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.
This is a global, multicenter, randomized, double-blind, placebo-controlled Phase 3 study to evaluate the efficacy and safety of GB-0895 adjunctive therapy in adults and adolescents with severe uncontrolled asthma with an optional open-label extension (OLE). The trial is designed to administer GB-0895 an investigational drug or placebo, subcutaneously every 6 months. The study is divided into several phases as described below: * Screening/Baseline (Weeks -6 to -4) * Run-in (Weeks -4 to 0, ±1) * Treatment (Weeks 0 to 52) * Follow-up (Weeks 52 to 90) or optional open-label extension (OLE) (Weeks 52 to 142, OLE includes GB-0895 treatment on Week 52 and Week 78) Approximately 786 eligible study participants will be screened and randomized globally to receive either GB-0895 or placebo at week 0 and week 26. The safety of the participants enrolled in this trial will be carefully monitored.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
786
Research Site 10
West Covina, California, United States
RECRUITINGResearch Site 06
Miami, Florida, United States
RECRUITINGTo evaluate the annualized asthma exacerbation rate (AAER) in adult and adolescent subjects with severe uncontrolled asthma.
The annual exacerbation rate is based on clinically significant (CS) exacerbations reported by the investigator in the electronic case (eCRF) over 52 weeks for subjects on GB-0895 as compared to placebo.
Time frame: From Day 1 (randomization) to Week 52
To evaluate the annualized asthma exacerbation rate (AAER) in adult and adolescent subjects with severe uncontrolled asthma and baseline eosinophils (EOS) < 300 cells/µL.
The annual exacerbation rate is based on CS exacerbations reported by the investigator in the eCRF over 52 weeks for subjects with baseline EOS \< 300 cells/ µL on GB-0895 as compared to placebo.
Time frame: From Day 1 (randomization) to Week 52
Change from baseline in pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1)
The change from baseline in pre-BD FEV1 for subjects on GB-0895 as compared to placebo at week 52. FEV1 is defined as the volume of air exhaled from the lungs in the first second of a forced expiration.
Time frame: From Day 1 (randomization) to Study Week 52
Change from baseline in Asthma Quality of Life Questionnaire AQLQ(S)12+ score
The change from baseline on AQLQ(S)12+ score for subjects on GB-0895 as compared to placebo at week 52. The AQLQ(S)12+ is a 32-question assessment with questions related to symptoms, activity limitations, emotional function, and environmental stimuli. Questions are scored on a 7-point scale, which ranges from 7 (no impairment) to 1 (severe impairment). The overall score is calculated as the mean to all questions.
Time frame: From Day 1 (randomization) to Week 52
Change from baseline in Asthma Control Questionnaire (ACQ-6) score
The change from baseline on ACQ-6 score for subjects on GB-0895 as compared to placebo at week 52. The ACQ-6 is a 6-question questionnaire that assesses asthma symptoms (e.g., activity limitation, shortness of breath, wheezing etc.). Questions are scored on a 6-point scale, where 0 corresponds to totally controlled asthma and 6 corresponds to severely uncontrolled asthma.
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Research Site 03
Miami, Florida, United States
Research 09
Orlando, Florida, United States
RECRUITINGResearch Site 01
Tamarac, Florida, United States
RECRUITINGResearch Site 04
Tampa, Florida, United States
RECRUITINGResearch Site 05
Tampa, Florida, United States
RECRUITINGResearch Site 02
Ypsilanti, Michigan, United States
RECRUITINGResearch Site 11
Dayton, Ohio, United States
RECRUITINGResearch Site 07
Sugar Land, Texas, United States
RECRUITING...and 1 more locations
Time frame: From Day 1 (randomization) to Week 52
Time to first asthma exacerbation from randomization
After subjects complete the screening period and are randomized to either GB-0895 or placebo, the time it takes until the first clinically significant asthma exacerbation occurs. Clinically significant asthma exacerbations are defined as requiring systemic corticosteroids (oral, IV, or intramuscular) and/or hospitalization or emergency department visits requiring systemic corticosteroids.
