Severe AsthmaPhase 3NCT07359846
A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma (SOLAIRIA-2)
A Phase 3 study testing GB-0895 in people with Severe Asthma, run by Generate Biomedicines at 158 sites in 19 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 80 years
- Conditions the study is for
- Severe Asthma
- What is being tested?
- GB-0895
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 786 participants
- Where
- 158 sitesin 19 countries
- Study dates
- 20 Jan 2026to Jan 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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).
- 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.
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- 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 that has not been successfully treated with, or has failed to respond to, standard of care therapy.
- 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) or other monoclonal antibodies used for asthma within 4 months or 5 half-lives.
- 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.
- Treatment with systemic immunosuppressive/immunomodulating drugs (e.g., methotrexate, cyclosporine) within 12 weeks prior to randomization.
- 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.
- Known history of sensitivity to any component of the study treatment formulation.
- History of life-threatening anaphylaxis following any biologic therapy.
- Concurrent enrollment in another clinical study involving investigational product (IP).
- Subject has been randomized in the current study or previous GB-0895 studies.
- 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.
- Cirrhosis (with or without hepatic dysfunction) or other active or clinically significant liver disease.
- Receipt of immunoglobulin or blood products within 30 days before Screening Visit 1.
- Receipt of live attenuated vaccines within 30 days before randomization and during the study, including the follow-up period.
- Receipt of the T2 cytokine inhibitor suplatast tosilate within 15 days before Screening Visit 1.
- Subjects treated with bronchial thermoplasty in the last 12 months before Screening Visit 1.
- Unwillingness or inability to follow study procedures, including poor adherence to asthma controller medications, in the opinion of the Investigator.
- Women who are pregnant, lactating, or planning to become pregnant during the study.
- History (or suspected history) of alcohol misuse or substance abuse within 2 years before Screening Visit 1.
Trial locations and contacts
158 sites in 19 countries. Contact the study team or a site near you to ask about taking part.
158 sites in 19 countries
Japan28 sites, 28 recruiting
- Recruiting
Research Site 137
Asahikawa-shi, Hokkaido, 070-0901
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- Recruiting
Research site 40
Chuo Ku, Tokyo, 103-0027
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- Recruiting
Research Site 54
Chuo Ku, Tokyo, 104-8560
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- Recruiting
Research Site 55
Ebino, Miyazaki, 889-4304
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- Recruiting
Research Site 32
Fukui-shi, Fukui, 910-0846
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- Recruiting
Research Site 15
Fukuoka, Tukuoka, 812-0054
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- Recruiting
Research Site 75
Hachioji-Shi, Tokyo, 193-0944
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- Recruiting
Research Site 41
Himeji, Hyōgo, 670-0849
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- Recruiting
Research Site 96
Hiroshima, Hiroshima, 730-0853
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- Recruiting
Research Site 90
Iizuka-Shi, Fukuoka, 820-8505
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- Recruiting
Research Site 88
Iruma, Saitama, 350-0451
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- Recruiting
Research Site 37
Isesaki-Shi, Gunma, 372-0831
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- Recruiting
Research Site 46
Kiyose-shi, Tokyo, 204-0022
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- Recruiting
Research Site 23
Matsuyama, Ehime, 790-092
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- Recruiting
Research Site 97
Naka-Gun, Ibaraki, 319-1113
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- Recruiting
Research Site 132
Nakano, 164-0012
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- Recruiting
Research Site 47
Niigata, Niigata, 950-1197
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- Recruiting
Research Site 34
Niigata, Niigata, 951-8520
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- Recruiting
Research Site 42
Sakai, Osaka, 590-0132
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- Recruiting
Research Site 68
Seto-shi, Aiti, 489-0065
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- Recruiting
Research Site 14
Shinagawa-Ku, Tokyo, 140-8522
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- Recruiting
Research Site 66
tabashi City, Tokyo, 173-8610
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- Recruiting
Research Site 157
Tokyo, Tokyo, 113-8655
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- Recruiting
Research Site 86
