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Clinical trials for Ustekinumab

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   44334   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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    138 result(s) found for: Ustekinumab. Displaying page 1 of 7.
    1  2  3  4  5  6  7  Next»
    EudraCT Number: 2014-005606-38 Sponsor Protocol Number: CNTO1275UCO3001 Start Date*: 2015-10-07
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects with M...
    Medical condition: Ulcerative Colitis
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10045365 Ulcerative colitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) HU (Completed) AT (Completed) CZ (Completed) DK (Completed) NL (Completed) SK (Completed) BE (Completed) BG (Completed) PL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2021-000345-41 Sponsor Protocol Number: BIRD2020001 Start Date*: 2021-09-10
    Sponsor Name:Belgian IBD research and development (BIRD vzw)
    Full Title: An Open-Label Extension and long-term efficacy and safety monitoring study of patients with Crohn’s disease previously included in the loss of RESponse to Ustekinumab treated by dose Escalation stu...
    Medical condition: Crohn's disease
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-005503-40 Sponsor Protocol Number: CNTO1275JPA3001 Start Date*: 2022-11-15
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Phase 3 Multicenter, Open-label Study to Evaluate the Efficacy, Pharmacokinetics, Safety, and Immunogenicity of Subcutaneously Administered Ustekinumab or Guselkumab in Pediatric Participants Wit...
    Medical condition: Juvenile Psoriatic Arthritis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10028395 - Musculoskeletal and connective tissue disorders 10076674 Juvenile psoriatic arthritis PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Ongoing) DE (Trial now transitioned) IT (Trial now transitioned) Outside EU/EEA FR (Trial now transitioned) NL (Trial now transitioned) DK (Trial now transitioned) PL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2010-022760-12 Sponsor Protocol Number: CNTO1275CRD3003 Start Date*: 2011-09-13
    Sponsor Name:Janssen-Cilag International N.V.
    Full Title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects with Moderately to Seve...
    Medical condition: Moderately to severely active 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: DE (Completed) AT (Completed) GB (Completed) BE (Completed) CZ (Completed) IS (Completed) IE (Completed) FR (Completed) HU (Completed) NL (Completed) DK (Completed) ES (Completed) BG (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2020-002674-26 Sponsor Protocol Number: M20-259 Start Date*: 2020-10-29
    Sponsor Name:AbbVie Deutschland GmbH & Co. KG
    Full Title: A phase 3, multicenter, Randomized, Efficacy Assessor-Blinded study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn’s Disease who have fail...
    Medical condition: Crohns 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: NL (Ongoing) SE (Completed) BE (Trial now transitioned) DE (Trial now transitioned) AT (Trial now transitioned) CZ (Trial now transitioned) HU (Trial now transitioned) SK (Trial now transitioned) FR (Trial now transitioned) GB (GB - no longer in EU/EEA) BG (Trial now transitioned) GR (Trial now transitioned) PL (Trial now transitioned) IT (Trial now transitioned) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-005205-42 Sponsor Protocol Number: 20200417 Start Date*: 2021-06-23
    Sponsor Name:Amgen, Inc.
    Full Title: A Multicenter, Randomized, Double-blinded Study Evaluating the Pharmacokinetics, Efficacy and Safety of Multiple Switches Between Ustekinumab and ABP 654 Compared With Continued Use of Ustekinumab ...
    Medical condition: Moderate to severe plaque psoriasis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004858 10071117 Plaque psoriasis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) HU (Completed) LV (Completed) EE (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2014-003022-40 Sponsor Protocol Number: UKM14_0008 Start Date*: 2015-03-19
    Sponsor Name:Universitätsklinikum Münster
    Full Title: Comparison of the bacterial microbiota in the skin and gut of psoriasis patients before and after sytemic treatment with adalimumab and ustekinumab or cyclosporin
    Medical condition: Psoriasis
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004858 10050576 Psoriasis vulgaris LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2013-003434-32 Sponsor Protocol Number: CAIN457A2317 Start Date*: 2014-01-30
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A 52-week, multicenter, randomized, double-blind study of subcutaneous secukinumab to demonstrate efficacy as assessed by Psoriasis Area and Severity Index at 16 weeks of treatment compared to uste...
    Medical condition: Plaque psoriasis
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004858 10050576 Psoriasis vulgaris LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) ES (Completed) AT (Completed) GB (Completed) DE (Completed) PT (Completed) IT (Completed) SK (Completed) BE (Completed) HU (Completed) GR (Completed) EE (Completed) BG (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2016-000121-40 Sponsor Protocol Number: CNTO1275PSO3013 Start Date*: 2016-05-02
    Sponsor Name:Janssen-Cilag International N.V.
    Full Title: A Phase 3 Open-label Study to Assess the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Ustekinumab in the Treatment of Moderate to Severe Chronic Plaque Psoriasis in Pedia...
