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 | JPRN-jRCT2051210017 | 15/10/2020 | 07/05/2021 | An extension study for seven patients in Japan with neuromyelitis optica spectrum disorder who completed the open-label period of study CD-IA-MEDI-551-1155 of Inebilizumab | An extension study for seven patients in Japan with neuromyelitis optica spectrum disorder who completed the open-label period of study CD-IA-MEDI-551-1155 of Inebilizumab | Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders | This study is designed to provide the opportunity of continued access to inebilizumab to patients with NMOSD who received inebilizumab in the completed Study CD-IA-MEDI-551-1155. The fixed dose of 300 mg inebilizumab every 26 weeks is injected to maintain peripheral B-cell suppression in subjects. | Sato Toshiyuki | NULL | Not Recruiting | >= 18age old | Not applicable | Both | 7 | Phase 3 | Japan |
| 2 | EUCTR2014-000253-36-NL (EUCTR) | 30/08/2018 | 16/04/2018 | A Clinical Study to test the effect of the drug MEDI-551 in Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders | A Double-masked, Placebo-controlled Study with Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders. - A Double-masked, Placebo-controlled Study with Open label Period to Evaluate MEDI-551 in NMO/NMOSD | Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders (NMO/NMOSD) MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: MEDI-551 Product Code: MEDI-551 INN or Proposed INN: Inebilizumab | MedImmune LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 252 | Phase 2;Phase 3 | Serbia;United States;Taiwan;Estonia;Hong Kong;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;India;Peru;Australia;South Africa;Netherlands;China;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Hungary;Mexico;Canada;Poland;Bulgaria;Germany;New Zealand;Japan | ||
| 3 | EUCTR2014-000253-36-GR (EUCTR) | 31/03/2017 | 30/01/2017 | A Clinical Study to test the effect of the drug MEDI-551 in Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders | A Double-masked, Placebo-controlled Study with Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders. - A Double-masked, Placebo-controlled Study with Open label Period to Evaluate MEDI-551 in NMO/NMOSD | Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders (NMO/NMOSD) MedDRA version: 19.1;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: MEDI-551 Product Code: MEDI-551 INN or Proposed INN: NA | MedImmune LLC | NULL | Not Recruiting | Female: yes Male: yes | 212 | Phase 2;Phase 3 | United States;Portugal;Serbia;Hong Kong;Estonia;Taiwan;Greece;Spain;Thailand;Ukraine;Israel;Russian Federation;Colombia;Australia;Peru;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;Turkey;Hungary;Czech Republic;Mexico;Canada;Poland;Bulgaria;Germany;Japan;New Zealand | ||
| 4 | EUCTR2014-000253-36-HU (EUCTR) | 24/01/2017 | 23/11/2016 | A Clinical Study to test the effect of the drug MEDI-551 in Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders | A Double-masked, Placebo-controlled Study with Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders. - A Double-masked, Placebo-controlled Study with Open label Period to Evaluate MEDI-551 in NMO/NMOSD | Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders (NMO/NMOSD) MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: MEDI-551 Product Code: MEDI-551 INN or Proposed INN: Inebilizumab | MedImmune LLC | NULL | Not Recruiting | Female: yes Male: yes | 252 | Phase 2;Phase 3 | United States;Portugal;Serbia;Hong Kong;Estonia;Taiwan;Greece;Spain;Thailand;Ukraine;Israel;Russian Federation;Colombia;Australia;Peru;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Hungary;Mexico;Canada;Poland;Bulgaria;Germany;Japan;New Zealand | ||
| 5 | NCT02200770 (ClinicalTrials.gov) | April 1, 2015 | 16/7/2014 | N-MOmentum: A Clinical Research Study of Inebilizumab in Neuromyelitis Optica Spectrum Disorders | A Double-masked, Placebo-controlled Study With Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects With Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders | Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders | Drug: Inebilizumab;Other: Placebo | MedImmune LLC | NULL | Completed | 18 Years | N/A | All | 231 | Phase 2/Phase 3 | United States;Australia;Bulgaria;Canada;Colombia;Czechia;Estonia;Germany;Hong Kong;Hungary;Israel;Japan;Korea, Republic of;Mexico;Moldova, Republic of;New Zealand;Peru;Poland;Russian Federation;Serbia;South Africa;Spain;Taiwan;Thailand;Turkey;China;Czech Republic;Greece;India;Netherlands;Portugal;Ukraine |
| 6 | EUCTR2014-000253-36-DE (EUCTR) | 27/02/2015 | 30/09/2014 | A Clinical Study to test the effect of the drug MEDI-551 in Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders | A Double-masked, Placebo-controlled Study with Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders. - A Double-masked, Placebo-controlled Study with Open label Period to Evaluate MEDI-551 in NMO/NMOSD | Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders (NMO/NMOSD) MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: MEDI-551 Product Code: MEDI-551 INN or Proposed INN: Inebilizumab | MedImmune LLC | NULL | Not Recruiting | Female: yes Male: yes | 231 | Phase 2;Phase 3 | United States;Serbia;Hong Kong;Estonia;Taiwan;Greece;Spain;Thailand;Ukraine;Israel;Russian Federation;Colombia;Australia;Peru;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;Turkey;Hungary;Czech Republic;Mexico;Canada;Poland;Bulgaria;Germany;Japan;New Zealand | ||
