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Clinical trials for Biopharmaceuticals

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   44341   clinical trials with a EudraCT protocol, of which   7370   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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    64 result(s) found for: Biopharmaceuticals. Displaying page 1 of 4.
    1  2  3  4  Next»
    EudraCT Number: 2018-002088-25 Sponsor Protocol Number: N-003-CRD003 Start Date*: 2019-01-11
    Sponsor Name:Noorik Biopharmaceuticals AG
    Full Title: A Phase II, Single-arm, Open-Label Study to Characterise the Effect on Portal Pressure, the Effect on Renal Function and the Pharmacokinetic Profile of N-003 in Patients with Decompensated Cirrhosis
    Medical condition: decompensated liver cirrhosis
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004871 10064704 Decompensated cirrhosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) AT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2011-005026-21 Sponsor Protocol Number: 1403740 Start Date*: 2012-01-31
    Sponsor Name:KYTHERA Biopharmaceuticals, Inc.
    Full Title: Long-term, follow-up study of subjects who completed phase III trials ATX-101-10-16 or ATX-101-10-17 (sodium deoxycholate injection) for the reduction of localized subcutaneous fat in the submental...
    Medical condition: Reduction of subcutaneous fat in the submental area
    Disease: Version SOC Term Classification Code Term Level
    17.1 10018065 - General disorders and administration site conditions 10016251 Fat tissue increased PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2022-001363-27 Sponsor Protocol Number: DAY101-002 Start Date*: 2023-01-18
    Sponsor Name:Day One Biopharmaceuticals, Inc. (Day One)
    Full Title: LOGGIC/FIREFLY-2: A Phase 3, Randomized, International Multicenter Trial of DAY101 Monotherapy Versus Standard of Care Chemotherapy in Patients with Pediatric Low-Grade Glioma Harboring an Activati...
    Medical condition: Pediatric low-grade glioma harboring an activating RAF alteration requiring first-line systemic therapy
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10065443 Malignant glioma PT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: SE (Trial now transitioned) IE (Trial now transitioned) HU (Trial now transitioned) DE (Trial now transitioned) NO (Trial now transitioned) BE (Trial now transitioned) FI (Trial now transitioned) AT (Trial now transitioned) SI (Trial now transitioned) GR (Trial now transitioned) DK (Trial now transitioned) CZ (Trial now transitioned) IT (Trial now transitioned) ES (Ongoing) NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2009-016501-41 Sponsor Protocol Number: 400-09-001 Start Date*: 2010-06-29
    Sponsor Name:Omrix Biopharmaceuticals Ltd
    Full Title: A Randomized, Controlled Study to Evaluate the Safety and Effectiveness of Evicel as an Adjunct to Sutured Dural Repair
    Medical condition: tissue adhesion/sealing and suture support in neurosurgery and surgical procedures where contact with cerebrospinal fluid or dura mater can occur e.g. otologic, rhinologic, ophthalmic and vertebral...
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Completed) BE (Completed) NL (Completed) FI (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2020-005104-20 Sponsor Protocol Number: N-003-CRD008 Start Date*: 2022-09-10
    Sponsor Name:Noorik Biopharmaceuticals AG
    Full Title: A randomised, double-blind, placebo-controlled trial to evaluate the efficacy and safety of ambrisentan in patients with severe COVID-19
    Medical condition: Treatment for respiratory complications of COVID-19 disease
    Disease: Version SOC Term Classification Code Term Level
    23.1 100000004862 10084401 COVID-19 respiratory infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SK (Prematurely Ended) CZ (Prematurely Ended) HR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2007-001326-26 Sponsor Protocol Number: AA-GYN-001 Start Date*: 2007-08-14
    Sponsor Name:Omrix Biopharmaceuticals Ltd.