Toshima-Ku, Tokyo, 171-0014
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- Recruiting
Research Site 121
Toyonaka, Osaka, 560-8552
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- Recruiting
Research Site 38
Ube, Yamaguchi, 755-8505
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- Recruiting
Research Site 63
Uruma, Okinawa, 904-2293
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- Recruiting
Research Site 43
Yokohama, Kanagawa, 223-0053
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United States25 sites, 25 recruiting
- Recruiting
Research Site 13
Bakersfield, California, 93301
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- Recruiting
Research Site 150
Colchester, Vermont, 05446-3052
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- Recruiting
Research Site 11
Dayton, Ohio, 45424
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- Recruiting
Research Site 20
Fall River, Massachusetts, 02723
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- Recruiting
Research Site 153
Houston, Texas, 77008
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- Recruiting
Research Site 12
Inglewood, California, 90301
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- Recruiting
Research Site 114
Kansas City, Kansas, 66160
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- Recruiting
Research Site 65
Lancaster, California, 93534
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- Recruiting
Research Site 06
Miami, Florida, 33126
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- Recruiting
Research Site 03
Miami, Florida, 33135
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- Recruiting
Research Site 69
New York, New York, 10016
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- Recruiting
Research Site 69
New York, New York, 10016
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- Recruiting
Research Site 21
Oklahoma City, Oklahoma, 73118
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- Recruiting
Research 09
Orlando, Florida, 32807
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- Recruiting
Research Site 16
Rock Hill, South Carolina, 29732
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- Recruiting
Research Site 17
San Antonio, Texas, 78258
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- Recruiting
Research Site 136
Southfield, Michigan, 48075
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- Recruiting
Research Site 134
St Louis, Missouri, 63110-1010
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- Recruiting
Research Site 07
Sugar Land, Texas, 77479
Solairiastudy@generatebiomedicines.com
888-469-0033
- Recruiting
Research Site 01
Tamarac, Florida, 33321
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- Recruiting
Research Site 04
Tampa, Florida, 33607
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- Recruiting
Research Site 05
Tampa, Florida, 33617
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- Recruiting
Research Site 10
West Covina, California, 91790
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- Recruiting
Research Site 08
Williamsburg, Virginia, 23188
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- Recruiting
Research Site 02
Ypsilanti, Michigan, 48197
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Argentina18 sites, 18 recruiting
- Recruiting
Research Site 120
Buenos Aires, Buenos Aires, 1128
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- Recruiting
Research Site 103
Buenos Aires, Buenos Aires, 1425
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- Recruiting
Research Site 67
Buenos Aires, Buenos Aires F.D., C1426AKD
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- Recruiting
Research Site 31
Ciudad Autónoma de Buenos Aires, Buenos Aires, 1426
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- Recruiting
Research Site 87
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1023AAB
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- Recruiting
Research Site 79
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1414AIF
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- Recruiting
Research Site 92
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1425FVH
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- Recruiting
Research Site 33
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ABP
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- Recruiting
Research Site 81
Concepción del Uruguay, Entre Ríos Province, 3260
solairiastudy@generatebiomedicines.com
- Recruiting
Research Site 116
Mar del Plata, Beunos Aires, B7600FZO
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- Recruiting
Research Site 94
Mar del Plata, Buenos Aires, B7612ENA
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- Recruiting
Research Site 80
Mendoza, Mendoza Province, 5519
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- Recruiting
Research Site 119
Rosario, Santa Fe Province, 2013
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- Recruiting
Research Site 98
Rosario, Santa Fe Province, S2000DBS
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- Recruiting
Research Site 100
San Miguel de Tucumán, Tucumán Province, 4000
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- Recruiting
