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确定 Anifrolumab 在系统性硬化症 (DAISY) 中的有效性 (DAISY)

2026年9月29日 更新者：AstraZeneca

一项多中心、随机、平行组、双盲、双组 III 期研究，旨在评估 Anifrolumab 与安慰剂相比，在 18 至 70 岁（含）患有系统性硬化症的男性和女性参与者中的安全性和有效性

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.

研究概览

地位

主动，不招人

条件

干预/治疗

详细说明

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).

研究类型

介入性

注册 (实际的)

314

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 70年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：Anifrolumab (subcutaneous weekly injection)

Anifrolumab subcutaneous injection once weekly
组合产品：Anifrolumab (blinded)

Anifrolumab treatment delivered subcutaneously, once weekly for 52 weeks

其他名称：
  • 治疗臂（盲法）
组合产品：Anifrolumab (unblinded, open label)

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

其他名称：
  • 治疗臂（非盲法）
安慰剂比较：matched placebo control (subcutaneous weekly injection)

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

matched placebo delivered subcutaneously, once weekly for 52 weeks

其他名称：
  • 安慰剂组（盲法）

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Number of participants responding to treatment based on the Revised Composite Response Index in Systemic Sclerosis (CRISS-25)
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Change from baseline in mRSS
大体时间：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)
大体时间：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
大体时间：at Week 52

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

Change from baseline in the Scleroderma Skin Patient Reported Outcome scores
at Week 52
Change from baseline in FVC
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：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)
大体时间：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)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

AstraZeneca

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2023年11月8日

初级完成 (估计的)

2027年1月6日

研究完成 (估计的)

2028年4月5日

研究注册日期

首次提交

2023年6月2日

首先提交符合 QC 标准的

2023年6月22日

首次发布 (实际的)

2023年6月29日

研究记录更新

最后更新发布 (实际的)

2026年9月30日

上次提交的符合 QC 标准的更新

2026年9月29日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • D3460C00002
  • 2023-505976-31 (其他标识符：EuCTR)
  • 2023 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

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.

IPD 共享时间框架

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.

IPD 共享访问标准

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.

IPD 共享支持信息类型

  • 研究方案
  • 树液

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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