300. IgG4関連疾患 IgG4-related disease Clinical trials / Disease details


臨床試験数 : 36 薬物数 : 49 - (DrugBank : 22) / 標的遺伝子数 : 16 - 標的パスウェイ数 : 98

  
7 trials found
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1NCT04918147
(ClinicalTrials.gov)
October 13, 20214/6/2021Elotuzumab in Immunoglobulin G4-Related Disease (IgG4-RD)Elotuzumab in Immunoglobulin G4-Related Disease (IgG4-RD)IgG4 Related Disease;IgG4-RDDrug: elotuzumab;Drug: placebo for elotuzumab;Drug: methylprednisolone;Drug: diphenhydramine;Drug: acetaminophen;Drug: famotidine;Drug: prednisoneNational Institute of Allergy and Infectious Diseases (NIAID)Autoimmunity Centers of Excellence;Bristol-Myers Squibb;Rho Federal Systems Division, Inc.Active, not recruiting18 Years70 YearsAll75Phase 2United States
2JPRN-jRCT2071210001
18/08/202101/04/2021A Study of Inebilizumab Efficacy and Safety in IgG4- Related DiseaseA Phase 3, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study of Inebilizumab Efficacy and Safety in IgG4-Related Disease - VIB0551.P3.S2 IgG4-Related DiseaseRCP: Blinded treatment on Day 1, Day 15, and Week 26:
- Inebilizumab group: Inebilizumab 300 mg intravenous (IV)
- Placebo group: IV placebo
Both groups: Oral prednisone (or equivalent) tablets from Day 1 to the end of Week 8
(tapering dose regimen: 2 weeks each at 20, 15, 10, and 5 mg/day of prednisone or equivalent, open-label, from commercial supply).

Optional OLP: Open-label inebilizumab 300 mg IV on Day 1 and Week 26; blinded
inebilizumab 300 mg or matching placebo on Day 15, depending on RCP treatment.
Katayama SotaNULLRecruiting>= 20age oldNot applicableBoth16Phase 3USA;China;Australia;Canada;France;Italy;Germay;Hong Kong;Hungary;Israel;Ireland;Mexico;Netherlands;Poland;Argentina;Spain;UK;Turkey;Ukraine;Sweden;India;Japan
3NCT04660565
(ClinicalTrials.gov)
January 202123/9/2020Belimumab Treatment for IgG4-related DiseaseBelimumab Treatment for IgG4-related Disease, a Prospective, Open-label Clinical TrialIgG4-related DiseaseDrug: Prednisone and Belimumab;Drug: PrednisonePeking Union Medical College HospitalNULLRecruiting18 Years75 YearsAll60Phase 4China
4EUCTR2020-000417-33-IT
(EUCTR)
16/12/202021/10/2020Inebilizumab efficacy and safety in IgG4 related diseaseA Phase 3, Randomized, Double-blind, Multicenter, Placebo-Controlled Study of Inebilizumab Efficacy and Safety in IgG4 Related Disease(short title: MITIGATE – InebilizuMab effIcacy and safeTy in IGg4 relATed disEase) - MITIGATE Immunoglobulin G4-related disease (IgG4-RD)
MedDRA version: 20.0;Level: PT;Classification code 10077271;Term: Immunoglobulin G4 related disease;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Inebilizumab
Product Code: [Inebilizumab]
INN or Proposed INN: Inebilizumab
Other descriptive name: afucosylated IgG1 kappa monoclonal antibody
Trade Name: PREDNISONE DOC GENERICI - 5 MG COMPRESSE 30 COMPRESSE IN BLISTER PVC-PVDC/ALU
Product Name: Prednisone
Product Code: [Prednisone]
INN or Proposed INN: PREDNISONE
Trade Name: CETIRIZINA SANDOZ - 10 MG COMPRESSE RIVESTITE CON FILM 20 COMPRESSE IN BLISTER PVC/ALU
Product Name: Cetirizina
Product Code: [Cetirizina]
INN or Proposed INN: CETIRIZINA
Trade Name: PARACETAMOLO NOVA ARGENTIA - 500 MG COMPRESSE 20 COMPRESSE
Product Name: Paracetamolo
Product Code: [Paracetamolo]
INN or Proposed INN: PARACETAMOLO
Trade Name: METILPREDNISOLONE HIKMA - 1000 MG POLVERE PER SOLUZIONE INIETTABILE 10 FLACONCINI IN VETRO
Product Name: Metilprednisolone
Product Code: [Metilprednisolone]
INN or Proposed INN: METILPREDNISOLONE
VIELABIO Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3United States;Spain;Ukraine;Israel;United Kingdom;Italy;India;France;Hungary;Mexico;Canada;Poland;Australia;Germany;Netherlands;China;Japan;Sweden;Korea, Republic of
5NCT02703194
(ClinicalTrials.gov)
March 201627/2/2016Leflunomide for Maintenance of Remission in IgG4 Related DiseaseA Study of Safety and Efficacy of Leflunomide for Maintenance of Remission in IgG4 Related DiseaseImmunoglobulin G4 Related Sclerosing DiseaseDrug: Prednisone;Drug: LeflunomideChinese PLA General HospitalNULLCompleted18 Years80 YearsAll68Phase 4China
6NCT02458196
(ClinicalTrials.gov)
April 201515/4/2015Study of Treatment Response on IgG4 Related Disease (IgG4RD)A Randomized Trial of Treatment in Patients With IgG4-Related DiseaseAutoimmune DiseaseDrug: Prednisone;Drug: Prednisone and Mycophenolate mofetilPeking Union Medical College HospitalNULLRecruiting18 Years70 YearsAll60Phase 2China
7NCT01758393
(ClinicalTrials.gov)
December 201224/12/2012Glucocorticoids in Patients With IgG4-RDA Randomized Trial of Glucocorticoids in Patients With IgG4-Related DiseaseIgG4-related DiseaseDrug: PrednisonePeking Union Medical College HospitalNULLRecruiting18 Years70 YearsBoth40Phase 2/Phase 3China