Research Site 113
San Miguel de Tucumán, Tucumán Province, T4000
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- Recruiting
Research Site 107
San Salvador, Entre Ríos Province, E3218CHH
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- Recruiting
Research Site 125
Santa Fe, Santa Fe Province, 3000
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United Kingdom15 sites, 15 recruiting
- Recruiting
Research Site 106
Ashburton, Devon, TQ13 7AP
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- Recruiting
Research Site 28
Bristol, England, BS8 2RA
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- Recruiting
Research Site 18
High Wycombe, Buckinghamshire, HP11 2QW
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- Recruiting
Research Site 85
Honiton, EX14 2NY
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- Recruiting
Research Site 30
London, England, N12 8BU
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- Recruiting
Research Site 26
London, Greater London, W1T 6AH
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- Recruiting
Research Site 62
London, Westminster, SW1P2PF
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- Recruiting
Research Site 70
Metropolitan Borough of Wirral, Wirral, CH48 5AA
solairiastudy@generatebiomedicines.com
- Recruiting
Research Site 27
Nottingham, Nottinghamshire, NG7 2QW
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- Recruiting
Research Site 48
Plymouth, PL66PH
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- Recruiting
Research Site 29
Romford, England, RM13PJ
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- Recruiting
Research Site 24
Rotherham, England, S61 1AH
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- Recruiting
Research Site 130
Sheffield, Sheffield, S9 4QH
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- Recruiting
Research Site 84
Somerton, Somerset, TA11 7PB
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- Recruiting
Research Site 25
Thetford, England, IP24 1JD
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Ukraine13 sites, 13 recruiting
- Recruiting
Research Site 49
Chernivtsi, Chernivtsi Oblast, 58001
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- Recruiting
Research Site 91
Ivano-Frankivsk, Ivano-Frankivs'k, 76008
solairiastudy@generatebiomedicines.com
- Recruiting
Research Site 108
Kyiv, Kyiv Oblast, 03057
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- Recruiting
Research Site 52
Kyiv, Kyivs'ka Oblast, 01135
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- Recruiting
Research Site 44
Kyiv, Kyïvs'ka Oblast, 02002
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- Recruiting
Research Site 82
Kyiv, Kyïvs'ka Oblast, 3038
solairiastudy@generatebiomedicines.com
- Recruiting
Research Site 76
Kyiv, Kyïvs'ka Oblast, 3049
solairiastudy@generatebiomedicines.com
- Recruiting
Research Site 74
Kyiv, Kyïvs'ka Oblast, 3151
solairiastudy@generatebiomedicines.com
- Recruiting
Research Site 64
Lutsk, Volyn Oblast, 43005
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- Recruiting
Research Site 60
Vinnytsia, Vinnytsia Oblast, 21029
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- Recruiting
Research Site 50
Vinnytsia, Vinnytsia Oblast, 21050
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- Recruiting
Research Site 83
Vinnytsia, Vinnytsya, 21001
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- Recruiting
Research Site 61
Vinnytsia, Vinnytsya, 21018
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Serbia8 sites, 8 recruiting
- Recruiting
Research Site 58
Belgrade, Belgrade, 11000
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- Recruiting
Research Site 19
Belgrade, Belgrade, 11070
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- Recruiting
Research Site 57
Belgrade, Belgrade, 11080
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- Recruiting
Research Site 51
Belgrade, 11000
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- Recruiting
Research Site 56
Kamenitz, 21204
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- Recruiting
Research Site 105
Kragujevac, 34000
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- Recruiting
Research Site 89
Novi Sad, 21000
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- Recruiting
Research Site 152
Zaječar, Serbia, 19000
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Spain7 sites, 7 recruiting
- Recruiting
Research Site 59
Barcelona, Barcelona, 08036
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- Recruiting
Research Site 139
Huelva, Huelva, 21005
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- Recruiting
Research Site 138
Huelva, Huelva, 21007
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- Recruiting
Research Site 110
Málaga, Málaga, 29009
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- Recruiting
Research site 144
Mataró, Barcelona, 08302
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- Recruiting
Research Site 104
Seville, Sevilla, 41009
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- Recruiting
Research Site 71
Zaragoza, Zaragoza, 50009
solairiastudy@generatebiomedicines.com
Turkey (Türkiye)7 sites, 7 recruiting
- Recruiting
Research Site 93
Ankara, Ankara, 6230
solairiastudy@generatebiomedicines.com
