AuthorisedTherapeutic confirmatory (Phase III)Interventional

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of GB-0895 Adjunctive Therapy in Adults and Adolescents with Severe Uncontrolled Asthma

This research is looking at a new medicine called GB-0895 for adults and young people with asthma that is severe and not currently well managed. We want to find out if this new treatment, when added to their current asthma medicines, can help reduce the number of severe asthma attacks they experience over a year. A severe asthma attack is one that needs strong steroid medications, a hospital visit, or emergency care. The study will also look at whether the new medicine improves their breathing, makes their asthma symptoms better, and generally improves their quality of life. Participants will be compared to others receiving a dummy medicine (placebo) to see the true effect of GB-0895.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Generate Biomedicines Inc.

Enrolment target

Start

26 May 2026

Severe uncontrolled asthma

What is this study about?

Imagine your asthma is really tough to live with, even with the medicines you're taking. You might be having lots of severe asthma attacks that land you in hospital or needing strong steroid treatments. This study is all about trying to find a new way to help people like you.

We're testing a new medicine called GB-0895. The main goal is to see if adding this medicine to your current treatments can stop these severe asthma attacks from happening so often. We'll be carefully counting how many severe attacks people have over a year – remembering that an attack counts as severe if it needs strong steroid medicine or a trip to A&E or hospital.

But it's not just about attacks. We also want to know if GB-0895 can make a real difference to your everyday life. This means checking if your breathing gets better, if your asthma symptoms during the day and night become less troublesome, and if you feel your overall quality of life improves. We'll be comparing people who take GB-0895 with those who take a 'dummy' medicine (a placebo) to understand the medicine's true effects. Your involvement could really help us understand more about treating severe asthma.

Key takeaways

Tests a new medicine (GB-0895) for severe asthma.
Aims to reduce severe asthma attacks.
Compares the new medicine to a dummy medicine (placebo).
Also looking at effects on breathing and quality of life.
Involves regular clinic visits and health checks.
Lasts for approximately one year.

Who may be eligible?

This study is looking for adults who are 18 years of age or older. We need people with severe asthma, which means your asthma isn't fully controlled even though you're already taking medicines for it. Both men and women can take part in this research.

There will also be other specific medical checks and criteria that the study doctors will go through with you to make sure the study is a good fit and safe for you. For example, they might look at your medical history, your current asthma medicines, and how often you've had severe asthma attacks in the past.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have severe asthma that isn't fully under control?
Are you currently taking medicines for your asthma?
Are you able to attend regular clinic appointments for about a year?

Answer every question to see your result.

What does participation involve?

If you join this study, it will last for about 52 weeks, which is roughly a year. Throughout this time, you'll be given either the new medicine, GB-0895, or a dummy medicine (placebo) – you won't know which one you're receiving. You'll continue with your usual asthma treatments alongside the study medicine.

Your participation will involve several visits to the clinic. At these visits, doctors and nurses will check your health, ask about your asthma symptoms, and carry out breathing tests to see how your lungs are working. You might also be asked to keep a diary of your symptoms at home. They will monitor you closely for any side effects and to make sure the medicine is safe for you. There will be regular follow-up appointments to track your progress.

Potential risks and benefits

Taking part in a study like this might offer some potential benefits, such as contributing to medical knowledge that could help others with severe asthma in the future. You'll also receive close medical attention and monitoring throughout the study. However, there's no guarantee that the new medicine will help your asthma, and like all medicines, GB-0895 may have side effects. Some people in the study will also receive a dummy medicine. You are completely free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (6)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Italy
—
Unverified
Slovakia
—
Unverified
Spain
—
Unverified
Ireland
—
Unverified
Belgium
—
Unverified
France

Common questions

What is 'severe uncontrolled asthma'?

It means your asthma is still causing significant problems, like frequent symptoms or severe attacks, even though you're taking your regular asthma medicines as prescribed.

What is GB-0895?

It's the experimental new medicine being tested in this study to see if it can help improve severe asthma.

What is a 'dummy medicine' (placebo)?

It's a treatment that looks exactly like the study medicine but doesn't contain any active drug. It helps us understand if any improvements are due to the real medicine or other factors.

How long will the study last?

The main part of the study will last for about one year (52 weeks).

Will I still take my regular asthma medicines?

Yes, you will continue to take your usual asthma treatments alongside the study medicine.