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A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma (SOLAIRIA-2)
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
2026-01-20
Completion Date
2029-01
Last Updated
2026-08-17
Healthy Volunteers
No
Conditions
Interventions
GB-0895
Study Drug
Placebo
Placebo
Locations (68)
Research Site 13
Bakersfield, California, United States
Research Site 12
Inglewood, California, United States
Research Site 65
Lancaster, California, United States
Research Site 10
West Covina, California, United States
Research Site 06
Miami, Florida, United States
Research Site 03
Miami, Florida, United States
Research 09
Orlando, Florida, United States
Research Site 01
Tamarac, Florida, United States
Research Site 04
Tampa, Florida, United States
Research Site 05
Tampa, Florida, United States
Research Site 20
Fall River, Massachusetts, United States
Research Site 02
Ypsilanti, Michigan, United States
Research Site 69
New York, New York, United States
Research Site 11
Dayton, Ohio, United States
Research Site 21
Oklahoma City, Oklahoma, United States
Research Site 16
Rock Hill, South Carolina, United States
Research Site 17
San Antonio, Texas, United States
Research Site 07
Sugar Land, Texas, United States
Research Site 08
Williamsburg, Virginia, United States
Research Site 31
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Research Site 33
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Research Site 67
Buenos Aires, Buenos Aires F.D., Argentina
Research site 39
Southport, Queensland, Australia
Research Site 22
Mechelen, Vlaams Brabant, Belgium
Research Site 45
Erpent, Belgium
Research Site 53
Brest, Finistère, France
Research Site 23
Matsuyama, Ehime, Japan
Research Site 32
Fukui-shi, Fukui, Japan
Research Site 37
Isesaki-Shi, Gunma, Japan
Research Site 41
Himeji, Hyōgo, Japan
Research Site 43
Yokohama, Kanagawa, Japan
Research Site 55
Ebino, Miyazaki, Japan
Research Site 47
Niigata, Niigata, Japan
Research Site 34
Niigata, Niigata, Japan
Research Site 63
Uruma, Okinawa, Japan
Research Site 42
Sakai, Osaka, Japan
Research site 40
Chuo Ku, Tokyo, Japan
Research Site 54
Chuo Ku, Tokyo, Japan
Research Site 66
Itabashi-ku, Tokyo, Japan
Research Site 46
Kiyose-shi, Tokyo, Japan
Research Site 14
Shinagawa-Ku, Tokyo, Japan
Research Site 15
Fukuoka, Tukuoka, Japan
Research Site 38
Ube, Yamaguchi, Japan
Research Site 58
Belgrade, Belgrade, Serbia
Research Site 19
Belgrade, Belgrade, Serbia
Research Site 57
Belgrade, Belgrade, Serbia
Research Site 51
Belgrade, Serbia
Research Site 56
Kamenitz, Serbia
Research Site 35
Spišská Nová Ves, Slovakia, Slovakia
Research Site 36
Košice, Slovakia
Research Site 59
Barcelona, Barcelona, Spain
Research Site 49
Chernivtsi, Chernivtsi Oblast, Ukraine
Research Site 52
Kyiv, Kyivs'ka Oblast, Ukraine
Research Site 44
Kyiv, Kyïvs'ka Oblast, Ukraine
Research Site 60
Vinnytsia, Vinnytsia Oblast, Ukraine
Research Site 50
Vinnytsia, Vinnytsia Oblast, Ukraine
Research Site 61
Vinnytsia, Vinnytsya, Ukraine
Research Site 64
Lutsk, Volyn Oblast, Ukraine
Research Site 18
High Wycombe, Buckinghamshire, United Kingdom
Research Site 28
Bristol, England, United Kingdom
Research Site 30
London, England, United Kingdom
Research Site 29
Romford, England, United Kingdom
Research Site 24
Rotherham, England, United Kingdom
Research Site 25
Thetford, England, United Kingdom
Research Site 26
London, Greater London, United Kingdom
Research Site 27
Nottingham, Nottinghamshire, United Kingdom
Research Site 62
London, Westminster, United Kingdom
Research Site 48
Plymouth, United Kingdom