- Recruiting
Research Site 111
Antalya, Antalya, 07070
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- Recruiting
Research Site 78
Antalya, 7070
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- Recruiting
Research Site 102
Bursa, 16059
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- Recruiting
Research Site 135
Denizli, Denizli, 20070
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- Recruiting
Research Site 109
Samsun, Samsun, 55270
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- Recruiting
Research Site 77
Trabzon, Trabzon, 61080
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Georgia6 sites, 6 recruiting
- Recruiting
Research Site 127
Batumi, 6000
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- Recruiting
Research Site 131
Batumi, 6000
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- Recruiting
Research Site 126
Tbilisi, 0114
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- Recruiting
Research Site 123
Tbilisi, 0119
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- Recruiting
Research Site 124
Tbilisi, 0144
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- Recruiting
Research Site 129
Tbilisi, 0186
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Italy5 sites, 5 recruiting
- Recruiting
Research Site 128
Brescia, Lombardy, 25123
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- Recruiting
Research Site 140
Pavia, Lombardy, 27100
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- Recruiting
Research Site 141
Reggio Emilia, Emilia-Romagna, 42123
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- Recruiting
Research Site 145
Sassari, Sardinia, 07100
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- Recruiting
Research Site 99
Trieste, Friuli Venezia Giulia, 34149
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Malaysia5 sites, 5 recruiting
- Recruiting
Research Site 154
Kota Kinabalu, Sabah, 88586
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- Recruiting
Research Site 156
Kuantan, Pahang, 25100
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- Recruiting
Research Site 148
Malacca, Melaka, 75400
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- Recruiting
Research Site 155
Miri, Sarawak, 98000
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- Recruiting
Research Site 147
Sungai Buloh, Selangor, 47000
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France4 sites, 4 recruiting
- Recruiting
Research Site 53
Brest, Finistère, 29000
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- Recruiting
Research Site 115
Le Kremlin-Bicêtre, 94270
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- Recruiting
Research Site 117
Paris, 75014
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- Recruiting
Research Site 112
Strasbourg, Alsace, 67000
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Belgium3 sites, 3 recruiting
- Recruiting
Research Site 45
Erpent, 5101
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- Recruiting
Research Site 22
Mechelen, Vlaams Brabant, 02800
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- Recruiting
Research Site 73
Mechelen, Vlaams Brabant, 2800
solairiastudy@generatebiomedicines.com
Ireland3 sites, 3 recruiting
- Recruiting
Research Site 158
Ballinasloe, Galway, H53 T971
Generate Recruitment, 888-469-0033, solairiastudy@generatebiomedicines.com
- Recruiting
Research Site 133
Drogheda, A92VW28
Generate Recruitment, 888-469-0033, solairiastudy@generatebiomedicines.com
- Recruiting
Research Site 142
Dublin, Dublin, D15X40D
Generate Recruitment, 888-469-0033, solairiastudy@generatebiomedicines.com
Slovakia3 sites, 3 recruiting
- Recruiting
Research Site 122
Košice, Košice Region, 040 01
Generate Recruitment, 888-469-0033, solairiastudy@generatebiomedicines.com
- Recruiting
Research Site 36
Košice, 04013
Generate Recruitment, 888-469-0033, solairiastudy@generatebiomedicines.com
- Recruiting
Research Site 35
Spišská Nová Ves, Slovakia, 05201
Generate Recruitment, 888-469-0033, solairiastudy@generatebiomedicines.com
Australia2 sites, 2 recruiting
- Recruiting
Research Site 72
Coffs Harbour, New South Wales, 2450
solairiastudy@generatebiomedicines.com
- Recruiting
Research site 39
Southport, Queensland, 4222
Generate Recruitment, 888-469-0033, solairiastudy@generatebiomedicines.com
Estonia2 sites, 2 recruiting
- Recruiting
Research Site 95
Tartu, Tartu, 50106
solairiastudy@generatebiomedicines.com
- Recruiting
Research Site 101
Tartu, Tartu, 50708
solairiastudy@generatebiomedicines.com
India2 sites, 2 recruiting
- Recruiting
Research Site 146
Nagpur, Maharashtra, 440016
Generate Recruitment, 888-469-0033, solairiastudy@generatebiomedicines.com
- Recruiting
Research site 143
Vadodara, Gujarat, 390012
Generate Recruitment, 888-469-0033, solairiastudy@generatebiomedicines.com
New Zealand2 sites, 2 recruiting
- Recruiting
Research Site 149
Auckland, Auckland, 1051
Generate Recruitment, 888-469-0033, solairiastudy@generatebiomedicines.com
- Recruiting
Research Site 118
Christchurch, Christchurch, 8011
Generate Recruitment, 888-469-0033, solairiastudy@generatebiomedicines.com
About this study
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
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.
