14. 慢性炎症性脱髄性多発神経炎／多巣性運動ニューロパチー Chronic inflammatory demyelinating polyneuropathy Clinical trials / Disease details
臨床試験数 : 175 / 薬物数 : 161 - (DrugBank : 41) / 標的遺伝子数 : 13 - 標的パスウェイ数 : 24
Showing 1 to 10 of 53 diseases
| 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 | NCT05405361 (ClinicalTrials.gov) | January 18, 2023 | 17/5/2022 | A Clinical Trial to Investigate the Long-term Safety and Tolerability, Efficacy, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of ARGX-117 in Adults With Multifocal Motor Neuropathy A Clinical Trial to Investigate the Long-term Safety and Tolerability, Efficacy, Pharmacodynamics, P ... | A Long-term Extension of the ARGX-117-2002 Trial to Evaluate the Long-term Safety and Tolerability, Efficacy, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of ARGX-117 in Adults With Multifocal Motor Neuropathy A Long-term Extension of the ARGX-117-2002 Trial to Evaluate the Long-term Safety and Tolerability, ... | Multifocal Motor Neuropathy (MMN) | Biological: ARGX-117;Other: Placebo | argenx | NULL | Recruiting | 18 Years | N/A | All | 48 | Phase 2 | United States |
| 2 | NCT05581199 (ClinicalTrials.gov) | December 15, 2022 | 12/10/2022 | To Assess Efficacy and Safety of Batoclimab in Adult Participants With Active CIDP | A Phase 2b, Multi-center, Randomized, Quadruple-blind, Placebo-controlled Study of Batoclimab Treatment in Adult Participants With Active Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) A Phase 2b, Multi-center, Randomized, Quadruple-blind, Placebo-controlled Study of Batoclimab Treatm ... | Chronic Inflammatory Demyelinating Polyneuropathy | Drug: Batoclimab 680 milligrams (mg) subcutaneous (SC) weekly;Drug: Batoclimab 340 mg SC weekly;Drug: Placebo Drug: Batoclimab680 milligrams (mg) subcutaneous (SC) weekly;Drug: Batoclimab340 mg SC weekly;Drug: ... | Immunovant Sciences GmbH | NULL | Recruiting | 18 Years | N/A | All | 240 | Phase 2 | United States |
| 3 | NCT05327114 (ClinicalTrials.gov) | September 23, 2022 | 7/4/2022 | Efficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Efficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneur ... | Phase 2/3, Multistage, Multicenter, Randomized, Double-Blind, Placebo-Controlled Parallel Group Withdrawal Study to Evaluate the Efficacy and Safety of Nipocalimab Administered to Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Phase 2/3, Multistage, Multicenter, Randomized, Double-Blind, Placebo-Controlled Parallel Group With ... | Polyradiculoneuropathy, Chronic Inflammatory Demyelinating | Drug: Nipocalimab;Drug: Placebo | Janssen Research & Development, LLC | NULL | Recruiting | 18 Years | N/A | All | 300 | Phase 2/Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;China;Colombia;Czechia;Denmark;France;Germany;Greece;Italy;Japan;Korea, Republic of;Mexico;Poland;Portugal;Slovakia;Spain;Taiwan;United Kingdom;Romania;South Africa United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;China;Colombia;Czechia;Denm ... |
| 4 | JPRN-jRCT2041220037 | 10/09/2022 | 23/06/2022 | Efficacy and Safety Study of Nipocalimab for Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Efficacy and Safety Study of Nipocalimab for Adults with Chronic Inflammatory Demyelinating Polyneur ... | Phase 2/3, Multistage, Multicenter, Randomized, Double-Blind, Placebo-Controlled Parallel Group Withdrawal Study to Evaluate the Efficacy and Safety of Nipocalimab Administered to Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Phase 2/3, Multistage, Multicenter, Randomized, Double-Blind, Placebo-Controlled Parallel Group With ... | Polyradiculoneuropathy, Chronic Inflammatory Demyelinating | Nipocalimab : Nipocalimab will be administered intravenously. Participants in Stage A (Open-label) will receive a loading dose of nipocalimab (Dose 1) intravenous (IV) infusion on Day 1, followed by nipocalimab (Dose 2) IV infusion once every 2 weeks (q2w) from Week 2 to Week 12. Participants who demonstrate evidence of clinical improvement in Stage A (responders) will enter Stage B (Double-blind) and receive nipocalimab (Dose 2) IV infusion q2w starting on Day 1 up to Week 52. After completion of Stage B or discontinuation from Stage B due to relapse, participants will have the option to enter the open label extension (OLE) phase and receive nipocalimab (Dose 2) IV infusion q2w starting on OLE Day 1 until 2 years after marketing authorization in a participant s local country or until nipocalimab becomes available commercially or via other continued access program, whichever comes first. Placebo : Placebo will be administered intravenously. Participants receiving nipocalimab in Stage A and who demonstrate evidence of clinical improvement in Stage A (responders) will enter Stage B (Double-blind) and receive placebo IV infusion q2w starting on Day 1 up to Week 