What this study is
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.
What's being tested
- GB-0895
Intervention · DRUG
Study Drug
- Placebo
Intervention · DRUG
Placebo
Study details
- 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
- Sponsor
- Generate Biomedicines
- Conditions
- Severe Asthma
- Enrolling
- 786 people
- Starts
- 2026-01-20
- Est. completion
- 2029-01
- Design
- Triple-blind, randomized, parallel groups, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 12 Years – 80 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Adults and adolescents ≥ 12 and ≤ 80 years of age.
- Documented diagnosis of asthma for > 12 months.
- Subjects must be on medium to high dose ICS for ≥ 12 months before Screening Visit 1 plus at least 1 additional asthma controller (e.g., LABA, LAMA) ≥ 3 months before Screening Visit 1 with no change in ICS or controller(s) for at least three months.
- Subjects must have a well-documented history of at least two asthma exacerbations requiring systemic corticosteroid treatment despite the use of medium-to-high dose ICS in the past 12 months before Screening Visit 1.
- Adults ≥ 18 years of age at Screening Visit 1, a pre-BD FEV1 <80% predicted at Screening Visit 1.
- Adolescents 12 to < 18 years of age at Screening Visit 1: A pre-BD FEV1 < 90% predicted OR, FEV1:Forced Vital Capacity (FVC) ratio < 0.80.
- Positive BD responsiveness test: Increase of at least 12% and 200 mL in FEV1 between 15 and 60 minutes after the administration of a short-acting β2-agonist (SABA) at least once during the screening period.
- ACQ-6 score ≥ 1.5 at the Screening Visit.
- Weight ≥40 kg at the Screening Visit 1
You can't join 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).
- 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 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (158)
158 openContact for 114 of 158 open sites
- Generate Recruitment · Contact888-469-0033solairiastudy@generatebiomedicines.com
Research Site 13
Bakersfield, California, United States
RecruitingResearch Site 12
Inglewood, California, United States
RecruitingResearch Site 65
Lancaster, California, United States
RecruitingResearch Site 10
West Covina, California, United States
RecruitingResearch Site 06
Miami, Florida, United States
RecruitingResearch Site 03
Miami, Florida, United States
Recruiting- Recruiting
Research Site 01
Tamarac, Florida, United States
RecruitingResearch Site 04
Tampa, Florida, United States
RecruitingResearch Site 05
Tampa, Florida, United States
RecruitingResearch Site 114
Kansas City, Kansas, United States
RecruitingResearch Site 20
Fall River, Massachusetts, United States
RecruitingResearch Site 136
Southfield, Michigan, United States
RecruitingResearch Site 02
Ypsilanti, Michigan, United States
RecruitingResearch Site 134
St Louis, Missouri, United States
RecruitingResearch Site 69
New York, New York, United States
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Research Site 11
Dayton, Ohio, United States
RecruitingResearch Site 21
Oklahoma City, Oklahoma, United States
RecruitingResearch Site 16
Rock Hill, South Carolina, United States
RecruitingResearch Site 153
Houston, Texas, United States
RecruitingResearch Site 17
San Antonio, Texas, United States
RecruitingResearch Site 07
Sugar Land, Texas, United States
- ContactSolairiastudy@generatebiomedicines.com
- Contact888-469-0033
RecruitingResearch Site 150
Colchester, Vermont, United States
RecruitingResearch Site 08
Williamsburg, Virginia, United States
Recruiting
133 sites outside the US
Research Site 116
Mar del Plata, Beunos Aires, Argentina
