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Clinical trials for ALXN1210-

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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    • 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   44336   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 ).  
     
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    19 result(s) found for: ALXN1210-. Displaying page 1 of 1.
    EudraCT Number: 2015-002674-20 Sponsor Protocol Number: ALXN1210-PNH-201 Start Date*: 2015-12-04
    Sponsor Name:Alexion Pharmaceuticals, Inc.
    Full Title: A Phase 2, Open-Label, Multiple Ascending Dose Study to Evaluate the Efficacy, Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of ALXN1210 Administered Intravenously to...
    Medical condition: Paroxysmal Nocturnal Hemoglobinuria (PNH)
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004857 10055629 Paroxysmal nocturnal hemoglobinuria LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) GB (GB - no longer in EU/EEA) SE (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2016-002025-11 Sponsor Protocol Number: ALXN1210-PNH-301 Start Date*: 2016-12-02
    Sponsor Name:Alexion Pharmaceuticals Incorporated
    Full Title: A Phase 3, Randomized, Open-Label, Active-Controlled Study of ALXN1210 Versus Eculizumab in Complement Inhibitor-Naïve Adult Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH)
    Medical condition: Paroxysmal Nocturnal Hemoglobinuria (PNH)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004857 10055629 Paroxysmal nocturnal hemoglobinuria LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) SE (Completed) BE (Completed) CZ (Completed) DK (Prematurely Ended) PT (Prematurely Ended) FI (Prematurely Ended) ES (Ongoing) NL (Completed) AT (Completed) EE (Completed) PL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2016-002026-36 Sponsor Protocol Number: ALXN1210-PNH-302 Start Date*: 2017-05-30
    Sponsor Name:Alexion Pharmaceuticals Incorporated
    Full Title: A Phase 3, Randomized, Open-Label, Active-Controlled Study of ALXN1210 Versus Eculizumab in Adult Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab
    Medical condition: Paroxysmal Nocturnal Hemoglobinuria (PNH)
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004857 10055629 Paroxysmal nocturnal hemoglobinuria LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) ES (Ongoing) NL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2017-002820-26 Sponsor Protocol Number: ALXN1210-PNH-304 Start Date*: 2017-11-24
    Sponsor Name:Alexion Pharmaceuticals Incorporated
    Full Title: A Phase 3, Open-Label Study of ALXN1210 in Children and Adolescents with Paroxysmal Nocturnal Hemoglobinuria (PNH)
    Medical condition: Paroxysmal Nocturnal Hemoglobinuria (PNH)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038359 - Renal and urinary disorders 10034042 Paroxysmal nocturnal haemoglobinuria PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) NL (Completed) FR (Completed) NO (Completed)
    Trial results: View results
    EudraCT Number: 2016-002499-29 Sponsor Protocol Number: ALXN1210-aHUS-312 Start Date*: 2017-05-18
    Sponsor Name:Alexion Pharmaceuticals Incorporated
    Full Title: A Phase 3, Open-Label, Multicenter Study of ALXN1210 in Children and Adolescents with Atypical Hemolytic Uremic Syndrome (aHUS)
    Medical condition: Atypical Hemolytic Uremic Syndrome (aHUS)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004851 10019515 Hemolytic uremic syndrome LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) AT (Completed) SE (Prematurely Ended) ES (Ongoing) BE (Completed) IT (Completed) FR (Ongoing)
    Trial results: View results
    EudraCT Number: 2016-002027-29 Sponsor Protocol Number: ALXN1210-aHUS-311 Start Date*: 2016-11-24
    Sponsor Name:Alexion Pharmaceuticals Incorporated
    Full Title: Single Arm Study of ALXN1210 in Complement Inhibitor Treatment-Naïve Adult and Adolescent Patients with Atypical Hemolytic Uremic Syndrome (aHUS)
    Medical condition: Atypical Hemolytic Uremic Syndrome (aHUS)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004851 10019515 Hemolytic uremic syndrome LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) AT (Completed) ES (Completed) SE (Completed) BE (Completed) CZ (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2017-002370-39 Sponsor Protocol Number: ALXN1210-PNH-303 Start Date*: 2019-07-02
    Sponsor Name:Alexion Pharmaceuticals, Inc.
