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Clinical trials for PSC

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   44351   clinical trials with a EudraCT protocol, of which   7378   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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    265 result(s) found for: PSC. Displaying page 8 of 14.
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    EudraCT Number: 2014-002123-10 Sponsor Protocol Number: 1200.120 Start Date*: 2015-04-18
    Sponsor Name:Boehringer Ingelheim España, S.A.
    Full Title: Phase I open label, dose escalation trial to determine the MTD, safety, PK and efficacy of afatinib monotherapy in children aged 2 years to <18 years with recurrent/refractory neuroectodermal tumou...
    Medical condition: Paediatric patients with recurrent//refractory high grade glioma (HGG), diffuse intrinsic pontine glioma (DIPG), low grade astrocytoma, neuroblastoma, ependymoma, medulloblastoma/primitive neuroect...
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004864 10029091 Neoplasm of unspecified nature of endocrine glands and other parts of nervous system LLT
    18.0 100000004864 10029006 Neoplasm of uncertain behavior of brain and spinal cord LLT
    18.0 100000004864 10029050 Neoplasm of uncertain behaviour of connective and other soft tissue LLT
    18.0 100000004864 10028992 Neoplasm CNS LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Temporarily Halted) DE (Completed) GB (GB - no longer in EU/EEA) AT (Completed) FR (Completed) DK (Completed) IT (Completed) NL (Completed) IE (Completed)
    Trial results: View results
    EudraCT Number: 2019-004167-45 Sponsor Protocol Number: 1305-0013 Start Date*: 2020-05-18
    Sponsor Name:Boehringer Ingelheim Finland Ky
    Full Title: A randomised, double-blind, placebo-controlled parallel group study in IPF patients over 12 weeks evaluating efficacy, safety and tolerability of BI 1015550 taken orally.
    Medical condition: Idiopathic Pulmonary Fibrosis
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10021240 Idiopathic pulmonary fibrosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed) NL (Completed) DK (Completed) CZ (Completed) DE (Completed) HU (Completed) GB (GB - no longer in EU/EEA) AT (Completed) PL (Completed) SK (Prematurely Ended) GR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2015-003625-34 Sponsor Protocol Number: 1311.5 Start Date*: 2016-04-13
    Sponsor Name:Boehringer Ingelheim Finland Ky
    Full Title: A randomised, double-blind, placebo-controlled, proof-of-concept, dose-ranging study of BI 655066 / ABBV-066 / risankiumab in patients with active psoriatic arthritis
    Medical condition: Active Psoriatic Arthritis
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004859 10037160 Psoriatic arthritis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed) ES (Completed) NL (Completed) DE (Completed) BE (Completed) CZ (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2011-005512-28 Sponsor Protocol Number: 205.443 Start Date*: 2012-10-04
    Sponsor Name:Boehringer Ingelheim
    Full Title: A phase II/III, randomised, double-blind, placebo-controlled, parallel group trial to evaluate safety and efficacy of tiotropium inhalation solution (2.5 µg and 5 µg) administered once daily in the...
    Medical condition: Asthma
    Disease: Version SOC Term Classification Code Term Level
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10003553 Asthma PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: NL (Completed) LT (Completed) LV (Completed) FI (Completed) DE (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2012-003535-27 Sponsor Protocol Number: 1241.36 Start Date*: 2012-10-17
    Sponsor Name:SCS Boehringer Ingelheim Comm.V
    Full Title: A phase III randomised, partially double-blind and placebo-controlled study of BI 207127 in combination with faldaprevir and ribavirin for chronic genotype 1 hepatitis C infection in an extended p...
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    17.0 10021881 - Infections and infestations 10008912 Chronic hepatitis C PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) DE (Completed) PT (Completed) GB (Completed) ES (Completed) GR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2009-018005-43 Sponsor Protocol Number: 205.419 Start Date*: 2010-06-14
    Sponsor Name:Boehringer Ingelheim Pharma GmbH & Co. KG
    Full Title: A Phase III randomised, double-blind, placebo-controlled, parallel-group trial to evaluate efficacy and safety of tiotropium inhalation solution delivered via Respimat® inhaler (2.5 and 5 μg once ...
