 weeks prior to screening.5. Other infection requiring oral or intravenous (IV) antibiotics, antivirals, or antimycotics within 2 weeks prior to screening6. History of tuberculosis or a positive Interferon-Gamma Release Assay (IGRA) test.7. Presence of hepatitis B surface antigen (HBsAg) at Screening or within 3 months prior to dosing.8. Positive hepatitis C (HCV) antibody test result at Screening or within 3 months prior to starting study treatment.9. Vaccine(s) within 4 weeks prior to Screening
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Dr
Clinical
Trials
+41 616878333
global.trial_information@roche.com
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by F.Hoffmann-La Roche Ltd. and funded by F. Hoffmann-La Roche Ltd.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Or CPMS 57069
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
