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Clinical trials for BLA

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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    31 result(s) found for: BLA. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2018-001476-37 Sponsor Protocol Number: HUB-INF-BEATLE-403 Start Date*: 2019-04-24
    Sponsor Name:Dra. Carlota Gudiol González. Servicio de Enfermedades Infecciosas. Hospital Universitari de Bellvitge.
    Full Title: Efficacy of extended infusion of β-lactam antibiotics for the treatment of febrile neutropenia in hematologic patients (BEATLE study).
    Medical condition: Febrile neutropenia is the presence of fever in compramised immune activity in patients with hematologic disease. In which case, an antibiotic must be started.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004851 10029357 Neutropenia malignant LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-005396-25 Sponsor Protocol Number: D3250C00037 Start Date*: 2016-06-22
    Sponsor Name:AstraZeneca AB
    Full Title: A Multicenter, Open-label, Safety Extension Study with Benralizumab (MEDI-563) for Asthmatic Adults on Inhaled Corticosteroid Plus Long-acting β2 Agonist (MELTEMI)
    Medical condition: Asthma
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10003553 Asthma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) ES (Completed) DE (Completed) CZ (Completed) PL (Completed) BG (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2013-003464-31 Sponsor Protocol Number: BIOS-13-004 Start Date*: 2014-02-21
    Sponsor Name:Ethicon Inc
    Full Title: A Single-blinded, Randomized, Controlled, Comparative Phase III Study Evaluating the Safety and Effectiveness of EVARREST™ Fibrin Sealant Patch as an Adjunct to Hemostasis During Cardiovascular Sur...
    Medical condition: subjects undergoing major aortic surgery, including ascending, arch, or descending aorta replacement, requiring adjunctive support for hemostasis at the anastomotic suture line
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2009-010273-20 Sponsor Protocol Number: 18081 Start Date*: 2012-11-28
    Sponsor Name:European organisation for research and treatment of Cancer
    Full Title: Adjuvant peginterferon alfa-2b for 2 years vs Observation in patients with an ulcerated primary cutaneous melanoma with T(2-4)bN0M0: a randomized phase III trial of the EORTC Melanoma Group.
    Medical condition: Ulcerated primary cutaneous melanoma >1mm (T2b-4bN0M0)
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004864 10027156 Skin melanomas (excl ocular) HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) GB (Completed) DE (Completed) FR (Completed) AT (Completed) IT (Completed) DK (Completed) ES (Completed) NL (Completed) PT (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2013-002535-24 Sponsor Protocol Number: BIOS-13-005 Start Date*: 2013-09-20
    Sponsor Name:Ethicon Inc., a Johnson & Johnson Co.
    Full Title: A Phase III Randomized, Controlled, Superiority Study Evaluating EVARREST™ Fibrin Sealant Patch Versus Standard of Care Treatment in Controlling Parenchymal Bleeding During Hepatic Surgery
    Medical condition: Subjects undergoing elective, open, hepatic surgery during which a resection plane is created and wherein an appropriate Target Bleeding Site is identified
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2010-022715-19 Sponsor Protocol Number: 27061954 Start Date*: 2010-12-20
    Sponsor Name:Universitetssjukhuset Linköping
    Full Title: Inflammation och koagulation vid habituell abort
    Medical condition: Upprepade missfall definieras som 3 eller fler konsekutiva spontana missfall. Incidensen av upprepade missfall är 1% och hos hälften påvisas ingen sannolik orsak (=RSA). Studier har visat att hos k...
    Disease: Version SOC Term Classification Code Term Level
    12.1 10018809 Habitual abortion (spontaneous) LLT
    Population Age: Adults Gender: Female
    Trial protocol: SE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-003557-24 Sponsor Protocol Number: 400-12-004 Start Date*: 2014-04-02
    Sponsor Name:Ethicon Inc
    Full Title: A Prospective, Randomised, Controlled, Study Evaluating the Safety and Effectiveness of EVARREST® Sealant Matrix in Controlling Mild or Moderate Hepatic Parenchyma or Soft Tissue Bleeding During O...
