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Un estudio para evaluar los resultados del tratamiento con anifrolumab subcutáneo en lupus eritematoso sistémico sin tratamiento previo con inmunosupresores ni biológicos (SUNFLOWER)

9 de noviembre de 2026 actualizado por: AstraZeneca

Estudio multinacional, intervencional, de 52 semanas, abierto y de un solo brazo para evaluar los resultados del tratamiento con anifrolumab 120 mg subcutáneo una vez por semana en pacientes con lupus eritematoso sistémico sin tratamiento previo con inmunosupresores ni biológicos (SUNFLOWER)

The purpose of the SUNFLOWER study is to describe clinical outcomes, including DORIS remission, achieved following the initiation of anifrolumab 120 mg SC once weekly (QW) as add-on therapy to an anti-malarial, with or without GC; in patients not in LLDAS at enrolment.

Patients will be naïve to any prior conventional immunosuppressant including prior biologic therapy at enrolment. The study will also employ a tapering protocol for a systematic approach to GC tapering, seeking to understand better the proportion of patients in remission who can successfully withdraw chronic GC completely.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

In this study, approximately 275 participants will be enrolled and the study duration will be up to approximately 69 weeks, including: A Screening Period lasting up to 35 days and A 52-week treatment period. Also, participants not continuing treatment with any preparation of anifrolumab after Week 52 will have additional safety follow up 12 weeks after last dose of anifrolumab. Anifrolumab will be administered SC via an aPFS during the 52-week Study.

The study population will comprise participants taking antimalarial with or without GCs (there is a recruitment cap of 50% of patients not on GC at baseline) who are IS-naïve and biologic-naïve and are not meeting LLDAS criteria, described by the following cohorts:

  • Clinical SLEDAI 2K ≥4 points regardless of GC dose and disease duration.
  • Clinical SLEDAI-2K < 4 with GC ≥ 7.5 mg/day for > 5 weeks. After receiving the first dose of anifrolumab (week 0), the participant is allowed to increase the GC dose up until week 4, based on the investigator's recommendation. Between week 5 and week 40, participants taking >5 mg/day GC dose at study entry will attempt a protocolized taper to 5 mg/day over 12 weeks. Participants achieving DORIS remission for 2 consecutive visits will attempt complete withdrawal of GC following a 12-week tapering regimen. Starting week 41 until the end of the study (week 52), there will be no further reduction of GC dose.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

