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Clinical trials for Biologics

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   44346   clinical trials with a EudraCT protocol, of which   7374   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.
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    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.
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    386 result(s) found for: Biologics. Displaying page 1 of 20.
    1  2  3  4  5  6  7  8  9  Next» Last»»
    EudraCT Number: 2011-005871-18 Sponsor Protocol Number: REDES-TNF/2012 Start Date*: 2012-04-03
    Sponsor Name:CLINICAL PHARMACOLOGY SPANISH SOCIETY
    Full Title: Evaluation of clinical value of a standardized protocol for dose reduction in patients with axial Spondyloarthritis and persistent clinical remission with anti-TNF therapy: Open-label, controlled, ...
    Medical condition: Axial Spondyloarthritis
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2017-002129-39 Sponsor Protocol Number: XC.ROD.2017 Start Date*: 2017-08-02
    Sponsor Name:XCELL Medical Solutions
    Full Title: Phase II Clinical Trial to Know the effectiviness and safety with a a treatment based in a therapy with serical autologous white cells versus the use of Platelet Rich Plasma in patients with rotu...
    Medical condition: Patients with Rotulian Tendinopathy
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004859 10043237 Tendon, ligament and cartilage disorders HLGT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2017-000225-12 Sponsor Protocol Number: CNTO148DML1001 Start Date*: 2017-08-01
    Sponsor Name:Janssen Biologics BV
    Full Title: A Phase 1b Study to Evaluate SIMPONI® (golimumab) Therapy in Children, Adolescents and Young Adults with Pre-Symptomatic Type 1 Diabetes
    Medical condition: A Phase 1b Study to Evaluate SIMPONI® (golimumab) Therapy in Children, Adolescents and Young Adults with Pre-Symptomatic Type 1 Diabetes
    Disease: Version SOC Term Classification Code Term Level
    20.0 10027433 - Metabolism and nutrition disorders 10067584 Type 1 diabetes mellitus PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: SE (Completed) FI (Completed)
    Trial results: View results
    EudraCT Number: 2020-003358-63 Sponsor Protocol Number: 2020033183. Start Date*: 2020-12-10
    Sponsor Name:Bispebjerg Hospital
    Full Title: OPTIMAL - Titration of treatment with biologics in severe asthma
    Medical condition: Severe asthma
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004855 10068462 Eosinophilic asthma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2021-006681-21 Sponsor Protocol Number: FVGEXACT@home2021 Start Date*: 2022-11-17
    Sponsor Name:Franciscus Gasthuis & Vlietland
    Full Title: Expertise Asthma COPD Program with Digital Support
    Medical condition: Asthma
    Disease: Version SOC Term Classification Code Term Level
    22.1 100000004855 10003555 Asthma bronchial LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-000943-17 Sponsor Protocol Number: NL54557.091.15 Start Date*: 2016-02-11
    Sponsor Name:Radboudumc
    Full Title: Tight control dose reductions of biologics in psoriasis patients with low disease activity: a randomized pragmatic trial.
    Medical condition: Adult Patients diagnosed psoriasis vulgaris
    Disease: Version SOC Term Classification Code Term Level
    18.1 10040785 - Skin and subcutaneous tissue disorders 10071117 Plaque psoriasis LLT
    18.1 10040785 - Skin and subcutaneous tissue disorders 10050576 Psoriasis vulgaris LLT
    18.1 10040785 - Skin and subcutaneous tissue disorders 10037153 Psoriasis PT
    18.1 10040785 - Skin and subcutaneous tissue disorders 10015581 Exacerbation of psoriasis LLT
    18.1 10040785 - Skin and subcutaneous tissue disorders 10037155 Psoriasis and similar disorders LLT
    18.1 10040785 - Skin and subcutaneous tissue disorders 10037156 Psoriasis flare-up LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2020-001172-15 Sponsor Protocol Number: APN01-01-COVID19 Start Date*: 2020-04-08
    Sponsor Name:APEIRON Biologics AG
    Full Title: Recombinant human angiotensin-converting enzyme 2 (rhACE2) as a treat-ment for patients with COVID-19
    Medical condition: Severe COVID-19 POSITIVE hospitalized male or female, between 18 and ≤ 80 years of age
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) DK (Completed) AT (Completed) GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2020-000421-76 Sponsor Protocol Number: AirGOs-biologics Start Date*: 2020-04-15
    Sponsor Name:Helsinki University Hospital
    Full Title: Aggravated airway inflammation: research on biological treatment (Mepolizumab) AirGOs-biologics
    Medical condition: A triad of chronic rhinosinusitis with nasal polyps (CRSwNP), asthma and NSAID exacerbated respiratory disease (NERD)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-004496-31 Sponsor Protocol Number: CNTO148UCO3003 Start Date*: 2018-11-07
    Sponsor Name:Janssen Biologics BV
    Full Title: A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFα Monoclonal Antibody, Administered Subcutaneously in Pediatric Pa...
    Medical condition: Ulcerative Colitis
    Disease: Version SOC Term Classification Code Term Level
    20.1 10017947 - Gastrointestinal disorders 10045365 Ulcerative colitis LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed) ES (Ongoing) FR (Trial now transitioned) NL (Ongoing) PL (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2008-005237-30 Sponsor Protocol Number: REMICADEPIB4002 Start Date*: 2009-12-01
    Sponsor Name:Janssen Biologics B.V.
    Full Title: A Multicenter, Prospective, Long-term Registry of Pediatric Patients with Crohn's Disease or Ulcerative Colitis
    Medical condition: Pediatric patients with a confirmed diagnosis of CD or UC .
