Recruiting
Phase 3
A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma (SOLAIRIA-2)
Condition(s) studied
Severe Asthma
Investigational drug(s) / intervention(s)
GB-0895: Study Drug
Placebo: Placebo
Study summary
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.
Eligibility
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.
Primary outcome measure(s)
- To evaluate the annualized asthma exacerbation rate (AAER) in adult and adolescent subjects with severe uncontrolled asthma. — From Day 1 (randomization) to Week 52
The annual exacerbation rate is based on clinically significant (CS) exacerbations reported by the investigator in the electronic case (eCRF) over 52 weeks for subjects on GB-0895 as compared to placebo.
Trial sites (132)
| Facility | City | Region | Status |
| Research Site 13 |
Bakersfield |
California |
Recruiting |
| Research Site 12 |
Inglewood |
California |
Recruiting |
| Research Site 65 |
Lancaster |
California |
Recruiting |
| Research Site 10 |
West Covina |
California |
Recruiting |
| Research Site 06 |
Miami |
Florida |
Recruiting |
| Research Site 03 |
Miami |
Florida |
Recruiting |
| Research 09 |
Orlando |
Florida |
Recruiting |
| Research Site 01 |
Tamarac |
Florida |
Recruiting |
| Research Site 04 |
Tampa |
Florida |
Recruiting |
| Research Site 05 |
Tampa |
Florida |
Recruiting |
| Research Site 114 |
Kansas City |
Kansas |
Recruiting |
| Research Site 20 |
Fall River |
Massachusetts |
Recruiting |
| Research Site 02 |
Ypsilanti |
Michigan |
Recruiting |
| Research Site 69 |
New York |
New York |
Recruiting |
| Research Site 69 |
New York |
New York |
Recruiting |
| Research Site 11 |
Dayton |
Ohio |
Recruiting |
| Research Site 21 |
Oklahoma City |
Oklahoma |
Recruiting |
| Research Site 16 |
Rock Hill |
South Carolina |
Recruiting |
| Research Site 17 |
San Antonio |
Texas |
Recruiting |
| Research Site 07 |
Sugar Land |
Texas |
Recruiting |
| Research Site 08 |
Williamsburg |
Virginia |
Recruiting |
| Research Site 116 |
Mar del Plata |
Beunos Aires |
Recruiting |
| Research Site 120 |
Buenos Aires |
Buenos Aires |
Recruiting |
| Research Site 103 |
Buenos Aires |
Buenos Aires |
Recruiting |
| Research Site 31 |
Ciudad Autónoma de Buenos Aires |
Buenos Aires |
Recruiting |
| Research Site 87 |
Ciudad Autónoma de Buenos Aires |
Buenos Aires |
Recruiting |
| Research Site 79 |
Ciudad Autónoma de Buenos Aires |
Buenos Aires |
Recruiting |
| Research Site 92 |
Ciudad Autónoma de Buenos Aires |
Buenos Aires |
Recruiting |
| Research Site 33 |
Ciudad Autónoma de Buenos Aires |
Buenos Aires |
Recruiting |
| Research Site 94 |
Mar del Plata |
Buenos Aires |
Recruiting |
| Research Site 67 |
Buenos Aires |
Buenos Aires F.D. |
Recruiting |
| Research Site 81 |
Concepción del Uruguay |
Entre Ríos Province |
Recruiting |
| Research Site 107 |
San Salvador |
Entre Ríos Province |
Recruiting |
| Research Site 80 |
Mendoza |
Mendoza Province |
Recruiting |
| Research Site 119 |
Rosario |
Santa Fe Province |
Recruiting |
| Research Site 98 |
Rosario |
Santa Fe Province |
Recruiting |
| Research Site 125 |
Santa Fe |
Santa Fe Province |
Recruiting |
| Research Site 100 |
San Miguel de Tucumán |
Tucumán Province |
Recruiting |
| Research Site 113 |
San Miguel de Tucumán |
Tucumán Province |
Recruiting |
| Research Site 72 |
Coffs Harbour |
New South Wales |
Recruiting |
+ 92 more sites — see the full list on the official registry below.