245

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Alemania
      • Bad Abbach, Alemania, 93077
        • Retirado
        • Research Site
      • Hamburg, Alemania, 22763
        • Aún no reclutando
        • Research Site
      • Mainz, Alemania, 55131
        • Aún no reclutando
        • Research Site
      • München, Alemania, 80336
        • Aún no reclutando
        • Research Site
  • Canadá
    • Alberta
      • Calgary, Alberta, Canadá, T2T 5C7
        • Aún no reclutando
        • Research Site
    • British Columbia
      • Richmond, British Columbia, Canadá, V6Z 1Y6
        • Aún no reclutando
        • Research Site
    • Manitoba
      • Winnipeg, Manitoba, Canadá, R3A 1M4
        • Aún no reclutando
        • Research Site
    • Ontario
      • Hamilton, Ontario, Canadá, L8N 3Z5
        • Aún no reclutando
        • Research Site
      • Toronto, Ontario, Canadá, M5T 2S8
        • Aún no reclutando
        • Research Site
  • España
      • Barcelona, España, 08035
        • Reclutamiento
        • Research Site
      • Barcelona, España, 08036
        • Reclutamiento
        • Research Site
      • Córdoba, España, 14004
        • Suspendido
        • Research Site
      • Galdakao, España, 48960
        • Reclutamiento
        • Research Site
      • Madrid, España, 28034
        • Reclutamiento
        • Research Site
      • Madrid, España, 28046
        • Reclutamiento
        • Research Site
      • Madrid, España, 28702
        • Reclutamiento
        • Research Site
      • Sabadell, España, 08208
        • Aún no reclutando
        • Research Site
      • Santander, España, 39008
        • Aún no reclutando
        • Research Site
      • Seville, España, 41014
        • Aún no reclutando
        • Research Site
      • Valencia, España, 46026
        • Aún no reclutando
        • Research Site
  • Estados Unidos
    • Alabama
      • Anniston, Alabama, Estados Unidos, 36207
        • Retirado
        • Research Site
      • Birmingham, Alabama, Estados Unidos, 35233
        • Reclutamiento
        • Research Site
    • Arizona
      • Phoenix, Arizona, Estados Unidos, 85032
        • Reclutamiento
        • Research Site
      • Tucson, Arizona, Estados Unidos, 85748
        • Reclutamiento
        • Research Site
    • California
      • Fontana, California, Estados Unidos, 92335
        • Aún no reclutando
        • Research Site
      • La Jolla, California, Estados Unidos, 92037
        • Reclutamiento
        • Research Site
      • La Palma, California, Estados Unidos, 90623
        • Reclutamiento
        • Research Site
      • Menifee, California, Estados Unidos, 92586
        • Reclutamiento
        • Research Site
      • San Leandro, California, Estados Unidos, 94578
        • Reclutamiento
        • Research Site
      • Temecula, California, Estados Unidos, 92592
        • Reclutamiento
        • Research Site
    • Florida
      • Brandon, Florida, Estados Unidos, 33511
        • Aún no reclutando
        • Research Site
      • Miami, Florida, Estados Unidos, 33136
        • Aún no reclutando
        • Research Site
      • Miami, Florida, Estados Unidos, 33145
        • Reclutamiento
        • Research Site
      • Miami, Florida, Estados Unidos, 33180
        • Suspendido
        • Research Site
      • St. Petersburg, Florida, Estados Unidos, 33705
        • Aún no reclutando
        • Research Site
    • Illinois
      • Willowbrook, Illinois, Estados Unidos, 60527
        • Reclutamiento
        • Research Site
    • Indiana
      • New Albany, Indiana, Estados Unidos, 47150
        • Reclutamiento
        • Research Site
    • Louisiana
      • Lake Charles, Louisiana, Estados Unidos, 70605
        • Reclutamiento
        • Research Site
    • Maryland
      • Silver Spring, Maryland, Estados Unidos, 20904
        • Reclutamiento
        • Research Site
    • Missouri
      • Kansas City, Missouri, Estados Unidos, 64151
        • Reclutamiento
        • Research Site
    • New Jersey
      • West Long Branch, New Jersey, Estados Unidos, 07764
        • Reclutamiento
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Estados Unidos, 73104
        • Aún no reclutando
        • Research Site
      • Oklahoma City, Oklahoma, Estados Unidos, 73116
        • Reclutamiento
        • Research Site
    • Tennessee
      • Memphis, Tennessee, Estados Unidos, 38119
        • Reclutamiento
        • Research Site
      • Memphis, Tennessee, Estados Unidos, 38104
        • Aún no reclutando
        • Research Site
    • Texas
      • Austin, Texas, Estados Unidos, 78745
        • Aún no reclutando
        • Research Site
      • Baytown, Texas, Estados Unidos, 77521
        • Reclutamiento
        • Research Site
      • Colleyville, Texas, Estados Unidos, 76034
        • Reclutamiento
        • Research Site
      • Edinburg, Texas, Estados Unidos, 78550
        • Reclutamiento
        • Research Site
      • Houston, Texas, Estados Unidos, 77054