    Full Title: A Prospective, Controlled, Randomized, Multi-Center, Phase I/II Study Evaluating the Safety and Efficacy of Adhexil™
    Medical condition: Patients that undergo surgery that involves the ovaries
    Disease: Version SOC Term Classification Code Term Level
    9.1 10033137 Ovarian cystectomy PT
    Population Age: Adults Gender: Female
    Trial protocol: DE (Prematurely Ended) GB (Prematurely Ended) ES (Completed)
    Trial results: View results
    EudraCT Number: 2021-000585-15 Sponsor Protocol Number: CBP-201-WW003 Start Date*: 2021-11-11
    Sponsor Name:Suzhou Connect Biopharmaceuticals Ltd.
    Full Title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate CBP-201 in Adult Patients with Chronic Rhinosinusitis with Nasal Polyps
    Medical condition: Chronic Rhinosinusitis with Nasal Polyps
    Disease: Version SOC Term Classification Code Term Level
    20.1 10038738 - Respiratory, thoracic and mediastinal disorders 10080060 Chronic rhinosinusitis with nasal polyps PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) PL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2021-000583-30 Sponsor Protocol Number: CBP-201-WW002 Start Date*: 2021-12-21
    Sponsor Name:Suzhou Connect Biopharmaceuticals Ltd.
    Full Title: A Multi-center, Randomized, Double-blind, Parallel Group, Placebo-controlled, Efficacy and Safety Study of CBP-201 in Patients with Moderate to Severe Persistent Asthma with Type 2 Inflammation.
    Medical condition: Moderate to Severe Persistent Asthma with Type 2 Inflammation
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Completed) HU (Completed)
    Trial results: (No results available)
    EudraCT Number: 2008-004835-39 Sponsor Protocol Number: 400-08-002 Start Date*: 2008-11-13
    Sponsor Name:OMRIX biopharmaceuticals Ltd
    Full Title: A Phase III Randomized, Controlled, Superiority Study Evaluating the Fibrin Pad Versus Standard of Care Treatment in Controlling Severe Soft Tissue Bleeding During Abdominal, Retroperitoneal, Pelvi...
    Medical condition: Patients undergoing abdominal, pelvic, retroperitoneal, and (non-cardiac) thoracic surgery.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2022-004193-39 Sponsor Protocol Number: TAK-665-4001 Start Date*: 2024-12-04
    Sponsor Name:Takeda Biopharmaceuticals India Pvt. Ltd.
    Full Title: A Prospective, Multicenter, Single-arm, Open-label, Interventional Phase IV Study to Evaluate the Safety and Efficacy of Idursulfase (r-DNA Origin) (Elaprase™) in Indian Pediatric and Adult Populat...
    Medical condition: Hunter syndrome (Mucopolysaccharidosis II, [MPS II])
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2018-003418-41 Sponsor Protocol Number: NAV3-32 Start Date*: 2020-05-18
    Sponsor Name:Navidea Biopharmaceuticals Ltd
    Full Title: A Comparison of Tc 99m Tilmanocept Quantitative Imaging with Immunohistochemical (IHC) Analysis of CD206 Expression in Synovial Tissue from Subjects Clinically Diagnosed with Rheumatoid Arthritis (RA)
    Medical condition: Rheumatoid arthritis
    Disease: Version SOC Term Classification Code Term Level
    23.1 10028395 - Musculoskeletal and connective tissue disorders 10039073 Rheumatoid arthritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2017-000863-34 Sponsor Protocol Number: NL58590.078.16 Start Date*: 2017-12-05
    Sponsor Name:
    Full Title: Curing chronic wounds with fibrin
    Medical condition: non-healing skin wounds
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-003077-15 Sponsor Protocol Number: EIG-LNF-002 Start Date*: 2015-11-23
    Sponsor Name:Eiger BioPharmaceuticals
    Full Title: A Phase 2, Open-Label Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Activity of Titrating-Dose Lonafarnib in Combination with Ritonavir in Patients Chronically Infected w...
    Medical condition: Chronic Hepatitis D Virus (HDV) Infection.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2016-001306-41 Sponsor Protocol Number: ALD403-CLIN-011 Start Date*: 2017-04-27
    Sponsor Name:Alder BioPharmaceuticals, Inc.
