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Determinar a eficácia do anifrolumabe na esclerose sistêmica (DAISY) (DAISY)

29 de setembro de 2026 atualizado por: AstraZeneca

Um estudo de fase III multicêntrico, randomizado, de grupos paralelos, duplo-cego e de dois braços para avaliar a segurança e a eficácia do anifrolumabe em comparação com o placebo em participantes do sexo masculino e feminino de 18 a 70 anos de idade, inclusive com esclerose sistêmica

The purpose of this study is to evaluate the efficacy and safety of treatment with subcutaneous anifrolumab versus placebo in adult participants with systemic sclerosis. The target population for this study includes patients who meet the 2013 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification for systemic sclerosis, either limited or diffuse cutaneous subsets, with a disease duration of less than 6 years from first non-Raynaud's phenomenon symptom.

Visão geral do estudo

Status

Ativo, não recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

This is a multicenter, randomized, double-blind, placebo-controlled, Phase III study to evaluate the efficacy and safety of anifrolumab in the treatment of adult participants with Systemic Sclerosis (SSc) who may be taking one or a combination of protocol-specified standard therapies. The use of one of the following standard immunosuppressant therapies is permitted at a stable dose, but not mandated: hydroxychloroquine, mycophenolate mofetil (MMF), mycophenolic acid or mycophenolate sodium (MPA/MPS), methotrexate, azathioprine, tacrolimus, and oral glucocorticoids. MMF or MPA/MPS, azathioprine, and methotrexate may be used in combination with hydroxychloroquine and/or low-dose oral glucocorticoids [≤ 10 mg/day].

Approximately 306 eligible participants will be randomized in a 1:1 ratio to receive either anifrolumab (or matching placebo) given subcutaneously once weekly for 52 weeks. The study will be stratified by the following factors:

  • Interstitial lung disease (ILD) (yes, no) at Week 0 (Day1);
  • MMF or MPA/MPS use (yes ,no) at Week 0 (Day 1); and
  • Disease duration, defined as the time from the first non-Raynaud's symptom attributable to SSc (<18 months, ≥ 18 months) at Week 0 (Day 1)

Study treatment will be administered subcutaneously via an accessorized prefilled syringe by study staff or by the participant or carer, either in the clinic or at home, with most doses being administered at home. The study consists of 4 periods: a 6-week screening period, a 52-week, double-blind, placebo-controlled period, a 52-week open-label active treatment period, and a 12-week safety follow-up period. There are a total of 16 study visits with most visits in the treatment period occurring every 8 to 12 weeks. The periods are described below:

  • Screening Period: This may involve one or more visits to the study site.
  • Double Blind Treatment Period: Treatment Period when participants will receive once weekly injections of anifrolumab or matching placebo. Participation will involve in-clinic study visits at Weeks 0 (Day 1), 1, 4, 8*, 16, 24, 36, 48 and 52. *The visit at Week 8 may be either by telephone or in person.
  • Open Label Treatment Period: At Week 52, all participants will be given anifrolumab (subcutaneous) once weekly for 52 weeks (last dose at Week 103). Participation will involve in-clinic study visits at Weeks 52, 53*, 56, 64, 76. 88 and 104. *The visit at Week 53 may be either by telephone or in person.
  • Safety Follow-up Period: All participants will return to the clinic for a 12-week post treatment visit. This will occur post Double Blind Treatment Period (Week 52 or Double Blind Period early discontinuation) or post Open Label Treatment Period (Week 104 or Open Label Period early discontinuation).

Tipo de estudo

Intervencional

Inscrição (Real)

314

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.