Time frame: From Day 1 (randomization) to Week 52
Change from baseline in weekly mean daily Asthma Daytime Symptom Diary (ADSD)
The change from baseline on weekly mean daily ADSD score for subjects on GB-0895 as compared to placebo at week 52. The ADSD is an 8-question diary that assesses asthma symptoms that the subjects will fill out at night before bed. The ADSD daily score is calculated by averaging the 8 daily score and a mean of 7-day ADSD score is calculated by averaging of the 7 daily score. The daily score is not calculated if any item response is missing.
Time frame: From Day 1 (randomization) to Week 52
Change from baseline in weekly mean daily Asthma Nighttime Symptom (ANSD)
The change from baseline on daily ANSD score for subjects on GB-0895 as compared to placebo at week 52. ANSD is an eight-question diary that assesses asthma symptoms that the subjects will fill out in the morning upon waking. The ANSD score is calculated by averaging the 8 daily score and a mean of 7-day ANSD score is calculated by averaging of the seven daily score.
Time frame: From Day 1 (randomization) to Week 52
Change from baseline in St. George's Respiratory Questionnaire (SGRQ) total score
The change from baseline on SGRQ score for subjects on GB-0895 as compared to placebo at week 52. The SGRQ is a 50-item questionnaire designed to measure health status. Questions are scored on a range of 0 to 100, with a lower score indicating a better quality of life
Time frame: From Day 1 (randomization) to Week 52
Change from baseline in 22-Item Sino-Nasal Outcomes Test (SNOT-22) score
The change from baseline on SNOT-22 score for subjects on GB-0895 as compared to placebo at week 52.The SNOT-22 is a 22-question questionnaire that assesses the impact on health-related quality of life and questions are scored from 0 to 110, with 0 indicating no disease and 110 as the worst disease.
Time frame: From Day 1 (randomization) to Week 52
Change from baseline in the 5-Level EuroQol 5 dimensions questionnaire (EQ-5D-5L) score
The change from baseline on EQ-5D-5L score for subjects on GB-0895 as compared to placebo at week 52. The EQ-5D-5L questionnaire includes a visual analogue scale (VAS) that allows subjects to rate current health status on a 0-100 scale, with 0 being the worst imaginable health state.
Time frame: From Day 1 (randomization) to Week 52
PGI-S response at Week 52
The Patient Global Impression of Asthma Severity (PGI-S) at Week 52 defined as an improvement by 1 or more points on the 0-5 scale. The PGI-S questionnaire asks the subjects to rate the overall severity of their asthma symptoms of the past 7 days with response options of: 1= no asthma symptoms, 2= mild, 3= moderate, 4= severe, and 5= worst possible asthma symptoms.
Time frame: From Day 1 (randomization) to Week 52
ACQ-6 response at Week 52
The Asthma Control Questionnaire-6 (ACQ-6) at Week 52 defined as an improvement in score of 0.5 or more. The ACQ-6 questionnaire is a 6-question subject-reported questionnaire that assesses the most common asthma symptoms and responses are calculated from the mean of the scores out of a value of 6, where 0 corresponds to totally controlled asthma and 6 corresponds to severely uncontrolled asthma.
Time frame: From Day 1 (randomization) to Week 52
AQLQ(S)12+ response at Week 52
The Asthma Quality of Life Questionnaire for 12-Year-Old and Older at week 52 defined as an improvement in score of 0.5 or more. The AQLQ(S)12+ is a 32-question subject-reported assessment. The questions are scored on a 7-point scale, which ranges from 7 (no impairment) to 1 (severe impairment). The overall score is calculated as the mean of all questions.
Time frame: From Day 1 (randomization) to Week 52
SGRQ response at Week 52
The St. George's Respiratory Questionnaire at week 52 defined as achieving ≥ 4-point reduction from baseline. The SGRQ is a 50-item questionnaire designed to measure health status and questions are scored on a range of 0 to 100, with a lower score indicating a better quality of life.
Time frame: From Day 1 (randomization) to Week 52