NCT07359846RecruitingPhase 3
A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma (SOLAIRIA-2)
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
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 786 (estimated)
- First submitted
- 21 Jan 2026
- Start date
- 20 Jan 2026
- Primary completion date
- 31 Jan 2029
- Lead sponsor
- Generate Biomedicines
- Diseases
- Asthma
- NCT number
- NCT07359846
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 786
- From 20 Jan 2026 to the primary completion date, 31 Jan 2029
- 157 sites in 19 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects 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 disease (including but not limited to emphysema and/or chronic bronchitis), or a history of lung cancer.
- Subjects 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.
- 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.
- 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 failure (lack of benefit). Prior use (at any time) of any other anti-TSLP or anti-TSLP receptor biologics is excluded.
- Treatment with systemic immunosuppressive/immunomodulating drugs (e.g., methotrexate, cyclosporine) within 12 weeks prior to randomization.
- Concurrent enrollment in another clinical study involving investigational product (IP).
- Subject has been randomized in the current study or previous GB-0895 studies.
- 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.
- Subjects 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.
Other illness
- 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 Investigator and could affect subject safety, influence study findings or interpretation, or impede completion of the study.
- 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.
- Hepatitis B, C, or HIV.
- Known history of sensitivity to any component of the study treatment formulation.
- History of life-threatening anaphylaxis following any biologic therapy.
- Cirrhosis (with or without hepatic dysfunction) or other active or clinically significant liver disease.
Lab values
- 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 results, or impede study completion.
Other
- Current smokers or subjects with a smoking history ≥10 pack-years, and subjects using vaping products, including electronic cigarettes.
- 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.
- 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.
Criteria the registry did not label
- Adults and adolescents ≥ 12 and ≤ 80 years of age.
- Documented diagnosis of asthma for \> 12 months.
- 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.
- 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 \<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
Age in the registry: 12 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (157)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Research Site 120 Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Recruiting |
| Research Site 67 Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Recruiting |
| Research Site 103 Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Recruiting |
| Research Site 33 Coordinator of this site? Confirm its status | Ciudad Autónoma de Buenos Aires | Argentina | Recruiting |
| Research Site 79 Coordinator of this site? Confirm its status | Ciudad Autónoma de Buenos Aires | Argentina | Recruiting |
| Research Site 87 Coordinator of this site? Confirm its status | Ciudad Autónoma de Buenos Aires | Argentina | Recruiting |
| Research Site 31 Coordinator of this site? Confirm its status | Ciudad Autónoma de Buenos Aires | Argentina | Recruiting |
| Research Site 92 Coordinator of this site? Confirm its status | Ciudad Autónoma de Buenos Aires | Argentina | Recruiting |
| Research Site 81 Coordinator of this site? Confirm its status | Concepción del Uruguay | Argentina | Recruiting |
| Research Site 116 Coordinator of this site? Confirm its status | Mar del Plata | Argentina | Recruiting |
| Research Site 94 Coordinator of this site? Confirm its status | Mar del Plata | Argentina | Recruiting |
| Research Site 80 Coordinator of this site? Confirm its status | Mendoza | Argentina | Recruiting |
| Research Site 98 Coordinator of this site? Confirm its status | Rosario | Argentina | Recruiting |
| Research Site 119 Coordinator of this site? Confirm its status | Rosario | Argentina | Recruiting |
| Research Site 113 Coordinator of this site? Confirm its status | San Miguel de Tucumán | Argentina | Recruiting |
| Research Site 100 Coordinator of this site? Confirm its status | San Miguel de Tucumán | Argentina | Recruiting |
| Research Site 107 Coordinator of this site? Confirm its status | San Salvador | Argentina | Recruiting |