Locais de estudo

  • Alemanha
      • Freiburg im Breisgau, Alemanha, 79106
        • Research Site
      • Mainz, Alemanha, 55131
        • Research Site
      • Minden, Alemanha, 32429
        • Research Site
      • Münster, Alemanha, 48149
        • Research Site
      • Tübingen, Alemanha, 72076
        • Research Site
  • Bélgica
      • Ghent, Bélgica, B-9000
        • Research Site
      • Leuven, Bélgica, 3000
        • Research Site
  • Canadá
    • Alberta
      • Calgary, Alberta, Canadá, T2N 4Z6
        • Research Site
    • Ontario
      • Toronto, Ontario, Canadá, M5T 3L9
        • Research Site
    • Quebec
      • Montreal, Quebec, Canadá, H4J 1C5
        • Research Site
      • Montreal, Quebec, Canadá, H3T 1E2
        • Research Site
      • Québec, Quebec, Canadá, G1V 4K5
        • Research Site
  • China
      • Beijing, China, 100191
        • Research Site
      • Beijing, China, CN-100730
        • Research Site
      • Guangzhou, China, 510100
        • Research Site
      • Guangzhou, China, 510530
        • Research Site
      • Hangzhou, China, 310014
        • Research Site
      • Lanzhou, China, 730000
        • Research Site
      • Shanghai, China, 200032
        • Research Site
      • Shanghai, China, 201210
        • Research Site
      • Tianjin, China, 300050
        • Research Site
  • Coréia do Sul
      • Busan, Coréia do Sul, 49241
        • Research Site
      • Seoul, Coréia do Sul, 03080
        • Research Site
      • Seoul, Coréia do Sul, 04763
        • Research Site
      • Seoul, Coréia do Sul, 04401
        • Research Site
      • Seoul, Coréia do Sul, 137-701
        • Research Site
  • Espanha
      • A Coruña, Espanha, 15006
        • Research Site
      • Barcelona, Espanha, 08041
        • Research Site
      • Barcelona, Espanha, 08003
        • Research Site
      • Madrid, Espanha, 28041
        • Research Site
      • Málaga, Espanha, 29009
        • Research Site
      • Valencia, Espanha, 46026
        • Research Site
      • Valencia, Espanha, 46017
        • Research Site
  • Estados Unidos
    • Arizona
      • Scottsdale, Arizona, Estados Unidos, 85259
        • Research Site
    • California
      • Chula Vista, California, Estados Unidos, 91910
        • Research Site
      • Los Angeles, California, Estados Unidos, 90095
        • Research Site
      • Orange, California, Estados Unidos, 92868
        • Research Site
    • Colorado
      • Aurora, Colorado, Estados Unidos, 80045
        • Research Site
    • Connecticut
      • New Haven, Connecticut, Estados Unidos, 06519
        • Research Site
    • District of Columbia
      • Washington D.C., District of Columbia, Estados Unidos, 20007
        • Research Site
    • Florida
      • Boca Raton, Florida, Estados Unidos, 33486
        • Research Site
      • Fort Lauderdale, Florida, Estados Unidos, 33309
        • Research Site
      • Gainesville, Florida, Estados Unidos, 32603
        • Research Site
      • Jacksonville, Florida, Estados Unidos, 32216
        • Research Site
      • Margate, Florida, Estados Unidos, 33063
        • Research Site
      • South Miami, Florida, Estados Unidos, 33143
        • Research Site
      • Tamarac, Florida, Estados Unidos, 33321
        • Research Site
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60611
        • Research Site
    • Kansas
      • Kansas City, Kansas, Estados Unidos, 66160
        • Research Site
    • Louisiana
      • New Orleans, Louisiana, Estados Unidos, 70121
        • Research Site
    • Maryland
      • Baltimore, Maryland, Estados Unidos, 21224
        • Research Site
    • Michigan
      • Ann Arbor, Michigan, Estados Unidos, 48109
        • Research Site
    • Minnesota
      • Rochester, Minnesota, Estados Unidos, 55905
        • Research Site
    • New York
      • Babylon, New York, Estados Unidos, 11702
        • Research Site
      • New York, New York, Estados Unidos, 10032
        • Research Site
    • Ohio
      • Cincinnati, Ohio, Estados Unidos, 45219
        • Research Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Estados Unidos, 15213
        • Research Site
    • Texas
      • Allen, Texas, Estados Unidos, 75013
        • Research Site
      • Houston, Texas, Estados Unidos, 77030
        • Research Site
  • França
      • Bordeaux, França, 33076
        • Research Site
      • Brest, França, 29609
        • Research Site
      • Paris, França, 75020
        • Research Site
      • Paris, França, 75679
        • Research Site
      • Rennes, França, 35033
        • Research Site
      • Strasbourg, França, 67098
        • Research Site
      • Toulouse, França, 31059
        • Research Site
  • Holanda
      • Groningen, Holanda, 9713 GZ
        • Research Site
  • Hungria
      • Budapest, Hungria, 1027
        • Research Site
      • Budapest, Hungria, 1023
        • Research Site
