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

  
No.TrialIDDate_
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registration
Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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Inclusion_
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PhaseCountries
1NCT04602598
(ClinicalTrials.gov)
January 15, 202220/10/2020Zanubrutinib in Patients With IgG4-Related DiseaseA Phase II, Single-Site, Open-Label Study of Zanubrutinib in Patients With IgG4-Related DiseaseIgG4 Related DiseaseDrug: Zanubrutinib 80 MGMatthew C. BakerStanford UniversityNot yet recruiting18 Years85 YearsAll10Phase 2United States
2NCT04918147
(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
3JPRN-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
4EUCTR2020-000417-33-SE
(EUCTR)
30/03/202119/11/2020Inebilizumab 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 - 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]
Trade Name: Uplizna
Product Name: Inebilizumab
INN or Proposed INN: INEBILIZUMAB
Other descriptive name: afucosylated IgG1 kappa monoclonal antibody
Viela Bio, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3Sweden;Japan;China;Germany;Netherlands;Australia;Poland;Argentina;Canada;Mexico;Hungary;France;India;Italy;United Kingdom;Israel;Turkey;Ireland;Ukraine;Spain;Hong Kong;United States
5EUCTR2020-000417-33-NL
(EUCTR)
26/02/202129/09/2020Inebilizumab 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 - 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]
Trade Name: Uplizna
Product Name: Inebilizumab
INN or Proposed INN: INEBILIZUMAB
Other descriptive name: afucosylated IgG1 kappa monoclonal antibody
Viela Bio, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3United States;Hong Kong;Spain;Ukraine;Ireland;Turkey;Israel;United Kingdom;Italy;India;France;Hungary;Mexico;Canada;Argentina;Poland;Australia;Germany;Netherlands;China;Japan;Sweden
6NCT04660565
(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
7EUCTR2020-000417-33-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
8NCT04540497
(ClinicalTrials.gov)
October 26, 20201/9/2020A 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 DiseaseIgG4 Related DiseaseDrug: Inebilizumab;Other: PlaceboViela BioNULLRecruiting18 YearsN/AAll160Phase 3United States;Argentina;Australia;Canada;China;France;Germany;Hong Kong;Hungary;India;Ireland;Israel;Italy;Japan;Mexico;Netherlands;Poland;Spain;Sweden;Turkey;Ukraine;United Kingdom
9EUCTR2020-000417-33-HU
(EUCTR)
06/10/202006/08/2020Inebilizumab 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 - 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
INN or Proposed INN: INEBILIZUMAB
Other descriptive name: afucosylated IgG1 kappa monoclonal antibody
Viela Bio, 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;Korea, Republic of
10EUCTR2020-000417-33-DE
(EUCTR)
30/09/202024/06/2020A Phase 3, Randomized, Double-blind, Multicenter, Placebo-Controlled Study of Inebilizumab Efficacy and Safety in IgG4 Related Disease - MITIGATE A Phase 3, Randomized, Double-blind, Multicenter, Placebo-Controlled Study of 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]
Trade Name: Uplizna
Product Name: Inebilizumab
INN or Proposed INN: INEBILIZUMAB
Other descriptive name: afucosylated IgG1 kappa monoclonal antibody
Viela Bio, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3United States;Hong Kong;Spain;Ukraine;Ireland;Turkey;Israel;United Kingdom;Italy;India;France;Hungary;Mexico;Canada;Argentina;Poland;Australia;Netherlands;Germany;Japan;China;Sweden
11EUCTR2020-000417-33-PL
(EUCTR)
02/09/202030/06/2020Inebilizumab 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 - 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]
Trade Name: Uplizna
Product Name: Inebilizumab
INN or Proposed INN: INEBILIZUMAB
Other descriptive name: afucosylated IgG1 kappa monoclonal antibody
