A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma (SOLAIRIA-2)

This study is looking for teenagers and adults aged between 12 and 80 years old who have been diagnosed with asthma for at least two years. Your asthma needs to be considered severe and not fully managed with your usual medicines, like medium-to-high dose inhaled steroids and at least one other asthma controller (such as a long-acting reliever).

To be considered, you should have had at least two serious asthma flare-ups in the past year that required treatment with steroid tablets or injections, despite using your regular asthma medicines. Doctors will also check your lung function (how much air you can breathe out) with a special test. You will also need to score at least 1.5 on a questionnaire about your asthma control.

There are also some reasons why you might not be able to join. For instance, if you've had a significant asthma flare-up or needed a change in your regular asthma treatment in the last 12 weeks. People with other breathing conditions (like certain infections or lung diseases), specific inflammatory conditions, or other serious health problems that aren't stable would also not be eligible.

If you decide to take part, you would be randomly assigned to receive either the study medicine, GB-0895, or a placebo (a dummy medicine). Both the study medicine and the placebo are given as an injection under the skin every six months for about a year. You wouldn't know whether you're getting the active medicine or the placebo, and neither would your study doctor.

The study involves several visits to the clinic. After an initial screening period, you would have clinic visits about every 1 to 2 months after the first month of treatment. These visits are important for the study team to check on your health and your asthma, monitor any side effects, and make sure the treatment is being taken correctly. The main treatment part of the study lasts for about 52 weeks (one year), and then there's a follow-up period of about 6 months. Some people might also have the option to continue into an 'open-label extension,' where everyone receives the active medicine, for an even longer period.