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Clinical trials for Drug Induced Lupus Erythematosus

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
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    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   43881   clinical trials with a EudraCT protocol, of which   7295   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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    14 result(s) found for: Drug Induced Lupus Erythematosus. Displaying page 1 of 1.
    EudraCT Number: 2009-012059-47 Sponsor Protocol Number: IFN-K-001 Start Date*: 2010-01-28
    Sponsor Name:Neovacs SA
    Full Title: A phase I-II, randomized, double-blind, placebo-controlled, dose escalation study of Neovacs’ IFNα-Kinoid in adult subjects with Systemic Lupus Erythematosus.
    Medical condition: Systemic Lupus Erythematosus (SLE)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10028395 - Musculoskeletal and connective tissue disorders 10042945 Systemic lupus erythematosus PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed) DE (Completed) FR (Completed) BG (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-019293-32 Sponsor Protocol Number: C33457/3075 Start Date*: 2011-02-10
    Sponsor Name:Cephalon, Inc.
    Full Title: An Open-Label Long-Term Study of the Safety and Tolerability of Repeated administration of CEP-33457 in Patients With Systemic Lupus Erythematosus
    Medical condition: Patients With Systemic Lupus Erythematosus (SLE)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10028395 - Musculoskeletal and connective tissue disorders 10042945 Systemic lupus erythematosus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) BE (Prematurely Ended) HU (Prematurely Ended) ES (Completed) CZ (Prematurely Ended) PT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2015-003341-25 Sponsor Protocol Number: IPP-201101/005 Start Date*: 2016-05-02
    Sponsor Name:ImmuPharma SA
    Full Title: A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lup...
    Medical condition: Systemic Lupus Erythematosus
    Disease: Version SOC Term Classification Code Term Level
    18.1 10028395 - Musculoskeletal and connective tissue disorders 10042945 Systemic lupus erythematosus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) DE (Completed) FR (Completed) GB (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2021-000962-14 Sponsor Protocol Number: CCM-RNT-202101 Start Date*: 2021-07-02
    Sponsor Name:Charité - Universitätsmedizin Berlin
    Full Title: A Monocenter, Open Label Study to Evaluate the Safety and Efficacy of Daratumumab in Combination with Standard Background Therapy in Participants with Moderate to Severe Systemic Lupus Erythematosus
    Medical condition: Systemic Lupus Erythematosus
    Disease: Version SOC Term Classification Code Term Level
    21.1 10028395 - Musculoskeletal and connective tissue disorders 10042945 Systemic lupus erythematosus PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2010-018383-16 Sponsor Protocol Number: C33457/2047 Start Date*: 2010-09-17
    Sponsor Name:Cephalon, Inc.
    Full Title: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus
    Medical condition: Patients With Systemic Lupus Erythematosus (SLE)
    Disease: Version SOC Term Classification Code Term Level
    14.0 10028395 - Musculoskeletal and connective tissue disorders 10042945 Systemic lupus erythematosus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) BE (Completed) HU (Completed) ES (Completed) CZ (Completed) PT (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2022-000831-21 Sponsor Protocol Number: HZNP-DAX-202 Start Date*: 2023-02-06
    Sponsor Name:Horizon Therapeutics Ireland DAC
    Full Title: A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP TRIAL TO INVESTIGATE THE EFFICACY AND SAFETY OF DAXDILIMAB SUBCUTANEOUS INJECTION IN REDUCING DISEASE ACTIVITY I...
    Medical condition: Discoid Lupus Erythematosus
    Disease: Version SOC Term Classification Code Term Level
    25.0 100000004858 10013072 Discoid lupus erythematosus LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Ongoing) BG (Ongoing) PL (Ongoing) CZ (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-001341-86 Sponsor Protocol Number: IFN-K-002 Start Date*: 2015-11-19
    Sponsor Name:Neovacs S.A.
    Full Title: A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Neutralization of the Interferon Gene Signature and the Clinical Efficacy of IFNα-Kinoid in Adult Subjects with Syste...
