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Clinical trials for Monoclonal antibody therapy

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   44393   clinical trials with a EudraCT protocol, of which   7405   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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    1,445 result(s) found for: Monoclonal antibody therapy. Displaying page 9 of 73.
    EudraCT Number: 2008-004454-33 Sponsor Protocol Number: EMR 062 240-506 Start Date*: 2009-01-21
    Sponsor Name:Merck KGaA
    Full Title: Open, randomized, multinational phase IIIb trial evaluating the activity and safety of cetuximab as 250 mg/m² weekly and 500 mg/m² every two weeks maintenance therapy after platinum-based chemother...
    Medical condition:
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) IE (Prematurely Ended) BE (Completed) CZ (Prematurely Ended) HU (Completed) SK (Completed) FR (Completed) AT (Prematurely Ended) ES (Completed) IT (Completed) GR (Completed) PL (Completed) GB (Prematurely Ended) NL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2009-009498-87 Sponsor Protocol Number: Q4577g Start Date*: 2009-06-25
    Sponsor Name:Genentech, Inc.
    Full Title: A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study Of Xolair (Omaluzimab) In Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic With Anith...
    Medical condition: Chronic Idiopathic Urticaria
    Disease: Version SOC Term Classification Code Term Level
    9.1 10009159 Chronic urticaria LLT
    9.1 10021247 Idiopathic urticaria LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2009-013869-26 Sponsor Protocol Number: P06119 Start Date*: 2009-10-02
    Sponsor Name:Associação para Desenvolvimento da Dermatologia do Hospital de Santa Maria
    Full Title: "Influence of Remicade (infliximab) in the skin proteome of psoriatic patients"
    Medical condition: This pilot lab-based study will assess skin biopsies from psoriatic patients treated with infliximab and aim to compare the proteomic profiles of samples obtained under the following conditions: 1-...
    Disease: Version SOC Term Classification Code Term Level
    12.0 10037153 Psoriasis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: PT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2013-002470-46 Sponsor Protocol Number: CIM003JG Start Date*: 2013-12-10
    Sponsor Name:Chugai Pharmaceutical Co. Ltd
    Full Title: A Phase II, randomized, double-blind, placebo-controlled, multiple-dose study to evaluate the safety, tolerability, and efficacy of CIM331 in atopic dermatitis patients who are inadequately control...
    Medical condition: Atopic dermatitis
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2013-004606-26 Sponsor Protocol Number: OBF-13 Start Date*: 2014-04-07
    Sponsor Name:Med. Uni. Wien, Klinik f. Innere Med. I
    Full Title: Exploratory study investigating ocular blood flow in colorectal cancer patients before and after treatment with anti-angiogenic therapy
    Medical condition: metastatic colorectal cancer
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2005-001224-36 Sponsor Protocol Number: A4021010 Start Date*: 2005-06-10
    Sponsor Name:Pfizer Inc. - Research & Development
    Full Title: Phase 1, Open Label, Multiple Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CP-751,871 in Patients with Advanced Solid Tumours
    Medical condition: Advanced Solid Tumours
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2010-022681-27 Sponsor Protocol Number: O-DEX-1 Start Date*: 2010-11-09
    Sponsor Name:University Hospital Brno
    Full Title: Ofatumumab Added to Dexamethasone in Subjects with Relapsed or Refractory Chronic Lymphocytic Leukemia
    Medical condition: Patients with refractory/relapsed CLL
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-000145-12 Sponsor Protocol Number: 5997 Start Date*: 2012-08-15
    Sponsor Name:The Newcastle upon Tyne Hospitals NHS Foundation Trust
    Full Title: Rituximab for the Treatment of Fatigue in Primary Biliary Cirrhosis (PBC)
    Medical condition: Severe fatigue in Primary Biliary Cirrhosis
    Disease: Version SOC Term Classification Code Term Level
    18.0 10019805 - Hepatobiliary disorders 10004661 Biliary cirrhosis primary PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2007-000442-12 Sponsor Protocol Number: KB-101-002 Start Date*: 2008-02-07
    Sponsor Name:Kenta Biotech Ltd
    Full Title: A non-comparative open pilot trial to assess the safety and pharmacokinetics of up to three single doses of AERUMAB 11 in patients with ventilator associated pneumonia caused by serotype O11 P. aer...
