Severe AsthmaPhase 3NCT07276724
A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma (SOLAIRIA-1)
A Phase 3 study testing GB-0895 in people with Severe Asthma, run by Generate Biomedicines at 134 sites in 17 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
- 134 sitesin 17 countries
- Study dates
- 3 Dec 2025to Dec 2028
- Phase
- Phase 3
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
134 sites in 17 countries. Contact the study team or a site near you to ask about taking part.
134 sites in 17 countries
United States36 sites, 36 recruiting
- Recruiting
Research Site 24
Amarillo, Texas, 79106
solairiastudy@generatebiomedicines.com
- Recruiting
Research Site 16
Baltimore, Maryland, 21237
Solairiastudy@generatebiomedicines.com
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Research Site 19
Baytown, Texas, 77521
Solairiastudy@generatebiomedicines.com
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Research Site 32
Brooksville, Florida, 34613
solairiastudy@generatebiomedicines.com
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Research Site 15
Colorado Springs, Colorado, 80923
Solairiastudy@generatebiomedicines.com
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Research Site 28
Columbia, Maryland, 21045
solairiastudy@generatebiomedicines.com
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Research Site 07
Dallas, Texas, 75230
Solairiastudy@generatebiomedicines.com
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Research Site 17
Dallas, Texas, 75254
Solairiastudy@generatebiomedicines.com
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Research Site 12
Doral, Florida, 33122
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Research Site 06
Flint, Michigan, 48504
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Research Site 14
Gainesville, Florida, 32607
Solairiastudy@generatebiomedicines.com
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Research Site 27
Gastonia, North Carolina, 28054
solairiastudy@generatebiomedicines.com
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Research Site 31
Glenview, Illinois, 60026
solairiastudy@generatebiomedicines.com
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Research Site 03
Hialeah, Florida, 33016
Solairiastudy@generatebiomedicines.com
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Research Site 11
Houston, Texas, 77084
Solairiastudy@generatebiomedicines.com
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Research Site 09
Houston, Texas, 77099
Solairiastudy@generatebiomedicines.com
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Research Site 25
Kendall, Florida, 33176
solairiastudy@generatebiomedicines.com
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Research Site 22
Kerrville, Texas, 78028
solairiastudy@generatebiomedicines.com
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Research Site 05
Lewisville, Texas, 75057
Solairiastudy@generatebiomedicines.com
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Research Site 33
McKinney, Texas, 75069
solairiastudy@generatebiomedicines.com
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Research Site 04
Miami, Florida, 33126
Solairiastudy@generatebiomedicines.com
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Research Site 01
Miami Lakes, Florida, 33014
Solairiastudy@generatebiomedicines.com
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Research Site 08
North Miami, Florida, 33169
Solairiastudy@generatebiomedicines.com
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Research Site 23
Northridge, California, 91324
solairiastudy@generatebiomedicines.com
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Research Site 30
Olive Branch, Mississippi, 38654
solairiastudy@generatebiomedicines.com
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Research Site 10
Palm Springs, Florida, 33461
Solairiastudy@generatebiomedicines.com
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Research Site 26
Pasadena, California, 91105
solairiastudy@generatebiomedicines.com
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Research Site 29
Rancho Cucamonga, California, 91730
solairiastudy@generatebiomedicines.com
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Research Site 18
Rincon, Georgia, 31326
Solairiastudy@generatebiomedicines.com
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Research Site 21
Riverton, Utah, 84096
Solairiastudy@generatebiomedicines.com
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Research Site 02
Tampa, Florida, 33613
Solairiastudy@generatebiomedicines.com
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Research Site 37
The Bronx, New York, 10461
Solairiastudy@generatebiomedicines.com
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Research Site 20
