RecruitingRecruiting
A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma (SOLAIRIA-2)
NCT07359846 · Generate Biomedicines
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
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
About this study
This is a global, multicenter, randomized, double-blind, placebo-controlled Phase 3 study to evaluate the efficacy and safety of GB-0895 adjunctive therapy in adults and adolescents with severe uncontrolled asthma with an optional open-label extension (OLE). The trial is designed to administer GB-0895 an investigational drug or placebo, subcutaneously every 6 months.
The study is divided into several phases as described below:
* Screening/Baseline (Weeks -6 to -4)
* Run-in (Weeks -4 to 0, ±1)
* Treatment (Weeks 0 to 52)
* Follow-up (Weeks 52 to 90) or optional open-label extension (OLE) (Weeks 52 to 142, OLE includes GB-0895 treatment on Week 52 and Week 78)
Approximately 786 eligible study participants will be screened and randomized globally to receive either GB-0895 or placebo at week 0 and week 26. The safety of the participants enrolled in this trial will be carefully monitored.
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 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, eosinophilic esophagitis).
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.
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) within 12 months before Screening Visit 1 or other monoclonal antibodies used for asthma within 4 months or 5 half-lives.
14. Prior use (at any time) of any anti-TSLP or anti-TSLP receptor biologics, approved (e.g., tezepelumab) or investigational.
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, OR receipt of an investigational non-biologic within 30 days or 5 half-lives 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 design
Enrollment target: 786 participants
Allocation: randomized
Masking: triple
Age groups: child, adult, older_adult
Timeline
Starts: 2026-01-20
Estimated completion: 2029-01
Last updated: 2026-09-08
Interventions
Drug: GB-0895Drug: Placebo
Primary outcomes
- • To evaluate the annualized asthma exacerbation rate (AAER) in adult and adolescent subjects with severe uncontrolled asthma. (From Day 1 (randomization) to Week 52)
Sponsor
Generate Biomedicines · industry
Contacts & investigators
ContactGenerate Recruitment · contact · solairiastudy@generatebiomedicines.com · 888-469-0033
InvestigatorSnodgres · study_director, Generate Biomedicines
All locations (96)
Research Site 13Recruiting
Bakersfield, California, United States
Research Site 12Recruiting
Inglewood, California, United States
Research Site 65Recruiting
Lancaster, California, United States
Research Site 10Recruiting
West Covina, California, United States
Research Site 06Recruiting
Miami, Florida, United States
Research Site 03Recruiting
Miami, Florida, United States
Research 09Recruiting
Orlando, Florida, United States
Research Site 01Recruiting
Tamarac, Florida, United States
Research Site 04Recruiting
Tampa, Florida, United States
Research Site 05Recruiting
Tampa, Florida, United States
Research Site 20Recruiting
Fall River, Massachusetts, United States
Research Site 02Recruiting
Ypsilanti, Michigan, United States
Research Site 69Recruiting
New York, New York, United States
Research Site 69Recruiting
New York, New York, United States
Research Site 11Recruiting
Dayton, Ohio, United States
Research Site 21Recruiting
Oklahoma City, Oklahoma, United States
Research Site 16Recruiting
Rock Hill, South Carolina, United States
Research Site 17Recruiting
San Antonio, Texas, United States
Research Site 07Recruiting
Sugar Land, Texas, United States
Research Site 08Recruiting
Williamsburg, Virginia, United States
Research Site 31Recruiting
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Research Site 87Recruiting
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Research Site 79Recruiting
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Research Site 92Recruiting
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Research Site 33Recruiting
