NCT07276724RecruitingPhase 3
A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma (SOLAIRIA-1)
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 22 Oct 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
- 1 Dec 2025
- Start date
- 3 Dec 2025
- Primary completion date
- Dec 2028
- Lead sponsor
- Generate Biomedicines
- Diseases
- Asthma
- NCT number
- NCT07276724
- EU CT number
- 2025-521950-41-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 786
- From 3 Dec 2025 to the primary completion date, Dec 2028
- 141 sites in 18 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 design.
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 (141)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical Center Pulmo - 2018 EOOD Coordinator of this site? Confirm its status | Haskovo | Bulgaria | Recruiting |
| Medical Center Zdrave-1 OOD Coordinator of this site? Confirm its status | Kozloduy | Bulgaria | Recruiting |
| Medical Center Medconsult Pleven OOD Coordinator of this site? Confirm its status | Pleven | Bulgaria | Recruiting |
| DCC V Plovdiv St. Archbishop Luka EOOD Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Recruiting |
| Specialized Hospital For Active Treatment Of Pneumo-Phthisiatric Diseases Dr. Dimitar Gramatikov-Ruse Coordinator of this site? Confirm its status | Ruse | Bulgaria | Recruiting |
| Medical Center Hermes Ruse Ltd. Coordinator of this site? Confirm its status | Ruse | Bulgaria | Recruiting |
| Multiprofile Hospital for Active Treatment "Knyaginya Klementina" - Sofia EAD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Recruiting |
| Alexandrovska University Hospital Coordinator of this site? Confirm its status | Sofia | Bulgaria | Recruiting |
| Medical Center Pulmovision Ltd. Coordinator of this site? Confirm its status | Sofia | Bulgaria | Recruiting |
| Multispecialty hospital for active treatment Sveta Sofia EOOD Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Recruiting |
| Diagnostics And Consultation Center Convex Ltd. Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Recruiting |
| Medical Center Excelsior OOD Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Recruiting |
| University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Recruiting |
| Medical Center Sv. Ivan Rilski EOOD Coordinator of this site? Confirm its status | Vidin | Bulgaria | Recruiting |
| - Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Recruiting |
| - Coordinator of this site? Confirm its status | Salvador | Brazil | Recruiting |
| - Coordinator of this site? Confirm its status | Santo André | Brazil | Recruiting |
| - Coordinator of this site? Confirm its status | São Bernardo do Campo | Brazil | Recruiting |
| - Coordinator of this site? Confirm its status | Curicó | Chile | Recruiting |
| - Coordinator of this site? Confirm its status | Providencia | Chile | Recruiting |
| - Coordinator of this site? Confirm its status | Temuco | Chile | Recruiting |
| - Coordinator of this site? Confirm its status | Temuco | Chile | Recruiting |
| Fakultni nemocnice Brno Coordinator of this site? Confirm its status | Brno | Czechia | Recruiting |
| Alergopraktik s.r.o. Coordinator of this site? Confirm its status | Jablonec Nad Nisou | Czechia | Recruiting |
| MEDITRIAL s.r.o. Coordinator of this site? Confirm its status | Jindrichuv Hradec III | Czechia | Recruiting |
| Prvni plicni ambulance s.r.o. Coordinator of this site? Confirm its status | Prague 9 | Czechia | Recruiting |
| Plicni Stredisko Teplice S.R.O Coordinator of this site? Confirm its status | Teplice | Czechia | Recruiting |
| PNEUMOLOGIE VARNSDORF s.r.o. Coordinator of this site? Confirm its status | Varnsdorf | Czechia | Recruiting |
| Studienpraxis Berlin-Brandenburg Cornelia Seelbinder Und Lennart Schaper GbR Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Clinical Studies Pankow Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Lungenpraxis Hohenzollerndamm Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| MECS Research GmbH Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Medizinisches Versorgungszentrum Jung GbR Coordinator of this site? Confirm its status | Deggingen | Germany | Recruiting |
| Universitaetsklinikum Essen (AoR) Coordinator of this site? Confirm its status | Essen | Germany | Recruiting |
| Studienzentrum Dr. Keller Coordinator of this site? Confirm its status | Frankfurt | Germany | Recruiting |
| IKF Pneumologie GmbH & Co. KG Coordinator of this site? Confirm its status | Frankfurt am Main | Germany | Recruiting |