    Medical condition: ventilator associated pneumonia (VAP) caused by serotype O11 Pseudomonas aeruginosa
    Disease: Version SOC Term Classification Code Term Level
    9.1 10065153 Ventilator associated pneumonia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) BE (Completed) GR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-002465-22 Sponsor Protocol Number: M16-011 Start Date*: 2018-12-11
    Sponsor Name:AbbVie Deutschland GmbH & Co. KG
    Full Title: A Phase 3, Randomized, Double-Blind, Study Comparing Risankizumab to Placebo in Subjects with Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to or intolerance to at Leas...
    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: SE (Completed) DK (Trial now transitioned) NL (Ongoing) LT (Trial now transitioned) PT (Trial now transitioned) LV (Trial now transitioned) DE (Trial now transitioned) GR (Trial now transitioned) FI (Trial now transitioned) BE (Trial now transitioned) SI (Completed) SK (Trial now transitioned) HR (Trial now transitioned) BG (Trial now transitioned) IT (Trial now transitioned) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-001033-27 Sponsor Protocol Number: REMODEL-WM3 Start Date*: 2016-08-25
    Sponsor Name:FILO
    Full Title: REMODEL - WM3 An Open Label non-randomized Phase II Study exploring «chemo-free » treatment association with Idelalisib + Obinutuzumab in Patient with relapsed/refractory Waldenstrom’s Macroglobuli...
    Medical condition: Waldenstrom’s Macroglobulinemia (MW)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-001088-38 Sponsor Protocol Number: BAY80-6946/17833 Start Date*: 2015-12-09
    Sponsor Name:Bayer AG
    Full Title: A Phase III, randomized, double-blind, controlled, multicenter study of intravenous PI3K inhibitor copanlisib in combination with standard immunochemotherapy versus standard immunochemotherapy in p...
    Medical condition: Patients with relapsed indolent non-Hodgkin's lymphoma
    Disease: Version SOC Term Classification Code Term Level
    23.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029600 Non-Hodgkin's lymphoma recurrent PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Prematurely Ended) DE (Prematurely Ended) BE (Completed) CZ (Completed) DK (Prematurely Ended) ES (Prematurely Ended) GB (Completed) FR (Completed) PL (Prematurely Ended) IE (Prematurely Ended) AT (Prematurely Ended) PT (Prematurely Ended) HU (Completed) SK (Prematurely Ended) GR (Completed) BG (Prematurely Ended) IT (Prematurely Ended) RO (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2017-003983-10 Sponsor Protocol Number: BGB-A317-208 Start Date*: 2018-05-10
    Sponsor Name: BeiGene Ltd., c/o BeiGene USA, Inc.
    Full Title: A Phase 2, Open-label, Multicenter Study to Investigate the Efficacy, Safety, and Pharmacokinetics of the Anti-PD-1 Monoclonal Antibody BGB-A317 in Patients with Previously Treated Hepatocellular U...
    Medical condition: Previously Treated Unresectable Hepatocellular Carcinoma
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10019828 Hepatocellular carcinoma non-resectable LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) ES (Completed) PL (Completed) IT (Completed)
    Trial results: View results
    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: 2007-001609-81 Sponsor Protocol Number: PH-L19ILGEM-01/07 Start Date*: 2007-11-05
    Sponsor Name:Philogen S.pA.