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Research Site 67Recruiting
Buenos Aires, Buenos Aires F.D., Argentina
Research Site 81Recruiting
Concepción del Uruguay, Entre Ríos Province, Argentina
Research Site 80Recruiting
Mendoza, Mendoza Province, Argentina
Research Site 100Recruiting
San Miguel de Tucumán, Tucumán Province, Argentina
Research Site 72Recruiting
Coffs Harbour, New South Wales, Australia
Research site 39Recruiting
Southport, Queensland, Australia
Research Site 22Recruiting
Mechelen, Vlaams Brabant, Belgium
Research Site 73Recruiting
Mechelen, Vlaams Brabant, Belgium
Research Site 45Recruiting
Erpent, Belgium
Research Site 95Recruiting
Tartu, Tartu, Estonia
Research Site 101Recruiting
Tartu, Tartu, Estonia
Research Site 53Recruiting
Brest, Finistère, France
Research Site 99Recruiting
Trieste, Friuli Venezia Giulia, Italy
Research Site 68Recruiting
Seto-shi, Aiti, Japan
Research Site 23Recruiting
Matsuyama, Ehime, Japan
Research Site 32Recruiting
Fukui-shi, Fukui, Japan
Research Site 37Recruiting
Isesaki-Shi, Gunma, Japan
Research Site 41Recruiting
Himeji, Hyōgo, Japan
Research Site 43Recruiting
Yokohama, Kanagawa, Japan
Research Site 55Recruiting
Ebino, Miyazaki, Japan
Research Site 47Recruiting
Niigata, Niigata, Japan
Research Site 34Recruiting
Niigata, Niigata, Japan
Research Site 63Recruiting
Uruma, Okinawa, Japan
Research Site 42Recruiting
Sakai, Osaka, Japan
Research site 40Recruiting
Chuo Ku, Tokyo, Japan
Research Site 54Recruiting
Chuo Ku, Tokyo, Japan
Research Site 75Recruiting
Hachioji-Shi, Tokyo, Japan
Research Site 66Recruiting
Itabashi-ku, Tokyo, Japan
Research Site 46Recruiting
Kiyose-shi, Tokyo, Japan
Research Site 14Recruiting
Shinagawa-Ku, Tokyo, Japan
Research Site 86Recruiting
Toshima-Ku, Tokyo, Japan
Research Site 15Recruiting
Fukuoka, Tukuoka, Japan
Research Site 38Recruiting
Ube, Yamaguchi, Japan
Research Site 58Recruiting
Belgrade, Belgrade, Serbia
Research Site 19Recruiting
Belgrade, Belgrade, Serbia
Research Site 57Recruiting
Belgrade, Belgrade, Serbia
Research Site 51Recruiting
Belgrade, Serbia
Research Site 56Recruiting
Kamenitz, Serbia
Research Site 89Recruiting
Novi Sad, Serbia
Research Site 35Recruiting
Spišská Nová Ves, Slovakia, Slovakia
Research Site 36Recruiting
Košice, Slovakia
Research Site 59Recruiting
Barcelona, Barcelona, Spain
Research Site 71Recruiting
Zaragoza, Zaragoza, Spain
Research Site 93Recruiting
Ankara, Ankara, Turkey (Türkiye)
Research Site 77Recruiting
Trabzon, Trabzon, Turkey (Türkiye)
Research Site 78Recruiting
Antalya, Turkey (Türkiye)
Research Site 49Recruiting
Chernivtsi, Chernivtsi Oblast, Ukraine
Research Site 91Recruiting
Ivano-Frankivsk, Ivano-Frankivs'k, Ukraine
Research Site 52Recruiting
Kyiv, Kyivs'ka Oblast, Ukraine
Research Site 44Recruiting
Kyiv, Kyïvs'ka Oblast, Ukraine
Research Site 82Recruiting
Kyiv, Kyïvs'ka Oblast, Ukraine
Research Site 76Recruiting
Kyiv, Kyïvs'ka Oblast, Ukraine
Research Site 74Recruiting
Kyiv, Kyïvs'ka Oblast, Ukraine
Research Site 60Recruiting
Vinnytsia, Vinnytsia Oblast, Ukraine
Research Site 50Recruiting
Vinnytsia, Vinnytsia Oblast, Ukraine
Research Site 83Recruiting
Vinnytsia, Vinnytsya, Ukraine
Research Site 61Recruiting
Vinnytsia, Vinnytsya, Ukraine
Research Site 64Recruiting
Lutsk, Volyn Oblast, Ukraine
Research Site 18Recruiting
High Wycombe, Buckinghamshire, United Kingdom
Research Site 28Recruiting
Bristol, England, United Kingdom
Research Site 30Recruiting
London, England, United Kingdom
Research Site 29Recruiting
Romford, England, United Kingdom
Research Site 24Recruiting
Rotherham, England, United Kingdom
Research Site 25Recruiting
Thetford, England, United Kingdom
Research Site 26Recruiting
London, Greater London, United Kingdom
Research Site 27Recruiting
Nottingham, Nottinghamshire, United Kingdom
Research Site 84Recruiting
Somerton, Somerset, United Kingdom
Research Site 62Recruiting
London, Westminster, United Kingdom
Research Site 70Recruiting
Metropolitan Borough of Wirral, Wirral, United Kingdom
Research Site 85Recruiting
Honiton, United Kingdom
Research Site 48Recruiting
Plymouth, United Kingdom