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Clinical trials for SAFETY

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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    27,966 result(s) found for: SAFETY. Displaying page 396 of 1,399.
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    EudraCT Number: 2020-004198-38 Sponsor Protocol Number: KPL-716-C201 Start Date*: Information not available in EudraCT
    Sponsor Name:Kiniksa Pharmaceuticals, Ltd.
    Full Title: KPL-716-C201: A Phase 2a/b, Randomized, Double-Blind, Placebo Controlled Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of KPL-716 in Reducing Pruritus in Subjects wit...
    Medical condition: Pruritus in Subjects with Prurigo Nodularis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004858 10037084 Prurigo nodularis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) DE (Completed) FR (Completed) BE (Completed) IT (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2015-003623-65 Sponsor Protocol Number: 1311.30 Start Date*: 2016-05-17
    Sponsor Name:Boehringer Ingelheim Pharma GmbH & Co. KG
    Full Title: BI 655066/ABBV-066 (risankizumab) versus adalimumab in a randomized, double blind, parallel group trial in moderate to severe plaque psoriasis to assess safety and efficacy after 16 weeks of treatm...
    Medical condition: psoriasis
    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) SE (Completed) FI (Completed) PT (Completed) CZ (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2021-005484-53 Sponsor Protocol Number: D5671C00006 Start Date*: 2022-06-20
    Sponsor Name:AstraZeneca AB
    Full Title: A Phase IIb/III Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Cotadutide in Participants with Non-cirrhotic Non-alcoholic Steatohepatitis with Fibrosis
    Medical condition: Non-cirrhotic non-alcoholic steatohepatitis with fibrosis
    Disease: Version SOC Term Classification Code Term Level
    24.1 100000004871 10086370 NASH with fibrosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GR (Completed) AT (Completed) ES (Ongoing) IT (Completed) FR (Prematurely Ended) HU (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-002475-35 Sponsor Protocol Number: BO42353 Start Date*: 2021-06-08
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A PHASE III, MULTICENTER, SINGLE-ARM STUDY EVALUATING THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF CROVALIMAB IN ADULT AND ADOLESCENT PATIENTS WITH ATYPICAL HEMOLYTIC UREMIC SYND...
    Medical condition: Atypical Hemolytic Uremic Syndrome (aHUS)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004851 10079841 Atypical hemolytic uremic syndrome LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) BE (Trial now transitioned) HU (Trial now transitioned) PL (Trial now transitioned) IT (Trial now transitioned) FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-000464-27 Sponsor Protocol Number: ART27.13-100 Start Date*: 2020-10-29
    Sponsor Name:Artelo Biosciences Limited
    Full Title: A Phase 1/2 Trial of the Synthetic Cannabinoid ART27.13 in Patients with Cancer Anorexia and Weight Loss
    Medical condition: Cancer anorexia and weight loss
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004861 10002646 Anorexia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) IE (Trial now transitioned) NO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-001733-12 Sponsor Protocol Number: MO41787 Start Date*: 2021-04-15
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A PHASE IIIb, MULTICENTER, OPEN-LABEL, SINGLE-ARM STUDY TO EVALUATE THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SUBCUTANEOUS EMICIZUMAB IN PATIENTS FROM BIRTH TO 12 MONTHS OF AG...
    Medical condition: Hemophilia A
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10053753 Hemophilia A without inhibitors LLT
    Population Age: Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) NL (Ongoing) AT (Trial now transitioned) FR (Trial now transitioned) BE (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-004839-23 Sponsor Protocol Number: CA-4948-102 Start Date*: 2023-02-09
    Sponsor Name:Curis, Inc
    Full Title: A Phase 1/2a, Open-Label Dose Escalation and Cohort Expansion Study of Orally Administered CA-4948(IRAK4i) as a Monotherapy in patients with Acute Myelogenous Leukemia or Myelodysplastic Syndrome a...
    Medical condition: Acute Myelogenous Leukemia (AML) or high risk Myelodysplastic Syndrome (MDS).
