13. 多発性硬化症／視神経脊髄炎 Multiple sclerosis/Neuromyelitis optica Clinical trials / Disease details
臨床試験数 : 3,340 / 薬物数 : 2,163 - (DrugBank : 383) / 標的遺伝子数 : 241 - 標的パスウェイ数 : 238
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05346354 (ClinicalTrials.gov) | June 23, 2022 | 20/4/2022 | Efficacy and Safety Study of Ravulizumab IV in Pediatric Participants With NMOSD | 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 With Aquaporin-4 Antibody Positive (AQP4-Ab [+]) Neuromyelitis Optica Spectrum Disorder (NMOSD) | Neuromyelitis Optica Spectrum Disorder | Drug: Ravulizumab | Alexion Pharmaceuticals | NULL | Recruiting | 2 Years | 17 Years | All | 12 | Phase 2/Phase 3 | United States;Japan;Korea, Republic of;Spain |
| 2 | EUCTR2021-006075-42-ES (EUCTR) | 17/05/2022 | 24/02/2022 | Clinical study testing the efficacy and safety of Ravulizumab in pediatric patients with NMOSD | 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 With Aquaporin-4 antibody Positive (AQP4-Ab [+]) Neuromyelitis Optica Spectrum Disorder (NMOSD) - A Phase 2/3 Efficacy and Safety Study of Ravulizumab in Pediatric Patients with NMOSD | Neuromyelitis Optica Spectrum Disorder (NMOSD) MedDRA version: 21.1;Level: PT;Classification code 10077875;Term: Neuromyelitis optica spectrum disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Trade Name: ULTOMIRIS® Product Name: Ravulizumab Product Code: ALXN1210 INN or Proposed INN: Ravulizumab | Alexion Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 12 | Phase 2;Phase 3 | United States;France;Canada;Spain;Germany;Japan;Italy;Korea, Republic of | ||
| 3 | JPRN-jRCT2031220259 | 06/07/2021 | 09/08/2022 | A Phase 2/3, Open-label, Historical-controlled, Single-arm, Multicenter Studyto Evaluate the Efficacy, Pharmacokinetics, Pharmacodynamics, and Safety ofRavulizumab in Children and Adolescents With Aquaporin-4 Antibody Positive(AQP4-Ab [+]) Neuromyelitis Optica Spectrum Disorder (NMOSD) | A Phase 2/3, Open-label, Historical-controlled, Single-arm, Multicenter Studyto Evaluate the Efficacy, Pharmacokinetics, Pharmacodynamics, and Safety ofRavulizumab in Children and Adolescents With Aquaporin-4 Antibody Positive(AQP4-Ab [+]) Neuromyelitis Optica Spectrum Disorder (NMOSD) - Phase 2/3 Efficacy and Safety Study of Ravulizumab IV in Pediatric ParticipantsWith NMOSD | Neuromyelitis Optica Spectrum Disorder NMOSD | Drug: Ravulizumab Participants will receive a weight-based loading dose of ravulizumab on Day 1, followed by weight-based maintenance treatment with ravulizumab on Day 15 and every 8 weeks (q8w) after or once every 4 weeks (q4w) depending on weight. During the Extension Period, participants will continue to receive weight- based maintenance doses of ravulizumab IV on Day 351 and q8w or q4w, depending on weight. | Wuebbenhorst Hiroaki | NULL | Recruiting | >= 2age old | < 18age old | Both | 12 | Phase 2-3 | US;Spain;Japan |
| 4 | EUCTR2019-003352-37-PL (EUCTR) | 05/10/2020 | 06/07/2020 | Clinical study testing the efficacy and safety of Ravulizumab in adults with NMOSD. | 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) - A Phase 3 Efficacy and Safety Study of Ravulizumab in Adult Patients with NMOSD | Neuromyelitis Optica Spectrum Disorder MedDRA version: 21.1;Level: PT;Classification code 10077875;Term: Neuromyelitis optica spectrum disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Trade Name: Ultomiris Product Name: ravulizumab Product Code: ALXN1210 INN or Proposed INN: RAVULIZUMAB Trade Name: Ultomiris Product Name: ravulizumab Product Code: ALXN1210 INN or Proposed INN: Ravulizumab | Alexion Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 55 | Phase 3 | United States;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Australia;Denmark;Netherlands;Germany;Japan;Korea, Republic of | ||
| 5 | EUCTR2019-003352-37-NL (EUCTR) | 11/06/2020 | 24/02/2020 | Clinical study testing the efficacy and safety of Ravulizumab in adults with NMOSD. | 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) - A Phase 3 Efficacy and Safety Study of Ravulizumab in Adult Patients with NMOSD | Neuromyelitis Optica Spectrum Disorder MedDRA version: 21.1;Level: PT;Classification code 10077875;Term: Neuromyelitis optica spectrum disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Trade Name: Ultomiris Product Name: ravulizumab Product Code: ALXN1210 INN or Proposed INN: RAVULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 55 | Phase 3 | United States;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Australia;Denmark;Netherlands;Germany;Japan;Korea, Republic of | ||
