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
| 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 | NCT05327114 (ClinicalTrials.gov) | September 23, 2022 | 7/4/2022 | Efficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) | 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) | 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 |
| 2 | JPRN-jRCT2041220037 | 10/09/2022 | 23/06/2022 | Efficacy and Safety Study of Nipocalimab for Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) | 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) | 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. | 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 |