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Clinical trials for Anifrolumab

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    12 result(s) found for: Anifrolumab. Displaying page 1 of 1.
    EudraCT Number: 2016-003246-93 Sponsor Protocol Number: D3461C00008 Start Date*: 2016-12-06
    Sponsor Name:Astrazeneca AB
    Full Title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study Characterizing the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab following subcutaneous administration in ...
    Medical condition: Systemic Lupus Erythematosus
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2022-002003-37 Sponsor Protocol Number: CHUBX2022/03 Start Date*: 2023-03-22
    Sponsor Name:Centre Hospitalier Universitaire de Bordeaux
    Full Title: Efficacy and tolerance of the association of ANIFROLUMAB (300mg) IV every four weeks and phototherapy versus phototherapy in adults with progressive vitiligo: a randomized double blind prospective,...
    Medical condition: non-segmental (symmetrical) vitiligo with a body surface area involved >5% excluding hands and feet
    Disease: Version SOC Term Classification Code Term Level
    21.1 10040785 - Skin and subcutaneous tissue disorders 10047642 Vitiligo PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2015-001442-29 Sponsor Protocol Number: D3461C00007 Start Date*: 2016-01-14
    Sponsor Name:AstraZeneca AB
    Full Title: A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 2 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects with Active Proliferative Lupus Nephritis
    Medical condition: Lupus Nephritis
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038359 - Renal and urinary disorders 10025140 Lupus nephritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) HU (Completed) DE (Completed) ES (Completed) GB (GB - no longer in EU/EEA) FR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2017-001717-92 Sponsor Protocol Number: TarIFNiRA Start Date*: 2017-12-11
    Sponsor Name:Medical University of Vienna
    Full Title: A randomised, double-blind, placebo-controlled Phase II study to target the type I IFN receptor by administrating Anifrolumab in RA patients with a high IFN signature (TarIFNiRA)
    Medical condition: High IFN siganture in patients with rheumatoid arthritis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10028395 - Musculoskeletal and connective tissue disorders 10039073 Rheumatoid arthritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-000625-39 Sponsor Protocol Number: D3461C00009 Start Date*: 2016-08-18
    Sponsor Name:AstraZeneca AB
    Full Title: A Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects with Active Systemic Lupus...
    Medical condition: Systemic Lupus Erythematosus
    Disease: Version SOC Term Classification Code Term Level
    20.0 10028395 - Musculoskeletal and connective tissue disorders 10042945 Systemic lupus erythematosus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) DE (Completed) ES (Completed) LT (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2022-000609-28 Sponsor Protocol Number: ESR-21-21284 Start Date*: 2022-08-10
    Sponsor Name:University Medical Centre Groningen
    Full Title: ANIfrolumab treatment for 24 weeks in patients with primary Sjögren’s syndrome – Efficacy and safety assessment in a randomized, double-blind, placebo-controlled phase-IIa proof-of-concept trial (A...
    Medical condition: Primary Sjögren's syndrome. Patients will be included if the fulfil the 2016 ACR/EULAR classification criteria for pSS and if they have active disease according to an ESSDAI score of 5 or more and/...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-004529-22 Sponsor Protocol Number: D3465C00001 Start Date*: 2021-08-24
    Sponsor Name:AstraZeneca
    Full Title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Subcutaneous Anifrolumab in Adult Patients with Systemic Lupus Erythematosus
    Medical condition: Moderate-to-severe Systemic Lupus Erythematosus (SLE)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10028395 - Musculoskeletal and connective tissue disorders 10042945 Systemic lupus erythematosus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Trial now transitioned) BG (Trial now transitioned) DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2014-004633-96 Sponsor Protocol Number: D3461C00005 Start Date*: 2015-07-16
    Sponsor Name:AstraZeneca AB
    Full Title: A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus
    Medical condition: Systemic Lupus Erythematosus
    Disease: Version SOC Term Classification Code Term Level
    20.0 10028395 - Musculoskeletal and connective tissue disorders 10042945 Systemic lupus erythematosus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) HU (Completed) PL (Completed) RO (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2021-002862-42 Sponsor Protocol Number: D3466C00001 Start Date*: 2022-02-11
    Sponsor Name:AstraZeneca AB
    Full Title: A Multicenter Randomized Double-Blind Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Anifrolumab in Adult Patients with Active Proliferative Lupus Nephritis
    Medical condition: Active Proliferative Lupus Nephritis
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038359 - Renal and urinary disorders 10025140 Lupus nephritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) NL (Trial now transitioned) PL (Trial now transitioned) BE (Trial now transitioned) HU (Trial now transitioned) FR (Trial now transitioned) BG (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2014-004632-19 Sponsor Protocol Number: D3461C00004 Start Date*: 2015-08-20
    Sponsor Name:AstraZeneca AB
    Full Title: A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus
    Medical condition: Systemic Lupus Erythematosus
    Disease: Version SOC Term Classification Code Term Level
    20.0 10028395 - Musculoskeletal and connective tissue disorders 10042945 Systemic lupus erythematosus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LT (Completed) BE (Completed) ES (Completed) CZ (Completed) DE (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2012-004619-30 Sponsor Protocol Number: CD-IA-MEDI-546-1145 Start Date*: 2013-08-29
    Sponsor Name:MedImmune, LLC, a wholly owned subsidiary of AstraZeneca
    Full Title: A Phase 2, Open-label Extension Study to Evaluate Long-term Safety of MEDI-546 in Adults with Systemic Lupus Erythematosus
    Medical condition: Systemic Lupus Erythematosus
    Disease: Version SOC Term Classification Code Term Level
    20.0 10028395 - Musculoskeletal and connective tissue disorders 10042945 Systemic lupus erythematosus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) HU (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2022-003137-19 Sponsor Protocol Number: M-2022-398 Start Date*: 2023-05-30
    Sponsor Name:Miltenyi Biomedicine GmbH
    Full Title: An open-label phase I/IIa, multicenter, interventional single-arm trial of MB-CART19.1 in patients with refractory SLE
    Medical condition: Adult patients with refractory active systemic lupus erythematosus (SLE) with organ involvement
    Disease: Version SOC Term Classification Code Term Level
    21.1 10028395 - Musculoskeletal and connective tissue disorders 10042945 Systemic lupus erythematosus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned)
    Trial results: (No results available)
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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