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10001941 AML LLT
    20.0 100000004864 10068361 MDS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) PL (Completed) FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2022-000648-32 Sponsor Protocol Number: SCY-078-302 Start Date*: 2023-03-31
    Sponsor Name:SCYNEXIS, Inc.
    Full Title: A Phase 3, Multicenter, Prospective, Randomized, Double-blind Study of Two Treatment Regimens for Candidemia and/or Invasive Candidiasis: Intravenous Echinocandin followed by Oral Ibrexafungerp ver...
    Medical condition: Invasive Candidiasis/ Candidemia
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10060573 Candidemia LLT
    20.0 10021881 - Infections and infestations 10064954 Invasive candidiasis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GR (Trial now transitioned) FR (Trial now transitioned) ES (Temporarily Halted) BE (Trial now transitioned) BG (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2015-002549-72 Sponsor Protocol Number: PH-L19IL2TNF-02/15 Start Date*: 2016-06-02
    Sponsor Name:Philogen S.p.A.
    Full Title: A Phase III, open-label, randomized, controlled multi-center study of the efficacy of L19IL2/L19TNF neoadjuvant intratumoral treatment followed by surgery versus surgery alone in clinical stage III...
    Medical condition: Malignant melanoma of the skin in patients with locally advanced and fully resectable melanoma with/without prior therapy and presence of injectable cutaneous and/or subcutaneous or nodal lesions.
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10025670 Malignant melanoma stage III PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) PL (Trial now transitioned) FR (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-003631-21 Sponsor Protocol Number: CLNA043A12203 Start Date*: 2021-06-28
    Sponsor Name:Novartis Pharma AG
    Full Title: A randomized, four-arm, canakinumab placebo-controlled, participant, investigator and sponsor-blinded study investigating the safety, tolerability and efficacy of intra-articular canakinumab follow...
    Medical condition: osteoarthritis
    Disease: Version SOC Term Classification Code Term Level
    21.1 10028395 - Musculoskeletal and connective tissue disorders 10023476 Knee osteoarthritis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) CZ (Prematurely Ended) HU (Prematurely Ended) EE (Completed) LT (Completed) LV (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-004366-18 Sponsor Protocol Number: CNTO148UCO1001 Start Date*: 2013-07-30
    Sponsor Name:Janssen Biologics B.V.
    Full Title: A Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human anti-TNFα Antibody, in Pediatric Subjects with Moderately to Severely Active ...
    Medical condition: Ulcerative Colitis in pediatric subjects
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10045365 Ulcerative colitis LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: AT (Completed) BE (Completed) DE (Completed) NL (Ongoing) DK (Completed) FR (Ongoing)
    Trial results: View results
    EudraCT Number: 2016-001668-13 Sponsor Protocol Number: GE-012-106 Start Date*: 2017-10-25
    Sponsor Name:GE Healthcare Ltd. and its Affiliates
    Full Title: Parallel-Group, Placebo-Controlled Randomized Study Investigating the Effect of Intravenous Iso-osmolar Iodinated Contrast Material Iodixanol (Visipaque™ Injection 320 mgI/mL) on Renal Function in ...
    Medical condition: Chronic Kidney Disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000070575 10076410 Chronic kidney disease stage 3 LLT
    20.0 100000070575 10076411 Chronic kidney disease stage 4 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) GB (Prematurely Ended) BE (Prematurely Ended) HU (Completed) PL (Prematurely Ended) NL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2021-003680-10 Sponsor Protocol Number: AROAPOC3-3001 Start Date*: 2022-01-13
    Sponsor Name:Arrowhead Pharmaceuticals, Inc.
    Full Title: A Phase 3 Study to Evaluate the Efficacy and Safety of ARO-APOC3 in Adults with Familial Chylomicronemia Syndrome
    Medical condition: Familial Chylomicronemia Syndrome
    Disease: Version SOC Term Classification Code Term Level
    24.1 10010331 - Congenital, familial and genetic disorders 10085051 Familial chylomicronemia syndrome LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Trial now transitioned) FR (Trial now transitioned) IE (Trial now transitioned) BE (Trial now transitioned) ES (Ongoing) HR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-003976-42 Sponsor Protocol Number: OT_101_001 Start Date*: Information not available in EudraCT
    Sponsor Name:Ocumension (Hong Kong) Limited
    Full Title: A phase III, randomized, double-masked, placebo controlled, parallel-group, multicenter study of the safety and efficacy of OT-101 (Atropine 0.01%) in treating the progression of myopia in pediatri...