        • Reclutamiento
        • Research Site
      • Sugar Land, Texas, Estados Unidos, 77479
        • Reclutamiento
        • Research Site
    • Washington
      • Spokane, Washington, Estados Unidos, 99204
        • Reclutamiento
        • Research Site
  • Francia
      • Clermont-Ferrand, Francia, 63000
        • Reclutamiento
        • Research Site
      • Lyon, Francia, 69437
        • Reclutamiento
        • Research Site
      • Marseille, Francia, 13385
        • Reclutamiento
        • Research Site
      • Paris, Francia, 75012
        • Reclutamiento
        • Research Site
      • Paris, Francia, 75013
        • Reclutamiento
        • Research Site
      • Pessac, Francia, 33604
        • Reclutamiento
        • Research Site
      • Saint-Denis, Francia, 97405
        • Aún no reclutando
        • Research Site
      • Saint-Pierre, Francia, 97448
        • Aún no reclutando
        • Research Site
      • Toulon, Francia, 83800, Cedex
        • Reclutamiento
        • Research Site
      • Tours, Francia, 37044
        • Reclutamiento
        • Research Site
      • Vandœuvre-lès-Nancy, Francia, 54511
        • Aún no reclutando
        • Research Site
  • Italia
      • Brescia, Italia, 25123
        • Aún no reclutando
        • Research Site
      • Catania, Italia, 95123
        • Aún no reclutando
        • Research Site
      • Ferrara, Italia, 44121
        • Reclutamiento
        • Research Site
      • Florence, Italia, 50141
        • Aún no reclutando
        • Research Site
      • Milan, Italia, 20122
        • Reclutamiento
        • Research Site
      • Milan, Italia, 20122
        • Suspendido
        • Research Site
      • Padova, Italia, 35128
        • Aún no reclutando
        • Research Site
      • Pisa, Italia, 56124
        • Aún no reclutando
        • Research Site
      • Roma, Italia, 00161
        • Aún no reclutando
        • Research Site
      • Roma, Italia, 00168
        • Suspendido
        • Research Site
      • Rozzano, Italia, 20089
        • Aún no reclutando
        • Research Site
      • Udine, Italia, 33100
        • Aún no reclutando
        • Research Site
  • México
      • Culiacán, México, 80000
        • Aún no reclutando
        • Research Site
      • Durango, México, 34080
        • Aún no reclutando
        • Research Site
      • Guadalajara, México, 44160
        • Aún no reclutando
        • Research Site
      • Guadalajara, México, 44650
        • Aún no reclutando
        • Research Site
      • Guadalajara, México, 44690
        • Suspendido
        • Research Site
      • Mérida, México, 97133
        • Aún no reclutando
        • Research Site
      • México, México, 14080
        • Aún no reclutando
        • Research Site
      • México, México, 03100
        • Aún no reclutando
        • Research Site
  • Polonia
      • Bydgoszcz, Polonia, 85-065
        • Reclutamiento
        • Research Site
      • Częstochowa, Polonia, 42-217
        • Reclutamiento
        • Research Site
      • Katowice, Polonia, 40-611
        • Reclutamiento
        • Research Site
      • Krakow, Polonia, 30-688
        • Aún no reclutando
        • Research Site
      • Lodz, Polonia, 90-368
        • Reclutamiento
        • Research Site
      • Lublin, Polonia, 20-607
        • Reclutamiento
        • Research Site
      • Nadarzyn, Polonia, 05-830
        • Reclutamiento
        • Research Site
      • Nowa Sól, Polonia, 67-100
        • Reclutamiento
        • Research Site
      • Poznan, Polonia, 60-693
        • Aún no reclutando
        • Research Site
      • Poznan, Polonia, 60-681
        • Aún no reclutando
        • Research Site
      • Poznan, Polonia, 61-397
        • Reclutamiento
        • Research Site
      • Warsaw, Polonia, 02-637
        • Aún no reclutando
        • Research Site
      • Warsaw, Polonia, 01-691
        • Reclutamiento
        • Research Site
      • Warsaw, Polonia, 05-077
        • Reclutamiento
        • Research Site
      • Wroclaw, Polonia, 53-673
        • Reclutamiento
        • Research Site
  • Taiwán
      • Kaohsiung City, Taiwán, 833
        • Aún no reclutando
        • Research Site
      • Kaohsiung City, Taiwán, 813414
        • Aún no reclutando
        • Research Site
      • New Taipei City, Taiwán, 23561
        • Aún no reclutando
        • Research Site
      • Taichung, Taiwán, 40705
        • Aún no reclutando
        • Research Site
      • Taichung, Taiwán, 40447
        • Aún no reclutando
        • Research Site
      • Tainan, Taiwán, 70403
        • Aún no reclutando
        • Research Site
      • Tainan County, Taiwán, 71044
        • Aún no reclutando
        • Research Site
      • Taipei, Taiwán, 100
        • Aún no reclutando
        • Research Site
      • Taoyuan, Taiwán, 33305
        • Aún no reclutando
        • Research Site
      • Zhubei, Taiwán, 302
        • Aún no reclutando
        • Research Site

