GB-0895 for Severe Uncontrolled Asthma

A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma (SOLAIRIA-1)

Recruiting Phase 3 Interventional Study
Severe Asthma
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
12 – 80
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
786 (estimated)
Sponsor
Generate Biomedicines · Industry
Who this trial is looking for

This trial is looking for adults and teenagers with severe asthma that isn't controlled well by their current treatments. Participants will receive either the study drug GB-0895 or a placebo every six months for a year, with regular check-ins.

Are You a Good Fit for This Trial?
Must be taking Inhaled corticosteroidsAsthma controller medications
Rules you out Eosinophilic diseaseHeart diseaseChronic lung diseaseSevere liver disease

You may be able to join if

  • I am between 12 and 80 years old.
  • I have been diagnosed with asthma for at least 2 years.
  • I have been on a medium to high dose of inhaled corticosteroids for over a year.
  • I have had at least two asthma flare-ups needing corticosteroids in the last year.
  • I weigh at least 40 kg.

You may not be able to join if

  • I have had a significant asthma flare-up in the last 12 weeks.
  • I have any other significant lung disease besides asthma.
  • I have a current infection that needs treatment.
  • I have a history of cancer in the last 5 years.
  • I smoke or have a significant history of smoking.
  • I have a serious medical condition that is not stable.
  • I am currently pregnant or breastfeeding.
  • I have abused alcohol or drugs in the last 2 years.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer a few quick questions to see if you may meet the eligibility requirements.

Check Your Eligibility
About This Trial
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. Visit frequency: every 1-2 …
Trial Locations
Loading…

Loading trial locations…

Eligibility Criteria
1. Adults and adolescents ≥ 12 and ≤ 80 years of age. 2. Documented physician diagnosis of asthma for ≥ 2 years. 3. Subjects must be on medium to high dose ICS for ≥ 12 months before Screening Visit 1 plus at least 1 additional asthma controller (e.g., LABA, LAMA) ≥ 3 months before Screening Visit 1…
Contacts

Generate Recruitment

888-469-0033

solairiastudy@generatebiomedicines.com

CONTACT