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

NCT07359846 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: GB-0895-302 (SOLAIRIA-2)
• Study Type: interventional
• Target: 786
• Locations: 13 countries
• Sites: 105

Brief 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.

Conditions

Severe Asthma

Keywords

Asthma; Severe Asthma

Outcome Measures

Primary Outcomes (1)

• To evaluate the annualized asthma exacerbation rate (AAER) in adult and adolescent subjects with severe uncontrolled asthma.

  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.

  From Day 1 (randomization) to Week 52

Secondary Outcomes (14)

• To evaluate the annualized asthma exacerbation rate (AAER) in adult and adolescent subjects with severe uncontrolled asthma and baseline eosinophils (EOS) < 300 cells/µL.

  From Day 1 (randomization) to Week 52

• Change from baseline in pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1)

  From Day 1 (randomization) to Study Week 52

• Change from baseline in Asthma Quality of Life Questionnaire AQLQ(S)12+ score

  From Day 1 (randomization) to Week 52

• Change from baseline in Asthma Control Questionnaire (ACQ-6) score

  From Day 1 (randomization) to Week 52

• Time to first asthma exacerbation from randomization

  From Day 1 (randomization) to Week 52

Study Arms (2)

GB-0895

EXPERIMENTAL

GB-0895 Subcutaneous (SC) injection

Drug: GB-0895

Placebo

PLACEBO COMPARATOR

Placebo Subcutaneous (SC) injection

Drug: Placebo

Interventions

Placebo DRUG

Placebo

Placebo

GB-0895 DRUG

Study Drug

GB-0895

Eligibility Criteria

• Age: 12 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.
• 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.
• Eosinophilic disease (e.g., eosinophilic granulomatosis with polyangiitis, eosinophilic esophagitis).
• 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.
• Clinically significant infection that is unresolved and requires systemic antibiotic, antifungal, antiparasitic, or antiviral medications preceding enrollment.
• A current malignancy or previous history of cancer within 5 years before screening.
• Clinically significant infection that is not resolved before study enrollment.
• Subjects with a known, pre-existing helminth parasitic infestation within 6 months before Screening Visit 1.
• Current smokers or subjects with a smoking history ≥10 pack-years, and subjects using vaping products, including electronic cigarettes.
• 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.
• Hepatitis B, C, or HIV.
• 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.
• 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.
• Prior use (at any time) of any anti-TSLP or anti-TSLP receptor biologics, approved (e.g., tezepelumab) or investigational.
• Treatment with systemic immunosuppressive/immunomodulating drugs (e.g., methotrexate, cyclosporine) within 12 weeks prior to randomization.

Sponsors & Collaborators

• Generate Biomedicines: lead

Study Sites (108)