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 70 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  1. Males or females aged 18 to 70 years of age.

  2. Participants who have a diagnosis of SLE confirmed by a rheumatologist.

  3. ANA-positive per the Central Lab at screening:

    (a) ANA (b) Anti-dsDNA (c) Anti-Smith (anti-Sm)

  4. Must be on the standard therapy regimen: antimalarials with or without OCSs

  5. Must have at screening and baseline:

    1. Clinical SLEDAI-2K ≥ 4 points OR
    2. Clinical SLEDAI-2K < 4 with GC dose ≥ 7.5 mg/day (prednisone equivalent)

  6. Should have no evidence of current active infection, (e.g., pneumonia, tuberculosis [TB]) or previous TB

  7. Should have no evidence of malignancy; and clinically significant abnormalities (unless due to SLE).

  8. No medical history or signs or symptoms of active TB prior to or during Screening.

  9. Body weight ≥ 40.0 kg

  10. Negative pregnancy test for females during screening

  11. Normal HPV test result within 2 years prior to Week 0 (Day 1).

  12. Willing and able to participate in all required study evaluations and procedures including completion of PROs.

  13. Willing to not use any other forms of experimental treatment during the study.

Exclusion Criteria:

  1. Subjects with history of, or current diagnosis of, a clinically significant non-SLE related vasculitis syndrome.

  2. Subjects with antiphospholipid antibody syndrome on stable anticoagulant therapy at an effective dose (e.g., if on warfarin, an international normalized ratio [INR] target 2 to 3 or as appropriate for the clinical situation) are only allowed if this is not the sole or the predominant feature of their SLE.

  3. Subjects with a serious thrombotic event (e.g., pulmonary embolism stroke, deep vein thrombosis) or unexplained pregnancy loss within 1 year before the screening visit are excluded.

  4. Subjects with a history of catastrophic antiphospholipid syndrome or saddle embolism.

  5. Subjects with a history of 3 or more unexplained consecutive pregnancy losses.

  6. History or evidence of suicidal ideation within the past 6 months; or any suicidal behavior within the past 12 months or recurrent suicidal behavior in the lifetime of the participant based on an assessment with the Columbia Suicide Severity Rating Scale (C SSRS) at Screening.

  7. Active severe or unstable neuropsychiatric SLE including, but not limited to aseptic meningitis, cerebral vasculitis, myelopathy, demyelination syndromes (ascending, transverse, acute inflammatory demyelinating polyradiculopathy), acute confusional state, impaired level of consciousness, psychosis, acute stroke or stroke syndrome, cranial neuropathy, status epilepticus, cerebellar ataxia, lupus headache and mononeuritis multiplex, where, protocol-specified standard therapy is insufficient.

  8. Active severe SLE-driven renal disease where, protocol-specified standard therapy is insufficient.

  9. Current diagnosis of, catastrophic antiphospholipid syndrome (APS).

  10. History of recurrent infection requiring hospitalization and IV antibiotics (e.g., 3 or more of the same type of infection over the previous 52 weeks).

  11. Known History of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the participant to infection, or a positive result for HIV at Screening.

  12. Confirmed positive test for hepatitis B.

  13. Any clinical cytomegalovirus (CMV) or Epstein-Barr virus (EBV) infection that has not completely resolved within 12 weeks prior to signing the ICF.

  14. Opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years of Week 0 (Day 1).

  15. Clinically significant chronic infection (e.g., osteomyelitis, bronchiectasis, etc.) within 8 weeks prior to signing the ICF (chronic nail infections are allowed).

