Flag of the European Union EU Clinical Trials Register Help

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   44349   clinical trials with a EudraCT protocol, of which   7376   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     
    138 result(s) found for: Ustekinumab. Displaying page 3 of 7.
    « Previous 1  2  3  4  5  6  7  Next»
    EudraCT Number: 2018-004614-18 Sponsor Protocol Number: I6T-MC-AMAM Start Date*: 2019-07-10
    Sponsor Name:Eli Lilly and Company
    Full Title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Acti...
    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: AT (Completed) HU (Completed) FR (Completed) GB (GB - no longer in EU/EEA) DE (Completed) NL (Completed) ES (Completed) PL (Completed) DK (Completed) BE (Completed) SK (Completed) LT (Completed) CZ (Completed) LV (Completed) HR (Completed) IT (Completed) RO (Ongoing)
    Trial results: View results
    EudraCT Number: 2017-004209-41 Sponsor Protocol Number: CNTO1275CRD3007 Start Date*: 2018-06-21
    Sponsor Name:Janssen-Cilag International N.V.
    Full Title: A Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to that of Adalimumab in the Treatment of Biologic Naïve Subjects with Modera...
    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: ES (Completed) CZ (Completed) FR (Completed) PL (Completed) DE (Completed) GB (GB - no longer in EU/EEA) NL (Completed) BG (Completed) BE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2019-004364-21 Sponsor Protocol Number: FYB202-03-01 Start Date*: 2020-05-12
    Sponsor Name:bioeq GmbH
    Full Title: A Randomised, Double-blind, Parallel-group, Phase 3 Study to Compare the Efficacy, Safety, and Immunogenicity of the Proposed Biosimilar Ustekinumab FYB202 to Stelara in Patients with Moderate-to-S...
    Medical condition: Moderate-to-Severe Plaque Psoriasis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10040785 - Skin and subcutaneous tissue disorders 10037153 Psoriasis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-005108-21 Sponsor Protocol Number: DMB-3115-2 Start Date*: 2021-04-29
    Sponsor Name:Dong-A ST Co. Ltd.
    Full Title: A Randomized, Double-Blind, Multicentric, Parallel Group Therapeutic Equivalence Study Comparing Efficacy, Safety and Immunogenicity of Subcutaneous DMB-3115 and EU Sourced Stelara® in Patients wit...
    Medical condition: Moderate to Severe Chronic Plaque Psoriasis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10040785 - Skin and subcutaneous tissue disorders 10071117 Plaque psoriasis LLT
    20.0 10040785 - Skin and subcutaneous tissue disorders 10040785 Skin and subcutaneous tissue disorders SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LV (Completed) HU (Completed) CZ (Completed) BG (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-022759-42 Sponsor Protocol Number: CNTO1275CRD3002 Start Date*: 2011-08-29
    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 Induction Therapy in Subjects with Moderately to Severe...
    Medical condition: Moderately to severely active Crohn's disease
    Disease: Version SOC Term Classification Code Term Level
    17.1 10017947 - Gastrointestinal disorders 10011401 Crohn's disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed) BE (Completed) ES (Completed) NL (Completed) HU (Completed) IS (Completed) BG (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2018-001048-70 Sponsor Protocol Number: CAIN457A2403 Start Date*: 2018-11-05
    Sponsor Name:Novartis Pharma AG
    Full Title: A 16-week randomized, open-label, multicenter study to assess the superiority of secukinumab over guselkumab in the complete treatment of ustekinumab-resistant psoriatic plaques – ARROW
    Medical condition: Plaque Psoriasis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004858 10050576 Psoriasis vulgaris LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2017-005151-83 Sponsor Protocol Number: MUCUS Start Date*: 2018-10-26
    Sponsor Name:Charité Universitätsmedizin Berlin
    Full Title: INDUCTION AND MAINTENANCE OF MUCOSAL HEALING IN CROHN’S DISEASE WITH USTEKINUMAB IN CLINICAL PRACTICE
    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 Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2020-004457-76 Sponsor Protocol Number: CNTO1275ISD3001 Start Date*: 2021-11-09
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Phase 3, Multicenter, Open-label, Basket, Long-term Extension Study of Ustekinumab in Pediatric Clinical Study Participants (2 to <18 Years of Age)
    Medical condition: Paediatric conditions in - Moderately to Severely Active Crohn's Disease - Moderately to Severely Active Ulcerative Colitis - Juvenile Psoriatic Arthritis
    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
    20.0 10028395 - Musculoskeletal and connective tissue disorders 10076674 Juvenile psoriatic arthritis PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) PL (Trial now transitioned) BE (Trial now transitioned) HU (Trial now transitioned) DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2012-005809-53 Sponsor Protocol Number: 10041986 Start Date*: 2013-05-23
    Sponsor Name:
    Full Title: A prospective study to determine the minimal biologic drug serum trough concentration required to maintain stable disease activity in psoriasis.
    Medical condition: Psoriasis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-004141-32 Sponsor Protocol Number: M19-977 Start Date*: 2020-09-24
    Sponsor Name:AbbVie Deutschland GmbH & Co. KG
    Full Title: A Randomized, Active-Controlled, Efficacy Assessor-Blinded Study to Evaluate Pharmacokinetics, Safety and Efficacy of Risankizumab in Patients from 6 to Less than 18 Years of Age with Moderate to S...
