ClinicaliQ Trial Snapshot
- A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma (SOLAIRIA-2) — Recruiting • Phase III • Respiratory / COPD / Asthma • NCT07359846.
- GB-0895 is being tested as an add-on therapy for adolescents and adults with severe asthma that remains uncontrolled despite treatment with inhaled corticosteroids and standard controller medications, representing an investigation into a novel adjunctive treatment approach.
- Patient eligibility includes adolescents and adults with severe uncontrolled asthma who have inadequate disease control on current ICS-based regimens, targeting a clinically challenging population with limited treatment options.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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 Snapshot
- Adults and adolescents ≥ 12 and ≤ 80 years of age. 2. Documented physician diagnosis of asthma for ≥ 2 years. 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.
- Adults ≥ 18 years of age at Screening Visit 1, a pre-BD FEV1
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.