  16. Severe HZ or recurrent HZ.

  17. Malignancy. History of cancer, apart from:

    (a) Squamous or basal cell carcinoma of the skin treated with documented success of curative therapy ≥ 3 months prior to Week 0 (Day 1).

    (a) Cervical cancer in situ treated with apparent success with curative therapy ≥ 1 year prior to Week 0 (Day 1).

  18. Received any SLE-related therapies other than antimalarials and GCs.

  19. History of allergy or reaction to any component of the study intervention formulation or history of anaphylaxis to any human gamma globulin therapy.

  20. History of an anaphylactic reaction to human proteins or mAbs.

  21. Received any live or attenuated vaccine within 8 weeks prior to signing the ICF.

  22. Blood transfusion or receipt of blood products except albumin.

  23. Received more than 2 investigational products for the SLE since time of diagnosis.

  24. Received any investigational product (small molecule or biologic agent) within 4 weeks or 5 half-lives prior to signing of the ICF, whichever is greater.

  25. Concurrent enrollment in another clinical study with a study intervention.

  26. Subjects with any abnormal lab result as specified in the protocol.

  27. Subjects with other autoimmune diseases (e.g., multiple sclerosis, psoriasis, IBD, etc.).

  28. Subjects with SLE overlap syndromes such as scleroderma and mixed connective tissue disease.

  29. Subject with non-SLE concomitant illness, as determined by medical judgment, who is likely to require additional systemic glucocorticosteroid therapy during the study (e.g., asthma).

  30. Any condition would interfere with treatment outcomes of the study intervention or put participant at safety risk.

  31. Lactating, breastfeeding, or pregnant females or females who intend to become pregnant or begin breastfeeding anytime from initiation of Screening until 16 weeks following last dose of study intervention.

  32. Spontaneous or induced abortion, still or live birth, or pregnancy ≤ 4 weeks prior to signing the ICF.

  33. Current alcohol, drug or chemical abuse, or a history of such abuse within 1 year before Week 0 (Day 1).

  34. Major surgery within 8 weeks before signing the ICF or elective major surgery planned during the study period.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Otro: Anifrolumab

Participants will receive dose A of anifrolumab on X dosing schedule beginning on Day 1 for a maximum of 52 -week during the study
Droga: Anifrolumab

Patients will receive Anifrolumab subcutaneous

Otros nombres:
  • Saphnelo

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Attainment of DORIS remission
Periodo de tiempo: At Week 52

Proportion of participants who are in DORIS remission at Week 52 will be assessed.

DORIS remission is defined as Clinical SLEDAI-2K (sum of all SLEDAI-2K items except for increased deoxyribonucleic acid [DNA] binding and low complement) = 0; PGA [0-3] < 0.5, prednisone 5 mg/day or less, and stable antimalarials, ISs, and biologics.
At Week 52

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
To assess the attainment of low level disease activity
Periodo de tiempo: At Week 28 and 52

Proportion of participants who are in LLDAS, or LLDAS-5 at Week 28 and 52 will be assessed.

Low level disease activity as measured by LLDAS and LLDAS 5

  • LLDAS criteria: SLEDAI 2K ≤ 4 without major organ involvement, no new disease activity, PGA ≤ 1 (0 - 3), prednisone 7.5 mg/day or less, and permitted use of the following medications: antimalarials, standard maintenance doses of ISs including biologics
  • LLDAS-5 criteria: SLEDAI-2K ≤ 4 without major organ involvement, no new disease activity, PGA ≤ 1 (0 - 3), prednisone 5.0 mg/day or less (this is modified LLDAS to include EULAR 2023 recommendations to lower daily maintenance GC ≤ 5.0 mg/day)
At Week 28 and 52
Time spent in DORIS remission, LLDAS or LLDAS-5
Periodo de tiempo: At Week 52

Time spent in DORIS remission, LLDAS or LLDAS-5 for participants initiated on anifrolumab will be measured.
At Week 52
Sustaining DORIS remission, LLDAS or LLDAS-5
Periodo de tiempo: All subsequent visits including 52 Week

The proportion of participants initiated on anifrolumab, sustaining DORIS remission, LLDAS or LLDAS-5 through to Week 52 will be measured.
All subsequent visits including 52 Week
Sustaining DORIS remission, LLDAS or LLDAS-5
Periodo de tiempo: At 3 consecutive visits occurring every 4 weeks during the 52 Week study

The proportion of participants initiated on anifrolumab, sustaining DORIS remission, LLDAS or LLDAS-5 for three or more consecutive visits will be measured.

