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Uno studio per valutare i risultati del trattamento con anifrolumab sottocutaneo in pazienti con lupus eritematoso sistemico naive agli immunosoppressori e naive ai biologici (SUNFLOWER)

24 settembre 2026 aggiornato da: AstraZeneca

Studio Multinazionale, Interventistico, di 52 settimane, in Aperto, a Braccio Singolo per Valutare gli Esiti del Trattamento con Anifrolumab 120 mg Sottocutaneo Una Volta alla Settimana in Pazienti con Lupus Eritematoso Sistemico Immunosoppressant-naïve e Biologico-naïve (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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

245

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 70 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Altro: 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

Altri nomi:
  • Sapnelo

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Attainment of DORIS remission
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
To assess the attainment of low level disease activity
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Through Week 52

The time to attain and sustain DORIS, or LLDAS, or LLDAS-5 will be analyzed.
Through Week 52
Daily GC dose
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: During 52 Week

Maintenance of this percent reduction in GC dose through Week 52 will be assessed
During 52 Week
Cumulative GC dose
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: At 52 Week

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

Safety and tolerability of anifrolumab will be assessed.
Up to 52 Weeks
Change in QoL and fatigue
Lasso di tempo: At 52 Week

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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

AstraZeneca

Collaboratori

ICON plc

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

13 aprile 2026

Completamento primario (Stimato)

26 gennaio 2029

Completamento dello studio (Stimato)

26 gennaio 2029

Date di iscrizione allo studio

Primo inviato

2 febbraio 2026

Primo inviato che soddisfa i criteri di controllo qualità

18 febbraio 2026

Primo Inserito (Effettivo)

24 febbraio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

25 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

24 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • D3461C00040

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano 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

Periodo di condivisione 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.

Criteri di accesso alla condivisione 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 di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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