    Medical condition: Moderate persistent asthma
    Disease: Version SOC Term Classification Code Term Level
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10003553 Asthma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2016-002254-20 Sponsor Protocol Number: 1297.9 Start Date*: 2017-08-04
    Sponsor Name:Boehringer Ingelheim International GmbH
    Full Title: VOLTAIRE-X: Pharmacokinetics, safety, immunogenicity and efficacy of BI 695501 versus Humira® in patients with moderate to severe chronic plaque psoriasis: a randomized, double-blind, parallel-arm,...
    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: LV (Completed) HU (Completed) DE (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2013-005031-24 Sponsor Protocol Number: 1289.5 Start Date*: 2014-12-04
    Sponsor Name:Boehringer Ingelheim Pharma GmbH & Co. KG
    Full Title: A multi-centre, double-blind, parallel-group, randomised controlled study to investigate efficacy, safety and tolerability of orally administered BI 409306 during a 12-week treatment period compare...
    Medical condition: Patients with diagnosis of AD according to the following criteria: • Symptoms noticed by the patients and/or informant • Cognitive testing confirming symptoms • Biomarker evidence of AD patholog...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000014713 10001896 Alzheimer's disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) IT (Completed) PT (Completed) ES (Completed) BE (Completed) AT (Completed) NL (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2010-018730-51 Sponsor Protocol Number: 113977 Start Date*: 2010-11-24
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase IIIb, open, multi-centre, controlled study to assess the long-term persistence of antibodies after a single dose of GlaxoSmithKline (GSK) Biologicals’ meningococcal serogroup ACWY tetanus-t...
    Medical condition: Vaccination of children 2 to 10 years of age against invasive disease caused by meningococcal serogroups A, C, W-135, and Y.
    Disease: Version SOC Term Classification Code Term Level
    12.1 10027274 Meningococcal infection LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2013-001291-38 Sponsor Protocol Number: 1230.27 Start Date*: 2013-09-23
    Sponsor Name:Boehringer Ingelheim Pharma GmbH & Co.KG
    Full Title: Open, non-controlled, dose escalating Phase I trial to evaluate the pharmacokinetics, pharmacodynamics, tolerability and toxicity of volasertib in paediatric patients from 2 years to less than 18 y...
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004864 10048683 Advanced cancer LLT
    17.1 10005329 - Blood and lymphatic system disorders 10024324 Leukaemias HLGT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) IT (Completed) CZ (Completed) AT (Completed) SK (Completed) BE (Completed) NL (Completed) GB (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2011-004354-25 Sponsor Protocol Number: 1245.78 Start Date*: 2013-10-29
    Sponsor Name:Boehringer Ingelheim Pharma GmbH & Co. KG
    Full Title: A 28-day randomised, placebo-controlled, double-blind parallel group phase IIa trial to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of once daily oral doses of 2.5 mg, 10...
    Medical condition: Diabetes mellitus type 1
    Disease: Version SOC Term Classification Code Term Level
    16.0 10027433 - Metabolism and nutrition disorders 10067584 Type 1 diabetes mellitus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2015-005427-10 Sponsor Protocol Number: 1200.261 Start Date*: 2016-04-29
    Sponsor Name:Boehringer Ingelheim España, S.A.
    Full Title: Phase II open label single arm exploratory trial of oral afatinib monotherapy following platinum failure for patients with advanced/metastatic urothelial tract carcinoma with ERBB receptor deregula...
    Medical condition: patients with advanced/metastatic urothelial tract carcinoma with ERBB receptor deregulation
    Disease: Version SOC Term Classification Code Term Level
    18.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10005003 Bladder cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2015-003148-38 Sponsor Protocol Number: 1199.227 Start Date*: 2016-06-13
    Sponsor Name:Boehringer Ingelheim España, S.A.
    Full Title: A 12-week, double blind, randomised, placebo controlled, parallel group trial followed by a single active arm phase of 40 weeks evaluating the effect of oral nintedanib 150 mg twice daily on change...