Towson, Maryland, 21204
Solairiastudy@generatebiomedicines.com
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Research Site 34
Valencia, California, 91355
solairiastudy@generatebiomedicines.com
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Research Site 13
West Hills, California, 91307
Solairiastudy@generatebiomedicines.com
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Research Site 83
Winston-Salem, North Carolina, 27103
solairiastudy@generatebiomedicines.com
Bulgaria15 sites, 15 recruiting
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Research Site 56
Haskovo, Haskovo, 6300
Solairiastudy@generatebiomedicines.com
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Research Site 38
Kozloduy, Vratsa, 3320
Solairiastudy@generatebiomedicines.com
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Research Site 54
Pleven, Pleven, 5800
Solairiastudy@generatebiomedicines.com
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Research Site 55
Plovdiv, Plovdiv, 4023
Solairiastudy@generatebiomedicines.com
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Research Site 73
Rousse, Ruse, 7002
solairiastudy@generatebiomedicines.com
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Research Site 88
Rousse, Ruse, 7002
solairiastudy@generatebiomedicines.com
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Research Site 95
Sofia, Sofia, 1233
solairiastudy@generatebiomedicines.com
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Research Site 75
Sofia, Sofia, 1404
solairiastudy@generatebiomedicines.com
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Research Site 65
Sofia, Sofia, 1407
solairiastudy@generatebiomedicines.com
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Research Site 91
Sofia, Sofia, 1431
solairiastudy@generatebiomedicines.com
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Research Site 103
Sofia, Sofia, 1606
solairiastudy@generatebiomedicines.com
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Research Site 69
Sofia, Sofia, 1680
solairiastudy@generatebiomedicines.com
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Research Site 81
Sofia, Sofia, 1680
solairiastudy@generatebiomedicines.com
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Research Site 63
Sofia, Sofia, 1756
solairiastudy@generatebiomedicines.com
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Research Site 39
Vidin, Vidin, 3703
Solairiastudy@generatebiomedicines.com
Germany13 sites, 13 recruiting
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Research Site 40
Berlin, State of Berlin, 10119
solairiastudy@generatebiomedicines.com
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Research Site 44
Berlin, State of Berlin, 10717
solairiastudy@generatebiomedicines.com
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Research Site 49
Berlin, State of Berlin, 13187
solairiastudy@generatebiomedicines.com
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Research Site 40
Berlin, 10119
Solairiastudy@generatebiomedicines.com
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Research Site 42
Deggingen, Baden-Wurttemberg, 73326
Solairiastudy@generatebiomedicines.com
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Research Site 67
Frankfurt am Main, Hesse, 60389
solairiastudy@generatebiomedicines.com
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Research Site 36
Frankfurt am Main, Hesse, 60596
Solairiastudy@generatebiomedicines.com
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Research site 79
Leipzig, Saxony, 4299
solairiastudy@generatebiomedicines.com
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Research Site 92
Leipzig, 04347
solairiastudy@generatebiomedicines.com
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Research Site 43
Lübeck, Schleswig-Holstein, 23552
Solairiastudy@generatebiomedicines.com
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Research Site 43
Lübeck
Solairiastudy@generatebiomedicines.com
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Research Site 80
München, Bavaria, 81241
solairiastudy@generatebiomedicines.com
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Research Site 76
Witten, North Rhine-Westphalia, 58452 Witten
solairiastudy@generatebiomedicines.com
Romania9 sites, 9 recruiting
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Research Site 50
Brasov, Brașov County, 500051
Solairiastudy@generatebiomedicines.com
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Research Site 35
Bucharest, Bucharest, 061692
solairiastudy@generatebiomedicines.com
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Research Site 84
Bucharest, Bucharest, 11658
solairiastudy@generatebiomedicines.com
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Research Site 87