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004856 10013099 Disease Crohns LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing) SE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2012-004482-40 Sponsor Protocol Number: OPTIBIO-2012 Start Date*: 2013-06-18
    Sponsor Name:FRANCISCO J. BLANCO GARCÍA
    Full Title: Evaluation of the clinical utility of a standardized protocol of strategies for the reduction of doses in patients with rheumatoid arthritis (RA) in persistent clinical remission in treatment with ...
    Medical condition: Evaluation of the clinical utility of a standardized protocol of strategies for the reduction of doses in patients with rheumatoid arthritis in clinical remission at treatment with biologic therapies
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-004751-20 Sponsor Protocol Number: PB006-03-01 Start Date*: 2019-07-22
    Sponsor Name:Polpharma Biologics S.A.
    Full Title: Antelope: Efficacy and Safety of the Biosimilar Natalizumab PB006 in Comparison to Tysabri® in Patients with Relapsing-Remitting Multiple Sclerosis (RRMS)
    Medical condition: Relapsing-Remitting Multiple Sclerosis (RRMS)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029205 - Nervous system disorders 10063399 Relapsing-remitting multiple sclerosis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: PL (Completed) HR (Completed)
    Trial results: View results
    EudraCT Number: 2018-000236-97 Sponsor Protocol Number: TX05-03E Start Date*: 2018-07-26
    Sponsor Name:Tanvex Biologics Corp.
    Full Title: A double-blinded extension study to provide adjuvant treatment with single agent Herceptin® or TX05 and assess continued safety and immunogenicity in subjects with HER2-positive early breast cancer...
    Medical condition: HER-2 positive breast cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10065430 HER-2 positive breast cancer PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: HU (Completed) BG (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2019-004230-42 Sponsor Protocol Number: 18562 Start Date*: 2020-07-31
    Sponsor Name:Radboudumc
    Full Title: Dose reduction of the new generation biologics (IL17 and IL23 inhibitors) in psoriasis: A pragmatic, multicentre, randomized, controlled, non-inferiority study - BeNeBio study
    Medical condition: psoriasis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10040785 - Skin and subcutaneous tissue disorders 10037153 Psoriasis PT
    20.0 10040785 - Skin and subcutaneous tissue disorders 10037155 Psoriasis and similar disorders LLT
    20.0 10040785 - Skin and subcutaneous tissue disorders 10050576 Psoriasis vulgaris LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-002187-40 Sponsor Protocol Number: GS-LHON-CLIN-05 Start Date*: 2018-03-15
    Sponsor Name:GENSIGHT BIOLOGICS
    Full Title: Efficacy and Safety of Bilateral Intravitreal Injection of GS010: A Randomized, Double-Masked, Placebo-Controlled Trial in Subjects Affected with G11778A ND4 Leber Hereditary Optic Neuropathy for U...
    Medical condition: Leber Hereditary Optic Neuropathy due to mutations in the mitochondrial NADH Dehydrogenase 4 gene
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) FR (Completed) GB (GB - no longer in EU/EEA) ES (Ongoing) NL (Ongoing) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-000609-58 Sponsor Protocol Number: NN8226-3612 Start Date*: 2013-02-20
    Sponsor Name:Novo Nordisk A/S
    Full Title: A randomised, double blind, placebo-controlled, multiple dose, phase 2b, 24 week trial followed by an open label extension of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoi...
    Medical condition: Rheumatoid arthritis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10028395 - Musculoskeletal and connective tissue disorders 10039073 Rheumatoid arthritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) HU (Prematurely Ended) GB (Prematurely Ended) CZ (Prematurely Ended) DE (Prematurely Ended) ES (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-004969-14 Sponsor Protocol Number: 2111 Start Date*: 2014-01-28
    Sponsor Name:Heidi Mäkinen
    Full Title: Measurement of levels of infliximab and anti-infliximab antibodies in rheumatic patients
    Medical condition: rheumatic diseases
    Disease: Version SOC Term Classification Code Term Level
    16.1 10028395 - Musculoskeletal and connective tissue disorders 10072736 Rheumatic disorder PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-000152-96 Sponsor Protocol Number: 2016-01 Start Date*: 2019-12-16
    Sponsor Name:GETAID
    Full Title: Intensive Treatment to Reach the target with Golimumab in ulcErative coliTis – In-TARGET
    Medical condition: Moderate to severe ulcerative colitis
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-004411-49 Sponsor Protocol Number: RBHP_2018_BUISSON Start Date*: 2019-05-23
    Sponsor Name:CHU de Clermont-Ferrand
    Full Title: .
    Medical condition: .
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-003964-30 Sponsor Protocol Number: BIOVAS Start Date*: 2020-10-22
    Sponsor Name:Cambridge University Hospitals NHS Foundation Trust
    Full Title: Biologics in refractory vasculitis (BIOVAS): A pragmatic, randomised, double-blind, placebo-controlled, modified-crossover trial of biologic therapy for refractory primary non-ANCA associated vascu...
    Medical condition: Non-ANCA associated vasculitides: 1. Giant cell arteritis (GCA) 2. Takayasu’s arteritis (TA) 3. Polyarteritis nodosa (PAN) or cutaneous polyarteritis unrelated to hepatitis B (CPAN) 4. Relapsing p...
    Disease: Version SOC Term Classification Code Term Level
    21.1 10047065 - Vascular disorders 10047115 Vasculitis PT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    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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