    Full Title: A Parallel Group, Double-Blind, Randomized, Placebo Controlled Phase 3 Trial to Evaluate the Efficacy and Safety of ALD403 Administered Intravenously in Patients with Chronic Migraine
    Medical condition: Chronic Migraine
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10027599 Migraine PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) CZ (Completed) DK (Completed) DE (Completed) BE (Completed) SK (Completed) HU (Completed) ES (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2018-003167-54 Sponsor Protocol Number: EIG-LNF-011 Start Date*: 2019-06-24
    Sponsor Name:Eiger BioPharmaceuticals, Inc.
    Full Title: A Phase 3, Matrix Design, Partially Double-Blind, Randomized Study of the Efficacy and Safety of 50 mg Lonafarnib/100 mg Ritonavir BID with and without 180 mcg PEG IFN-alfa-2a for 48 Weeks Compared...
    Medical condition: The proposed indication for lonafarnib coadministered with ritonavir is for the treatment of chronic HDV infection. Approximately 5% of HBV-infected individuals are infected with HDV worldwide. Ch...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10019763 Hepatitis delta LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) GB (GB - no longer in EU/EEA) FR (Completed) BG (Completed) GR (Completed) ES (Ongoing) SE (Completed) IT (Completed) RO (Completed)
    Trial results: (No results available)
    EudraCT Number: 2007-005034-36 Sponsor Protocol Number: KWI-300-104 Start Date*: 2008-07-15
    Sponsor Name:Apotex Inc.
    Full Title: A non comparative, multicentre, repeat dose safety in use study of Neukine® (Filgrastim) in patients receiving chemotherapy known to induce neutropenia
    Medical condition: Febrile neutropenia in breast cancer patients undergoing TAC chemotherapy
    Disease: Version SOC Term Classification Code Term Level
    9.1 10016288 Febrile neutropenia LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: HU (Completed) AT (Completed) PL (Completed) BG (Completed) GR (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2020-004272-17 Sponsor Protocol Number: CLO-SCB-2019-003 Start Date*: 2021-03-25
    Sponsor Name:Clover Biopharmaceuticals AUS Pty Ltd
    Full Title: A Double-blind, Randomized, Controlled, Phase 2/3 Study to Evaluate the Efficacy, Immunogenicity, and Safety of CpG 1018/Alum-Adjuvanted Recombinant SARS-CoV-2 Trimeric S-protein Subunit Vaccine (S...
    Medical condition: SARS-CoV-2-mediated COVID-19
    Disease: Version SOC Term Classification Code Term Level
    23.1 100000004865 10084465 COVID-19 vaccination LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2016-002226-36 Sponsor Protocol Number: N-003-CRD002 Start Date*: 2016-11-04
    Sponsor Name:Noorik Biopharmaceuticals AG
    Full Title: A double-blind, placebo-controlled, escalating-dose study of the effect of N-003 on renal function, pharmacodynamics, pharmacokinetics, safety and tolerability in patients with advanced liver disease.
    Medical condition: Decompensated cirrhosis of the liver
    Disease: Version SOC Term Classification Code Term Level
    19.0 10019805 - Hepatobiliary disorders 10019641 Hepatic cirrhosis PT
    19.0 100000004857 10038448 Renal failure NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GR (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2016-003341-28 Sponsor Protocol Number: PARA_003 Start Date*: 2016-11-14
    Sponsor Name:Paradigm Biopharmaceuticals
    Full Title: A phase 2, randomised, double-blind, placebo-controlled, crossover study to evaluate the effects of a topical pentosan polysulphate sodium (PPS) formulation in subjects with seasonal allergic rhinitis
    Medical condition: Seasonal allergic rhinitis
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004870 10039776 Seasonal allergic rhinitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: View results
    EudraCT Number: 2007-000146-13 Sponsor Protocol Number: ATX-101-06-03 Start Date*: 2007-07-03
    Sponsor Name:Kythera Biopharmaceuticals, Inc.
    Full Title: Phase 1-2, Multi-Centre, Randomized, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of ATX-101 (Sodium Deoxycholate for Injection) for the Reduction of Subcutaneous Fat in the ...
    Medical condition: Reduction of subcutaneous fat in the submental area
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (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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