Research Site 13

Bakersfield, California, 93301, United States

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Research Site 12

Inglewood, California, 90301, United States

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Research Site 65

Lancaster, California, 93534, United States

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Research Site 10

West Covina, California, 91790, United States

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Research Site 06

Miami, Florida, 33126, United States

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Research Site 03

Miami, Florida, 33135, United States

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Research 09

Orlando, Florida, 32807, United States

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Research Site 01

Tamarac, Florida, 33321, United States

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Research Site 04

Tampa, Florida, 33607, United States

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Research Site 05

Tampa, Florida, 33617, United States

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Research Site 20

Fall River, Massachusetts, 02723, United States

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Research Site 02

Ypsilanti, Michigan, 48197, United States

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Research Site 69

New York, New York, 10016, United States

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Research Site 69

New York, New York, 10016, United States

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Research Site 11

Dayton, Ohio, 45424, United States

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Research Site 21

Oklahoma City, Oklahoma, 73118, United States

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Research Site 16

Rock Hill, South Carolina, 29732, United States

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Research Site 17

San Antonio, Texas, 78258, United States

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Research Site 07

Sugar Land, Texas, 77479, United States

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Research Site 08

Williamsburg, Virginia, 23188, United States

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Research Site 103

Buenos Aires, Buenos Aires, 1425, Argentina

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Research Site 31

Ciudad Autónoma de Buenos Aires, Buenos Aires, 1426, Argentina

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Research Site 87

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1023AAB, Argentina

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Research Site 79

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1414AIF, Argentina

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Research Site 92

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1425FVH, Argentina

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Research Site 33

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ABP, Argentina

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Research Site 94

Mar del Plata, Buenos Aires, B7612ENA, Argentina

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Research Site 67

Buenos Aires, Buenos Aires F.D., C1426AKD, Argentina

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Research Site 81

Concepción del Uruguay, Entre Ríos Province, 3260, Argentina

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Research Site 107

San Salvador, Entre Ríos Province, E3218CHH, Argentina

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Research Site 80

Mendoza, Mendoza Province, 5519, Argentina

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Research Site 98

Rosario, Santa Fe Province, S2000DBS, Argentina

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Research Site 100

San Miguel de Tucumán, Tucumán Province, 4000, Argentina

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Research Site 72

Coffs Harbour, New South Wales, 2450, Australia

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Research site 39

Southport, Queensland, 4222, Australia

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Research Site 22

Mechelen, Vlaams Brabant, 02800, Belgium

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Research Site 73

Mechelen, Vlaams Brabant, 2800, Belgium

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Research Site 45

Erpent, 5101, Belgium

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Research Site 95

Tartu, Tartu, 50106, Estonia

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Research Site 101

Tartu, Tartu, 50708, Estonia

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Research Site 53

Brest, Finistère, 29000, France

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Research Site 99

Trieste, Friuli Venezia Giulia, 34149, Italy

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Research Site 68

Seto-shi, Aiti, 489-0065, Japan

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Research Site 23

Matsuyama, Ehime, 790-092, Japan

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Research Site 32

Fukui-shi, Fukui, 910-0846, Japan

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Research Site 90

Iizuka-Shi, Fukuoka, 820-8505, Japan

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Research Site 37

Isesaki-Shi, Gunma, 372-0831, Japan

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Research Site 96

Hiroshima, Hiroshima, 730-0853, Japan

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Research Site 41

Himeji, Hyōgo, 670-0849, Japan

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Research Site 97

Naka-Gun, Ibaraki, 319-1113, Japan

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Research Site 43

Yokohama, Kanagawa, 223-0053, Japan

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Research Site 55

Ebino, Miyazaki, 889-4304, Japan

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Research Site 47

Niigata, Niigata, 950-1197, Japan

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Research Site 34

Niigata, Niigata, 951-8520, Japan

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Research Site 63

Uruma, Okinawa, 904-2293, Japan

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Research Site 42

Sakai, Osaka, 590-0132, Japan

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Research Site 88

Iruma, Saitama, 350-0451, Japan

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Research site 40

Chuo Ku, Tokyo, 103-0027, Japan

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Research Site 54

Chuo Ku, Tokyo, 104-8560, Japan

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Research Site 75

Hachioji-Shi, Tokyo, 193-0944, Japan

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Research Site 66

Itabashi-ku, Tokyo, 173-8610, Japan

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Research Site 46

Kiyose-shi, Tokyo, 204-0022, Japan

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Research Site 14

Shinagawa-Ku, Tokyo, 140-8522, Japan

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Research Site 86

Toshima-Ku, Tokyo, 171-0014, Japan

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Research Site 15

Fukuoka, Tukuoka, 812-0054, Japan

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Research Site 38

Ube, Yamaguchi, 755-8505, Japan

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Research Site 58

Belgrade, Belgrade, 11000, Serbia

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Research Site 19

Belgrade, Belgrade, 11070, Serbia

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Research Site 57

Belgrade, Belgrade, 11080, Serbia

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Research Site 51

Belgrade, 11000, Serbia

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Research Site 56

Kamenitz, 21204, Serbia

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Research Site 105

Kragujevac, 34000, Serbia

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Research Site 89

Novi Sad, 21000, Serbia

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Research Site 35

Spišská Nová Ves, Slovakia, 05201, Slovakia

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Research Site 36

Košice, 04013, Slovakia

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Research Site 59

Barcelona, Barcelona, 08036, Spain

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Research Site 104

Seville, Sevilla, 41009, Spain

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Research Site 71

Zaragoza, Zaragoza, 50009, Spain

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Research Site 93

Ankara, Ankara, 6230, Turkey (Türkiye)

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Research Site 77

Trabzon, Trabzon, 61080, Turkey (Türkiye)

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Research Site 78

Antalya, 7070, Turkey (Türkiye)

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Research Site 102

Bursa, 16059, Turkey (Türkiye)

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Research Site 49

Chernivtsi, Chernivtsi Oblast, 58001, Ukraine

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Research Site 91

Ivano-Frankivsk, Ivano-Frankivs'k, 76008, Ukraine

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Research Site 52

Kyiv, Kyivs'ka Oblast, 01135, Ukraine

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Research Site 44

Kyiv, Kyïvs'ka Oblast, 02002, Ukraine

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Research Site 82

Kyiv, Kyïvs'ka Oblast, 3038, Ukraine

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Research Site 76

Kyiv, Kyïvs'ka Oblast, 3049, Ukraine

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Research Site 74

Kyiv, Kyïvs'ka Oblast, 3151, Ukraine

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Research Site 60

Vinnytsia, Vinnytsia Oblast, 21029, Ukraine

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Research Site 50

Vinnytsia, Vinnytsia Oblast, 21050, Ukraine

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Research Site 83

Vinnytsia, Vinnytsya, 21001, Ukraine

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Research Site 61

Vinnytsia, Vinnytsya, 21018, Ukraine

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Research Site 64

Lutsk, Volyn Oblast, 43005, Ukraine

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Research Site 18

High Wycombe, Buckinghamshire, HP11 2QW, United Kingdom

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Research Site 106

Ashburton, Devon, TQ13 7AP, United Kingdom

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Research Site 28

Bristol, England, BS8 2RA, United Kingdom

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Research Site 30

London, England, N12 8BU, United Kingdom

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Research Site 29

Romford, England, RM13PJ, United Kingdom

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Research Site 24

Rotherham, England, S61 1AH, United Kingdom

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Research Site 25

Thetford, England, IP24 1JD, United Kingdom

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Research Site 26

London, Greater London, W1T 6AH, United Kingdom

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Research Site 27

Nottingham, Nottinghamshire, NG7 2QW, United Kingdom

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Research Site 84

Somerton, Somerset, TA11 7PB, United Kingdom

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Research Site 62

London, Westminster, SW1P2PF, United Kingdom

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Research Site 70

Metropolitan Borough of Wirral, Wirral, CH48 5AA, United Kingdom

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Research Site 85

Honiton, EX14 2NY, United Kingdom

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Research Site 48

Plymouth, PL66PH, United Kingdom

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MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Snodgres

  Generate Biomedicines

  STUDY DIRECTOR

Central Study Contacts

Generate Recruitment

CONTACT

888-469-0033; solairiastudy@generatebiomedicines.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: January 22, 2026
• Study Start: January 20, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: September 22, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (20); IT (1); TU (4); UA (12); JP (24); SL (2); FR (1); AU (2); SE (7); GB (14); BE (3); AR (13); ES (2)