      • Budapest, Hungria, 1138
        • Research Site
      • Debrecen, Hungria, 4032
        • Research Site
      • Pécs, Hungria, 7632
        • Research Site
      • Szeged, Hungria, 6725
        • Research Site
  • Israel
      • Afula, Israel, 18101
        • Research Site
      • Haifa, Israel, 31096
        • Research Site
      • Haifa, Israel, 31048
        • Research Site
      • Jerusalem, Israel, 00000
        • Research Site
      • Kfar Saba, Israel, 4428164
        • Research Site
      • Ramat Gan, Israel, 52621
        • Research Site
  • Itália
      • Ancona, Itália, 60126
        • Research Site
      • Brescia, Itália, 25123
        • Research Site
      • Cona, Itália, 44124
        • Research Site
      • Milan, Itália, 20122
        • Research Site
      • Padova, Itália, 35128
        • Research Site
      • Roma, Itália, 00168
        • Research Site
      • Roma, Itália, 00128
        • Research Site
      • Roma, Itália, 161
        • Research Site
  • Japão
      • Bunkyō City, Japão, 113-8603
        • Research Site
      • Fukuoka, Japão, 812-8582
        • Research Site
      • Iruma-Gun, Japão, 350-0495
        • Research Site
      • Kanazawa, Japão, 920-8641
        • Research Site
      • Maebashi, Japão, 371-8511
        • Research Site
      • Nagasaki, Japão, 852-8501
        • Research Site
      • Nagoya, Japão, 457-0866
        • Research Site
      • Sapporo, Japão, 060-8638
        • Research Site
      • Sendai, Japão, 980-8574
        • Research Site
      • Shinjuku-ku, Japão, 160-8582
        • Research Site
      • Suita-shi, Japão, 565-0871
        • Research Site
      • Takatsuki-shi, Japão, 569-8686
        • Research Site
      • Toyoake-shi, Japão, 470-1192
        • Research Site
      • Yokohama, Japão, 236-0004
        • Research Site
  • Malásia
      • Kuala Lumpur, Malásia, 59100
        • Research Site
      • Kuching, Malásia, 93586
        • Research Site
      • Seremban, Malásia, 70300
        • Research Site
  • México
      • Chihuahua City, México, 31000
        • Research Site
      • Guadalajara, México, 44650
        • Research Site
      • Guadalajara, México, 44158
        • Research Site
      • Mexico City, México, 06700
        • Research Site
      • San Luis Potosí City, México, 78250
        • Research Site
      • San Luis Potosí City, México, 78213
        • Research Site
  • Polônia
      • Bydgoszcz, Polônia, 85-168
        • Research Site
      • Krakow, Polônia, 30-002
        • Research Site
      • Krakow, Polônia, 30-105
        • Research Site
      • Lodz, Polônia, 90-549
        • Research Site
      • Sosnowiec, Polônia, 41-200
        • Research Site
      • Warsaw, Polônia, 00-874
        • Research Site
  • Reino Unido
      • Cannock, Reino Unido, WS11 2XY
        • Research Site
      • Leeds, Reino Unido, LS7 4SA
        • Research Site
      • London, Reino Unido, NW3 2QG
        • Research Site
      • Sheffield, Reino Unido, S10 2JF
        • Research Site
  • Romênia
      • Bucharest, Romênia, 011172
        • Research Site
      • Bucharest, Romênia, 020475
        • Research Site
      • Cluj-Napoca, Romênia, 400006
        • Research Site
      • Iași, Romênia, 700661
        • Research Site
  • Turquia (Türkiye)
      • Ankara, Turquia (Türkiye), 06100
        • Research Site
      • Ankara, Turquia (Türkiye), 06230
        • Research Site
      • Antalya, Turquia (Türkiye), 07059
        • Research Site
      • Center, Turquia (Türkiye), 23200
        • Research Site
      • Kazımkarabekir, Turquia (Türkiye), 01230
        • Research Site
      • Kocaeli, Turquia (Türkiye), 41380
        • Research Site
  • Vietnã
      • Hanoi, Vietnã, 10000
        • Research Site
      • Ho Chi Minh City, Vietnã, 700000
        • Research Site
      • Ho Chi Minh City, Vietnã, 70000
        • Research Site
      • Hochiminh, Vietnã, 70000
        • Research Site
      • Hà Nội, Vietnã, 100000
        • Research Site
  • África do Sul
      • Parktown, África do Sul, 2193
        • Research Site
      • Pretoria, África do Sul, 0083
        • Research Site
  • Áustria
      • Graz, Áustria, 8036
        • Research Site
      • Innsbruck, Áustria, 6020
        • Research Site
      • Vienna, Áustria, 1090
        • Research Site
  • Índia
      • Ahmedabad, Índia, 380006
        • Research Site
      • Delhi, Índia, 110060
        • Research Site
      • Gurugram, Índia, 122001
        • Research Site
      • Hyderabad, Índia, 500082
        • Research Site
      • Kolkata, Índia, 700020
        • Research Site
      • Mumbai, Índia, 400053
        • Research Site
      • Mysuru, Índia, 570004
        • Research Site
      • New Delhi, Índia, 11029
        • Research Site
      • Pune, Índia, 411001
        • Research Site
      • Secunderabad, Índia, 500003
        • Research Site