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    18.1 10038738 - Respiratory, thoracic and mediastinal disorders 10021240 Idiopathic pulmonary fibrosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) CZ (Completed) FI (Completed) HU (Completed) GB (Completed) BE (Completed) FR (Completed) DE (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2013-002622-23 Sponsor Protocol Number: 1301.4 Start Date*: 2014-06-24
    Sponsor Name:Boehringer Ingelheim International GmbH
    Full Title: Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial
    Medical condition: moderately to severely active rheumatoid arthritis
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004870 10039075 Rheumatoid arthritis and associated conditions HLT
    16.1 10028395 - Musculoskeletal and connective tissue disorders 10039073 Rheumatoid arthritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Prematurely Ended) PT (Prematurely Ended) BG (Prematurely Ended) BE (Completed) DE (Prematurely Ended) HU (Prematurely Ended) ES (Prematurely Ended) GR (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-001758-26 Sponsor Protocol Number: 205.445 Start Date*: 2012-05-15
    Sponsor Name:Boehringer
    Full Title: A randomised, double-blind, placebo-controlled, parallel-group trial to evaluate efficacy and safety of tiotropium inhalation solution (2.5 µg and 5 µg) delivered via Respimat® inhaler once daily i...
    Medical condition: Moderate persisten asthma
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004855 10003560 Asthma NOS LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: LV (Completed) LT (Completed) PT (Completed) DE (Completed) BG (Completed) SE (Completed) HU (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2009-016243-20 Sponsor Protocol Number: 1245.20 Start Date*: 2010-10-26
    Sponsor Name:SCS Boehringer Ingelheim Comm.V
    Full Title: A phase III randomised, double-blind, placebo-controlled parallel group efficacy and safety study of BI 10773 and sitagliptin administered orally over 24 weeks, in drug naïve patients with type 2 d...
    Medical condition: Patients with type 2 diabetes mellitus.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10027433 - Metabolism and nutrition disorders 10045242 Type II diabetes mellitus LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) IE (Completed)
    Trial results: View results
    EudraCT Number: 2014-005102-38 Sponsor Protocol Number: 1311.4 Start Date*: 2016-04-14
    Sponsor Name:Boehringer Ingelheim Pharma GmbH & Co. KG
    Full Title: BI 655066 / ABBV-066 (risankizumab) versus placebo In a Multicenter randomized double-blind study in patients with Moderate to severe chronic plaque psoriasis evaluating the efficacy and safety ...
    Medical condition:
    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: DE (Completed) BE (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2012-004544-30 Sponsor Protocol Number: 1241.37 Start Date*: 2013-04-03
    Sponsor Name:SCS Boehringer Ingelheim Comm.V
    Full Title: A phase III, randomised, open label, active-controlled study of an interferon-free regimen of BI 207127 in combination with Faldaprevir and Ribavirin compared to Telaprevir in combination with pe...
    Medical condition: Hepatitis C
    Disease: Version SOC Term Classification Code Term Level
    16.0 10021881 - Infections and infestations 10008912 Chronic hepatitis C PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) SE (Prematurely Ended) NO (Completed) IT (Prematurely Ended) GB (Prematurely Ended) ES (Prematurely Ended) DE (Completed) DK (Prematurely Ended) FR (Completed)
    Trial results: View results
    EudraCT Number: 2015-002974-20 Sponsor Protocol Number: 1237.28 Start Date*: 2016-08-04
    Sponsor Name:SCS Boehringer Ingelheim Comm. V
    Full Title: A randomised, double-blind, cross-over study to evaluate the effect of 6 weeks treatment of orally inhaled tiotropium + olodaterol fixed dose combination (5/5 µg) compared with tiotropium (5 µg),...
    Medical condition: Patients with moderate to severe Chronic Obstructive Pulmonary Disease according to the GOLD guidelines.
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004855 10009026 Chronic obstructive airways disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2014-004794-16 Sponsor Protocol Number: 1270.11 Start Date*: 2015-10-21
    Sponsor Name:SCS Boehringer Ingelheim Comm. V
    Full Title: An open label multicenter Phase Ib/II trial to determine the dose of BI 836826 in combination with gemcitabine and oxaliplatin (GemOx) and the efficacy of BI 836826 – GemOx versus rituximab ( R ) w...
    Medical condition: Patients with relapsed/refractory diffuse large B-cell lymphoma including transformed follicular lymphoma) who have been previously treated with an anti-CD20 monoclonal antibody (e.g. rituximab) in...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10012822 Diffuse large B-cell lymphoma refractory PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) IT (Completed)
    Trial results: View results
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    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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