| Medical Center- University of Freiburg Coordinator of this site? Confirm its status | Freiburg im Breisgau | Germany | Recruiting |
| POIS Sachsen GmbH Coordinator of this site? Confirm its status | Leipzig | Germany | Recruiting |
| Berufsausuebungsgemeinschaft Bag Prof. Dr. Med Gerhard Hoheisel Dr. Med Andreas Bonitz GbR Coordinator of this site? Confirm its status | Leipzig | Germany | Recruiting |
| Velocity Clinical Research Germany GmbH Coordinator of this site? Confirm its status | Luebeck | Germany | Recruiting |
| Pneumologische Studienzentrum München-West Coordinator of this site? Confirm its status | München | Germany | Recruiting |
| Lungenpraxis - Fachärztliche Gemeinschaftspraxis Witten Coordinator of this site? Confirm its status | Witten | Germany | Recruiting |
| University General Hospital of Alexandroupoli Coordinator of this site? Confirm its status | Alexandroupoli | Greece | Recruiting |
| Athens Naval Hospital Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| University General Hospital of Heraklion Coordinator of this site? Confirm its status | Heraklion | Greece | Recruiting |
| University General Hospital of Ioannina Coordinator of this site? Confirm its status | Ioannina | Greece | Recruiting |
| Athens Medical Center S.A. Coordinator of this site? Confirm its status | Paleo Faliro | Greece | Recruiting |
| Geniko Nosokomeio Thessalonikis George Papanikolaou Coordinator of this site? Confirm its status | Thessaloniki | Greece | Recruiting |
| Clinical Hospital Dubrava Coordinator of this site? Confirm its status | Grad Zagreb | Croatia | Not yet recruiting |
| Djecja bolnica Srebrnjak Coordinator of this site? Confirm its status | Grad Zagreb | Croatia | Not yet recruiting |
| KBC Split Coordinator of this site? Confirm its status | Split | Croatia | Not yet recruiting |
| Pulmo Protect Kft. Coordinator of this site? Confirm its status | Budapest | Hungary | Recruiting |
| Obudai Egeszseguegyi Centrum Kft. Coordinator of this site? Confirm its status | Budapest III | Hungary | Recruiting |
| Clinic Of Pulmonology Semmelweis University Coordinator of this site? Confirm its status | Budapest Viii | Hungary | Recruiting |
| Bekes Varmegyei Koezponti Korhaz Coordinator of this site? Confirm its status | Gyula | Hungary | Recruiting |
| Szalay János Rendelőintézet Coordinator of this site? Confirm its status | Hajdúnánás | Hungary | Recruiting |
| Omnimodus Elixír Kft. Coordinator of this site? Confirm its status | Mosonmagyaróvár | Hungary | Recruiting |
| Papp es tarsa Bt. Coordinator of this site? Confirm its status | Szigetvar | Hungary | Recruiting |
| K & B Sleepmed Kft. Coordinator of this site? Confirm its status | Szombathely | Hungary | Recruiting |
| Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz Coordinator of this site? Confirm its status | Szombathely | Hungary | Recruiting |
| - Coordinator of this site? Confirm its status | Haifa | Israel | Recruiting |
| - Coordinator of this site? Confirm its status | Jerusalem | Israel | Recruiting |
| - Coordinator of this site? Confirm its status | Jerusalem | Israel | Recruiting |
| - Coordinator of this site? Confirm its status | Kfar Saba | Israel | Recruiting |
| - Coordinator of this site? Confirm its status | Petah Tikva | Israel | Recruiting |
| - Coordinator of this site? Confirm its status | Ramat Gan | Israel | Recruiting |
| - Coordinator of this site? Confirm its status | Tel Aviv | Israel | Recruiting |
| - Coordinator of this site? Confirm its status | Anyang-si | South Korea | Recruiting |
| - Coordinator of this site? Confirm its status | Busan | South Korea | Recruiting |
| - Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| - Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| - Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| - Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| - Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| - Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Veselibas centru apvieniba AS Coordinator of this site? Confirm its status | Daugavpils | Latvia | Recruiting |
| Consilium Medicum SIA Coordinator of this site? Confirm its status | Riga | Latvia | Recruiting |
| Pauls Stradins Clinical University Hospital Coordinator of this site? Confirm its status | Riga | Latvia | Recruiting |
| LOR Klinika Coordinator of this site? Confirm its status | Riga | Latvia | Recruiting |
| Medisch Spectrum Twente Coordinator of this site? Confirm its status | Enschede | Netherlands | Recruiting |
| Zuyderland Medisch Centrum Stichting Coordinator of this site? Confirm its status | Heerlen | Netherlands | Recruiting |