Read the 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/Run-In (Weeks -5 to 0)
- 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)
- Conditions
- Severe Asthma
- Being tested
- GB-0895, Placebo
- Keywords
- Asthma, Severe Asthma, Uncontrolled Asthma, Adolescent Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GB-0895Drug
Study Drug
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| GB-0895 | Experimental | GB-0895 Subcutaneous (SC) injection Receives: Drug: GB-0895 |
| Placebo | Placebo comparator | Placebo Subcutaneous (SC) injection Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From Day 1 (randomization) to Week 52
Secondary outcomes (21)
To evaluate the annualized asthma exacerbation rate (AAER) in adult and adolescent subjects with severe uncontrolled asthma and baseline eosinophils (EOS) < 300 cells/µL.
The annual exacerbation rate is based on CS exacerbations reported by the investigator in the eCRF over 52 weeks for subjects with baseline EOS < 300 cells/ µL on GB-0895 as compared to placebo.
Measured: From Day 1 (randomization) to Week 52
Change from baseline in pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1)
The change from baseline in pre-BD FEV1 for subjects on GB-0895 as compared to placebo at week 52. FEV1 is defined as the volume of air exhaled from the lungs in the first second of a forced expiration.
Measured: From Day 1 (randomization) to Study Week 52
Change from baseline in Asthma Quality of Life Questionnaire AQLQ(S)12+ score
The change from baseline on AQLQ(S)12+ score for subjects on GB-0895 as compared to placebo at week 52. The AQLQ(S)12+ is a 32-question assessment with questions related to symptoms, activity limitations, emotional function, and environmental stimuli. Questions are scored on a 7-point scale, which ranges from 7 (no impairment) to 1 (severe impairment). The overall score is calculated as the mean to all questions.
Measured: From Day 1 (randomization) to Week 52
Change from baseline in Asthma Control Questionnaire (ACQ-6) score
The change from baseline on ACQ-6 score for subjects on GB-0895 as compared to placebo at week 52. The ACQ-6 is a 6-question questionnaire that assesses asthma symptoms (e.g., activity limitation, shortness of breath, wheezing etc.). Questions are scored on a 6-point scale, where 0 corresponds to totally controlled asthma and 6 corresponds to severely uncontrolled asthma.
Measured: From Day 1 (randomization) to Week 52
Time to first asthma exacerbation from randomization
After subjects complete the screening period and are randomized to either GB-0895 or placebo, the time it takes until the first clinically significant asthma exacerbation to occur.
Measured: From Day 1 (randomization) to Week 52
Change from baseline in weekly mean daily Asthma Daytime Symptom Diary (ADSD)
The change from baseline on weekly mean daily ADSD score for subjects on GB-0895 as compared to placebo at week 52. The ADSD is an 8-question diary that assesses asthma daytime symptoms that the subjects will fill out at night before bed.
The ADSD daily score is calculated by averaging the 8 daily score and a mean of 7-day ADSD score is calculated by averaging of the seven daily score.
Measured: From Day 1 (randomization) to Week 52
Change from baseline in weekly mean daily Asthma Nighttime Symptom (ANSD)
The change from baseline on daily ANSD score for subjects on GB-0895 as compared to placebo at week 52. ANSD is an eight-question diary that assesses asthma symptoms that the subjects will fill out in the morning upon waking. The ANSD score is calculated by averaging the 8 daily score and a mean of 7-day ANSD score is calculated by averaging of the seven daily score.