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

18 anos a 70 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Key Inclusion Criteria:

  1. Adult patients from 18 to 70 years of age inclusive
  2. Systemic sclerosis according to 2013 ACR/EULAR classification criteria
  3. Limited or diffuse cutaneous subsets
  4. Systemic sclerosis disease duration within 6 years from first non-Raynaud's phenomenon manifestation at the time of signing the ICF
  5. Either HAQ-DI score ≥ 0.25 points or PtGA score ≥ 3 points
  6. mRSS > 10 with early disease or rapid progression as defined by the protocol
  7. mRSS ≥ 15 with disease duration ≥ 18 months and active disease as defined by the protocol
  8. Stable background therapies can be used including hydroxychloroquine, methotrexate, azathioprine, mycophenolate mofetil, mycophenolate sodium, mycophenolic acid, oral glucocorticoids or tacrolimus
  9. Women of childbearing potential with a negative urine pregnancy test
  10. Uninvolved skin at injection sites

Key Exclusion Criteria:

  1. Anticentromere antibody seropositivity on central laboratory
  2. Severe cardiopulmonary disease as defined by the protocol
  3. History of systemic sclerosis renal crisis within past 12 months (estimated glomerular filtration rate(eGFR) < 45 mL/min/1.73m2)
  4. Overlap syndromes, systemic lupus erythematosus with anti-double-stranded deoxyribonucleic acid antibody seropositivity or anti-citrullinated protein antibodies-positive rheumatoid arthritis, or SSc mimics (eg, scleromyxedema, eosinophilic fasciitis)
  5. History of, or current, any other inflammatory diseases, eg, inflammatory bowel disease, skin disease, that, in the opinion of the investigator, could interfere with efficacy and safety assessments or require immunomodulatory therapy
  6. Evidence of moderately severe concurrent nervous system, renal, endocrine, hepatic (eg, underlying chronic liver disease [Child Pugh A, B, C hepatic impairment]), or gastrointestinal disease (eg, clinical signs of malabsorption or needing parenteral nutrition) not related to SSc, as determined by the investigator
  7. Hematopoietic stem cell transplantation or solid organ/limb transplantation
  8. Any severe case of Herpes Zoster infection as defined by the protocol
  9. Known malignancy or a history of malignancy within 5 years, with exception of excised/cured local basal or squamous cell carcinoma of the skin or carcinoma in situ of the uterine cervix
  10. Major surgery within 8 weeks prior to and/or during study enrollment
  11. Known active current or history of recurrent infections
  12. Any condition that, in the opinion of the investigator or AstraZeneca, would interfere with the efficacy or safety evaluation of the study intervention or put participant at safety risk

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: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Anifrolumab (subcutaneous weekly injection)

