A Phase 3 interventional study of GB-0895 and Placebo in Severe Asthma, sponsored by Generate Biomedicines. Recruiting at 158 sites in 19 countries. Open to participants aged 12 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Generate Biomedicines · Phase 3, Interventional, and Treatment
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.
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:
4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.
This study's planned enrollment of 786 is above the median of 78 across 3,341 interventional studies indexed under Asthma.
Browse Asthma studies →Generate Biomedicines is the lead sponsor of 6 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 7, 2026. See what changed
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GB-0895 Subcutaneous (SC) injection
Drug: GB-0895
Placebo Subcutaneous (SC) injection
Drug: Placebo
Study Drug
Placebo
To 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.
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 to occur.
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 daytime 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 seven daily score.
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 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.
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.
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.
Time frame: From Day 1 (randomization) to Week 52
PGI-C responder at Week 52
The Patient Global Impression of Change (PGI-C) improved response is defined as reporting at least 'moderately better' at week 52. The PGI-C questionnaire asks the subjects to describe the overall change in their asthma since they started taking new medication with response options of: 1= much better, 2= better, 3= a little better, 4= no change, 5= a little worse, 6= worse, and 7= much worse.
Time frame: From Day 1 (randomization) to Week 52
To evaluate the effect of GB-0895 on asthma exacerbations associated with Emergency Room or Hospitalization Visits
The time to first clinically significant asthma exacerbation, from randomization, requiring hospitalization or emergency room visit.
Time frame: From Day 1 (randomization) to Week 52
To evaluate the effect of GB-0895 on annualized asthma exacerbation rate (AAER) associated with Emergency Room or Hospitalization Visits
The AAER associated with clinically significant exacerbations associated with hospital or emergency room visits over 52 weeks.
Time frame: From Day 1 (randomization) to Week 52
Adverse Events (AEs) and Serious Adverse Events (SAEs)
To investigate the incidence, severity, and relationship to GB-0895 of AEs and SAEs throughout the study as reported by the Investigator in the electronic case report forms (eCRFs).
Time frame: From Day 1 (randomization) to Week 52
Clinical Laboratory Evaluations
The absolute values and changes from baseline of clinical laboratory evaluations over time.
Time frame: From Day 1 (randomization) to Week 52
Vital Signs
The absolute values and changes from baseline of vital signs over time.
Time frame: From Day 1 (randomization) to Week 52
ECGs (electrocardiogram)
The absolute values and changes from baseline of ECGs over time.
Time frame: From Day 1 (randomization) to Week 52
Immunogenicity of GB-0895
The measurement of anti-drug antibodies (ADA) responses throughout the course of the study. for subjects on GB-0895 as compared to placebo at week 52.
Time frame: From Day 1 (randomization) to Week 52
Showing the first 100 of 158 sites across 19 countries. Choose a country and city above to see the rest.
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2026 (actual). Primary completion is estimated for Jan 2029, 36 months after the start.
Of 173 industry-sponsored phase 3 interventional studies under Asthma, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 41. This study's planned 36 months is above that.
Counting every sponsor, half of 205 studies reached it within 27 months; a quarter within 14 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: GB-0895
Generate Biomedicines