Cluj-Napoca, Cluj, 400006
solairiastudy@generatebiomedicines.com
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Research Site 66
Cluj-Napoca, Cluj, 400332
solairiastudy@generatebiomedicines.com
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Research Site 64
Cluj-Napoca, Cluj, 400371
solairiastudy@generatebiomedicines.com
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Research Site 51
Craiova, Dolj, 200678
Solairiastudy@generatebiomedicines.com
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Research Site 41
Oradea, Bihor County, 410163
Solairiastudy@generatebiomedicines.com
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Research Site 72
Timișoara, Timiș County, 300310
solairiastudy@generatebiomedicines.com
South Africa9 sites, 9 recruiting
- Recruiting
Research Site 68
Cape Town, Western Cape, 7530
solairiastudy@generatebiomedicines.com
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Research Site 96
Cape Town, Western Cape, 7700
solairiastudy@generatebiomedicines.com
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Research Site 58
Durban, KwaZulu-Natal, 4092
solairiastudy@generatebiomedicines.com
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Research Site 89
Johannesburg, Gauteng, 1820
solairiastudy@generatebiomedicines.com
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Research Site 59
Johannesburg, Gauteng, 2001
solairiastudy@generatebiomedicines.com
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Research Site 101
Johannesburg, Gauteng, 2193
solairiastudy@generatebiomedicines.com
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Research Site 60
KwaDukuza, Gauteng, 4449
solairiastudy@generatebiomedicines.com
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Research Site 57
Sydenham, KwaZulu-Natal, 4091
solairiastudy@generatebiomedicines.com
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Research Site 61
Welkom, Free State, 9460
solairiastudy@generatebiomedicines.com
South Korea8 sites, 8 recruiting
- Recruiting
Research Site 100
Anyang-si, Gyeonggi-do, 14068
solairiastudy@generatebiomedicines.com
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Research Site 106
Busan, Busan, 48108
solairiastudy@generatebiomedicines.com
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Research Site 119
Seoul, Seoul, 02481
solairiastudy@generatebiomedicines.com
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Research Site 132
Seoul, Seoul, 03181
solairiastudy@generatebiomedicines.com
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Research Site 112
Seoul, Seoul, 3722
solairiastudy@generatebiomedicines.com
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Research Site 129
Seoul, Seoul, 4763
solairiastudy@generatebiomedicines.com
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Research Site 108
Seoul, Seoul, 5030
solairiastudy@generatebiomedicines.com
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Research Site 99
Seoul, Seoul, 6351
solairiastudy@generatebiomedicines.com
Greece7 sites, 7 recruiting
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Research Site 104
Alexandroupoli, Evros, 68100
solairiastudy@generatebiomedicines.com
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Research Site 90
Athens, Attica, 11521
solairiastudy@generatebiomedicines.com
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Research Site 113
Heraklion, Crete, 71500
solairiastudy@generatebiomedicines.com
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Research Site 122
Ioannina, Epirus, 45500
solairiastudy@generatebiomedicines.com
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Research Site 97
Palaió Fáliro, Attica, 17562
solairiastudy@generatebiomedicines.com
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Research Site 82
Thessaloniki, Exochi, 57010
solairiastudy@generatebiomedicines.com
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Research Site 126
Thessaloniki, Makedonia, 57001
solairiastudy@generatebiomedicines.com
Israel7 sites, 7 recruiting
- Recruiting
Research Site 115
Haifa, Haifa District, 3436212
solairiastudy@generatebiomedicines.com
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Research Site 117
Jerusalem, Jerusalem, 9103102
solairiastudy@generatebiomedicines.com
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Research Site 118
Jerusalem, Jerusalem, 91120
solairiastudy@generatebiomedicines.com
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Research Site 111
Kfar Saba, 44281
solairiastudy@generatebiomedicines.com
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Research Site 124
Petah Tikva, Israel, 4920235
solairiastudy@generatebiomedicines.com
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Research Site 105
Ramat Gan, 5266202
