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Clinical trials for Vedolizumab

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   43881   clinical trials with a EudraCT protocol, of which   7295   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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    112 result(s) found for: Vedolizumab. Displaying page 1 of 6.
    1  2  3  4  5  6  Next»
    EudraCT Number: 2015-000480-14 Sponsor Protocol Number: MLN0002SC-3027 Start Date*: 2016-03-21
    Sponsor Name:Takeda Development Centre Europe, Ltd.
    Full Title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects...
    Medical condition: Ulcerative Colitis
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004856 10045365 Ulcerative colitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) SK (Completed) CZ (Completed) BG (Completed) GB (Completed) DE (Completed) BE (Completed) SE (Completed) DK (Completed) LT (Completed) ES (Completed) HU (Completed) RO (Completed) HR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2015-000482-31 Sponsor Protocol Number: MLN0002SC-3030 Start Date*: 2016-01-22
    Sponsor Name:Takeda Development Centre Europe, Ltd.
    Full Title: A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease
    Medical condition: Ulcerative Colitis Crohn’s Disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10017947 - Gastrointestinal disorders 10011401 Crohn's disease PT
    20.1 10017947 - Gastrointestinal disorders 10045365 Ulcerative colitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SK (Completed) CZ (Completed) NL (Ongoing) BG (Completed) GB (GB - no longer in EU/EEA) DE (Completed) BE (Completed) SE (Completed) DK (Completed) LT (Completed) ES (Prematurely Ended) HU (Completed) RO (Ongoing) HR (Ongoing) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-000481-58 Sponsor Protocol Number: MLN0002SC-3031 Start Date*: 2016-01-22
    Sponsor Name:Takeda Development Centre Europe, Ltd.
    Full Title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Cr...
    Medical condition: Crohn’s Disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10017947 - Gastrointestinal disorders 10011401 Crohn's disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SK (Completed) CZ (Completed) NL (Completed) BG (Completed) GB (Completed) DE (Completed) BE (Completed) SE (Completed) DK (Completed) LT (Completed) HU (Completed) ES (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2016-000678-40 Sponsor Protocol Number: Vedolizumab-4013 Start Date*: 2016-08-19
    Sponsor Name:Takeda Development Centre Europe Limited
    Full Title: Entyvio (Vedolizumab IV) Extended Access Program in Ulcerative Colitis and Crohn’s Disease
    Medical condition: Ulcerative Colitis and Crohn’s Disease
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10045365 Ulcerative colitis LLT
    20.0 100000004856 10013099 Disease Crohns LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LV (Completed) CZ (Completed) HU (Completed) EE (Completed) BG (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2016-002985-30 Sponsor Protocol Number: Vedolizumab-2004 Start Date*: 2017-03-13
    Sponsor Name:Millennium Pharmaceuticals, Inc.
    Full Title: An Open-Label, Dose-Finding Study of Vedolizumab IV for Treatment of Steroid-Refractory Acute Intestinal Graft-Versus-Host Disease (GvHD) in Patients who Have Undergone Allogeneic Hematopoietic Ste...
    Medical condition: Steroid-Refractory Acute Intestinal Graft-Versus-Host Disease (GvHD)
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021428 - Immune system disorders 10066264 Acute graft versus host disease in intestine PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) FR (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2022-000837-17 Sponsor Protocol Number: NL80854.018.22 Start Date*: 2022-12-07
    Sponsor Name:Amsterdam UMC
    Full Title: Subcutaneous vedolizumab drug de-escalation using therapeutic drug monitoring in inflammatory bowel disease: a randomized controlled pilot study
    Medical condition: Inflammatory bowel diseases (Crohn's disease, ulcerative colitis)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-002794-21 Sponsor Protocol Number: FAVOUR Start Date*: 2018-09-11
    Sponsor Name:Guy's & St Thomas NHS Foundation Trust
    Full Title: Investigation of the Faecal loss of Vedolizumab and its role in influencing serum drug levels, Outcomes and Response in ulcerative colitis
    Medical condition: Ulcerative colitis (UC)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10017947 - Gastrointestinal disorders 10009900 Colitis ulcerative PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2015-003270-32 Sponsor Protocol Number: IISR-2014-100922 Start Date*: 2016-02-09
    Sponsor Name:FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO
    Full Title: Identification of circulating and tissutal T cell subsets to predict clinical and endoscopical response to Entyvio® (vedolizumab) in patients with Ulcerative Colitis (UC) and Crohn’s disease (CD)
    Medical condition: Ulcerative colitis (UC) and Crohn disease (CD)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10017947 - Gastrointestinal disorders 10017947 Gastrointestinal disorders SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-000939-33 Sponsor Protocol Number: MLN0002-3026 Start Date*: 2015-11-11
    Sponsor Name:Takeda Development Centre Europe, Ltd.
    Full Title: A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis
    Medical condition: Ulcerative Colitis
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004856 10045365 Ulcerative colitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) SK (Completed) NL (Completed) BG (Completed) GB (Completed) DE (Completed) HU (Completed) BE (Completed) ES (Completed) LV (Completed) EE (Completed) LT (Completed) PL (Completed) DK (Completed) PT (Completed) HR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2020-004301-31 Sponsor Protocol Number: MLN0002-3025 Start Date*: 2021-06-25
    Sponsor Name:Takeda Development Center Americas, Inc.
    Full Title: A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Crohn’s Dise...
