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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
2026-06-11
Healthy Volunteers
No
Conditions
Interventions
GB-0895
Study Drug
Placebo
Placebo
Locations (35)
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 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 35
Bucharest, Bucharest, Romania