solairiastudy@generatebiomedicines.com
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Research Site 128
Tel Aviv, Tel Aviv, 6423906
solairiastudy@generatebiomedicines.com
Hungary6 sites, 6 recruiting
- Recruiting
Research Site 110
Budapest, Budapest, 1036
solairiastudy@generatebiomedicines.com
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Research Site 45
Budapest, Budapest, 1047
Solairiastudy@generatebiomedicines.com
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Research Site 47
Mosonmagyaróvár, Győr-Moson-Sopron, 9200
Solairiastudy@generatebiomedicines.com
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Research Site 53
Szigetvár, Baranya Varmegye, 7900
Solairiastudy@generatebiomedicines.com
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Research Site 46
Szombathely, Vas County, 9700
Solairiastudy@generatebiomedicines.com
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Research Site 78
Szombathely, Vas County, H-9700
solairiastudy@generatebiomedicines.com
Czechia5 sites, 5 recruiting
- Not yet recruiting
Research Site 86
Jablonec nad Nisou, 466 01
solairiastudy@generatebiomedicines.com
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Research Site 109
Jindřichův Hradec, Jindřichův Hradec, 377 01
solairiastudy@generatebiomedicines.com
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Research Site 98
Prague, Prague, 190 00
solairiastudy@generatebiomedicines.com
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Research Site 94
Teplice, 415 01
solairiastudy@generatebiomedicines.com
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Research Site 85
Varnsdorf, Czechia, 407 47
solairiastudy@generatebiomedicines.com
Brazil4 sites, 4 recruiting
- Recruiting
Research Site 131
Porto Alegre, Rio Grande do Sul, 90035-074
solairiastudy@generatebiomedicines.com
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Research Site 127
Salvador, Estado de Bahia, 40.060-325
solairiastudy@generatebiomedicines.com
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Research Site 130
Santo André, São Paulo, 09060-870
solairiastudy@generatebiomedicines.com
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Research Site 125
São Bernardo do Campo, São Paulo, 09715-090
solairiastudy@generatebiomedicines.com
Chile4 sites, 4 recruiting
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Research Site 107
Curicó, Maule Region, 3341643
solairiastudy@generatebiomedicines.com
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Research Site 123
Providencia, Santiago Metropolitan, 7500587
solairiastudy@generatebiomedicines.com
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Research Site 116
Temuco, Araucania, 4781151
solairiastudy@generatebiomedicines.com
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Research Site 102
Temuco, Araucania, 4810345
solairiastudy@generatebiomedicines.com
Latvia4 sites, 4 recruiting
- Recruiting
Research Site 114
Daugavpils, Daugavpils Novads, LV-5410
solairiastudy@generatebiomedicines.com
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Research Site 52
Riga, Riga, LV-1002
Solariastudy@generatebiomedicines.com
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Research Site 71
Riga, Riga, LV-1004
solairiastudy@generatebiomedicines.com
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Research Site 70
Riga, Riga, LV-1010
solairiastudy@generatebiomedicines.com
Netherlands2 sites, 2 recruiting
- Recruiting
Research Site 77
Enschede, Overijssel, 7512 AV
solairiastudy@generatebiomedicines.com
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Research Site 62
Heerlen, Limburg, 6419PC
solairiastudy@generatebiomedicines.com
Philippines2 sites, 2 recruiting
- Recruiting
Research Site 121
Lipa City, Batangas, 4217
solairiastudy@generatebiomedicines.com
- Recruiting
Research Site 120
Marilao, Bulacan, 3019
solairiastudy@generatebiomedicines.com
Portugal2 sites, 2 recruiting
- Recruiting
Research Site 48
Figueira da Foz Municipality, Figueira da Foz, 3094-001
solairiastudy@generatebiomedicines.com
- Recruiting
Research Site 74
Porto, Senhora Da Hora, 4464-513
solairiastudy@generatebiomedicines.com
Singapore1 site, 1 recruiting
- Recruiting
Research Site 93
Singapore, Singapore, 119074
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)
- 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 clinically significant (CS) exacerbations 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 posted11 Dec 2025
- Study start3 Dec 2025
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (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
- NCT07276724
- Sponsor's protocol ID
- GB-0895-301 (SOLAIRIA-1)
- Status last verified
- Dec 2025
- First submitted
- 1 Dec 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No