A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma (SOLAIRIA-1)
Start Date
12/3/2025
Completion Date
12/1/2028
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 23
Northridge, California 91324
United States
Research Site 26
Pasadena, California 91105
United States
Research Site 29
Rancho Cucamonga, California 91730
United States
Research Site 34
Valencia, California 91355
United States
Research Site 13
West Hills, California 91307
United States
Research Site 15
Colorado Springs, Colorado 80923
United States
Research Site 32
Brooksville, Florida 34613
United States
Research Site 12
Doral, Florida 33122
United States
Research Site 14
Gainesville, Florida 32607
United States
Research Site 03
Hialeah, Florida 33016
United States
Research Site 25
Kendall, Florida 33176
United States
Research Site 04
Miami, Florida 33126
United States
Research Site 01
Miami Lakes, Florida 33014
United States
Research Site 08
North Miami, Florida 33169
United States
Research Site 10
Palm Springs, Florida 33461
United States
Research Site 02
Tampa, Florida 33613
United States
Research Site 18
Rincon, Georgia 31326
United States
Research Site 31
Glenview, Illinois 60026
United States
Research Site 16
Baltimore, Maryland 21237
United States
Research Site 28
Columbia, Maryland 21045
United States
Research Site 20
Towson, Maryland 21204
United States
Research Site 06
Flint, Michigan 48504
United States
Research Site 30
Olive Branch, Mississippi 38654
United States
Research Site 37
The Bronx, New York 10461
United States
Research Site 27
Gastonia, North Carolina 28054
United States
Research Site 24
Amarillo, Texas 79106
United States
Research Site 19
Baytown, Texas 77521
United States
Research Site 07
Dallas, Texas 75230
United States
Research Site 17
Dallas, Texas 75254
United States
Research Site 11
Houston, Texas 77084
United States
Research Site 09
Houston, Texas 77099
United States
Research Site 22
Kerrville, Texas 78028
United States
Research Site 05
Lewisville, Texas 75057
United States
Research Site 33
McKinney, Texas 75069
United States
Research Site 21
Riverton, Utah 84096
United States
Research Site 38
Kozloduy, Vratsa 3320
Bulgaria
Research Site 56
Haskovo, 6300
Bulgaria
Research Site 54
Pleven,
Bulgaria
Research Site 55
Plovdiv,
Bulgaria
Research Site 39
Vidin, 3703
Bulgaria
Research Site 42
Deggingen, Baden-Wurttemberg 73326
Germany
Research Site 36
Frankfurt am Main, Hesse 60596
Germany
Research Site 40
Berlin, 10119
Germany
Research Site 43
Lübeck,
Germany
Research Site 45
Budapest, 1047
Hungary
Research Site 47
Mosonmagyaróvár, 9200
Hungary
Research Site 53
Szigetvár, 7900
Hungary
Research Site 46
Szombathely, 9700
Hungary
Research Site 52
Riga,
Latvia
Research Site 41
Oradea, Bihor County 410163
Romania
Research Site 35
Bucharest, Bucharest 061692
Romania
Research Site 51
Craiova, Dolj 200678
Romania
Research Site 50
Brasov, 500051
Romania