Anifrolumab subcutaneous injection once weekly
Produto combinado: Anifrolumab (blinded)

Anifrolumab treatment delivered subcutaneously, once weekly for 52 weeks

Outros nomes:
  • Braço de tratamento (cego)
Produto combinado: Anifrolumab (unblinded, open label)

At Week 52, all patients will receive Anifrolumab subcutaneously once weekly for 52 weeks

Outros nomes:
  • Braço de tratamento (não cego)
Comparador de Placebo: matched placebo control (subcutaneous weekly injection)

matched placebo control subcutaneous injection once weekly
Medicamento: Placebo (blinded)

matched placebo delivered subcutaneously, once weekly for 52 weeks

Outros nomes:
  • Braço placebo (cego)

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Number of participants responding to treatment based on the Revised Composite Response Index in Systemic Sclerosis (CRISS-25)
Prazo: at Week 52

Number of participants meeting all the criteria:

  • Improvement in at least 2 components (≥5% increase for percent predicted Forced Vital Capacity (FVC) and/or≥25% decrease for Modified Rodnan Skin Score (mRSS), Health Assessment Questionnaire Disability Index (HAQ-DI), Patient Global Assessment (PtGA), Clinician Global Assessment (CGA)
  • Worsening in no more than one component (≥5% decrease percent predicted FVC and/or≥25% increase for mRSS, HAQ-DI, PtGA, CGA)
  • No significant SSc-related event as defined by:

New scleroderma renal crisis New decline in percent predicted FVC≥15% in established interstitial lung disease or new percent predicted FVC below 80% predicted New onset of left ventricular failure requiring treatment New onset of pulmonary arterial hypertension requiring treatment Gastrointestinal dysmotility requiring enteral or parenteral nutrition Digital ischemia with gangrene, amputation, or hospitalization requiring treatment

-Otherwise, a participant is a non-responder
at Week 52

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change from baseline in mRSS
Prazo: at Week 52

Change from baseline in mRSS score. The mRSS scoring ranges from 0 (normal) to 51 (severe).
at Week 52
Number of patients with improvement in individual revised Composite Response Index in Systemic Sclerosis (CRISS-25)
Prazo: at Week 52

Number of participants who have improvements in the following improvement components, evaluated separately:

  • ≥ 5% increase in percent predicted Forced Vital Capacity (FVC)
  • ≥ 25% decrease in mRSS
  • ≥ 25% decrease in HAQ-DI
  • ≥25% decrease in PtGA
  • ≥25% decrease in CGA
at Week 52
Change from baseline in chest computed tomography imaging
Prazo: at Week 52

Change from baseline in quantitative interstitial lung disease score
at Week 52
Change from baseline in Scleroderma Skin Patient Reported Outcome
Prazo: at Week 52

Change from baseline in the Scleroderma Skin Patient Reported Outcome scores
at Week 52
Change from baseline in FVC
Prazo: at Week 52
  1. Change from baseline in FVC (ml) in patients with interstitial lung disease
  2. Change from baseline in FVC (ml) in all patients
at Week 52
Change from baseline in percent predicted FVC
Prazo: at Week 52
  1. Change from baseline in percent predicted FVC in patients with interstitial lung disease
  2. Change from baseline in percent predicted FVC in all patient
at Week 52
Anifrolumab pharmacokinetic parameters in serum
Prazo: Weeks 4, 16, 24, 36, 52, 56, 76, and 104 to follow-up (max 116 weeks)

Anifrolumab serum concentrations will be summarised using descriptive statistics at each visit. Due to sparse pharmacokinetic sampling, the pharmacokinetic assessment will be primarily based on observed serum trough concentrations (Ctrough)
Weeks 4, 16, 24, 36, 52, 56, 76, and 104 to follow-up (max 116 weeks)
Anifrolumab pharmacodynamics via changes in type I IFN 21-gene signature generated from blood
Prazo: Double-blind treatment period: pre-dose (Day 1) Weeks 4, 16, 24, 52; open-label period: weeks 56, 76 and 104