    Medical condition: Moderate to Severe Chronic Plaque Psoriasis
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004858 10071117 Plaque psoriasis LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed) HU (Completed) DE (Completed) PL (Completed) FR (Completed) NL (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2021-005085-18 Sponsor Protocol Number: CNTO1275ISD1001 Start Date*: 2024-05-06
    Sponsor Name:Janssen Research & Development, LLC
    Full Title: Open-label Study to Evaluate the Pharmacokinetics, Safety, and Immunogenicity of Ustekinumab in Pediatric Participants
    Medical condition: Pediatric psoriasis(PsO) Juvenile psoriatic arthritis (jPsA)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10028395 - Musculoskeletal and connective tissue disorders 10076674 Juvenile psoriatic arthritis PT
    20.0 10040785 - Skin and subcutaneous tissue disorders 10037153 Psoriasis PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2020-003184-25 Sponsor Protocol Number: 20190232 Start Date*: 2021-02-12
    Sponsor Name:Amgen, Inc.
    Full Title: A Phase 3, Multicenter , Randomized, Double-Blind Study Evaluating the Efficacy and Safety of ABP 654 Compared with Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis
    Medical condition: Moderate to Severe Plaque Psoriasis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004858 10071117 Plaque psoriasis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) LT (Completed) EE (Completed) BG (Prematurely Ended) HU (Completed) SK (Prematurely Ended) LV (Completed)
    Trial results: View results
    EudraCT Number: 2016-001956-22 Sponsor Protocol Number: CNTO1275CRD1001 Start Date*: 2017-01-25
    Sponsor Name:Janssen-Cilag International N.V.
    Full Title: A Randomized Double-blind Pharmacokinetic study of Ustekinumab in Pediatric Subjects with Moderately to Severely Active Crohn's Disease
    Medical condition: Moderately to severely active Crohn's disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10017947 - Gastrointestinal disorders 10011401 Crohn's disease PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed) DE (Completed) PL (Completed) FR (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2011-000554-31 Sponsor Protocol Number: CNTO1275PBC2001 Start Date*: 2011-09-21
    Sponsor Name:Janssen-Cilag International N.V.
    Full Title: A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Evaluating the Efficacy and Safety of Ustekinumab in Subjects with Primary Biliary Cirrhosis Who had an I...
    Medical condition: Primary Biliary Cirrhosis
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004871 10036680 Primary biliary cirrhosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) SE (Completed)
    Trial results: View results
    EudraCT Number: 2015-000289-67 Sponsor Protocol Number: CNTO1275AKS3003 Start Date*: 2015-06-22
    Sponsor Name:Janssen-Cilag International N.V.
    Full Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Ustekinumab in the Treatment of Subjects With Active Nonradiographic Axial Spondyloa...
    Medical condition: Nonradiographic Axial Spondylitis, Ankylosing
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004859 10076297 Non-radiographic axial spondyloarthritis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed) HU (Completed) DE (Prematurely Ended) CZ (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2019-002038-35 Sponsor Protocol Number: S62619 Start Date*: 2019-06-27
    Sponsor Name:UZ Leuven
    Full Title: A prospective study investigating ustekinumab concentrations through dried blood spot sampling in Crohn’s disease patients
    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: BE (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 (Completed)
    Trial results: View results
    EudraCT Number: 2019-004225-24 Sponsor Protocol Number: CNTO1275CRD3004 Start Date*: 2021-03-17
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Phase 3 Study of the Efficacy, Safety, and Pharmacokinetics of Ustekinumab as Open-label Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance i...
    Medical condition: Moderately to Severely Active Crohn's Disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10017947 - Gastrointestinal disorders 10011401 Crohn's disease PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) HU (Trial now transitioned) BE (Trial now transitioned) GB (GB - no longer in EU/EEA) PL (Trial now transitioned) Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2019-004224-38 Sponsor Protocol Number: CNTO1275PUC3001 Start Date*: 2021-02-25
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Phase 3 Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Open-label Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in...
    Medical condition: Moderately to Severely Active Ulcerative Colitis
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10045365 Ulcerative colitis LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) HU (Trial now transitioned) GB (GB - no longer in EU/EEA) PL (Trial now transitioned) Outside EU/EEA BE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-002629-51 Sponsor Protocol Number: CNTO1275CRD3008 Start Date*: 2019-01-08
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Phase 3b, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Crohn...
    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: NL (Completed) ES (Ongoing) SE (Completed) FR (Completed) AT (Completed) GB (GB - no longer in EU/EEA) CZ (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2019-004246-15 Sponsor Protocol Number: CAIN457FDE04 Start Date*: 2020-08-27
    Sponsor Name:Novartis Pharma GmbH
    Full Title: A 28-week, randomized, double-blind, active-controlled, multicenter study to evaluate the efficacy of subcutaneously administered secukinumab compared to ustekinumab in adult patients with psoriati...
    Medical condition: Psoriatic arthritis
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004859 10037160 Psoriatic arthritis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
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