GB-0895 for Severe Uncontrolled Asthma

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

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 adolescents with severe asthma that is not well controlled by standard treatments. Participants will receive either the study drug GB-0895 or a placebo every 6 months for one year, with regular visits to monitor their health.

Are You a Good Fit for This Trial?
Must be taking Inhaled corticosteroidsAdditional asthma controller
Rules you out Eosinophilic diseaseCirrhosisCurrent malignancyActive infection

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 using a medium to high dose of inhaled corticosteroids for at least 12 months.
  • I have taken at least one additional asthma controller for at least 3 months.
  • I have had at least two asthma flare-ups in the past year that needed treatment with corticosteroids.
  • I have a specific lung function level that is below normal.
  • 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 major respiratory disease besides asthma.
  • I have a history of cancer in the last 5 years.
  • I am currently a smoker or have a significant smoking history.
  • I have a serious infection that hasn’t been resolved.
  • I have any major health issues that are not stable.
  • I am pregnant, breastfeeding, or plan to become pregnant during the study.
  • 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.

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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
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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