Type I Interferon inducible gene signature will be assessed by a 21-gene assay in whole blood. The suppression of the type I IFN 21-gene signature will be showed as a percent of baseline through study completion, during both the double-blind treatment and open label periods.
Double-blind treatment period: pre-dose (Day 1) Weeks 4, 16, 24, 52; open-label period: weeks 56, 76 and 104
Prevalence of anti-drug antibodies to Anifrolumab
Prazo: Weeks 4, 16, 24, 36, 52, 56, 76, and 104 to follow-up (max 116 weeks)

Anti-drug antibodies and titer determination in anti-drug antibody positive participants. The presence of neutralizing anti-drug antibodies will also be tested in all anti-drug positive samples.
Weeks 4, 16, 24, 36, 52, 56, 76, and 104 to follow-up (max 116 weeks)
Incidence of adverse events
Prazo: From screening to follow-up (max 126 weeks)

Adverse events (non-serious, serious, and adverse event of special interest (AESI)) are assessed as variables of safety and tolerability of anifrolumab.

The AESIs are non-opportunistic serious infections, opportunistic infections, malignancy, herpes zoster, Tuberculosis (TB) (including latent TB), injection site reactions, and major adverse cardiac events.
From screening to follow-up (max 126 weeks)
Incidence of abnormal vital signs
Prazo: From screening to follow-up (max 126 weeks)

Change from baseline of pulse rate, blood pressure, respiration rate, and body temperature will be assessed by visit and treatment group including participants with treatment-emergent changes.
From screening to follow-up (max 126 weeks)
Incidence of abnormal laboratory parameters
Prazo: From screening to follow-up (max 126 weeks)

Changes from baseline in haematology, clinical chemistry and lipid variables will be assessed by visit and treatment including participants with treatment-emergent changes.
From screening to follow-up (max 126 weeks)
Incidence of abnormal ECG findings
Prazo: From screening to end of treatment visit (max 110 weeks)

Observed values of heart rate, QRS duration, PR interval, RR interval and QT interval will be summarised by visit and treatment group including participants with clinically significant abnormal results.
From screening to end of treatment visit (max 110 weeks)
Incidence of abnormal physical exam findings
Prazo: From screening to follow-up (max 126 weeks)

Changes from baseline in weight (kilograms) will be assessed by visit and treatment and medically significant changes from the screening physical examination will be recorded as adverse events.
From screening to follow-up (max 126 weeks)
Number of subjects with suicidal ideation and behavior and suicide attempts via Columbia-Suicide Severity Rating Scale (C-SSRS)
Prazo: From screening to follow-up (max 126 weeks)

The C-SSRS is used to assess suicidal ideation, behavior, and suicide on a graded scale from 1 to 5. 1 indicates as low suicidal and 5 as high suicidal behavior.
From screening to follow-up (max 126 weeks)
Total score of Personal Health Questionnaire Depression Scale-8 (PHQD-8)
Prazo: From screening to follow-up (max 126 weeks)

PHQ-8 is an 8-item self-report scale, all items are rated on a score of 0-3, for a total range of 0-24. PHQD-8 assesses symptoms of depression over the previous 2 weeks. Higher scores indicate more depressive symptoms.
From screening to follow-up (max 126 weeks)

Colaboradores e Investigadores

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

Patrocinador

AstraZeneca

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

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)

8 de novembro de 2023

Conclusão Primária (Estimado)

6 de janeiro de 2027

Conclusão do estudo (Estimado)

5 de abril de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

2 de junho de 2023

Enviado pela primeira vez que atendeu aos critérios de CQ

22 de junho de 2023

Primeira postagem (Real)

29 de junho de 2023

Atualizações de registro de estudo

Última Atualização Postada (Real)

30 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

29 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • D3460C00002
  • 2023-505976-31 (Outro identificador: EuCTR)
  • 2023 (Concessão/Contrato do NIH dos EUA)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AstraZeneca disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AstraZeneca group of companies sponsored clinical trials are accepting requests for IPD, but this does not mean all requests will be shared.

Prazo de Compartilhamento de IPD

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. The timelines vary per request and can take up to a year upon full submission of the request for analysis, decision, anonymisation and sharing of the requested data or documents. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Critérios de acesso de compartilhamento IPD

When a request has been approved, AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA

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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