52. After completion of Stage B or discontinuation from Stage B due to relapse, participants will have the option to enter the open label extension (OLE) phase and receive nipocalimab (Dose 2) IV infusion q2w starting on OLE Day 1 until 2 years after marketing authorization in a participant s local country or until nipocalimab becomes available commercially or via other continued access program, whichever comes first. Nipocalimab: Nipocalimabwill be administered intravenously. Participants in Stage A (Open-label) will ... | Nakano Masayoshi | NULL | Pending | >= 18age old | Not applicable | Both | 300 | Phase 2-3 | Argentina;Australia;Austria;Belgium;Brazil;Canada;China;Colombia;Czechia;Germany;Denmark;Spain;France;UnitedKingdomOf GreatBritainAndNorthernIreland;Greece;Italy;Korea,RepublicOf;Mexico;Poland;Portugal;Slovakia;Taiwan,ProvinceOf China;UnitedStates OfAmerica;Japan Argentina;Australia;Austria;Belgium;Brazil;Canada;China;Colombia;Czechia;Germany;Denmark;Spain;Franc ... |
| 5 | EUCTR2021-003302-50-AT (EUCTR) | 22/04/2022 | 20/12/2021 | A clinical trial to investigate the safety and tolerability, efficacy pharmacokinetics, pharmacodynamics, and immunogenicity of 2 dose regimens of ARGX-117 in adults with multifocal motor neuropathy A clinical trial to investigate the safety and tolerability, efficacy pharmacokinetics, pharmacodyna ... | A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group, Multicenter Trial to Evaluate the Safety and Tolerability, Efficacy, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of 2 Dose Regimens of ARGX-117 in Adults With Multifocal Motor Neuropathy - ARDA A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group, Multicenter Trial to Eval ... | Multifocal Motor Neuropathy MedDRA version: 21.1;Level: PT;Classification code 10065579;Term: Multifocal motor neuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] Multifocal Motor Neuropathy MedDRA version: 21.1;Level: PT;Classification code 10065579;Term: Multif ... | Product Name: ARGX-117 IV Product Code: ARGX-117 IV INN or Proposed INN: not defined Other descriptive name: ARGX-117 Product Name: ARGX-117IV Product Code: ARGX-117IV INN or Proposed INN: not defined Other descriptive na ... | argenx BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 48 | Phase 2 | France;United States;Canada;Belgium;Spain;Poland;Denmark;Austria;Germany;Netherlands;United Kingdom;Italy France;United States;Canada;Belgium;Spain;Poland;Denmark;Austria;Germany;Netherlands;United Kingdom; ... | ||
| 6 | NCT05225675 (ClinicalTrials.gov) | March 31, 2022 | 5/11/2021 | A Clinical Trial to Investigate the Safety and Tolerability, Efficacy, Pharmacokinetics, Pharmacodynamics and Immunogenicity of 2 Dose Regimens of ARGX-117 in Adults With Multifocal Motor Neuropathy A Clinical Trial to Investigate the Safety and Tolerability, Efficacy, Pharmacokinetics, Pharmacodyn ... | A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group, Multicenter Trial to Evaluate the Safety and Tolerability, Efficacy, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of 2 Dose Regimens of ARGX-117 in Adults With Multifocal Motor Neuropathy A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group, Multicenter Trial to Eval ... | Multifocal Motor Neuropathy | Biological: ARGX-117;Other: Placebo | argenx | NULL | Recruiting | 18 Years | N/A | All | 48 | Phase 2 | United States;Austria;Belgium;France;Germany;Italy;Netherlands;Poland;Spain;United Kingdom |
| 7 | EUCTR2021-003302-50-ES (EUCTR) | 08/03/2022 | 02/11/2021 | A clinical trial to investigate the safety and tolerability, efficacy pharmacokinetics, pharmacodynamics, and immunogenicity of 2 dose regimens of ARGX-117 in adults with multifocal motor neuropathy A clinical trial to investigate the safety and tolerability, efficacy pharmacokinetics, pharmacodyna ... | A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group, Multicenter Trial to Evaluate the Safety and Tolerability, Efficacy, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of 2 Dose Regimens of ARGX-117 in Adults With Multifocal Motor Neuropathy - ARDA A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group, Multicenter Trial to Eval ... | Multifocal Motor Neuropathy MedDRA version: 21.1;Level: PT;Classification code 10065579;Term: Multifocal motor neuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] Multifocal Motor Neuropathy MedDRA version: 21.1;Level: PT;Classification code 10065579;Term: Multif ... | Product Name: ARGX-117 IV Product Code: ARGX-117 IV INN or Proposed INN: not defined Other descriptive name: ARGX-117 Product Name: ARGX-117IV Product Code: ARGX-117IV INN or Proposed INN: not defined Other descriptive na ... | argenx BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 48 | Phase 2 | France;United States;Canada;Poland;Belgium;Spain;Denmark;Austria;Netherlands;Germany;United Kingdom;Italy France;United States;Canada;Poland;Belgium;Spain;Denmark;Austria;Netherlands;Germany;United Kingdom; ... | ||