Measured: From Day 1 (randomization) to Week 52
Change from baseline in St. George's Respiratory Questionnaire (SGRQ) total score
The change from baseline on SGRQ score for subjects on GB-0895 as compared to placebo at week 52. The SGRQ is a 50-item questionnaire designed to measure health status. Questions are scored on a range of 0 to 100, with a lower score indicating a better quality of life
Measured: From Day 1 (randomization) to Week 52
Change from baseline in the 5-Level EuroQol 5 dimensions questionnaire (EQ-5D-5L) score
The change from baseline on EQ-5D-5L score for subjects on GB-0895 as compared to placebo at week 52. The EQ-5D-5L questionnaire includes a visual analogue scale (VAS) that allows subjects to rate current health status on a 0-100 scale, with 0 being the worst imaginable health state.
Measured: From Day 1 (randomization) to Week 52
PGI-S response at Week 52
The Patient Global Impression of Asthma Severity (PGI-S) at Week 52 defined as an improvement by 1 or more points on the 0-5 scale. The PGI-S questionnaire asks the subjects to rate the overall severity of their asthma symptoms of the past 7 days with response options of: 1= no asthma symptoms, 2= mild, 3= moderate, 4= severe, and 5= worst possible asthma symptoms.
Measured: From Day 1 (randomization) to Week 52
ACQ-6 response at Week 52
The Asthma Control Questionnaire-6 (ACQ-6) at Week 52 defined as an improvement in score of 0.5 or more.
Measured: From Day 1 (randomization) to Week 52
AQLQ(S)12+ response at Week 52
The Asthma Quality of Life Questionnaire for 12 Year Old and Older at week 52 defined as an improvement in score of 0.5 or more.
Measured: From Day 1 (randomization) to Week 52
SGRQ response at Week 52
The St. George's Respiratory Questionnaire at week 52 defined as achieving ≥ 4-point reduction from baseline.
Measured: From Day 1 (randomization) to Week 52
PGI-C responder at Week 52
The Patient Global Impression of Change (PGI-C) improved response is defined as reporting at least 'moderately better' at week 52. The PGI-C questionnaire asks the subjects to describe the overall change in their asthma since they started taking new medication with response options of: 1= much better, 2= better, 3= a little better, 4= no change, 5= a little worse, 6= worse, and 7= much worse.
Measured: From Day 1 (randomization) to Week 52
To evaluate the effect of GB-0895 on asthma exacerbations associated with Emergency Room or Hospitalization Visits
The time to first clinically significant asthma exacerbation, from randomization, requiring hospitalization or emergency room visit.
Measured: From Day 1 (randomization) to Week 52
To evaluate the effect of GB-0895 on annualized asthma exacerbation rate (AAER) associated with Emergency Room or Hospitalization Visits
The AAER associated with clinically significant exacerbations associated with hospital or emergency room visits over 52 weeks.
Measured: From Day 1 (randomization) to Week 52
Adverse Events (AEs) and Serious Adverse Events (SAEs)
To investigate the incidence, severity, and relationship to GB-0895 of AEs and SAEs throughout the study as reported by the Investigator in the electronic case report forms (eCRFs).
Measured: From Day 1 (randomization) to Week 52
Clinical Laboratory Evaluations
The absolute values and changes from baseline of clinical laboratory evaluations over time.
Measured: From Day 1 (randomization) to Week 52
Vital Signs
The absolute values and changes from baseline of vital signs over time.
Measured: From Day 1 (randomization) to Week 52
ECGs (electrocardiogram)
The absolute values and changes from baseline of ECGs over time.
Measured: From Day 1 (randomization) to Week 52
Immunogenicity of GB-0895
The measurement of anti-drug antibodies (ADA) responses throughout the course of the study. for subjects on GB-0895 as compared to placebo at week 52.