    Full Title: A Phase 3, Randomized, Parallel-Group, Multicenter, Open-Label, Pharmacokinetic, Noninferiority Study of Ravulizumab Administered Subcutaneously Versus Intravenously in Adult Patients With Paroxys...
    Medical condition: Paroxysmal Nocturnal Hemoglobinuria
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004857 10055629 Paroxysmal nocturnal hemoglobinuria LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) FR (Completed) BE (Completed) GB (GB - no longer in EU/EEA) NL (Ongoing) SE (Completed) FI (Completed) CZ (Completed) ES (Ongoing) AT (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2019-003440-74 Sponsor Protocol Number: ALXN1210-PNH-401 Start Date*: 2020-05-14
    Sponsor Name:Alexion Pharmaceuticals Inc.
    Full Title: Phase 4, Single-Arm Study of Ravulizumab in Adult Participants with Paroxysmal Nocturnal Hemoglobinuria Currently Treated with High-Dose Eculizumab
    Medical condition: Paroxysmal nocturnal hemoglobinuria (PNH)
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004857 10055629 Paroxysmal nocturnal hemoglobinuria LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2018-003243-39 Sponsor Protocol Number: ALXN1210-MG-306 Start Date*: 2019-07-30
    Sponsor Name:Alexion Pharmaceuticals Inc.
    Full Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myastheni...
    Medical condition: Generalized Myasthenia Gravis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004859 10071942 Myasthenia gravis and related conditions HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed) NL (Completed) DK (Completed) ES (Completed) FR (Completed) CZ (Completed) GB (GB - no longer in EU/EEA) PT (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2021-001200-15 Sponsor Protocol Number: ALXN1210-DM-310 Start Date*: 2021-10-05
    Sponsor Name:Alexion Pharmaceuticals, Inc.
    Full Title: A Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants with Dermatomyositis.
    Medical condition: Dermatomyositis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10040785 - Skin and subcutaneous tissue disorders 10012503 Dermatomyositis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) FR (Completed) ES (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2020-001497-30 Sponsor Protocol Number: ALXN1210-COV-305 Start Date*: 2020-05-07
    Sponsor Name:Alexion Pharmaceuticals, Inc.
    Full Title: COVID-19 A Phase 3 Open-label, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Intravenously Administered Ravulizumab Compared with Best Supportive Care in Patients with COVID-1...
    Medical condition: COVID-19 severe pneumonia, acute lung injury, or acute respiratory distress syndrome
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10061229 Lung infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) FR (Prematurely Ended) DE (Prematurely Ended) ES (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2019-003352-37 Sponsor Protocol Number: ALXN1210-NMO-307 Start Date*: 2020-06-08
    Sponsor Name:Alexion Pharmaceuticals, Inc.
    Full Title: A Phase 3, External Placebo-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Patients with Neuromyelitis Optica Spectrum Disorder (NMOSD)
    Medical condition: Neuromyelitis Optica Spectrum Disorder
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029205 - Nervous system disorders 10077875 Neuromyelitis optica spectrum disorder PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Prematurely Ended) DK (Completed) GB (GB - no longer in EU/EEA) DE (Completed) ES (Ongoing) AT (Completed) PL (Completed) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-000144-61 Sponsor Protocol Number: ALXN1210-TMA-313 Start Date*: 2020-08-17
    Sponsor Name:Alexion Pharmaceuticals, Inc.
    Full Title: A Phase 3, Open-label, Randomized, Multicenter Study of Ravulizumab in Adult and Adolescent Participants who have Thrombotic Microangiopathy (TMA) after Hematopoietic Stem Cell Transplant (HSCT)
    Medical condition: Hematopoietic stem cell transplant-associated thrombotic microangiopathy
    Disease: Version SOC Term Classification Code Term Level
    20.0 10005329 - Blood and lymphatic system disorders 10043645 Thrombotic microangiopathy PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) IT (Trial now transitioned) SE (Trial now transitioned) DE (Trial now transitioned) NL (Trial now transitioned) BE (Trial now transitioned) GR (Trial now transitioned) PL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-000761-16 Sponsor Protocol Number: ALXN1210-TMA-314 Start Date*: Information not available in EudraCT
    Sponsor Name:Alexion Pharmaceuticals, Inc.
