Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT07276724

PHASE3

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

Sponsor: Generate Biomedicines

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

12 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

786

Start Date

2025-12-03

Completion Date

2028-12

Last Updated

2026-10-07

Healthy Volunteers

Conditions

Severe Asthma

Interventions

DRUG

GB-0895

Study Drug

DRUG

Placebo

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.

Locations (123)

Research Site 23

Northridge, California, United States

Research Site 26

Pasadena, California, United States

Research Site 29

Rancho Cucamonga, California, United States

Research Site 34

Valencia, California, United States

Research Site 13

West Hills, California, United States

Research Site 15

Colorado Springs, Colorado, United States

Research Site 32

Brooksville, Florida, United States

Research Site 12

Doral, Florida, United States

Research Site 14

Gainesville, Florida, United States

Research Site 03

Hialeah, Florida, United States

Research Site 25

Kendall, Florida, United States

Research Site 04

Miami, Florida, United States

Research Site 01

Miami Lakes, Florida, United States

Research Site 08

North Miami, Florida, United States

Research Site 10

Palm Springs, Florida, United States

Research Site 02

Tampa, Florida, United States

Research Site 18

Rincon, Georgia, United States

Research Site 31

Glenview, Illinois, United States

Research Site 16

Baltimore, Maryland, United States

Research Site 28

Columbia, Maryland, United States

Research Site 20

Towson, Maryland, United States

Research Site 06

Flint, Michigan, United States

Research Site 30

Olive Branch, Mississippi, United States

Research Site 37

The Bronx, New York, United States

Research Site 27

Gastonia, North Carolina, United States

Research Site 83

Winston-Salem, North Carolina, United States

Research Site 24

Amarillo, Texas, United States

Research Site 19

Baytown, Texas, United States

Research Site 07

Dallas, Texas, United States

Research Site 17

Dallas, Texas, United States

Research Site 11

Houston, Texas, United States

Research Site 09

Houston, Texas, United States

Research Site 22

Kerrville, Texas, United States

Research Site 05

Lewisville, Texas, United States

Research Site 33

McKinney, Texas, United States

Research Site 21

Riverton, Utah, United States

Research Site 56

Haskovo, Haskovo, Bulgaria

Research Site 54

Pleven, Pleven, Bulgaria

Research Site 55

Plovdiv, Plovdiv, Bulgaria

Research Site 73

Rousse, Ruse, Bulgaria

Research Site 88

Rousse, Ruse, Bulgaria

Research Site 95

Sofia, Sofia, Bulgaria

Research Site 75

Sofia, Sofia, Bulgaria

Research Site 65

Sofia, Sofia, Bulgaria

Research Site 91

Sofia, Sofia, Bulgaria

Research Site 103

Sofia, Sofia, Bulgaria

Research Site 69

Sofia, Sofia, Bulgaria

Research Site 81

Sofia, Sofia, Bulgaria

Research Site 63

Sofia, Sofia, Bulgaria

Research Site 39

Vidin, Vidin, Bulgaria

Research Site 38

Kozloduy, Vratsa, Bulgaria

Research Site 116

Temuco, Araucania, Chile

Research Site 102

Temuco, Araucania, Chile

Research Site 107

Curicó, Maule Region, Chile

Research Site 85

Varnsdorf, Czechia, Czechia

Research Site 109

Jindřichův Hradec, Jindřichův Hradec, Czechia

Research Site 98

Prague, Prague, Czechia

Research Site 86

Jablonec nad Nisou, Czechia

Research Site 94

Teplice, Czechia

Research Site 42

Deggingen, Baden-Wurttemberg, Germany

Research Site 80

München, Bavaria, Germany

Research Site 67

Frankfurt am Main, Hesse, Germany

Research Site 36

Frankfurt am Main, Hesse, Germany

Research Site 76

Witten, North Rhine-Westphalia, Germany

Research site 79

Leipzig, Saxony, Germany

Research Site 43

Lübeck, Schleswig-Holstein, Germany

Research Site 40

Berlin, State of Berlin, Germany

Research Site 44

Berlin, State of Berlin, Germany

Research Site 49

Berlin, State of Berlin, Germany

Research Site 40

Berlin, Germany

Research Site 92

Leipzig, Germany

Research Site 43

Lübeck, Germany

Research Site 90

Athens, Attica, Greece

Research Site 97

Palaió Fáliro, Attica, Greece

Research Site 113

Heraklion, Crete, Greece

Research Site 104

Alexandroupoli, Evros, Greece

Research Site 82

Thessaloniki, Exochi, Greece

Research Site 53

Szigetvár, Baranya Varmegye, Hungary

Research Site 110

Budapest, Budapest, Hungary

Research Site 45

Budapest, Budapest, Hungary

Research Site 47

Mosonmagyaróvár, Győr-Moson-Sopron, Hungary

Research Site 46

Szombathely, Vas County, Hungary

Research Site 78

Szombathely, Vas County, Hungary

Research Site 115

Haifa, Haifa District, Israel

Research Site 117

Jerusalem, Jerusalem, Israel

Research Site 118

Jerusalem, Jerusalem, Israel

Research Site 111

Kfar Saba, Israel

Research Site 105

Ramat Gan, Israel

Research Site 114

Daugavpils, Daugavpils Novads, Latvia

Research Site 52

Riga, Riga, Latvia

Research Site 71

Riga, Riga, Latvia

Research Site 70

Riga, Riga, Latvia

Research Site 62

Heerlen, Limburg, Netherlands

Research Site 77

Enschede, Overijssel, Netherlands

Research Site 121

Lipa City, Batangas, Philippines

Research Site 120

Marilao, Bulacan, Philippines

Research Site 48

Figueira da Foz Municipality, Figueira da Foz, Portugal

Research Site 74

Porto, Senhora Da Hora, Portugal

Research Site 41

Oradea, Bihor County, Romania

Research Site 50

Brasov, Brașov County, Romania

Research Site 35

Bucharest, Bucharest, Romania

Research Site 84

Bucharest, Bucharest, Romania

Research Site 87

Cluj-Napoca, Cluj, Romania

Research Site 66

Cluj-Napoca, Cluj, Romania

Research Site 64

Cluj-Napoca, Cluj, Romania

Research Site 51

Craiova, Dolj, Romania

Research Site 72

Timișoara, Timiș County, Romania

Research Site 93

Singapore, Singapore, Singapore

Research Site 61

Welkom, Free State, South Africa

Research Site 89

Johannesburg, Gauteng, South Africa

Research Site 59

Johannesburg, Gauteng, South Africa

Research Site 101

Johannesburg, Gauteng, South Africa

Research Site 60

KwaDukuza, Gauteng, South Africa

Research Site 58

Durban, KwaZulu-Natal, South Africa

Research Site 57

Sydenham, KwaZulu-Natal, South Africa

Research Site 68

Cape Town, Western Cape, South Africa

Research Site 96

Cape Town, Western Cape, South Africa

Research Site 106

Busan, Busan, South Korea

Research Site 100

Anyang-si, Gyeonggi-do, South Korea

Research Site 119

Seoul, Seoul, South Korea

Research Site 112

Seoul, Seoul, South Korea

Research Site 108

Seoul, Seoul, South Korea

Research Site 99

Seoul, Seoul, South Korea

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (123)