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RECRUITING
NCT07276724
PHASE3

A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma (SOLAIRIA-1)

Sponsor: Generate Biomedicines

View on ClinicalTrials.gov

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

DRUG

GB-0895

Study Drug

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