    Medical condition: Plaque Psoriasis
    Disease: Version SOC Term Classification Code Term Level
    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 PL (Trial now transitioned) DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-002195-13 Sponsor Protocol Number: CNTO1959CRD3001 Start Date*: 2019-06-05
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants 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: GB (GB - no longer in EU/EEA) DE (Trial now transitioned) BE (Trial now transitioned) AT (Completed) FR (Trial now transitioned) LT (Completed) CZ (Trial now transitioned) SK (Trial now transitioned) NL (Trial now transitioned) LV (Trial now transitioned) ES (Ongoing) PL (Trial now transitioned) GR (Completed) PT (Trial now transitioned) HR (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-001489-53 Sponsor Protocol Number: CNTO1275SLE3001 Start Date*: 2018-06-12
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in 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: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) LT (Prematurely Ended) DE (Completed) BG (Completed) HU (Completed) PL (Completed) PT (Completed)
    Trial results: View results
    EudraCT Number: 2020-004493-22 Sponsor Protocol Number: AVT04-GL-301 Start Date*: 2021-04-20
    Sponsor Name:Alvotech Swiss AG
    Full Title: A Randomized, Double-blind, Multicenter Study to Demonstrate Equivalent Efficacy and to Compare Safety and Immunogenicity of a Biosimilar Ustekinumab (AVT04) and Stelara® in Patients With Moderate ...
    Medical condition: Moderate to Severe Chronic Plaque-type Psoriasis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10040785 - Skin and subcutaneous tissue disorders 10037153 Psoriasis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2009-012264-14 Sponsor Protocol Number: CNTO1275PSA3001 Start Date*: 2009-12-29
    Sponsor Name:Janssen Biologics B.V.
    Full Title: A Phase 3 Multicenter, Randomized, Double-blind, Placebo controlled trial of Ustekinumab, a Fully Human anti-IL 12/23p40 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Ps...
    Medical condition: Psoriatic Arthritis
    Disease: Version SOC Term Classification Code Term Level
    12.0 10037160 Psoriatic arthritis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LV (Completed) HU (Completed) DE (Completed) GB (Completed) LT (Completed) AT (Completed) FI (Completed) ES (Completed) DK (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-003425-42 Sponsor Protocol Number: PS0009 Start Date*: 2018-03-16
    Sponsor Name:UCB Biopharma SPRL
    Full Title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active Comparator-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects with Moderate ...
    Medical condition: Moderate to Severe Chronic 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) GB (Completed) HU (Completed) BE (Completed) FR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2021-001984-25 Sponsor Protocol Number: - Start Date*: 2022-08-09
    Sponsor Name:AZIENDA SOCIO SANITARIA TERRITORIALE DEI SETTE LAGHI
    Full Title: Mucosal healing after systemic steroid therapy by early treatment with ustekinumab in moderate-to-severe ulcerative colitis: an open-label prospective pilot study
    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: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2009-010714-30 Sponsor Protocol Number: 1275148SCD2001 Start Date*: 2009-10-23
    Sponsor Name:Janssen Biologics B.V.
    Full Title: A Phase 2, Multicenter, Randomized, Double blind, Parallel group, Placebo controlled Study Evaluating the Safety and Efficacy of Treatment with Ustekinumab or Golimumab in Subjects with Chronic Sar...
    Medical condition: Chronic sarcoidosis
    Disease: Version SOC Term Classification Code Term Level
    9.1 10039486 Sarcoidosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) BE (Completed) GB (Completed) DK (Completed) FR (Completed) IT (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2019-001868-30 Sponsor Protocol Number: LP0160-1396 Start Date*: 2020-08-04
    Sponsor Name:LEO Pharma A/S
    Full Title: A phase 3, randomised, double-blind, multi-centre trial to evaluate the efficacy, safety, and tolerability of brodalumab treatment compared to placebo (blinded) and ustekinumab (open-label) in adol...
    Medical condition: Moderate-to-severe plaque psoriasis in adolescents from 12 to 17 years of age
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004858 10071117 Plaque psoriasis LLT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed) DE (Prematurely Ended) GB (GB - no longer in EU/EEA) NL (Completed) BE (Completed) IT (Prematurely Ended) HU (Prematurely Ended) PL (Completed)
    Trial results: View results
    EudraCT Number: 2011-001122-18 Sponsor Protocol Number: CNTO1275ARA2001 Start Date*: 2012-06-13
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Study Evaluating the Efficacy and Safety of Ustekinumab (STELARA®) and CNTO 1959 Administered Subcutaneously in...
    Medical condition: Rheumatoid Arthritis
    Disease: Version SOC Term Classification Code Term Level
    15.0 10028395 - Musculoskeletal and connective tissue disorders 10039073 Rheumatoid arthritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) CZ (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2021-006668-25 Sponsor Protocol Number: BM12H-PSO-03-G-02 Start Date*: 2022-07-12
    Sponsor Name:Biocon Biologics UK Limited
    Full Title: A Randomized, Double-Blind, Parallel Group, Multicenter, Phase 3 Study to Compare the Efficacy and Safety of Bmab 1200 and Stelara® in Patients with Moderate to Severe Chronic Plaque Psoriasis
    Medical condition: Moderate to Severe Chronic 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: EE (Completed) LV (Completed)
    Trial results: (No results available)
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    « Previous 1  2  3  4  5  6  7  Next»
    Query did not match any studies.
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Wed Jul 16 10:05:41 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA