RecruitingPhase 3NCT07359846

A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma (SOLAIRIA-2)

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

Jan 20, 2026

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 study tests a new add-on treatment called GB-0895 for people with severe asthma that is not well controlled even with multiple inhalers. It is part of the SOLAIRIA-2 trial, looking at whether GB-0895 reduces asthma attacks and improves lung function. **You may be eligible if...** - You are between 12 and 80 years old - You have had asthma diagnosed for at least 2 years - You have been on medium-to-high dose inhaled steroids for at least 12 months and at least one additional controller inhaler (like a long-acting bronchodilator) for at least 3 months - You have had at least 2 asthma attacks in the past year that needed oral steroids - Your lung function tests (FEV1) are below normal levels - You weigh at least 40 kg **You may NOT be eligible if...** - You had a significant asthma attack in the past 12 weeks - You have another lung disease (such as COPD, bronchiectasis, or pulmonary fibrosis) - You are currently receiving another biologic (injectable) asthma treatment - You are pregnant or breastfeeding - You have a severe immune system disorder 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(96)

Research Site 13

Bakersfield, California, United States

Research Site 12

Inglewood, California, United States

Research Site 65

Lancaster, California, United States

Research Site 10

West Covina, California, United States

Research Site 06

Miami, Florida, United States

Research Site 03

Miami, Florida, United States

Research 09

Orlando, Florida, United States

Research Site 01

Tamarac, Florida, United States

Research Site 04

Tampa, Florida, United States

Research Site 05

Tampa, Florida, United States

Research Site 20

Fall River, Massachusetts, United States

Research Site 02

Ypsilanti, Michigan, United States

Research Site 69

New York, New York, United States

Research Site 69

New York, New York, United States

Research Site 11

Dayton, Ohio, United States

Research Site 21

Oklahoma City, Oklahoma, United States

Research Site 16

Rock Hill, South Carolina, United States

Research Site 17

San Antonio, Texas, United States

Research Site 07

Sugar Land, Texas, United States

Research Site 08

Williamsburg, Virginia, United States

Research Site 31