    Full Title: A Phase 3, Open-label, Single Arm, Multicenter Study of Ravulizumab in Addition to Best Supportive Care in Pediatric Participants (from 1 month to < 18 years of age) with Thrombotic Microangiopathy...
    Medical condition: hematopoietic stem cell transplant-associated thrombotic microangiopathy
    Disease: Version SOC Term Classification Code Term Level
    20.0 10005329 - Blood and lymphatic system disorders 10043645 Thrombotic microangiopathy PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) FR (Trial now transitioned) DE (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-006075-42 Sponsor Protocol Number: ALXN1210-NMO-317 Start Date*: 2022-05-17
    Sponsor Name:Alexion Pharmaceuticals, Inc.
    Full Title: A Phase 2/3, Open-label, Historical-controlled, Single-arm, Multicenter Study to Evaluate the Efficacy, Pharmacokinetics, Pharmacodynamics, and Safety of Ravulizumab in Children and Adolescents Wit...
    Medical condition: Neuromyelitis Optica Spectrum Disorder (NMOSD)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029205 - Nervous system disorders 10077875 Neuromyelitis optica spectrum disorder PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Ongoing) FR (Trial now transitioned) DE (Ongoing) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-004619-30 Sponsor Protocol Number: ALXN1210-ALS-308 Start Date*: 2020-09-14
    Sponsor Name:Alexion Pharmaceuticals
    Full Title: A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Ravulizumab in Patients With Amyotroph...
    Medical condition: Amyotrophic Lateral Sclerosis (ALS), motor neuron disease
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029205 - Nervous system disorders 10002026 Amyotrophic lateral sclerosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IE (Completed) SE (Prematurely Ended) GB (GB - no longer in EU/EEA) DE (Prematurely Ended) DK (Prematurely Ended) ES (Prematurely Ended) NL (Prematurely Ended) BE (Prematurely Ended) FR (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2021-005609-28 Sponsor Protocol Number: RAV-IgA Start Date*: 2022-03-18
    Sponsor Name:Dr. Alfons Segarra Medrano
    Full Title: A PILOT PROOF-OF–CONCEPT STUDY TO ASSESS THE EFFICACY AND SAFETY OF A 6 MONTHS RAVULIZUMAB TREATMENT IN PATIENTS WITH FLARES OF CORTICOSTEROID-RESISTANT IDIOPATHIC IgA NEPHROPATHY
    Medical condition: Treatment for IgA nephropathy flares
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-005328-13 Sponsor Protocol Number: ALXN1210-TMA-315 Start Date*: 2021-10-04
    Sponsor Name:Alexion Pharmaceuticals, Inc.
    Full Title: A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants Who Have Thrombotic Microangiopathy Associated wi...
    Medical condition: thrombotic microangiopathy associated with a trigger
    Disease: Version SOC Term Classification Code Term Level
    20.0 10005329 - Blood and lymphatic system disorders 10043645 Thrombotic microangiopathy PT
    20.0 10047065 - Vascular disorders 10062198 Microangiopathy PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) BE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2020-001537-13 Sponsor Protocol Number: ALXN1210-NEPH-202 Start Date*: 2021-03-25
    Sponsor Name:Alexion Pharmaceuticals, Inc.
    Full Title: A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants With Proliferative Lupus Nephritis (LN) or Immunoglobulin A Ne...
    Medical condition: Lupus Nephritis (LN) Immunoglobulin A Nephropathy (IgAN)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038359 - Renal and urinary disorders 10025140 Lupus nephritis PT
    20.0 10038359 - Renal and urinary disorders 10021263 IgA nephropathy PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) DE (Trial now transitioned) SE (Trial now transitioned) ES (Ongoing) IT (Trial now transitioned)
    Trial results: (No results available)
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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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