A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma (SOLAIRIA-2)
Start Date
1/20/2026
Completion Date
1/1/2029
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.
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/Baseline (Weeks -6 to -4) * Run-in (Weeks -4 to 0, ±1) * Treatment (Weeks 0 to 52) * Follow-up (Weeks 52 to 90) or optional open-label extension (OLE) (Weeks 52 to 142, OLE includes GB-0895 treatment on Week 52 and Week 78) Approximately 786 eligible study participants will be screened and randomized globally to receive either GB-0895 or placebo at week 0 and week 26. The safety of the participants enrolled in this trial will be carefully monitored.
Eligibility Criteria
Age Range: 12 years to 80 years
Interventions
GB-0895
Placebo
Conditions
Locations
Research Site 13
Bakersfield, California 93301
United States
Research Site 12
Inglewood, California 90301
United States
Research Site 10
West Covina, California 91790
United States
Research Site 06
Miami, Florida 33126
United States
Research Site 03
Miami, Florida 33135
United States
Research 09
Orlando, Florida 32807
United States
Research Site 01
Tamarac, Florida 33321
United States
Research Site 04
Tampa, Florida 33607
United States
Research Site 05
Tampa, Florida 33617
United States
Research Site 20
Fall River, Massachusetts 02723
United States
Research Site 02
Ypsilanti, Michigan 48197
United States
Research Site 11
Dayton, Ohio 45424
United States
Research Site 21
Oklahoma City, Oklahoma 73118
United States
Research Site 16
Rock Hill, South Carolina 29732
United States
Research Site 17
San Antonio, Texas 78258
United States
Research Site 07
Sugar Land, Texas 77479
United States
Research Site 08
Williamsburg, Virginia 23188
United States
Research Site 31
Ciudad Autónoma de Buenos Aires, Buenos Aires 1426
Argentina
Research Site 33
Ciudad Autónoma de Buenos Aires, Buenos Aires C1426ABP
Argentina
Research Site 22
Mechelen, Vlaams Brabant 02800
Belgium
Research Site 23
Matsuyama, Ehime 790-092
Japan
Research Site 32
Fukui-shi, Fukui 910-0846
Japan
Research Site 37
Isesaki-Shi, Gunma 372-0831
Japan
Research Site 34
Niigata, Niigata 951-8520
Japan
Research Site 14
Shinagawa-Ku, Tokyo 140-8522
Japan
Research Site 15
Fukuoka, Tukuoka 812-0054
Japan
Research Site 38
Ube, Yamaguchi 755-8505
Japan
Research Site 19
Belgrade, Belgrade 11070
Serbia
Research Site 18
High Wycombe, Buckinghamshire HP11 2QW
United Kingdom
Research Site 28
Bristol, England BS8 2RA
United Kingdom
Research Site 30
London, England N12 8BU
United Kingdom
Research Site 25
Thetford, England IP24 1JD
United Kingdom
Research Site 26
London, Greater London W1T 6AH
United Kingdom
Research Site 27
Nottingham, Nottinghamshire NG7 2QW
United Kingdom