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Um Estudo para Investigar a Terapêutica Adjuvante com GB-0895 em Adultos e Adolescentes com Asma Grave Não Controlada (SOLAIRIA-1)

12 de novembro de 2026 atualizado por: Generate Biomedicines

Um Estudo de Fase 3, Randomizado, Duplo-Cego, Controlado por Placebo para Avaliar a Eficácia e Segurança da Terapia Adjuvante com GB-0895 em Adultos e Adolescentes com Asma Grave Não Controlada

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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

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/Run-In (Weeks -5 to 0)
  • Treatment (Weeks 0 to 52)
  • Follow-up (Weeks 52 to 90) or optional open-label extension (OLE, Weeks 52 to 142)

Tipo de estudo

Intervencional

Inscrição (Estimado)

786

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

12 anos a 80 anos (Filho, Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

  1. Adults and adolescents ≥ 12 and ≤ 80 years of age.
  2. Documented diagnosis of asthma for > 12 months.
  3. 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.
  4. 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.
  5. Adults ≥ 18 years of age at Screening Visit 1, a pre-BD FEV1 <80% predicted at Screening Visit 1.
  6. 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.
  7. 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.
  8. ACQ-6 score ≥ 1.5 at the Screening Visit.
  9. Weight ≥40 kg at the Screening Visit 1

Exclusion Criteria:

  1. 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.
  2. 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.
  3. Eosinophilic disease (e.g., eosinophilic granulomatosis with polyangiitis).
  4. 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.
  5. Clinically significant infection that is unresolved and requires systemic antibiotic, antifungal, antiparasitic, or antiviral medications preceding enrollment.
  6. A current malignancy or previous history of cancer within 5 years before screening.
  7. Clinically significant infection that is not resolved before study enrollment.
  8. 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.
  9. Current smokers or subjects with a smoking history ≥10 pack-years, and subjects using vaping products, including electronic cigarettes.
  10. 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.
  11. Hepatitis B, C, or HIV.
  12. 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.
  13. 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.
  14. 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.
  15. Treatment with systemic immunosuppressive/immunomodulating drugs (e.g., methotrexate, cyclosporine) within 12 weeks prior to randomization.
  16. 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.
  17. Known history of sensitivity to any component of the study treatment formulation.
  18. History of life-threatening anaphylaxis following any biologic therapy.
  19. Concurrent enrollment in another clinical study involving investigational product (IP).
  20. Subject has been randomized in the current study or previous GB-0895 studies.
  21. 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.
  22. Cirrhosis (with or without hepatic dysfunction) or other active or clinically significant liver disease.
  23. Receipt of immunoglobulin or blood products within 30 days before Screening Visit 1.
  24. Receipt of live attenuated vaccines within 30 days before randomization and during the study, including the follow-up period.
  25. Receipt of the T2 cytokine inhibitor suplatast tosilate within 15 days before Screening Visit 1.
  26. Subjects treated with bronchial thermoplasty in the last 12 months before Screening Visit 1.
  27. Unwillingness or inability to follow study procedures, including poor adherence to asthma controller medications, in the opinion of the Investigator.
  28. Women who are pregnant, lactating, or planning to become pregnant during the study.
  29. History (or suspected history) of alcohol misuse or substance abuse within 2 years before Screening Visit 1.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Triplo

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: GB-0895

GB-0895 Subcutaneous (SC) injection
Medicamento: GB-0895

Study Drug
Comparador de Placebo: Placebo

Placebo Subcutaneous (SC) injection
Medicamento: Placebo

Placebo

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
To evaluate the annualized asthma exacerbation rate (AAER) in adult and adolescent subjects with severe uncontrolled asthma.
Prazo: From Day 1 (randomization) to Week 52

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.
From Day 1 (randomization) to Week 52

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
To evaluate the annualized asthma exacerbation rate (AAER) in adult and adolescent subjects with severe uncontrolled asthma and baseline eosinophils (EOS) < 300 cells/µL.
Prazo: From Day 1 (randomization) to Week 52

The annual exacerbation rate is based on clinically significant (CS) exacerbations for subjects with baseline EOS < 300 cells/ µL on GB-0895 as compared to placebo.
From Day 1 (randomization) to Week 52
Change from baseline in pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1)
Prazo: From Day 1 (randomization) to Study Week 52

