← Back to all trials
Recruiting
NCT07359846
A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma (SOLAIRIA-2)
Conditions: Severe Asthma
Sex: All
Ages: 12 Years – 80 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 786
Sponsor: Generate Biomedicines
Location: Research Site 13 Bakersfield California
Summary
The objective of this study is to assess the potential for GB-0895 to improve the health of adolescents and adults with severe asthma that is uncontrolled by inhaled corticosteroids (ICS) and conventional asthma controllers.
Additional information is available at www.SOLAIRIA.com.
Eligibility Criteria
1. Adults and adolescents ≥ 12 and ≤ 80 years of age.
2. Documented diagnosis of asthma for \> 12 months.
3. Subjects must be on medium to high dose ICS for ≥ 12 months before Screening Visit 1 plus at least 1 additional asthma controller (e.g., LABA, LAMA) ≥ 3 months before Screening Visit 1 with no change in ICS or controller(s) for at least three months.
4. Subjects must have a well-documented history of at least two asthma exacerbations requiring systemic corticosteroid treatment despite the use of medium-to-high dose ICS in the past 12 months before Screening Visit 1.
5. Adults ≥ 18 years of age at Screening Visit 1, a pre-BD FEV1 \
Source: ClinicalTrials.gov (NCT07359846). StuddyBuddy aggregates publicly available trial information.