    Full Title: Phase I/II study of the tumor-targeting human L19IL2 monoclonal antibody-cytokine fusion protein in combination with gemcitabine in patients with advanced pancreatic cancer
    Medical condition: Histologically or cytologically confirmed solid cancer of any pathology or adenocarcinoma of the pancreas
    Disease: Version SOC Term Classification Code Term Level
    9.1 10065147 Malignant solid tumor LLT
    9.1 10052747 Adenocarcinoma pancreas LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2005-003100-11 Sponsor Protocol Number: OSAG 101-BSC-05 Start Date*: 2006-02-14
    Sponsor Name:Oncoscience AG
    Full Title: Phase III Study on the effectiveness of OSAG 101 (Theraloc) in newly diagnosed intrinsic pontine gliomas of children and adolescents
    Medical condition: Newly diagnosed pontine glioma
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2010-024194-39 Sponsor Protocol Number: BO21005 Start Date*: 2011-04-15
    Sponsor Name:F. Hoffmann-La Roche Ltd.
    Full Title: ENSAYO DE FASE III, MULTICÉNTRICO, ABIERTO Y ALEATORIZADO PARA COMPARAR LA EFICACIA DE GA101 (RO5072759) EN COMBINACIÓN CON CHOP (G-CHOP) FRENTE A RITUXIMAB Y CHOP (R-CHOP) EN PACIENTES CON LINFOMA...
    Medical condition: PREVIOUSLY UNTREATED PATIENTS WITH CD20-POSITIVE DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL) Pacientes CD20+ con linfoma difuso de celulas B grandes que no han sido previamente tratados
    Disease: Version SOC Term Classification Code Term Level
    12.1 10012819 Diffuse large B-cell lymphomas HLT
    12.1 10012818 Diffuse large B-cell lymphoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) GB (Completed) SK (Completed) CZ (Completed) HU (Completed) IT (Completed) DE (Completed) AT (Completed) DK (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2013-003893-29 Sponsor Protocol Number: BAY80-6946/17067 Start Date*: 2015-06-25
    Sponsor Name:Bayer AG
    Full Title: A Phase III, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of copanlisib in combination with rituximab in patients with relapsed indolent B-cell non-Hodgkin’...
    Medical condition: Patients with relapsed indolent B-cell non-Hodgkin's lymphoma
    Disease: Version SOC Term Classification Code Term Level
    23.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029600 Non-Hodgkin's lymphoma recurrent PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IE (Prematurely Ended) PT (Completed) DE (Prematurely Ended) ES (Prematurely Ended) BE (Completed) LT (Completed) HU (Prematurely Ended) AT (Prematurely Ended) DK (Prematurely Ended) FR (Prematurely Ended) BG (Prematurely Ended) LU (Completed) GR (Completed) SK (Prematurely Ended) IT (Prematurely Ended) RO (Completed)
    Trial results: View results
    EudraCT Number: 2007-004367-22 Sponsor Protocol Number: CACZ885D2306 Start Date*: 2008-05-01
    Sponsor Name:Novartis Pharma Services AG
    Full Title: An open-label, long-term safety and efficacy study of ACZ885 (anti-interleukin-1β monoclonal antibody) administered for at least 6 months in patients with the following cryopyrin-associated periodi...
    Medical condition: The following cryopyrin-associated periodic syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Neonatal Onset Multisystem Inflammatory Disease
    Disease: Version SOC Term Classification Code Term Level
    9.1 10064569 Muckle-Wells syndrome LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) FR (Completed) ES (Completed) IT (Prematurely Ended) BE (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2009-009035-30 Sponsor Protocol Number: CP15-0802 Start Date*: 2009-10-27
    Sponsor Name:ImClone LLC
    Full Title: Randomized Phase 2 Trial Investigating Liposomal Doxorubicin With or Without Anti Platelet Derived Growth Factor Receptor-Alpha (PDGFRα) Monoclonal Antibody IMC-3G3 in Patients With Platinum-Refrac...
    Medical condition: Platinium-refractory or Platinium-resistant Advanced Ovarian Cancer
    Disease: Version SOC Term Classification Code Term Level
    12.0 10033128 Ovarian cancer PT
    Population Age: Adults, Elderly Gender: 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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