    Medical condition: Mild or moderate hepatic parenchyma or soft tissue bleeding during open, abdominal, retroperitoneal, pelvic and thoracic (non-cardiac) surgery
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) BE (Completed)
    Trial results: View results
    EudraCT Number: 2016-005225-37 Sponsor Protocol Number: 16-12301 Start Date*: 2018-08-10
    Sponsor Name:Sahlgrenska University Hospital
    Full Title: The ASTEROID trial - Ablative STEreotactic RadiOtherapy wIth Durvalumab (MEDI4736). An open label randomized phase II trial with durvalumab following Stereotactic Body radiotherapy (SBRT) in patien...
    Medical condition: Stage I Non-small cell lung cancer (NSCLC) that has been treated with Stereotactic Body Radiotherapy (SBRT).
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Trial now transitioned) FI (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-003756-16 Sponsor Protocol Number: BP43445 Start Date*: 2022-03-18
    Sponsor Name:Roche Farma S. A. U. que realiza el ensayo en España y que actúa como representante F. Hoffmann-La Roche Ltd
    Full Title: A PHASE II, MULTICENTER, RANDOMIZED, DOUBLE MASKED, ACTIVE COMPARATORCONTROLLED STUDY TO INVESTIGATE THE EFFICACY, SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF RO7200220 ADMINIST...
    Medical condition: Diabetic Macular Edema (DME)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004853 10057934 Diabetic macular edema LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) CZ (Completed) PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-001961-20 Sponsor Protocol Number: FYB201-C2015-01-P3 Start Date*: 2015-11-24
    Sponsor Name:Bioeq GmbH
    Full Title: Efficacy and safety of the biosimilar ranibizumab FYB201 in comparison to Lucentis in patients with neovascular age-related macular degeneration (COLUMBUS-AMD)
    Medical condition: Subfoveal neovascular age-related macular degeneration
    Disease: Version SOC Term Classification Code Term Level
    20.0 10015919 - Eye disorders 10071129 Neovascular age-related macular degeneration PT
    20.0 100000116602 10067791 Wet macular degeneration LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) AT (Completed) DE (Completed) HU (Completed) ES (Completed) FR (Completed) GB (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2021-000542-18 Sponsor Protocol Number: 20200497 Start Date*: 2021-12-21
    Sponsor Name:Amgen Inc.
    Full Title: A Multicenter, Randomized, Double-blind Study Evaluating the Pharmacokinetics, Efficacy, Safety, and Immunogenicity of Multiple Switches Between Humira® (adalimumab [US]) and ABP 501 Compared With ...
    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) LV (Completed)
    Trial results: View results
    EudraCT Number: 2019-004657-89 Sponsor Protocol Number: BIOS-16-001 Start Date*: 2020-12-14
    Sponsor Name:Ethicon Inc
    Full Title: A Prospective Study Evaluating the Safety and Effectiveness of EVARREST® Fibrin Sealant Patch in Controlling Mild or Moderate Hepatic Parenchyma or Soft Tissue Bleeding During Open, Abdominal, Retr...
    Medical condition: Mild or moderate hepatic parenchyma or soft tissue bleeding during open, abdominal, retroperitoneal, pelvic and thoracic (non-cardiac) surgery
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2014-000109-11 Sponsor Protocol Number: FKB327-002 Start Date*: 2015-01-22
    Sponsor Name:Fujifilm Kyowa Kirin Biologics Co., Ltd.
    Full Title: A Randomised, Blinded, Active-Controlled Study to Compare FKB327 Efficacy and Safety with the Comparator Humira® in Rheumatoid Arthritis Patients Inadequately Controlled on Methotrexate.
