Are you living with severe asthma?
You may be eligible to participate in a clinical study.
About the
SOLAIRIA Study
This is a randomised, double-blind, placebo-controlled study to evaluate the investigational drug and see how well it works to reduce serious asthma attacks in adults and adolescents with severe asthma, when used along with other treatments.
What is the medicine in the study?
This investigational drug, a monoclonal antibody. In this study, it is given by injection under the skin every six months and used as an add-on to participants’ usual asthma medicines; some participants will receive placebo. It is being studied in adults and adolescents with severe, uncontrolled asthma.
Details
Program design:
The SOLAIRIA program includes two Phase 3, randomised, double-blind, placebo-controlled studies in adults and adolescents with severe, uncontrolled asthma. The main goal is to see whether the investigational drug reduces the rate of serious asthma attacks over 52 weeks, compared with placebo, when used along with participants’ usual asthma medicines. Researchers will also assess lung function, symptom control and health-related quality of life.
Participants are randomly assigned to receive the investigational drug or placebo; neither participants nor the study team will know which treatment is given until the study ends (double-blind). This design helps ensure unbiased and reliable results.
Each study includes screening, one year of treatment and about nine months of follow-up; some participants may be able to join an optional open-label extension after the first year.
Early proven results:
In a Phase 1 study of 100 patients with mild to moderate asthma, a single injection of the investigational drug reduced airway inflammation for at least six months. Inflammation was measured through the presence of immune cells such as blood eosinophils and cytokines, as well as exhaled nitric oxide, a common signal of inflammation and asthma.
Unlike most current biologics, which require injections every 2-4 weeks (and some every 8 weeks), the investigational drug could offer durable asthma control with only two planned doses per year. Importantly, the investigational drug may be effective across patients regardless of their baseline eosinophil levels, which could make it accessible to more people than many existing treatments.
These findings, presented at the European Respiratory Society (ERS) International Congress in September 2025, suggest the investigational drug has the potential to reduce treatment burden while maintaining lasting asthma control. Because the investigational drug targets TSLP, a well-validated driver of asthma, and showed durable activity with a favourable safety profile in Phase 1, Generate is moving directly into Phase 3 studies with the support of the FDA and EMA.
Study timeline:
| Time period | Description | ||||
|---|---|---|---|---|---|
| 2 Weeks | Screening period
|
||||
| 4 Weeks | Run-in period
|
||||
| 52 Weeks | Treatment period
|
||||
| Option 1Weeks 52-90 | Follow-up period
|
||||
| Option 2Weeks 52-142 | Open-label extension
|
||||
|
|||||
Study locations
Clinical FAQ
What is a clinical study?
A clinical study, also called a clinical trial or research study, is a carefully designed scientific evaluation of a potential new investigational medication. Clinical studies are conducted by doctors and researchers. A clinical study helps to answer important questions about a potential new medication or investigational drug, such as:
- Are there side effects?
- How safe is it?
- Does it work?
What is an investigational drug?
An investigational drug, also called study medication or study drug, is a new treatment that has been tested in a lab and approved for testing in people by health authorities. It may also be a medication already approved for one condition but being tested for another. Investigational drugs can be used only in clinical studies.
What is a placebo?
A placebo is a “fake” treatment that looks like the real medicine but doesn’t contain any active ingredients. It’s used in some studies to help researchers understand if the real treatment works.
Is there a cost to taking part?
No, there is no cost to participate. The study drug and all related tests and procedures are provided for free. Travel expenses to and from the study site may also be reimbursed.
Eligibility
Participation in the SOLAIRIA Study may be possible for you or someone you care about if you/they:
- Are 12 to 80 years old
- Have had an asthma diagnosis for more than 2 years
- Are on medium to high doses of inhaled corticosteroids (ICS).
- Have required corticosteroids at least twice over the last 12 months to control asthma
- Are willing to attend regular study visits and follow study procedures
- Meet all other study requirements, as confirmed by the study doctor