Measured: From Day 1 (randomization) to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start20 Jan 2026
- Primary completionJan 2029 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 786 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Generate Biomedicines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Snodgres, Study director, Generate Biomedicines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07359846
- Sponsor's protocol ID
- GB-0895-302 (SOLAIRIA-2)
- Status last verified
- Dec 2025
- First submitted
- 21 Jan 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07359846
- Acronym / sponsor ID
- GB-0895-302 (SOLAIRIA-2)
- Conditions
- Severe Asthma
- Keywords
- Asthma, Severe Asthma, Uncontrolled Asthma, Adolescent Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 786 participants (estimated)
- Lead sponsor
- Generate BiomedicinesIndustry (pharma, biotech, devices)
- Study start
- 20 Jan 2026 (actual)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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/Run-In (Weeks -5 to 0)
- 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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GB-0895 | Experimental | Drug: GB-0895GB-0895 Subcutaneous (SC) injection |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo Subcutaneous (SC) injection |
Who may qualify
- Ages
- 12 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (29 listed)
- 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).
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GB-0895Study Drug | Drug | GB-0895 |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
To evaluate the annualized asthma exacerbation rate (AAER) in adult and adolescent subjects with severe uncontrolled asthma.
Time frame: 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.
21 secondary outcomes
To evaluate the annualized asthma exacerbation rate (AAER) in adult and adolescent subjects with severe uncontrolled asthma and baseline eosinophils (EOS) < 300 cells/µL.
Time frame: From Day 1 (randomization) to Week 52
Change from baseline in pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1)
Time frame: From Day 1 (randomization) to Study Week 52
Change from baseline in Asthma Quality of Life Questionnaire AQLQ(S)12+ score
Time frame: From Day 1 (randomization) to Week 52
Change from baseline in Asthma Control Questionnaire (ACQ-6) score
Time frame: From Day 1 (randomization) to Week 52
Time to first asthma exacerbation from randomization
Time frame: From Day 1 (randomization) to Week 52
Change from baseline in weekly mean daily Asthma Daytime Symptom Diary (ADSD)
Time frame: From Day 1 (randomization) to Week 52
Change from baseline in weekly mean daily Asthma Nighttime Symptom (ANSD)
Time frame: From Day 1 (randomization) to Week 52
Change from baseline in St. George's Respiratory Questionnaire (SGRQ) total score
Time frame: From Day 1 (randomization) to Week 52
Change from baseline in the 5-Level EuroQol 5 dimensions questionnaire (EQ-5D-5L) score
Time frame: From Day 1 (randomization) to Week 52
PGI-S response at Week 52
Time frame: From Day 1 (randomization) to Week 52
ACQ-6 response at Week 52
Time frame: From Day 1 (randomization) to Week 52
AQLQ(S)12+ response at Week 52
Time frame: From Day 1 (randomization) to Week 52
SGRQ response at Week 52
Time frame: From Day 1 (randomization) to Week 52
PGI-C responder at Week 52
Time frame: From Day 1 (randomization) to Week 52
To evaluate the effect of GB-0895 on asthma exacerbations associated with Emergency Room or Hospitalization Visits
Time frame: From Day 1 (randomization) to Week 52
To evaluate the effect of GB-0895 on annualized asthma exacerbation rate (AAER) associated with Emergency Room or Hospitalization Visits
Time frame: From Day 1 (randomization) to Week 52
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From Day 1 (randomization) to Week 52
Clinical Laboratory Evaluations
Time frame: From Day 1 (randomization) to Week 52
Vital Signs
Time frame: From Day 1 (randomization) to Week 52
ECGs (electrocardiogram)
Time frame: From Day 1 (randomization) to Week 52
Immunogenicity of GB-0895
Time frame: From Day 1 (randomization) to Week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Snodgres study director
Generate Biomedicines
158 sites in 19 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GB-0895 in people with Severe Asthma, run by Generate Biomedicines at 158 sites in 19 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 158 sites in Japan, United States, Argentina, United Kingdom, Ukraine and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Generate Recruitment (888-469-0033, solairiastudy@generatebiomedicines.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the annualized asthma exacerbation rate (AAER) in adult and adolescent subjects with severe uncontrolled asthma. (time frame: From Day 1 (randomization) to Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.