| - Coordinator of this site? Confirm its status | Lipa City | Philippines | Recruiting |
| - Coordinator of this site? Confirm its status | Marilao | Philippines | Recruiting |
| Unidade Local de Saúde de Coimbra, E.P.E. Coordinator of this site? Confirm its status | Coimbra | Portugal | Recruiting |
| Unidade Local De Saude Do Baixo Mondego Coordinator of this site? Confirm its status | Figueira Da Foz | Portugal | Recruiting |
| Unidade Local De Saude De Santa Maria E.P.E. Coordinator of this site? Confirm its status | Lisbon | Portugal | Recruiting |
| Unidade Local De Saude De Matosinhos E.P.E. Coordinator of this site? Confirm its status | Senhora Da Hora | Portugal | Recruiting |
| Theramed Healthcare S.R.L. Coordinator of this site? Confirm its status | Brasov | Romania | Recruiting |
| Anima Specialty Medical Services S.R.L. Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
| Arensia Clinics S.R.L. Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
| Spitalul Clinic Judetean De Urgenta Cluj Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Recruiting |
| Spitalul Clinic de Pneumoftiziologie Leon Daniello Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Recruiting |
| Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie "Victor Babeș" Craiova Coordinator of this site? Confirm its status | Craiova | Romania | Recruiting |
| Spital De Pneumologie Dr. Lavinia Davidescu S.R.L. Coordinator of this site? Confirm its status | Oradea | Romania | Recruiting |
| Cabinet Medical Pneumologie Pneumo Bronho Med Dr. Vancea Dorin Coordinator of this site? Confirm its status | Timisoara, Timis | Romania | Recruiting |
| - Coordinator of this site? Confirm its status | Singapore | Singapore | Recruiting |
| - Coordinator of this site? Confirm its status | Amarillo | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Baytown | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Brooksville | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Colorado Springs | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Columbia | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Doral | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Flint | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Gainesville | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Gastonia | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Glenview | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Hialeah | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Kendall | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Kerrville | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Lewisville | United States | Recruiting |
| - Coordinator of this site? Confirm its status | McKinney | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Miami Lakes | United States | Recruiting |
| - Coordinator of this site? Confirm its status | North Miami | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Northridge | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Olive Branch | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Palm Springs | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Pasadena | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Rancho Cucamonga | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Rincon | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Riverton | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
| - Coordinator of this site? Confirm its status | The Bronx | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Towson | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Valencia | United States | Recruiting |
| - Coordinator of this site? Confirm its status | West Hills | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Winston-Salem | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Cape Town | South Africa | Recruiting |
| - Coordinator of this site? Confirm its status | Cape Town | South Africa | Recruiting |
| - Coordinator of this site? Confirm its status | Durban | South Africa | Recruiting |
| - Coordinator of this site? Confirm its status | Johannesburg | South Africa | Recruiting |
| - Coordinator of this site? Confirm its status | Johannesburg | South Africa | Recruiting |
| - Coordinator of this site? Confirm its status | Johannesburg | South Africa | Recruiting |
| - Coordinator of this site? Confirm its status | KwaDukuza | South Africa | Recruiting |
| - Coordinator of this site? Confirm its status | Sydenham | South Africa | Recruiting |
| - Coordinator of this site? Confirm its status | Welkom | South Africa | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.