RecruitingResearch Site 120
Buenos Aires, Buenos Aires, Argentina
RecruitingResearch Site 103
Buenos Aires, Buenos Aires, Argentina
RecruitingResearch Site 31
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
RecruitingResearch Site 87
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
RecruitingResearch Site 79
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
RecruitingResearch Site 92
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
RecruitingResearch Site 33
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
RecruitingResearch Site 94
Mar del Plata, Buenos Aires, Argentina
RecruitingResearch Site 67
Buenos Aires, Buenos Aires F.D., Argentina
RecruitingResearch Site 81
Concepción del Uruguay, Entre Ríos Province, Argentina
RecruitingResearch Site 107
San Salvador, Entre Ríos Province, Argentina
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Research Site 119
Rosario, Santa Fe Province, Argentina
RecruitingResearch Site 98
Rosario, Santa Fe Province, Argentina
RecruitingResearch Site 125
Santa Fe, Santa Fe Province, Argentina
RecruitingResearch Site 100
San Miguel de Tucumán, Tucumán Province, Argentina
RecruitingResearch Site 113
San Miguel de Tucumán, Tucumán Province, Argentina
RecruitingResearch Site 72
Coffs Harbour, New South Wales, Australia
RecruitingResearch site 39
Southport, Queensland, Australia
RecruitingResearch Site 22
Mechelen, Vlaams Brabant, Belgium
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Research Site 45
Erpent, Belgium
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- Recruiting
Research Site 112
Strasbourg, Alsace, France
RecruitingResearch Site 53
Brest, Finistère, France
RecruitingResearch Site 115
Le Kremlin-Bicêtre, France
RecruitingResearch Site 117
Paris, France
RecruitingResearch Site 127
Batumi, Georgia
RecruitingResearch Site 131
Batumi, Georgia
RecruitingResearch Site 126
Tbilisi, Georgia
RecruitingResearch Site 123
Tbilisi, Georgia
RecruitingResearch Site 124
Tbilisi, Georgia
RecruitingResearch Site 129
Tbilisi, Georgia
RecruitingResearch site 143
Vadodara, Gujarat, India
RecruitingResearch Site 146
Nagpur, Maharashtra, India
RecruitingResearch Site 142
Dublin, Dublin, Ireland
RecruitingResearch Site 158
Ballinasloe, Galway, Ireland
RecruitingResearch Site 133
Drogheda, Ireland
RecruitingResearch Site 141
Reggio Emilia, Emilia-Romagna, Italy
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Research Site 128
Brescia, Lombardy, Italy
RecruitingResearch Site 140
Pavia, Lombardy, Italy
RecruitingResearch Site 145
Sassari, Sardinia, Italy
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Research Site 23
Matsuyama, Ehime, Japan
RecruitingResearch Site 32
Fukui-shi, Fukui, Japan
RecruitingResearch Site 90
Iizuka-Shi, Fukuoka, Japan
RecruitingResearch Site 37
Isesaki-Shi, Gunma, Japan
RecruitingResearch Site 96
Hiroshima, Hiroshima, Japan
RecruitingResearch Site 137
Asahikawa-shi, Hokkaido, Japan
RecruitingResearch Site 41
Himeji, Hyōgo, Japan
RecruitingResearch Site 97
Naka-Gun, Ibaraki, Japan
RecruitingResearch Site 43
Yokohama, Kanagawa, Japan
RecruitingResearch Site 55
Ebino, Miyazaki, Japan
RecruitingResearch Site 47
Niigata, Niigata, Japan
RecruitingResearch Site 34
Niigata, Niigata, Japan
RecruitingResearch Site 63
Uruma, Okinawa, Japan
RecruitingResearch Site 42
Sakai, Osaka, Japan
RecruitingResearch Site 121
Toyonaka, Osaka, Japan
RecruitingResearch Site 88
Iruma, Saitama, Japan
RecruitingResearch site 40
Chuo Ku, Tokyo, Japan
RecruitingResearch Site 54
Chuo Ku, Tokyo, Japan
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Research Site 46
Kiyose-shi, Tokyo, Japan