| Research Site 125 Coordinator of this site? Confirm its status | Santa Fe | Argentina | Recruiting |
| Research Site 72 Coordinator of this site? Confirm its status | Coffs Harbour | Australia | Recruiting |
| Research site 39 Coordinator of this site? Confirm its status | Southport | Australia | Recruiting |
| Research Site 45 Coordinator of this site? Confirm its status | Erpent | Belgium | Recruiting |
| Research Site 22 Coordinator of this site? Confirm its status | Mechelen | Belgium | Recruiting |
| Research Site 73 Coordinator of this site? Confirm its status | Mechelen | Belgium | Recruiting |
| Research Site 95 Coordinator of this site? Confirm its status | Tartu | Estonia | Recruiting |
| Research Site 101 Coordinator of this site? Confirm its status | Tartu | Estonia | Recruiting |
| Research Site 59 Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Research Site 139 Coordinator of this site? Confirm its status | Huelva | Spain | Recruiting |
| Research Site 138 Coordinator of this site? Confirm its status | Huelva | Spain | Recruiting |
| Research Site 110 Coordinator of this site? Confirm its status | Málaga | Spain | Recruiting |
| Research site 144 Coordinator of this site? Confirm its status | Mataró | Spain | Recruiting |
| Research Site 104 Coordinator of this site? Confirm its status | Seville | Spain | Recruiting |
| Research Site 71 Coordinator of this site? Confirm its status | Zaragoza | Spain | Recruiting |
| Research Site 53 Coordinator of this site? Confirm its status | Brest | France | Recruiting |
| Research Site 115 Coordinator of this site? Confirm its status | Le Kremlin-Bicêtre | France | Recruiting |
| Research Site 117 Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Research Site 112 Coordinator of this site? Confirm its status | Strasbourg | France | Recruiting |
| Research Site 106 Coordinator of this site? Confirm its status | Ashburton | United Kingdom | Recruiting |
| Research Site 28 Coordinator of this site? Confirm its status | Bristol | United Kingdom | Recruiting |
| Research Site 18 Coordinator of this site? Confirm its status | High Wycombe | United Kingdom | Recruiting |
| Research Site 85 Coordinator of this site? Confirm its status | Honiton | United Kingdom | Recruiting |
| Research Site 26 Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Research Site 30 Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Research Site 62 Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Research Site 70 Coordinator of this site? Confirm its status | Metropolitan Borough of Wirral | United Kingdom | Recruiting |
| Research Site 27 Coordinator of this site? Confirm its status | Nottingham | United Kingdom | Recruiting |
| Research Site 48 Coordinator of this site? Confirm its status | Plymouth | United Kingdom | Recruiting |
| Research Site 29 Coordinator of this site? Confirm its status | Romford | United Kingdom | Recruiting |
| Research Site 24 Coordinator of this site? Confirm its status | Rotherham | United Kingdom | Recruiting |
| Research Site 130 Coordinator of this site? Confirm its status | Sheffield | United Kingdom | Recruiting |
| Research Site 84 Coordinator of this site? Confirm its status | Somerton | United Kingdom | Recruiting |
| Research Site 25 Coordinator of this site? Confirm its status | Thetford | United Kingdom | Recruiting |
| Research Site 127 Coordinator of this site? Confirm its status | Batumi | Georgia | Recruiting |
| Research Site 131 Coordinator of this site? Confirm its status | Batumi | Georgia | Recruiting |
| Research Site 129 Coordinator of this site? Confirm its status | Tbilisi | Georgia | Recruiting |
| Research Site 124 Coordinator of this site? Confirm its status | Tbilisi | Georgia | Recruiting |
| Research Site 123 Coordinator of this site? Confirm its status | Tbilisi | Georgia | Recruiting |
| Research Site 126 Coordinator of this site? Confirm its status | Tbilisi | Georgia | Recruiting |
| Research Site 158 Coordinator of this site? Confirm its status | Ballinasloe | Ireland | Recruiting |
| Research Site 133 Coordinator of this site? Confirm its status | Drogheda | Ireland | Recruiting |
| Research Site 142 Coordinator of this site? Confirm its status | Dublin | Ireland | Recruiting |
| Research Site 146 Coordinator of this site? Confirm its status | Nagpur | India | Recruiting |
| Research site 143 Coordinator of this site? Confirm its status | Vadodara | India | Recruiting |
| Research Site 128 Coordinator of this site? Confirm its status | Brescia | Italy | Recruiting |