    Medical condition: Moderately to severely active Crohn’s disease (CD)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10058815 Crohn's disease acute episode LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: LT (Completed) CZ (Ongoing) SK (Prematurely Ended) HU (Ongoing) IT (Ongoing) ES (Prematurely Ended) HR (Ongoing) PL (Ongoing) BE (Ongoing) Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2020-004391-18 Sponsor Protocol Number: PI2020_843_0114 Start Date*: 2020-10-28
    Sponsor Name:CHU Amiens-Picardie
    Full Title: IMPACT OF ANTI-TNF, VEDOLIZUMAB AND TOFACITINIB ON AORTIC STIFFNESS, CAROTID INTIMA-MEDIA THICKNESS AND CARDIOVASCULAR RISK OF PATIENTS WITH ULCERATIVE COLITIS
    Medical condition: ulcerative colitis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-005793-10 Sponsor Protocol Number: 01012121 Start Date*: 2021-07-08
    Sponsor Name:Jakob Benedict Seidelin
    Full Title: Open label Randomized Controlled clinical Trial of vedolizumab versus conventional treatment for Checkpoint Inhibitor induced Colitis
    Medical condition: Immune check point inhibitor induced colitis
    Disease: Version SOC Term Classification Code Term Level
    22.0 100000004856 10082455 Immune-mediated colitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-004300-34 Sponsor Protocol Number: MLN0002-3024 Start Date*: 2021-06-25
    Sponsor Name:Takeda Development Center Americas, Inc.
    Full Title: A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Ulcerative C...
    Medical condition: Moderately to severely active Ulcerative Colitis (UC)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10066678 Acute ulcerative colitis LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: LT (Completed) CZ (Ongoing) SK (Prematurely Ended) HU (Ongoing) GR (Ongoing) IT (Ongoing) ES (Prematurely Ended) HR (Ongoing) BE (Ongoing) Outside EU/EEA PL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-002182-21 Sponsor Protocol Number: Vedolizumab-2005 Start Date*: 2017-11-16
    Sponsor Name:Takeda Development Centre Europe, Ltd.
    Full Title: A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease. (Long-term Safety With Vedolizumab IV in Pediatric...
    Medical condition: Ulcerative Colitis or Crohn’s Disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10017947 - Gastrointestinal disorders 10011401 Crohn's disease PT
    20.1 10017947 - Gastrointestinal disorders 10045365 Ulcerative colitis LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) HU (Trial now transitioned) DE (Ongoing) BE (Ongoing) NL (Ongoing) PL (Trial now transitioned) FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-000555-24 Sponsor Protocol Number: 2015-100752 Start Date*: 2016-06-16
    Sponsor Name:Academic Medical Center Amsterdam
    Full Title: Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Determine the Efficacy and Safety of Vedolizumab in Prevention of Endoscopic Recurrence of Crohn's Disease in Patients with Ileo-c...
    Medical condition: Crohn's disease
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) ES (Ongoing) FR (Ongoing) IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-002231-41 Sponsor Protocol Number: MLN0002-2003 Start Date*: 2017-11-15
    Sponsor Name:Takeda Development Centre Europe, Ltd.
    Full Title: A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease...
    Medical condition: Ulcerative Colitis and Crohn’s Disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10017947 - Gastrointestinal disorders 10011401 Crohn's disease PT
    20.1 10017947 - Gastrointestinal disorders 10045365 Ulcerative colitis LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) BE (Completed) HU (Completed) NL (Completed) PL (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2018-002141-11 Sponsor Protocol Number: Vedolizumab-3035 Start Date*: 2018-11-08
    Sponsor Name:Millennium Pharmaceuticals, Inc.
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Vedolizumab in the Prophylaxis of Intestinal Acute Graft Versus Host Disease in Subjects Und...
    Medical condition: Intestinal acute graft-versus-host disease (aGvHD)
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021428 - Immune system disorders 10066264 Acute graft versus host disease in intestine PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) SE (Completed) GB (GB - no longer in EU/EEA) NO (Completed) DE (Completed) AT (Completed) PL (Completed) ES (Ongoing) PT (Completed) BE (Completed) GR (Completed) IT (Completed) RO (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-005443-40 Sponsor Protocol Number: 2014-100756 Start Date*: 2015-07-15
    Sponsor Name:Academic Medical Center/ Gastroenterology
    Full Title: An open label observational phase 4 study to Evaluate Efficacy, Safety and Mucosal Healing of early versus late use of vedolizumab in ulcerative colitis: the LOVE-UC study (LOw countries VEdolizuma...
    Medical condition: Ulcerative colitis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) BE (Completed) HU (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-003472-78 Sponsor Protocol Number: Vedolizumab-4004 Start Date*: 2016-09-02
    Sponsor Name:Takeda Development Centre Europe, Ltd.
    Full Title: A Randomized, Double-Blind, Placebo-Controlled Phase 4 Study to Evaluate the Efficacy and Safety of Entyvio (Vedolizumab IV) in the Treatment of Chronic Pouchitis
    Medical condition: Chronic Pouchitis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10017947 - Gastrointestinal disorders 10036463 Pouchitis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (GB - no longer in EU/EEA) BE (Completed) ES (Completed) NL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2018-003189-15 Sponsor Protocol Number: S61472 Start Date*: 2018-10-05
    Sponsor Name:University Hospitals Leuven
    Full Title: STRAUSS: responSe To ustekinumab foR Anti-tnf IndUced pSoriasiform Skin lesions
    Medical condition: Anti-TNF induced psoriasiform skin lesions in patients with inflammatory bowel diseases
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Ongoing)
    Trial results: (No results available)
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