    Medical condition: myopia
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing) SK (Trial now transitioned) IE (Trial now transitioned) HU (Trial now transitioned) ES (Ongoing) PL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-003405-94 Sponsor Protocol Number: ABY-035-202 Start Date*: 2020-05-05
    Sponsor Name:ACELYRIN, Inc.
    Full Title: A multicenter, randomized, double-blind, placebo-controlled, dose-finding clinical trial inpatients with active psoriatic arthritis to investigate efficacy, tolerability, safety, pharmacokinetics a...
    Medical condition: Active 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: AT (Completed) HU (Completed) CZ (Completed) DE (Completed) ES (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2021-006040-27 Sponsor Protocol Number: CDR132L-P2-01 Start Date*: 2022-06-01
    Sponsor Name:Cardior Pharmaceuticals GmbH
    Full Title: Phase 2, Multicenter, Randomized, Parallel, 3-arm, Placebo-controlled Study to Assess Efficacy and Safety of CDR132L in Patients with Reduced Left Ventricular Ejection Fraction (≤ 45%) After Myocar...
    Medical condition: Reduced Left Ventricular Ejection Fraction After Myocardial Infarction
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004849 10036233 Post myocardial infarction syndrome LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) NL (Trial now transitioned) CZ (Trial now transitioned) PL (Trial now transitioned) GR (Trial now transitioned) HU (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2022-000790-94 Sponsor Protocol Number: NN9536-4999 Start Date*: 2022-11-07
    Sponsor Name:Novo Nordisk A/S
    Full Title: Effect and safety of semaglutide 7.2 mg once-weekly in participants with obesity.
    Medical condition: Obesity
    Disease: Version SOC Term Classification Code Term Level
    20.0 10027433 - Metabolism and nutrition disorders 10029883 Obesity PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GR (Completed) PT (Completed) NO (Completed) SK (Completed) HU (Completed) BG (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-003208-42 Sponsor Protocol Number: CA209-6GE Start Date*: 2022-06-15
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Phase 3, Open Label, Randomized, Non-Inferiority Pharmacokinetic Study of Nivolumab Administered Subcutaneously (Nivo SC) Versus Intravenous Administration of Nivolumab in Participants with Stage...
    Medical condition: Resected Stage IIIA/B/C/D or Stage IV melanoma in an adjuvant setting
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10025671 Malignant melanoma stage IV PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10025670 Malignant melanoma stage III PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Temporarily Halted) BE (Completed) PL (Completed) DE (Prematurely Ended) IT (Completed)
    Trial results: View results
    EudraCT Number: 2018-004567-31 Sponsor Protocol Number: XL184–313 Start Date*: 2019-09-04
    Sponsor Name:Exelixis, Inc.
    Full Title: A Randomized, Double-Blind, Controlled Phase 3 Study of Cabozantinib in Combination with Nivolumab and Ipilimumab versus Nivolumab and Ipilimumab in Subjects with Previously Untreated Advanced or M...
    Medical condition: Metastatic Renal Cell Carcinoma
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10050076 Metastatic renal carcinoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) FR (Trial now transitioned) DE (Trial now transitioned) ES (Ongoing) HU (Completed) BE (Trial now transitioned) FI (Trial now transitioned) NL (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-000662-38 Sponsor Protocol Number: D419NC00001 Start Date*: 2017-01-18
    Sponsor Name:MedImmune, LLC, a wholly owned subsidiary of AstraZeneca PLC
    Full Title: A Phase 1 Study of Durvalumab and IPH2201 in Adult Subjects with Select Advanced Solid Tumors
    Medical condition: Advanced solid tumor
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) HU (Completed) ES (Ongoing) FR (Completed) BE (Completed) IT (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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