Severe Asthma study: GB-0895
Official title A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma (SOLAIRIA-1)
ClinicalTrials.gov ID: NCT07276724
What this study is testing
What is GB-0895?
GB-0895 is an investigational medicine, being studied as a potential treatment for severe asthma.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find out if adding GB-0895 to current asthma treatments improves health for people whose asthma is not well controlled.
- Who it's for
- The study is looking for adults and teenagers who have severe asthma that is not managed well by standard inhaled steroid medicines.
- What's involved
- Participants will be randomly assigned to receive either the new medicine GB-0895 or a placebo (sugar pill) every 6 months. They will also continue their usual asthma treatments.
- Time commitment
- The study lasts 52 weeks, with visits required every 1 to 2 months after the first month.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 80
You may be able to join if
- Adults and adolescents ≥ 12 and ≤ 80 years of age.
- Documented diagnosis of asthma for \> 12 months.
- people 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) ≥...
- people must have a well-documented history of at least two asthma exacerbations requiring systemic corticosteroid treatment despite the use of...
- Adults ≥ 18 years of age at Screening Visit 1, a pre-BD FEV1 \<80% predicted at Screening Visit 1.
You likely can't join if
- people who experience a clinically significant asthma exacerbation within 12 weeks before the Screening Visit or during the run-in period and require...
- Other concurrent respiratory disease other than asthma, including (but not limited to) current infection, bronchiectasis, pulmonary fibrosis...
- Eosinophilic disease (e.g., eosinophilic granulomatosis with polyangiitis).
- Any cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or...
- Clinically significant infection that is unresolved and requires systemic antibiotic, antifungal, antiparasitic, or antiviral medications preceding...
- A current malignancy or previous history of cancer within 5 years before screening.
See the full eligibility criteria
Who can join
- Adults and adolescents ≥ 12 and ≤ 80 years of age.
- Documented diagnosis of asthma for \> 12 months.
- people 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...
- people 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 \<80% predicted at Screening Visit 1.
- Adolescents 12 to \< 18 years of age at Screening Visit 1: A pre-BD FEV1 \< 90% predicted OR, FEV1:Forced Vital Capacity (FVC) ratio \< 0.80.
- Positive BD responsiveness test: Increase of at least 12% and 200 mL in FEV1 between 15 and 60 minutes after the administration of a short-acting β2-agonist (SABA) at least once during the screening period.
- ACQ-6 score ≥ 1.5 at the Screening Visit.
- Weight ≥40 kg at the Screening Visit 1
What rules you out
- people who experience a clinically significant asthma exacerbation within 12 weeks before the Screening Visit or during the run-in period and require a change in asthma maintenance therapy.
- Other concurrent respiratory disease other than asthma, including (but not limited to) current infection, bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis, tuberculosis, diagnosis of chronic pulmonary...
- Eosinophilic disease (e.g., eosinophilic granulomatosis with polyangiitis).
- Any cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable in the opinion of the...
- Clinically significant infection that is unresolved and requires systemic antibiotic, antifungal, antiparasitic, or antiviral medications preceding enrollment.
- A current malignancy or previous history of cancer within 5 years before screening.
- Clinically significant infection that is not resolved before study enrollment.
- people with a known, pre-existing helminth parasitic infestation within 6 months before Screening Visit 1 that has not been successfully treated with, or has failed to respond to, standard of care therapy.
- Current smokers or people with a smoking history ≥10 pack-years, and people using vaping products, including electronic cigarettes.
- Former smokers with a smoking history of \<10 pack-years and users of vaping/e-cigarette products must have stopped for at least 6 months before Screening Visit 1 to be eligible.
- Hepatitis B, C, or HIV.
- Major surgery within 8 weeks before Screening Visit 1 or planned surgical procedures requiring general anesthesia or inpatient status for \>1 day during the study.
- Use of any anti-IL-5 therapy (e.g., mepolizumab, reslizumab, benralizumab, depemokimab) or other monoclonal antibodies used for asthma within 4 months or 5 half-lives.
- Previous use of tezepelumab within 12 months before Screening Visit 1 is excluded. Previous tezepelumab use is exclusionary regardless of 12-month washout if discontinuation was due to safety (intolerance) or treatment...
- Treatment with systemic immunosuppressive/immunomodulating drugs (e.g., methotrexate, cyclosporine) within 12 weeks prior to randomization.
- Receipt of an investigational biologic within 4 months or 5 half-lives (whichever is longer), OR receipt of an investigational non-biologic within 30 days or 5 half-lives (whichever is longer) before Screening Visit 1.
- Known history of sensitivity to any component of the study treatment formulation.
- History of life-threatening anaphylaxis following any biologic therapy.
- Concurrent enrollment in another clinical study involving investigational product (IP).
- Subject has been assigned by chance in the current study or previous GB-0895 studies.
- Any clinically meaningful abnormal finding in physical examination, vital signs, ECG, hematology, serum chemistry, or urinalysis that, in the opinion of the Investigator, may put the subject at risk, influence study...
- Cirrhosis (with or without hepatic dysfunction) or other active or clinically significant liver disease.
- Receipt of immunoglobulin or blood products within 30 days before Screening Visit 1.
- Receipt of live attenuated vaccines within 30 days before randomization and during the study, including the follow-up period.
- Receipt of the T2 cytokine inhibitor suplatast tosilate within 15 days before Screening Visit 1.
- people treated with bronchial thermoplasty in the last 12 months before Screening Visit 1.
- Unwillingness or inability to follow study procedures, including poor adherence to asthma controller medications, in the opinion of the Investigator.
- Women who are pregnant, lactating, or planning to become pregnant during the study.
- History (or suspected history) of alcohol misuse or substance abuse within 2 years before Screening Visit 1.
The study team makes the final eligibility decision.
Where it is enrolling
- Northridge, California, United States
- Pasadena, California, United States
- Rancho Cucamonga, California, United States
- Valencia, California, United States
- West Hills, California, United States
- Colorado Springs, Colorado, United States
- Brooksville, Florida, United States
- Doral, Florida, United States
- Gainesville, Florida, United States
- Hialeah, Florida, United States
- Kendall, Florida, United States
- Miami, Florida, United States
- Miami Lakes, Florida, United States
- North Miami, Florida, United States
- Palm Springs, Florida, United States
- Tampa, Florida, United States
- Rincon, Georgia, United States
- Glenview, Illinois, United States
- Baltimore, Maryland, United States
- Columbia, Maryland, United States
+ 99 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Northridge, California, United States; Pasadena, California, United States; Rancho Cucamonga, California, United States; Valencia, California, United States; West Hills, California, United States; Colorado Springs, Colorado, United States and 113 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.