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A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma (SOLAIRIA-1)
Sponsor: Generate Biomedicines
Summary
The objective of this study is to assess the potential for GB-0895 treatment to improve the health of adolescents and adults with severe asthma that is uncontrolled by inhaled corticosteroids (ICS) and conventional asthma controllers. The study details include: Study treatment: randomized to receive either GB-0895 or placebo administered every 6 months over 52 weeks. Visit frequency: every 1-2 months after the first month.
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma
Key Details
Gender
All
Age Range
12 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
786
Start Date
2025-12-03
Completion Date
2028-12
Last Updated
2026-08-17
Healthy Volunteers
No
Conditions
Interventions
GB-0895
Study Drug
Placebo
Placebo
Locations (78)
Research Site 23
Northridge, California, United States
Research Site 26
Pasadena, California, United States
Research Site 29
Rancho Cucamonga, California, United States
Research Site 34
Valencia, California, United States
Research Site 13
West Hills, California, United States
Research Site 15
Colorado Springs, Colorado, United States
Research Site 32
Brooksville, Florida, United States
Research Site 12
Doral, Florida, United States
Research Site 14
Gainesville, Florida, United States
Research Site 03
Hialeah, Florida, United States
Research Site 25
Kendall, Florida, United States
Research Site 04
Miami, Florida, United States
Research Site 01
Miami Lakes, Florida, United States
Research Site 08
North Miami, Florida, United States
Research Site 10
Palm Springs, Florida, United States
Research Site 02
Tampa, Florida, United States
Research Site 18
Rincon, Georgia, United States
Research Site 31
Glenview, Illinois, United States
Research Site 16
Baltimore, Maryland, United States
Research Site 28
Columbia, Maryland, United States
Research Site 20
Towson, Maryland, United States
Research Site 06
Flint, Michigan, United States
Research Site 30
Olive Branch, Mississippi, United States
Research Site 37
The Bronx, New York, United States
Research Site 27
Gastonia, North Carolina, United States
Research Site 24
Amarillo, Texas, United States
Research Site 19
Baytown, Texas, United States
Research Site 07
Dallas, Texas, United States
Research Site 17
Dallas, Texas, United States
Research Site 11
Houston, Texas, United States
Research Site 09
Houston, Texas, United States
Research Site 22
Kerrville, Texas, United States
Research Site 05
Lewisville, Texas, United States
Research Site 33
McKinney, Texas, United States
Research Site 21
Riverton, Utah, United States
Research Site 56
Haskovo, Haskovo, Bulgaria
Research Site 54
Pleven, Pleven, Bulgaria
Research Site 55
Plovdiv, Plovdiv, Bulgaria
Research Site 65
Sofia, Sofia, Bulgaria
Research Site 69
Sofia, Sofia, Bulgaria
Research Site 63
Sofia, Sofia, Bulgaria
Research Site 39
Vidin, Vidin, Bulgaria
Research Site 38
Kozloduy, Vratsa, Bulgaria
Research Site 42
Deggingen, Baden-Wurttemberg, Germany
Research Site 67
Frankfurt am Main, Hesse, Germany
Research Site 36
Frankfurt am Main, Hesse, Germany
Research Site 76
Witten, North Rhine-Westphalia, Germany
Research Site 43
Lübeck, Schleswig-Holstein, Germany
Research Site 40
Berlin, State of Berlin, Germany
Research Site 44
Berlin, State of Berlin, Germany
Research Site 49
Berlin, State of Berlin, Germany
Research Site 40
Berlin, Germany
Research Site 43
Lübeck, Germany
Research Site 53
Szigetvár, Baranya Varmegye, Hungary
Research Site 45
Budapest, Budapest, Hungary
Research Site 47
Mosonmagyaróvár, Győr-Moson-Sopron, Hungary
Research Site 46
Szombathely, Vas County, Hungary
Research Site 78
Szombathely, Vas County, Hungary
Research Site 52
Riga, Riga, Latvia
Research Site 71
Riga, Riga, Latvia
Research Site 70
Riga, Riga, Latvia
Research Site 62
Heerlen, Limburg, Netherlands
Research Site 77
Enschede, Overijssel, Netherlands
Research Site 48
Figueira da Foz Municipality, Figueira da Foz, Portugal
Research Site 74
Porto, Senhora Da Hora, Portugal
Research Site 41
Oradea, Bihor County, Romania
Research Site 50
Brasov, Brașov County, Romania
Research Site 35
Bucharest, Bucharest, Romania
Research Site 66
Cluj-Napoca, Cluj, Romania
Research Site 64
Cluj-Napoca, Cluj, Romania
Research Site 51
Craiova, Dolj, Romania
Research Site 72
Timișoara, Timiș County, Romania
Research Site 61
Welkom, Free State, South Africa
Research Site 59
Johannesburg, Gauteng, South Africa
Research Site 60
KwaDukuza, Gauteng, South Africa
Research Site 58
Durban, KwaZulu-Natal, South Africa
Research Site 57
Sydenham, KwaZulu-Natal, South Africa
Research Site 68
Cape Town, Western Cape, South Africa