Asthma

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

Recruiting · 14 sites across 7 states

✓ Study treatment at no cost✓ PHASE3

Always free

Study care at no cost to you

For your time and travel

Many studies pay you back

Most need no insurance or papers

Legal status usually isn't required; we'll tell you each study's requirements

Interpreters available

Ask for your language

Your choice

Voluntary — you can stop anytime

What is this study?

The objective of this study is to assess the potential for GB-0895 treatment to improve the health of adolescents and adults with severe asthma that is uncontrolled by inhaled corticosteroids (ICS) and conventional asthma controllers. The study details include: Study treatment: randomized to receive either GB-0895 or placebo administered every 6 months over 52 weeks.

It is , overseen by an independent and licensed medical staff.

Read the full clinical description

Who this study is looking for

In plain language, from the study's own rules. The study team confirms the full details with you — this isn't a final yes or no.

✅ You may be able to join if…

•Adults and adolescents ages 12 to 80 years old.
•A doctor has diagnosed asthma for at least 2 years.
•Asthma is still uncontrolled despite medium-to-high dose inhaled corticosteroids (ICS) for at least 12 months plus at least one other asthma controller for at least 3 months, with no changes for at least 3 months.
•They have had at least two asthma flare-ups in the past 12 months that required systemic (by mouth/IV) steroid treatment.
•They meet lung function and breathing test requirements (including a positive response test after a short-acting beta-agonist/SABA).

🚫 You may not be able to join if…

•They had a clinically significant asthma flare-up within 12 weeks before Screening or during the run-in period that required changing asthma maintenance therapy.
•They have another serious lung disease besides asthma (examples given include bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis, tuberculosis, emphysema, chronic bronchitis, or a history of lung cancer).
•They have eosinophilic disease (examples given include eosinophilic granulomatosis with polyangiitis and eosinophilic esophagitis).
•They have a clinically significant unresolved infection, or other major medical problems that are not stable and could affect safety or study results (as judged by the investigator).
•They have certain cancer or infection concerns, or certain medication/vaccine timing issues (including current malignancy or cancer within 5 years, hepatitis B/C/HIV, and recent live vaccines).

Are you a good fit?

Simplified highlights. The study team always confirms the full details with you.

✓Adults roughly 12–80
✓Have COPD (chronic lung disease) or Asthma

!Some conditions may not be a fit: Heart / cardiovascular disease
!Not for people who are pregnant or breastfeeding

What to expect, step by step

1
Usually a few weeks
The study team checks whether the study is a good fit for you, with a visit and sometimes lab tests. You can ask any questions before deciding.
2
Treatment
If you join and choose to continue, you receive the study treatment and are watched closely by medical staff.
3
Follow-up
After treatment, the team checks on your health and confirms the visit schedule with you. You can leave the study at any point.

Has this treatment been tested before?

Yes. This treatment has already been through earlier human studies for safety before reaching this stage.

What you need to know before you apply

What is this study testing?+

Is it safe? Who makes sure of that?+

This is a late-stage study (Phase 3), testing how well the treatment works in more people. Every study is reviewed and monitored by an independent ethics board (called an IRB) whose job is to protect participants, and care is overseen by licensed medical staff. You'll be told the known risks before you agree to anything, and you can stop at any time.

Will I get a placebo instead of the real treatment?+

Some studies compare a treatment against a placebo (an inactive version), and some don't. If this one does, the study team will explain your chances of receiving the active treatment before you decide. Nothing is hidden from you.

Do I have to stop taking my current medications?+

It depends on the study. Some let you stay on your current medications and some ask you to adjust them. Never stop a medication on your own — the study team will review everything with you first.

Does it cost anything? Will I be paid?+

The study treatment and study-related visits are provided at no cost to you. Some studies also pay for your time; the coordinator can tell you if this one does. You should never be asked to pay to take part.

Do I need insurance? Will anyone ask about my immigration status?+

No. You do not need health insurance to take part in a research study, and you will not be asked about your immigration status to join. Taking part is about whether you're a medical fit for the study.

What if English isn't my first language?+

You have the right to understand everything before you agree. Study sites can often provide materials or an interpreter in your language — you can ask the coordinator for one.

Is my information private?+

Yes. Your health information is only shared with the study sites you choose to be contacted by, and only to help match and enroll you. It is never sold, and you can ask us to delete it at any time.

Some requirements (like specific lab values or timing) are confirmed directly by the study team, not by us.

Source: ClinicalTrials.gov · NCT07359846 · Locations: California · Florida · Michigan · Ohio · Texas · Virginia · Tokyo