| 6 | EUCTR2019-003352-37-DE (EUCTR) | 11/05/2020 | 06/01/2020 | Clinical study testing the efficacy and safety of Ravulizumab in adults with NMOSD. | 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) - A Phase 3 Efficacy and Safety Study of Ravulizumab in Adult Patients with NMOSD | Neuromyelitis Optica Spectrum Disorder MedDRA version: 21.1;Level: PT;Classification code 10077875;Term: Neuromyelitis optica spectrum disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Trade Name: Ultomiris Product Name: ravulizumab Product Code: ALXN1210 INN or Proposed INN: RAVULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 55 | Phase 3 | Germany;Netherlands;Japan;Korea, Republic of;United States;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Australia;Denmark | ||
| 7 | EUCTR2019-003352-37-AT (EUCTR) | 27/03/2020 | 13/02/2020 | Clinical study testing the efficacy and safety of Ravulizumab in adults with NMOSD. | 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) - A Phase 3 Efficacy and Safety Study of Ravulizumab in Adult Patients with NMOSD | Neuromyelitis Optica Spectrum Disorder MedDRA version: 21.1;Level: PT;Classification code 10077875;Term: Neuromyelitis optica spectrum disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Trade Name: Ultomiris Product Name: ravulizumab Product Code: ALXN1210 INN or Proposed INN: RAVULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 55 | Phase 3 | United States;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Australia;Denmark;Germany;Netherlands;Japan;Korea, Republic of | ||
| 8 | EUCTR2019-003352-37-IT (EUCTR) | 04/03/2020 | 17/06/2021 | A Phase 3 Efficacy and Safety Study of Ravulizumab in Adult Patients with NMOSD | 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) - NA | Neuromyelitis Optica Spectrum Disorder MedDRA version: 21.1;Level: PT;Classification code 10077875;Term: Neuromyelitis optica spectrum disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Trade Name: Ultromiris Product Name: Ravulizumab Product Code: [ALXN1210] | ALEXION PHARMACEUTICALS INCORPORATED | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 55 | Phase 3 | United States;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Australia;Denmark;Germany;Netherlands;Japan;Korea, Republic of | ||
| 9 | EUCTR2019-003352-37-ES (EUCTR) | 25/02/2020 | 14/01/2020 | Clinical study testing the efficacy and safety of Ravulizumab in adults with NMOSD. | 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) - A Phase 3 Efficacy and Safety Study of Ravulizumab in Adult Patients with NMOSD | Neuromyelitis Optica Spectrum Disorder MedDRA version: 21.1;Level: PT;Classification code 10077875;Term: Neuromyelitis optica spectrum disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Trade Name: Ultomiris Product Name: ravulizumab Product Code: ALXN1210 INN or Proposed INN: RAVULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 55 | Phase 3 | Russian Federation;United States;Japan;United Kingdom;Spain;Canada;Austria;Netherlands;Turkey;Denmark;Korea, Republic of;Poland;Italy;Australia;France;Germany | ||
| 10 | EUCTR2019-003352-37-DK (EUCTR) | 15/01/2020 | 19/12/2019 | Clinical study testing the efficacy and safety of Ravulizumab in adults with NMOSD. | 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) - A Phase 3 Efficacy and Safety Study of Ravulizumab in Adult Patients with NMOSD | Neuromyelitis Optica Spectrum Disorder MedDRA version: 21.1;Level: PT;Classification code 10077875;Term: Neuromyelitis optica spectrum disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Trade Name: Ultomiris Product Name: ravulizumab Product Code: ALXN1210 INN or Proposed INN: RAVULIZUMAB Trade Name: Ultomiris Product Name: ravulizumab Product Code: ALXN1210 INN or Proposed INN: Ravulizumab | Alexion Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 55 | Phase 3 | United States;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Denmark;Australia;Germany;Netherlands;Japan;Korea, Republic of | ||
| 11 | NCT04201262 (ClinicalTrials.gov) | December 13, 2019 | 11/12/2019 | An Efficacy and Safety Study of Ravulizumab in Adult Participants With NMOSD | 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) | Neuromyelitis Optica;Neuromyelitis Optica Spectrum Disorder | Biological: Ravulizumab | Alexion | NULL | Active, not recruiting | 18 Years | N/A | All | 58 | Phase 3 | United States;Australia;Austria;Canada;Denmark;France;Germany;Italy;Japan;Korea, Republic of;Poland;Spain;United Kingdom |
| 12 | EUCTR2021-006075-42-DE (EUCTR) | 17/06/2022 | Clinical study testing the efficacy and safety of Ravulizumab in pediatric patients with NMOSD | 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 With Aquaporin-4 antibody Positive (AQP4-Ab [+]) Neuromyelitis Optica Spectrum Disorder (NMOSD) - A Phase 2/3 Efficacy and Safety Study of Ravulizumab in Pediatric Patients with NMOSD | Neuromyelitis Optica Spectrum Disorder (NMOSD) MedDRA version: 21.1;Level: PT;Classification code 10077875;Term: Neuromyelitis optica spectrum disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Trade Name: ULTOMIRIS® Product Name: Ravulizumab Product Code: ALXN1210 INN or Proposed INN: Ravulizumab | Alexion Pharmaceuticals, Inc. | NULL | NA | Female: yes Male: yes | 12 | Phase 2;Phase 3 | France;United States;Canada;Spain;Germany;Italy;Japan;Korea, Republic of |