| Research Site 140 Coordinator of this site? Confirm its status | Pavia | Italy | Recruiting |
| Research Site 141 Coordinator of this site? Confirm its status | Reggio Emilia | Italy | Recruiting |
| Research Site 145 Coordinator of this site? Confirm its status | Sassari | Italy | Recruiting |
| Research Site 99 Coordinator of this site? Confirm its status | Trieste | Italy | Recruiting |
| Research Site 137 Coordinator of this site? Confirm its status | Asahikawa-shi | Japan | Recruiting |
| Research Site 54 Coordinator of this site? Confirm its status | Chuo Ku | Japan | Recruiting |
| Research site 40 Coordinator of this site? Confirm its status | Chuo Ku | Japan | Recruiting |
| Research Site 55 Coordinator of this site? Confirm its status | Ebino | Japan | Recruiting |
| Research Site 32 Coordinator of this site? Confirm its status | Fukui-shi | Japan | Recruiting |
| Research Site 15 Coordinator of this site? Confirm its status | Fukuoka | Japan | Recruiting |
| Research Site 75 Coordinator of this site? Confirm its status | Hachioji-Shi | Japan | Recruiting |
| Research Site 41 Coordinator of this site? Confirm its status | Himeji | Japan | Recruiting |
| Research Site 96 Coordinator of this site? Confirm its status | Hiroshima | Japan | Recruiting |
| Research Site 90 Coordinator of this site? Confirm its status | Iizuka-Shi | Japan | Recruiting |
| Research Site 88 Coordinator of this site? Confirm its status | Iruma | Japan | Recruiting |
| Research Site 37 Coordinator of this site? Confirm its status | Isesaki-Shi | Japan | Recruiting |
| Research Site 46 Coordinator of this site? Confirm its status | Kiyose-shi | Japan | Recruiting |
| Research Site 23 Coordinator of this site? Confirm its status | Matsuyama | Japan | Recruiting |
| Research Site 97 Coordinator of this site? Confirm its status | Naka-Gun | Japan | Recruiting |
| Research Site 132 Coordinator of this site? Confirm its status | Nakano | Japan | Recruiting |
| Research Site 47 Coordinator of this site? Confirm its status | Niigata | Japan | Recruiting |
| Research Site 34 Coordinator of this site? Confirm its status | Niigata | Japan | Recruiting |
| Research Site 42 Coordinator of this site? Confirm its status | Sakai | Japan | Recruiting |
| Research Site 68 Coordinator of this site? Confirm its status | Seto-shi | Japan | Recruiting |
| Research Site 14 Coordinator of this site? Confirm its status | Shinagawa-Ku | Japan | Recruiting |
| Research Site 66 Coordinator of this site? Confirm its status | tabashi City | Japan | Recruiting |
| Research Site 157 Coordinator of this site? Confirm its status | Tokyo | Japan | Recruiting |
| Research Site 86 Coordinator of this site? Confirm its status | Toshima-Ku | Japan | Recruiting |
| Research Site 121 Coordinator of this site? Confirm its status | Toyonaka | Japan | Recruiting |
| Research Site 38 Coordinator of this site? Confirm its status | Ube | Japan | Recruiting |
| Research Site 63 Coordinator of this site? Confirm its status | Uruma | Japan | Recruiting |
| Research Site 43 Coordinator of this site? Confirm its status | Yokohama | Japan | Recruiting |
| Research Site 154 Coordinator of this site? Confirm its status | Kota Kinabalu | Malaysia | Recruiting |
| Research Site 156 Coordinator of this site? Confirm its status | Kuantan | Malaysia | Recruiting |
| Research Site 148 Coordinator of this site? Confirm its status | Malacca | Malaysia | Recruiting |
| Research Site 155 Coordinator of this site? Confirm its status | Miri | Malaysia | Recruiting |
| Research Site 147 Coordinator of this site? Confirm its status | Sungai Buloh | Malaysia | Recruiting |
| Research Site 149 Coordinator of this site? Confirm its status | Auckland | New Zealand | Recruiting |
| Research Site 118 Coordinator of this site? Confirm its status | Christchurch | New Zealand | Recruiting |
| Research Site 19 Coordinator of this site? Confirm its status | Belgrade | Serbia | Recruiting |
| Research Site 51 Coordinator of this site? Confirm its status | Belgrade | Serbia | Recruiting |
| Research Site 58 Coordinator of this site? Confirm its status | Belgrade | Serbia | Recruiting |
| Research Site 57 Coordinator of this site? Confirm its status | Belgrade | Serbia | Recruiting |
| Research Site 56 Coordinator of this site? Confirm its status | Kamenitz | Serbia | Recruiting |
| Research Site 105 Coordinator of this site? Confirm its status | Kragujevac | Serbia | Recruiting |
| Research Site 89 Coordinator of this site? Confirm its status | Novi Sad | Serbia | Recruiting |
| Research Site 152 Coordinator of this site? Confirm its status | Zaječar | Serbia | Recruiting |
