RecruitingPhase 3NCT07276724

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

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

Sponsor

Generate Biomedicines

Enrollment

786 participants

Start Date

Dec 3, 2025

Study Type

INTERVENTIONAL

Conditions

Severe Asthma

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.

Eligibility

Min Age: 12 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This trial (SOLAIRIA-1) is testing a new drug called GB-0895 as an add-on treatment for adolescents and adults with severe asthma that is not controlled despite high-dose inhaler therapy. **You may be eligible if...** - You are 12–80 years old - You have had asthma for at least 2 years - You have been on medium-to-high dose inhaled steroids plus at least one other asthma controller for at least 3 months - You have had at least 2 severe asthma attacks in the past year requiring oral steroids - Your lung function tests show reduced breathing capacity - You weigh at least 40 kg **You may NOT be eligible if...** - You have had a severe asthma attack in the past 12 weeks - You have another lung disease (like COPD, pulmonary fibrosis, or lung cancer) - You currently smoke or have a significant smoking history (10+ pack-years) - You have used anti-IL-5 therapy in the past year or anti-TSLP therapy at any point - You have HIV, active hepatitis B or C - You are pregnant or breastfeeding - You have serious liver disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGB-0895

Study Drug

DRUGPlacebo

Placebo

Locations(27)

Research Site 23

Northridge, California, United States

Research Site 26

Pasadena, California, United States

Research Site 13

West Hills, California, United States

Research Site 15

Colorado Springs, Colorado, 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 16

Baltimore, Maryland, United States

Research Site 20

Towson, Maryland, United States

Research Site 06

Flint, Michigan, 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 21

Riverton, Utah, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07276724

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