Consecutive visits' are defined as three back-to-back completed visits.
At 3 consecutive visits occurring every 4 weeks during the 52 Week study
Time to attain and sustain DORIS, or LLDAS, or LLDAS-5
Periodo de tiempo: Through Week 52

The time to attain and sustain DORIS, or LLDAS, or LLDAS-5 will be analyzed.
Through Week 52
Daily GC dose
Periodo de tiempo: At Week 40 and Week 52

The daily GC dose at Week 40 and 52 in participants initiated on anifrolumab alongside a systematic approach to GC tapering and to assess the maintenance of this GC reduction through Week 52 will be assessed.
At Week 40 and Week 52
Reduction in GC use
Periodo de tiempo: From Week 4 to Week 40

The reduction in GC use from Week 4 to Week 40 in participants initiated on anifrolumab alongside a systematic approach to GC tapering will be assessed
From Week 4 to Week 40
Maintenance of reduction in GC dose
Periodo de tiempo: During 52 Week

Maintenance of this percent reduction in GC dose through Week 52 will be assessed
During 52 Week
Cumulative GC dose
Periodo de tiempo: Week 0 to Week 52

The cumulative GC dose from Week 0 to Week 52 in participants initiated on anifrolumab alongside a systematic approach to GC tapering will be assessed.
Week 0 to Week 52
Attainment of DORIS-0
Periodo de tiempo: From baseline over 52 Weeks

Proportion of participants who attain DORIS-0 from baseline over 52 weeks. DORIS-0 is defined as DORIS criteria with prednisone 0 mg daily.
From baseline over 52 Weeks
Time to first moderate-to-severe flare
Periodo de tiempo: Through Week 52

Time to first moderate-to-severe flare through to Week 52 assessed based on MFI. Moderate-to-severe flare is defined as any one criterion present in the moderate or severe flare categories within the MFI will be assessed.
Through Week 52
Change in active skin manifestations
Periodo de tiempo: At Week 4, Week 16, and Week 52

The change in active skin manifestations of SLE measured by CLASI activity score in participants initiated on anifrolumab will be assessed.
At Week 4, Week 16, and Week 52
Change in joint activity
Periodo de tiempo: At Week 28 and 52

The average change in number of active joints (swollen and tender joints) in participants initiated on anifrolumab compared to baseline will be assessed
At Week 28 and 52
Change in QoL and fatigue
Periodo de tiempo: At 52 Week

Change in QoL and fatigue in participants initiated on anifrolumab will be assessed using FACIT-F.
At 52 Week
Adverse Events
Periodo de tiempo: Up to 52 Weeks

Safety and tolerability of anifrolumab will be assessed.
Up to 52 Weeks
Change in QoL and fatigue
Periodo de tiempo: At 52 Week

Change in QoL and fatigue in participants initiated on anifrolumab will be assessed using PROMIS Lupus.
At 52 Week

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

AstraZeneca

Colaboradores

ICON plc

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

13 de abril de 2026

Finalización primaria (Estimado)

26 de enero de 2029

Finalización del estudio (Estimado)

26 de enero de 2029

Fechas de registro del estudio

Enviado por primera vez

2 de febrero de 2026

Primero enviado que cumplió con los criterios de control de calidad

18 de febrero de 2026

Publicado por primera vez (Actual)

24 de febrero de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

10 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

9 de noviembre de 2026

Última verificación

1 de noviembre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • D3461C00040

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan 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 requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

Marco de tiempo para compartir IPD

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Criterios de acceso compartido de IPD

When a request has been approved AstraZeneca will provide access to the de-identified 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.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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