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NCT07276724PHASE3Recruiting

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

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Start Date

12/3/2025

Completion Date

12/1/2028

Summary

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 months after the first month.

Detailed Description

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

Age Range: 12 years to 80 years

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.

Interventions

DRUG

GB-0895

DRUG

Placebo

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Conditions

Severe Asthma

Locations

Research Site 23

Northridge, California 91324

United States

Research Site 26

Pasadena, California 91105

United States

Research Site 29

Rancho Cucamonga, California 91730

United States

Research Site 34

Valencia, California 91355

United States

Research Site 13

West Hills, California 91307

United States

Research Site 15

Colorado Springs, Colorado 80923

United States

Research Site 32

Brooksville, Florida 34613

United States

Research Site 12

Doral, Florida 33122

United States

Research Site 14

Gainesville, Florida 32607

United States

Research Site 03

Hialeah, Florida 33016

United States

Research Site 25

Kendall, Florida 33176

United States

Research Site 04

Miami, Florida 33126

United States

Research Site 01

Miami Lakes, Florida 33014

United States

Research Site 08

North Miami, Florida 33169

United States

Research Site 10

Palm Springs, Florida 33461

United States

Research Site 02

Tampa, Florida 33613

United States

Research Site 18

Rincon, Georgia 31326

United States

Research Site 31

Glenview, Illinois 60026

United States

Research Site 16

Baltimore, Maryland 21237

United States

Research Site 28

Columbia, Maryland 21045

United States

Research Site 20

Towson, Maryland 21204

United States

Research Site 06

Flint, Michigan 48504

United States

Research Site 30

Olive Branch, Mississippi 38654

United States

Research Site 37

The Bronx, New York 10461

United States

Research Site 27

Gastonia, North Carolina 28054

United States

Research Site 24

Amarillo, Texas 79106

United States

Research Site 19

Baytown, Texas 77521

United States

Research Site 07

Dallas, Texas 75230

United States

Research Site 17

Dallas, Texas 75254

United States

Research Site 11

Houston, Texas 77084

United States

Research Site 09

Houston, Texas 77099

United States

Research Site 22

Kerrville, Texas 78028

United States

Research Site 05

Lewisville, Texas 75057

United States

Research Site 33

McKinney, Texas 75069

United States

Research Site 21

Riverton, Utah 84096

United States

Research Site 38

Kozloduy, Vratsa 3320

Bulgaria

Research Site 56

Haskovo, 6300

Bulgaria

Research Site 54

Pleven,

Bulgaria

Research Site 55

Plovdiv,

Bulgaria

Research Site 39

Vidin, 3703

Bulgaria

Research Site 42

Deggingen, Baden-Wurttemberg 73326

Germany

Research Site 36

Frankfurt am Main, Hesse 60596

Germany

Research Site 40

Berlin, 10119

Germany

Research Site 43

Lübeck,

Germany

Research Site 45

Budapest, 1047

Hungary

Research Site 47

Mosonmagyaróvár, 9200

Hungary

Research Site 53

Szigetvár, 7900

Hungary

Research Site 46

Szombathely, 9700

Hungary

Research Site 52

Riga,

Latvia

Research Site 41

Oradea, Bihor County 410163

Romania

Research Site 35

Bucharest, Bucharest 061692

Romania

Research Site 51

Craiova, Dolj 200678

Romania

Research Site 50

Brasov, 500051

Romania