    Medical condition: Systemic Lupus Erythematosus
    Disease: Version SOC Term Classification Code Term Level
    20.0 10028395 - Musculoskeletal and connective tissue disorders 10042945 Systemic lupus erythematosus PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) BE (Completed) HR (Completed) ES (Completed) BG (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2010-019689-10 Sponsor Protocol Number: CKRP203A2202 Start Date*: 2010-09-20
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A multi-center, double-blind, placebo-controlled, proof-of-concept study to evaluate the efficacy and tolerability of KRP203 in patients with active subacute cutaneous lupus erythematosus
    Medical condition: Subacute cutaneous lupus erythematosus, in patients who do not respond to first line therapies (i.e. antimalarials)
    Disease: Version SOC Term Classification Code Term Level
    12.1 10025135 Lupus erythematosus (incl subtypes) HLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) IT (Prematurely Ended) GR (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2007-001377-28 Sponsor Protocol Number: 27577 Start Date*: 2008-06-11
    Sponsor Name:Merck Serono International S.A.
    Full Title: Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of...
    Medical condition: Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosp...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10061664 Autoimmune disorder LLT
    9.1 10025139 Lupus erythematosus systemic LLT
    9.1 10047888 Wegener's granulomatosis LLT
    9.1 10002817 Antiphospholipid syndrome LLT
    9.1 10040767 Sjogren's syndrome LLT
    9.1 10039073 Rheumatoid arthritis LLT
    9.1 10028245 Multiple sclerosis LLT
    9.1 10045228 Type I diabetes mellitus LLT
    9.1 10011401 Crohn's disease LLT
    9.1 10009900 Colitis ulcerative LLT
    9.1 10003827 Autoimmune hepatitis LLT
    9.1 10049046 Autoimmune thyroiditis LLT
    9.1 10003822 Autoimmune haemolytic anaemia NOS LLT
    9.1 10034697 Pernicious anemia LLT
    9.1 10028417 Myasthenia gravis LLT
    9.1 10018620 Goodpasture's syndrome LLT
    9.1 10018766 Guillain Barre syndrome LLT
    9.1 10043554 Thrombocytopenia LLT
    9.1 10037153 Psoriasis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) DE (Prematurely Ended) AT (Prematurely Ended) NL (Prematurely Ended) PT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2012-000714-11 Sponsor Protocol Number: IM101-291 Start Date*: 2013-04-20
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BMS-188667 (Abatacept) or Placebo on a Background of Mycophenolate Mofetil (MMF) and Corticostero...
    Medical condition: Active Class III or IV lupus glomerulonephritis
    Disease: Version SOC Term Classification Code Term Level
    15.1 10038359 - Renal and urinary disorders 10025140 Lupus nephritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed) CZ (Completed) ES (Completed) RO (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2007-004892-21 Sponsor Protocol Number: IP-004 Start Date*: 2008-04-08
    Sponsor Name:IMMUPHARMA SA
    Full Title: Estudio Fase IIb, Multicéntrico, Aleatorizado, Doble-Ciego, Controlado con Placebo de Búsqueda de dosis, para Evaluar Eficacia, Seguridad y Tolerabilidad de Dos Dosis Subcutáneas de IPP-201101 Más ...
    Medical condition: Lupus Eritematoso Sistémico (LES)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) BG (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-004034-42 Sponsor Protocol Number: CA41705 Start Date*: 2020-08-31
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OBINUTUZUMAB IN PATIENTS WITH ISN/RPS 2003 CLASS III OR IV LUPUS NEPHRITIS
    Medical condition: lupus nephritis
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038359 - Renal and urinary disorders 10025140 Lupus nephritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) PL (Trial now transitioned) FR (Trial now transitioned) GB (GB - no longer in EU/EEA) IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-002022-39 Sponsor Protocol Number: WA29748 Start Date*: 2015-09-24
    Sponsor Name:Roche Farma, S.A., que representa en España a F. Hoffmann-La Roche Ltd.
    Full Title: A randomized, double-blind, placebo-controlled, multi-center study to evaluate the safety and efficacy of Obinutuzumab in patients with ISN/RPS 2003 class III or IV Lupus Nephritis
    Medical condition: Lupus Nephritis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) FR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2021-000010-41 Sponsor Protocol Number: ACT17012 Start Date*: 2021-11-30
    Sponsor Name:Sanofi-Aventis Recherche & Développement
    Full Title: A multi-cohort, randomized, Phase 2, open-label study to assess the preliminary efficacy, safety, and pharmacokinetics of BIVV020 (SAR445088) for prevention and treatment of antibody-mediated reje...
    Medical condition: Antibody-mediated rejection in adult kidney transplant recipients
    Disease: Version SOC Term Classification Code Term Level
    21.1 10021428 - Immune system disorders 10044439 Transplant rejection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Ongoing) ES (Ongoing) SE (Ongoing) IT (Ongoing)
    Trial results: (No results available)
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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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