    Medical condition: Rheumatoid Arthritis
    Disease: Version SOC Term Classification Code Term Level
    18.1 10028395 - Musculoskeletal and connective tissue disorders 10039073 Rheumatoid arthritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) CZ (Completed) BG (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2021-004390-31 Sponsor Protocol Number: BP43464 Start Date*: 2022-06-06
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A PHASE II, MULTICENTER, RANDOMIZED, DOUBLE MASKED, ACTIVE COMPARATORCONTROLLED STUDY TO INVESTIGATE THE EFFICACY, SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF RO7200220 IN COMBI...
    Medical condition: Diabetic Macular Edema (DME)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004853 10057934 Diabetic macular edema LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-003433-10 Sponsor Protocol Number: GP17-302 Start Date*: 2016-06-08
    Sponsor Name:Hexal, AG
    Full Title: GP17-302 A randomized, double-blind, parallel-group, multicenter study to demonstrate similar efficacy and to compare safety and immunogenicity of GP2017 and Humira® in patients with moderate t...
    Medical condition: rheumatoid arthritis
    Disease: Version SOC Term Classification Code Term Level
    19.1 10028395 - Musculoskeletal and connective tissue disorders 10039073 Rheumatoid arthritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) GB (Completed) DE (Completed) HU (Completed) RO (Completed) ES (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2014-000444-14 Sponsor Protocol Number: CHS-0214-04 Start Date*: 2015-01-12
    Sponsor Name:Coherus Biosciences, Inc
    Full Title: A Double-Blind, Randomized, Parallel-Group, Active Control Study to Compare the Efficacy and Safety of CHS-0214 Versus Enbrel ® in Subjects With Chronic Plaque Psoriasis (CHS-0214-04) (RaPsOdy)
    Medical condition: Chronic Plaque Psoriasis
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004858 10071117 Plaque psoriasis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2020-003746-36 Sponsor Protocol Number: D-FR-10200-002 Start Date*: 2021-01-26
    Sponsor Name:Ipsen Innovation
    Full Title: A Phase Ib/II, Multicentre, Double-blind, Randomised, Placebo-controlled, Dose Escalation and Dose-finding Study to Evaluate the Safety and Efficacy of IPN10200 in Improving the Appearance of Moder...
    Medical condition: Treatment of Moderate to Severe Upper Facial Lines
    Disease: Version SOC Term Classification Code Term Level
    21.1 10040785 - Skin and subcutaneous tissue disorders 10052610 Frown lines LLT
    21.1 10040785 - Skin and subcutaneous tissue disorders 10052609 Glabellar frown lines LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2014-002374-36 Sponsor Protocol Number: CO-STAR Start Date*: 2014-11-19
    Sponsor Name:The Karolinska Institutet, ClinTRID
    Full Title: A multicenter, randomized, open-label, blinded-assessor, follow-up, phase 4 study in patients with rheumatoid arthritis who have completed the initial treatment part (active conventional therapy ve...
    Medical condition: Rheumatoid arthritis (RA)
    Disease: Version SOC Term Classification Code Term Level
    17.0 10028395 - Musculoskeletal and connective tissue disorders 10039073 Rheumatoid arthritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-003658-22 Sponsor Protocol Number: XmAb13676-03 Start Date*: 2022-09-21
    Sponsor Name:Xencor, Inc.
    Full Title: A Phase 2 Randomized, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of XmAb®13676 (Plamotamab) Combined with Tafasitamab Plus Lenalidomide Versus Tafasitamab Plus Lenalidomide i...
    Medical condition: Relapsed or refractory diffuse large B-cell lymphoma
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10012820 Diffuse large B-cell lymphoma NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2014-000110-61 Sponsor Protocol Number: FKB327-003 Start Date*: 2015-10-15
    Sponsor Name:Fujifilm Kyowa Kirin Biologics Co., Ltd.
    Full Title: An Open-label Extension Study to Compare the Long-term Efficacy, Safety, Immunogenicity and Pharmacokinetics of FKB327 and Humira® in Patients with Rheumatoid Arthritis on Concomitant Methotrexate
    Medical condition: 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: DE (Completed) CZ (Completed) ES (Completed)
    Trial results: View results
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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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