| 8 | EUCTR2021-003302-50-IT (EUCTR) | 17/02/2022 | 26/11/2021 | A clinical trial to investigate the safety and tolerability, efficacy pharmacokinetics, pharmacodynamics, and immunogenicity of 2 dose regimens of ARGX-117 in adults with multifocal motor neuropathy A clinical trial to investigate the safety and tolerability, efficacy pharmacokinetics, pharmacodyna ... | A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel- Group, Multicenter Trial to Evaluate the Safety and Tolerability, Efficacy,Pharmacokinetics, Pharmacodynamics, and Immunogenicity of 2 Dose Regimens of ARGX-117 in Adults With Multifocal Motor Neuropathy - ARDA A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel- Group, Multicenter Trial to Eva ... | Multifocal Motor Neuropathy MedDRA version: 21.1;Level: PT;Classification code 10065579;Term: Multifocal motor neuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] Multifocal Motor Neuropathy MedDRA version: 21.1;Level: PT;Classification code 10065579;Term: Multif ... | Product Name: ARGX-117 IV Product Code: [ARGX-117 IV] Trade Name: Act-HiB Product Name: Haemophilus type b vaccine (conjugated) Product Code: [.] Other descriptive name: HAEMOPHILUS TYPE B CONJUGATE VACCINE (TETANUS TOXOID CONJUGATE) Trade Name: Intratect Product Name: Human normal immunoglobulin (IVIg) Product Code: [-] INN or Proposed INN: Human normal immunoglobulin (IVIg) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) Trade Name: Menjugate Product Name: Group C meningococcal conjugate vaccine Product Code: [J07AH07] INN or Proposed INN: Group C meningococcal conjugate vaccine Other descriptive name: N. MENINGITIDIS GROUP C POLYSACCHARIDE Trade Name: Prevenar 13 sospensione per iniezione Product Name: pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed) Product Code: [NA] INN or Proposed INN: VACCINO PNEUMOCOCCICO SACCARIDICO Product Name: ARGX-117 IV Product Code: [ARGX-117 IV] Trade Name: Act-HiB Product Name: Haemophilus typ ... | ARGENX BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 48 | Phase 2 | France;United States;Canada;Spain;Poland;Belgium;Denmark;Austria;Netherlands;Germany;United Kingdom;Italy France;United States;Canada;Spain;Poland;Belgium;Denmark;Austria;Netherlands;Germany;United Kingdom; ... | ||
| 9 | EUCTR2021-003302-50-NL (EUCTR) | 14/02/2022 | 27/12/2021 | A study for adult patients with Multifocal Motor Neuropathy comparing 2 doses of ARGX-117 | A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group, Multicenter Trial to Evaluate the Safety and Tolerability, Efficacy, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of 2 Dose Regimens of ARGX-117 in Adults With Multifocal Motor Neuropathy - ARDA A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group, Multicenter Trial to Eval ... | Multifocal Motor Neuropathy MedDRA version: 21.1;Level: PT;Classification code 10065579;Term: Multifocal motor neuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] Multifocal Motor Neuropathy MedDRA version: 21.1;Level: PT;Classification code 10065579;Term: Multif ... | Product Name: ARGX-117 IV Product Code: ARGX-117 IV INN or Proposed INN: not defined Other descriptive name: ARGX-117 Product Name: ARGX-117IV Product Code: ARGX-117IV INN or Proposed INN: not defined Other descriptive na ... | argenx BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 48 | Phase 2 | France;United States;Canada;Spain;Poland;Belgium;Denmark;Austria;Germany;Netherlands;United Kingdom;Italy France;United States;Canada;Spain;Poland;Belgium;Denmark;Austria;Germany;Netherlands;United Kingdom; ... | ||
| 10 | NCT04281472 (ClinicalTrials.gov) | April 15, 2020 | 20/2/2020 | A Study to Assess the Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP, an Autoimmune Disorder That Affects the Peripheral Nerves) A Study to Assess the Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults Wi ... | A Phase 2 Trial to Investigate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 SC in Adult Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) A Phase 2 Trial to Investigate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 SC in Adu ... | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) | Biological: efgartigimod PH20 SC in stage B;Other: placebo in stage B | argenx | NULL | Active, not recruiting | 18 Years | N/A | All | 360 | Phase 2 | United States;Austria;Belgium;Bulgaria;China;Czechia;Denmark;France;Georgia;Germany;Hungary;Israel;Italy;Japan;Latvia;Netherlands;Poland;Romania;Russian Federation;Serbia;Spain;Taiwan;Turkey;Ukraine;United Kingdom United States;Austria;Belgium;Bulgaria;China;Czechia;Denmark;France;Georgia;Germany;Hungary;Israel;I ... |