| 7 | EUCTR2014-000253-36-ES (EUCTR) | 16/02/2015 | 22/12/2014 | A Clinical Study to test the effect of the drug MEDI-551 in Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders | A Double-masked, Placebo-controlled Study with Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders. - A Double-masked, Placebo-controlled Study with Open label Period to Evaluate MEDI-551 in NMO/NMOSD | Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders (NMO/NMOSD) MedDRA version: 17.1;Level: PT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: MEDI-551 Product Code: MEDI-551 INN or Proposed INN: NA | MedImmune LLC | NULL | Not Recruiting | Female: yes Male: yes | 212 | Phase 2;Phase 3 | United States;Hong Kong;Estonia;Taiwan;Greece;Spain;Thailand;Ukraine;Israel;Russian Federation;Colombia;Australia;Peru;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;Turkey;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Bulgaria;Germany;Japan;New Zealand | ||
| 8 | EUCTR2014-000253-36-BG (EUCTR) | 04/02/2015 | 05/11/2014 | A Clinical Study to test the effect of the drug MEDI-551 in Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders | A Double-masked, Placebo-controlled Study with Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders. - A Double-masked, Placebo-controlled Study with Open label Period to Evaluate MEDI-551 in NMO/NMOSD | Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders (NMO/NMOSD) MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: MEDI-551 Product Code: MEDI-551 INN or Proposed INN: Inebilizumab | MedImmune LLC | NULL | Not Recruiting | Female: yes Male: yes | 231 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Estonia;Taiwan;Hong Kong;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Australia;Peru;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Hungary;Mexico;Canada;Poland;Bulgaria;Germany;Japan;New Zealand | ||
| 9 | EUCTR2014-000253-36-PL (EUCTR) | 30/12/2014 | 14/11/2014 | A Clinical Study to test the effect of the drug MEDI-551 in Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders | A Double-masked, Placebo-controlled Study with Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders. - A Double-masked, Placebo-controlled Study with Open label Period to Evaluate MEDI-551 in NMO/NMOSD | Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders (NMO/NMOSD) MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: MEDI-551 Product Code: MEDI-551 INN or Proposed INN: Inebilizumab | MedImmune LLC | NULL | Not Recruiting | Female: yes Male: yes | 231 | Phase 2;Phase 3 | United States;Portugal;Serbia;Hong Kong;Estonia;Taiwan;Greece;Spain;Thailand;Ukraine;Israel;Russian Federation;Colombia;Australia;Peru;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;Turkey;Hungary;Czech Republic;Mexico;Canada;Poland;Bulgaria;Germany;Japan;New Zealand | ||
| 10 | EUCTR2014-000253-36-CZ (EUCTR) | 08/12/2014 | 14/08/2014 | A Clinical Study to test the effect of the drug MEDI-551 in Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders | A Double-masked, Placebo-controlled Study with Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders. - A Double-masked, Placebo-controlled Study with Open label Period to Evaluate MEDI-551 in NMO/NMOSD | Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders (NMO/NMOSD) MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: MEDI-551 Product Code: MEDI-551 INN or Proposed INN: Inebilizumab | MedImmune LLC | NULL | Not Recruiting | Female: yes Male: yes | 231 | Phase 2;Phase 3 | United States;Serbia;Hong Kong;Estonia;Taiwan;Greece;Spain;Thailand;Ukraine;Israel;Russian Federation;Colombia;Australia;Peru;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;Turkey;Hungary;Czech Republic;Mexico;Canada;Poland;Bulgaria;Germany;Japan;New Zealand | ||
| 11 | EUCTR2014-000253-36-EE (EUCTR) | 24/10/2014 | 13/10/2014 | A Clinical Study to test the effect of the drug MEDI-551 in Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders | A Double-masked, Placebo-controlled Study with Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders. - A Double-masked, Placebo-controlled Study with Open label Period to Evaluate MEDI-551 in NMO/NMOSD | Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders (NMO/NMOSD) MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: MEDI-551 Product Code: MEDI-551 INN or Proposed INN: Inebilizumab | MedImmune LLC | NULL | Not Recruiting | Female: yes Male: yes | 231 | Phase 2;Phase 3 | United States;Serbia;Hong Kong;Estonia;Taiwan;Greece;Spain;Thailand;Ukraine;Israel;Russian Federation;Colombia;Australia;Peru;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;Turkey;Hungary;Czech Republic;Mexico;Canada;Poland;Bulgaria;Germany;Japan;New Zealand | ||
| 12 | EUCTR2011-005475-16-GB (EUCTR) | 25/07/2012 | 05/03/2012 | A Phase 1/2 study to test how effective different doses of MEDI-551 is for treating subjects with Relapsing-Remitting Multiple Sclerosis | A Phase 1/2 Randomized, Dose-finding Study of MEDI-551 in Subjects with Relapsing-Remitting Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: MEDI-551 Product Code: MEDI-551 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: interferon beta-1a | MedImmune LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 512 | Phase 1/2 | Hungary;Germany;Turkey;Switzerland;Netherlands;France;Ireland;Italy;Austria;Sweden;Israel;Russian Federation;United Kingdom;Czech Republic;Ukraine;Canada;Denmark;Spain;United States;Poland | ||
| 13 | NCT01585766 (ClinicalTrials.gov) | April 24, 2012 | 9/4/2012 | Safety and Tolerability Study of MEDI-551, a B-cell Depleting Agent, to Treat Relapsing Forms of Multiple Sclerosis | A Phase 1 Randomized Study of MEDI-551 in Subjects With Relapsing Forms of Multiple Sclerosis | Multiple Sclerosis, Relapsing Forms | Drug: MEDI-551 30 MG-IV;Drug: MEDI-551 60 MG-SC;Drug: PLACEBO-IV-SC;Drug: MEDI-551 100 MG-IV;Drug: MEDI-551 300 MG-SC;Drug: MEDI-551 600 MG-IV | MedImmune LLC | NULL | Completed | 18 Years | 65 Years | All | 56 | Phase 1 | United States;Poland;Spain;Ukraine;Czech Republic;United Kingdom |