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Research Site 66
tabashi City, Tokyo, Japan
RecruitingResearch Site 157
Tokyo, Tokyo, Japan
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- Recruiting
Research Site 38
Ube, Yamaguchi, Japan
RecruitingResearch Site 132
Nakano, Japan
RecruitingResearch Site 148
Malacca, Melaka, Malaysia
RecruitingResearch Site 156
Kuantan, Pahang, Malaysia
RecruitingResearch Site 154
Kota Kinabalu, Sabah, Malaysia
RecruitingResearch Site 155
Miri, Sarawak, Malaysia
RecruitingResearch Site 147
Sungai Buloh, Selangor, Malaysia
RecruitingResearch Site 149
Auckland, Auckland, New Zealand
RecruitingResearch Site 118
Christchurch, Christchurch, New Zealand
RecruitingResearch Site 58
Belgrade, Belgrade, Serbia
RecruitingResearch Site 19
Belgrade, Belgrade, Serbia
RecruitingResearch Site 57
Belgrade, Belgrade, Serbia
RecruitingResearch Site 152
Zaječar, Serbia, Serbia
RecruitingResearch Site 51
Belgrade, Serbia
RecruitingResearch Site 56
Kamenitz, Serbia
RecruitingResearch Site 105
Kragujevac, Serbia
Recruiting- Recruiting
Research Site 122
Košice, Košice Region, Slovakia
RecruitingResearch Site 35
Spišská Nová Ves, Slovakia, Slovakia
RecruitingResearch Site 36
Košice, Slovakia
RecruitingResearch Site 59
Barcelona, Barcelona, Spain
RecruitingResearch site 144
Mataró, Barcelona, Spain
RecruitingResearch Site 139
Huelva, Huelva, Spain
RecruitingResearch Site 138
Huelva, Huelva, Spain
RecruitingResearch Site 110
Málaga, Málaga, Spain
RecruitingResearch Site 104
Seville, Sevilla, Spain
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Research Site 111
Antalya, Antalya, Turkey (Türkiye)
RecruitingResearch Site 135
Denizli, Denizli, Turkey (Türkiye)
RecruitingResearch Site 109
Samsun, Samsun, Turkey (Türkiye)
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Research Site 102
Bursa, Turkey (Türkiye)
RecruitingResearch Site 49
Chernivtsi, Chernivtsi Oblast, Ukraine
RecruitingResearch Site 91
Ivano-Frankivsk, Ivano-Frankivs'k, Ukraine
RecruitingResearch Site 108
Kyiv, Kyiv Oblast, Ukraine
RecruitingResearch Site 52
Kyiv, Kyivs'ka Oblast, Ukraine
RecruitingResearch Site 44
Kyiv, Kyïvs'ka Oblast, Ukraine
Recruiting- Recruiting
- Recruiting
- Recruiting
Research Site 60
Vinnytsia, Vinnytsia Oblast, Ukraine
RecruitingResearch Site 50
Vinnytsia, Vinnytsia Oblast, Ukraine
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Research Site 61
Vinnytsia, Vinnytsya, Ukraine
RecruitingResearch Site 64
Lutsk, Volyn Oblast, Ukraine
RecruitingResearch Site 18
High Wycombe, Buckinghamshire, United Kingdom
RecruitingResearch Site 106
Ashburton, Devon, United Kingdom
RecruitingResearch Site 28
Bristol, England, United Kingdom
RecruitingResearch Site 30
London, England, United Kingdom
RecruitingResearch Site 29
Romford, England, United Kingdom
RecruitingResearch Site 24
Rotherham, England, United Kingdom
RecruitingResearch Site 25
Thetford, England, United Kingdom
RecruitingResearch Site 26
London, Greater London, United Kingdom
RecruitingResearch Site 27
Nottingham, Nottinghamshire, United Kingdom
RecruitingResearch Site 130
Sheffield, Sheffield, United Kingdom
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Research Site 62
London, Westminster, United Kingdom
RecruitingResearch Site 70
Metropolitan Borough of Wirral, Wirral, United Kingdom
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Research Site 48
Plymouth, United Kingdom
Recruiting
Study team
Sponsor
Generate Biomedicines
Study ID GB-0895-302 (SOLAIRIA-2)
Study director
Snodgres
Generate Biomedicines
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.