RecruitingPhase 3

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
12 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether adding GB-0895 to usual asthma medicines can improve health. It is for people ages 12 to 80 with severe asthma that is not controlled by inhaled steroids and other asthma medicines.

The objective of this study is to assess the potential for GB-0895 to improve the health of adolescents and adults with severe asthma that is uncontrolled by inhaled corticosteroids (ICS) and conventional asthma controllers. Additional information is available at www.SOLAIRIA.com.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 12 to 80 years old and weigh at least 40 kg (about 88 pounds).
  • Have a documented asthma diagnosis for more than 12 months.
  • Have used medium- or high-dose inhaled steroids for at least 12 months and another asthma control medicine for at least 3 months. Neither treatment can have changed in the past 3 months.
  • Have had at least 2 asthma flare-ups needing steroid pills or shots in the past 12 months, despite using medium- or high-dose inhaled steroids.
  • For adults: before a medicine that opens the airways, a breathing test must show less than 80% of the expected amount of air breathed out in one second.
  • For ages 12–17: that breathing test must show less than 90% of the expected amount, or the amount breathed out in one second must be less than 80% of the total air breathed out.
  • During screening, breathing must improve by at least 12% and 200 mL within 15–60 minutes after a quick-relief asthma medicine.
  • Have a score of at least 1.5 on the ACQ-6 survey, which measures asthma control.

Who can't join

  • A serious asthma flare-up within 12 weeks before screening or during the study's preparation period that requires a change in regular asthma treatment.
  • Another lung disease, a history of lung cancer, or a disease involving too many eosinophils, a type of white blood cell.
  • An ongoing serious infection; hepatitis B, hepatitis C, or HIV; or a recent parasitic worm infection that was not successfully treated.
  • Current cancer or cancer within the past 5 years, serious liver disease, or an unstable health condition or abnormal test result that could make the study unsafe or affect its results.
  • Current smoking or vaping, quitting less than 6 months ago, or a smoking history of at least 10 pack-years—such as 1 pack a day for 10 years.
  • Certain recent asthma treatments, immune-system medicines, study drugs, blood products, live vaccines, surgery, or heat treatment of the airways. Some past asthma treatments also rule out joining.
  • Allergy to a study treatment ingredient, a past life-threatening allergic reaction to a biologic medicine, another drug study at the same time, or past assignment to treatment in this or another GB-0895 study.
  • Pregnancy, breastfeeding, plans to become pregnant during the study, alcohol or drug misuse within 2 years, or inability or unwillingness to follow study steps and take asthma medicines as directed.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

1. Adults and adolescents ≥ 12 and ≤ 80 years of age. 2. Documented diagnosis of asthma for \> 12 months. 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 with no change in ICS or controller(s) for at least three months. 4. Subjects must have a well-documented history of at least two asthma exacerbations requiring systemic corticosteroid treatment despite the use of medium-to-high dose ICS in the past 12 months before Screening Visit 1. 5. Adults ≥ 18 years of age at Screening Visit 1, a pre-BD FEV1 \<80% predicted at Screening Visit 1. 6. Adolescents 12 to \< 18 years of age at Screening Visit 1: A pre-BD FEV1 \< 90% predicted OR, FEV1:Forced Vital Capacity (FVC) ratio \< 0.80. 7. Positive BD responsiveness test: Increase of at least 12% and 200 mL in FEV1 between 15 and 60 minutes after the administration of a short-acting β2-agonist (SABA) at least once during the screening period. 8. ACQ-6 score ≥ 1.5 at the Screening Visit. 9. Weight ≥40 kg at the Screening Visit 1 Exclusion Criteria: 1. Subjects who experience a clinically significant asthma exacerbation within 12 weeks before the Screening Visit or during the run-in period and require a change in asthma maintenance therapy. 2. Other concurrent respiratory disease other than asthma, including (but not limited to) current infection, bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis, tuberculosis, diagnosis of chronic pulmonary disease (including but not limited to emphysema and/or chronic bronchitis), or a history of lung cancer. 3. Eosinophilic disease (e.g., eosinophilic granulomatosis with polyangiitis). 4. Any cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could affect subject safety, influence study findings or interpretation, or impede completion of the study. 5. Clinically significant infection that is unresolved and requires systemic antibiotic, antifungal, antiparasitic, or antiviral medications preceding enrollment. 6. A current malignancy or previous history of cancer within 5 years before screening. 7. Clinically significant infection that is not resolved before study enrollment. 8. Subjects with a known, pre-existing helminth parasitic infestation within 6 months before Screening Visit 1 that has not been successfully treated with, or has failed to respond to, standard of care therapy. 9. Current smokers or subjects with a smoking history ≥10 pack-years, and subjects using vaping products, including electronic cigarettes. 10. Former smokers with a smoking history of \<10 pack-years and users of vaping/e-cigarette products must have stopped for at least 6 months before Screening Visit 1 to be eligible. 11. Hepatitis B, C, or HIV. 12. Major surgery within 8 weeks before Screening Visit 1 or planned surgical procedures requiring general anesthesia or inpatient status for \>1 day during the study. 13. Use of any anti-IL-5 therapy (e.g., mepolizumab, reslizumab, benralizumab, depemokimab) or other monoclonal antibodies used for asthma within 4 months or 5 half-lives. 14. Previous use of tezepelumab within 12 months before Screening Visit 1 is excluded. Previous tezepelumab use is exclusionary regardless of 12-month washout if discontinuation was due to safety (intolerance) or treatment failure (lack of benefit). Prior use (at any time) of any other anti-TSLP or anti-TSLP receptor biologics is excluded. 15. Treatment with systemic immunosuppressive/immunomodulating drugs (e.g., methotrexate, cyclosporine) within 12 weeks prior to randomization. 16. Receipt of an investigational biologic within 4 months or 5 half-lives (whichever is longer), OR receipt of an investigational non-biologic within 30 days or 5 half-lives (whichever is longer) before Screening Visit 1. 17. Known history of sensitivity to any component of the study treatment formulation. 18. History of life-threatening anaphylaxis following any biologic therapy. 19. Concurrent enrollment in another clinical study involving investigational product (IP). 20. Subject has been randomized in the current study or previous GB-0895 studies. 21. Any clinically meaningful abnormal finding in physical examination, vital signs, ECG, hematology, serum chemistry, or urinalysis that, in the opinion of the Investigator, may put the subject at risk, influence study results, or impede study completion. 22. Cirrhosis (with or without hepatic dysfunction) or other active or clinically significant liver disease. 23. Receipt of immunoglobulin or blood products within 30 days before Screening Visit 1. 24. Receipt of live attenuated vaccines within 30 days before randomization and during the study, including the follow-up period. 25. Receipt of the T2 cytokine inhibitor suplatast tosilate within 15 days before Screening Visit 1. 26. Subjects treated with bronchial thermoplasty in the last 12 months before Screening Visit 1. 27. Unwillingness or inability to follow study procedures, including poor adherence to asthma controller medications, in the opinion of the Investigator. 28. Women who are pregnant, lactating, or planning to become pregnant during the study. 29. History (or suspected history) of alcohol misuse or substance abuse within 2 years before Screening Visit 1.

Study sites (21)

CA

FL

KS

MA

MI

NY

OH

OK

SC

TX

VA