| Research Site 36 Coordinator of this site? Confirm its status | Košice | Slovakia | Recruiting |
| Research Site 122 Coordinator of this site? Confirm its status | Košice | Slovakia | Recruiting |
| Research Site 35 Coordinator of this site? Confirm its status | Spišská Nová Ves | Slovakia | Recruiting |
| Research Site 49 Coordinator of this site? Confirm its status | Chernivtsi | Ukraine | Recruiting |
| Research Site 91 Coordinator of this site? Confirm its status | Ivano-Frankivsk | Ukraine | Recruiting |
| Research Site 108 Coordinator of this site? Confirm its status | Kyiv | Ukraine | Recruiting |
| Research Site 76 Coordinator of this site? Confirm its status | Kyiv | Ukraine | Recruiting |
| Research Site 44 Coordinator of this site? Confirm its status | Kyiv | Ukraine | Recruiting |
| Research Site 82 Coordinator of this site? Confirm its status | Kyiv | Ukraine | Recruiting |
| Research Site 52 Coordinator of this site? Confirm its status | Kyiv | Ukraine | Recruiting |
| Research Site 74 Coordinator of this site? Confirm its status | Kyiv | Ukraine | Recruiting |
| Research Site 64 Coordinator of this site? Confirm its status | Lutsk | Ukraine | Recruiting |
| Research Site 60 Coordinator of this site? Confirm its status | Vinnytsia | Ukraine | Recruiting |
| Research Site 50 Coordinator of this site? Confirm its status | Vinnytsia | Ukraine | Recruiting |
| Research Site 61 Coordinator of this site? Confirm its status | Vinnytsia | Ukraine | Recruiting |
| Research Site 83 Coordinator of this site? Confirm its status | Vinnytsia | Ukraine | Recruiting |
| Research Site 13 Coordinator of this site? Confirm its status | Bakersfield | United States | Recruiting |
| Research Site 150 Coordinator of this site? Confirm its status | Colchester | United States | Recruiting |
| Research Site 11 Coordinator of this site? Confirm its status | Dayton | United States | Recruiting |
| Research Site 20 Coordinator of this site? Confirm its status | Fall River | United States | Recruiting |
| Research Site 153 Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Research Site 12 Coordinator of this site? Confirm its status | Inglewood | United States | Recruiting |
| Research Site 114 Coordinator of this site? Confirm its status | Kansas City | United States | Recruiting |
| Research Site 65 Coordinator of this site? Confirm its status | Lancaster | United States | Recruiting |
| Research Site 06 Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| Research Site 03 Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| Research Site 69 Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Research Site 21 Coordinator of this site? Confirm its status | Oklahoma City | United States | Recruiting |
| Research 09 Coordinator of this site? Confirm its status | Orlando | United States | Recruiting |
| Research Site 16 Coordinator of this site? Confirm its status | Rock Hill | United States | Recruiting |
| Research Site 17 Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| Research Site 136 Coordinator of this site? Confirm its status | Southfield | United States | Recruiting |
| Research Site 134 Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| Research Site 07 Coordinator of this site? Confirm its status | Sugar Land | United States | Recruiting |
| Research Site 01 Coordinator of this site? Confirm its status | Tamarac | United States | Recruiting |
| Research Site 05 Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
| Research Site 04 Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
| Research Site 10 Coordinator of this site? Confirm its status | West Covina | United States | Recruiting |
| Research Site 08 Coordinator of this site? Confirm its status | Williamsburg | United States | Recruiting |
| Research Site 02 Coordinator of this site? Confirm its status | Ypsilanti | United States | Recruiting |
| Research Site 93 Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Recruiting |
| Research Site 111 Coordinator of this site? Confirm its status | Antalya | Turkey (Türkiye) | Recruiting |
| Research Site 78 Coordinator of this site? Confirm its status | Antalya | Turkey (Türkiye) | Recruiting |
| Research Site 102 Coordinator of this site? Confirm its status | Bursa | Turkey (Türkiye) | Recruiting |
| Research Site 135 Coordinator of this site? Confirm its status | Denizli | Turkey (Türkiye) | Recruiting |
| Research Site 109 Coordinator of this site? Confirm its status | Samsun | Turkey (Türkiye) | Recruiting |
| Research Site 77 Coordinator of this site? Confirm its status | Trabzon | Turkey (Türkiye) | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.