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.
From Day 1 (randomization) to Study Week 52
Change from baseline in Asthma Quality of Life Questionnaire AQLQ(S)12+ score
Prazo: From Day 1 (randomization) to Week 52

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.
From Day 1 (randomization) to Week 52
Change from baseline in Asthma Control Questionnaire (ACQ-6) score
Prazo: From Day 1 (randomization) to Week 52

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.
From Day 1 (randomization) to Week 52
Time to first asthma exacerbation from randomization
Prazo: From Day 1 (randomization) to Week 52

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.
From Day 1 (randomization) to Week 52
Change from baseline in weekly mean daily Asthma Daytime Symptom Diary (ADSD)
Prazo: From Day 1 (randomization) to Week 52

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.
From Day 1 (randomization) to Week 52
Change from baseline in weekly mean daily Asthma Nighttime Symptom (ANSD)
Prazo: From Day 1 (randomization) to Week 52

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.
From Day 1 (randomization) to Week 52
Change from baseline in St. George's Respiratory Questionnaire (SGRQ) total score
Prazo: From Day 1 (randomization) to Week 52

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
From Day 1 (randomization) to Week 52
Change from baseline in the 5-Level EuroQol 5 dimensions questionnaire (EQ-5D-5L) score
Prazo: From Day 1 (randomization) to Week 52

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.
From Day 1 (randomization) to Week 52
PGI-S response at Week 52
Prazo: From Day 1 (randomization) to 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.
From Day 1 (randomization) to Week 52
ACQ-6 response at Week 52
Prazo: From Day 1 (randomization) to Week 52

The Asthma Control Questionnaire-6 (ACQ-6) at Week 52 defined as an improvement in score of 0.5 or more.
From Day 1 (randomization) to Week 52
AQLQ(S)12+ response at Week 52
Prazo: From Day 1 (randomization) to 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.
From Day 1 (randomization) to Week 52
SGRQ response at Week 52
Prazo: From Day 1 (randomization) to Week 52

The St. George's Respiratory Questionnaire at week 52 defined as achieving ≥ 4-point reduction from baseline.
From Day 1 (randomization) to Week 52
PGI-C responder at Week 52
Prazo: From Day 1 (randomization) to 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.
From Day 1 (randomization) to Week 52
To evaluate the effect of GB-0895 on asthma exacerbations associated with Emergency Room or Hospitalization Visits
Prazo: From Day 1 (randomization) to Week 52

The time to first clinically significant asthma exacerbation, from randomization, requiring hospitalization or emergency room visit.
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
Prazo: From Day 1 (randomization) to Week 52

The AAER associated with clinically significant exacerbations associated with hospital or emergency room visits over 52 weeks.
From Day 1 (randomization) to Week 52
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Prazo: From Day 1 (randomization) to Week 52

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).
From Day 1 (randomization) to Week 52
Clinical Laboratory Evaluations
Prazo: From Day 1 (randomization) to Week 52

The absolute values and changes from baseline of clinical laboratory evaluations over time.
From Day 1 (randomization) to Week 52
Vital Signs
Prazo: From Day 1 (randomization) to Week 52

The absolute values and changes from baseline of vital signs over time.
From Day 1 (randomization) to Week 52
ECGs (electrocardiogram)
Prazo: From Day 1 (randomization) to Week 52

The absolute values and changes from baseline of ECGs over time.
From Day 1 (randomization) to Week 52
Immunogenicity of GB-0895
Prazo: From Day 1 (randomization) to Week 52

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.
From Day 1 (randomization) to Week 52

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Generate Biomedicines

Investigadores

  • Diretor de estudo: Snodgres, Generate Biomedicines

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

3 de dezembro de 2025

Conclusão Primária (Estimado)

1 de dezembro de 2028

Conclusão do estudo (Estimado)

1 de dezembro de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

1 de dezembro de 2025

Enviado pela primeira vez que atendeu aos critérios de CQ

1 de dezembro de 2025

Primeira postagem (Real)

11 de dezembro de 2025

Atualizações de registro de estudo

Última Atualização Postada (Real)

13 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

12 de novembro de 2026

Última verificação

1 de dezembro de 2025

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • GB-0895-301 (SOLAIRIA-1)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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