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

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-521950-41-00

Enrollment

122

Registered

2026-05-12

Start date

Unknown

Completion date

Unknown

Last updated

2026-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

severe uncontrolled asthma

Brief summary

Annualized asthma exacerbation rate (AAER) of clinically significant exacerbations over 52 weeks, defined as exacerbations requiring systemic corticosteroids (oral, intravenous [IV], or intramuscular) and/or hospitalization or emergency department visits requiring systemic corticosteroids

Detailed description

• AAER over 52 weeks, • Change from baseline in pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1) at Week 52, • Change from baseline in Asthma Quality of Life Questionnaire (AQLQ(S)12+) score at Week 52, • Change from baseline in Asthma Control Questionnaire (ACQ-6) score at Week 52, • Time to first clinically significant exacerbation from randomization, • Change from baseline in weekly mean daily Asthma Daytime Symptom Diary (ADSD) score at Week 52, • Change from baseline in weekly mean daily Asthma Nighttime Symptom Diary (ANSD) score at Week 52

Interventions

DRUG0.9% sodium chloride

DRUGGB-0895

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Annualized asthma exacerbation rate (AAER) of clinically significant exacerbations over 52 weeks, defined as exacerbations requiring systemic corticosteroids (oral, intravenous [IV], or intramuscular) and/or hospitalization or emergency department visits requiring systemic corticosteroids	—

Secondary

Measure	Time frame
• AAER over 52 weeks, • Change from baseline in pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1) at Week 52, • Change from baseline in Asthma Quality of Life Questionnaire (AQLQ(S)12+) score at Week 52, • Change from baseline in Asthma Control Questionnaire (ACQ-6) score at Week 52, • Time to first clinically significant exacerbation from randomization, • Change from baseline in weekly mean daily Asthma Daytime Symptom Diary (ADSD) score at Week 52, • Change from baseline in weekly mean daily Asthma Nighttime Symptom Diary (ANSD) score at Week 52	—

Measure

Time frame

—

Outcome results

None listed

Source: EU CTIS · Data processed: May 14, 2026