Viela Bio, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3United States;Hong Kong;Spain;Ukraine;Ireland;Turkey;Israel;United Kingdom;Italy;India;France;Hungary;Mexico;Canada;Argentina;Poland;Australia;Netherlands;Germany;Japan;China;Sweden
12NCT04520451
(ClinicalTrials.gov)
August 22, 202011/8/2020Open Label Two-Arm Study to Evaluate Rilzabrutinib (PRN1008) in IgG4-Related Disease PatientsAn Open Label, Two-Arm Study to Evaluate the Effect of Rilzabrutinib (PRN1008) on Safety and Disease Activity in Patients With IgG4-Related DiseaseIgG4-Related DiseaseDrug: rilzabrutinib;Drug: GlucocorticoidsPrincipia Biopharma, a Sanofi CompanyMassachusetts General HospitalRecruiting18 YearsN/AAll25Phase 2United States;Canada
13ChiCTR2000028918
2020-01-012020-01-07A randomized, double-blind controlled study of glucocorticoids combination with thalidomide in the treatment of IgG4-related diseasesEfficacy and safety of thalidomide in IgG4-related diseases IgG4 related diseasecontrol group:prednison combined with placebo;experimental group:prednison combined with thalidomide;Tongji Hospital, Tongji Medical College, Huazhong University of Science and TechnologyNULLRecruiting1880Bothcontrol group:51;experimental group:51;Phase 4China
14NCT04125511
(ClinicalTrials.gov)
November 1, 201928/8/2019Characterizing IgG4-RD With 68Ga-FAPI PET/CTCharacterizing IgG4-related Disease With 68Ga-FAPI PET/CTIgG4-related DiseaseDrug: 68Ga-FAPIPeking Union Medical College HospitalNULLRecruiting18 Years90 YearsAll100Early Phase 1China
15NCT04124861
(ClinicalTrials.gov)
October 15, 201913/2/2019Withdraw Drug in Stable IgG4-Related DiseaseEvaluation and Prediction of Relapse Risk After Glucocorticoid and Immunosuppressant Withdrawal in Patients With Stable IgG4 Related Disease: An Open-labeled Multi-centric Randomized Controlled Study From ChinaAutoimmune DiseasesDrug: Drug free, IS monotherapy and GC combined with ISPeking Union Medical College HospitalChinese PLA General Hospital;Peking University People's Hospital;The People's Hospital of Hebei Province;Shengjing Hospital;Tongji HospitalNot yet recruiting18 Years70 YearsAll138N/ANULL
16EUCTR2017-002214-31-NL
(EUCTR)
23/07/201909/08/2018Study to Evaluate The Safety And Effectiveness of XmAb®5871 In Patients With IgG4-Related Disease (INDIGO)A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of XmAb®5871 in Patients with IgG4-Related Disease (INDIGO) IgG4-Related Disease
MedDRA version: 20.0;Level: LLT;Classification code 10071581;Term: IgG4 related sclerosing disease;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: XmAb5871
INN or Proposed INN: XmAb5871
Other descriptive name: XMAB5871
Xencor, Inc.NULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Netherlands;Germany;Sweden
17EUCTR2017-002214-31-IT
(EUCTR)
26/02/201904/11/2020Study to Evaluate the Safety and Effectiveness of XmAb®5871 in Patients with IgG4-Related Disease (INDIGO)Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of XmAb®5871 in Patients with IgG4-Related Disease (INDIGO) - INDIGO IgG4-Related Disease
MedDRA version: 21.0;Level: LLT;Classification code 10071581;Term: IgG4 related sclerosing disease;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: NA
Product Code: [XmAb5871]
Xencor INCNULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Hungary;Canada;Belgium;Poland;Germany;Netherlands;Sweden
18NCT03669861
(ClinicalTrials.gov)
November 13, 20184/6/2018Safety and Efficacy of Abatacept in IgG4-Related DiseaseA Prospective, Open-label, Single Center Abatacept in IgG4-Related Disease 10-patient Proof-of-concept StudyIgG4-related DiseaseDrug: AbataceptMassachusetts General HospitalBristol-Myers SquibbActive, not recruiting18 YearsN/AAll10Phase 2United States
19JPRN-UMIN000030735
2018/01/1515/01/2018Diagnostic accuracy of contrast enhanced endoscopic ultrasonography in pancreatbiliary diseaseDiagnostic accuracy of contrast enhanced endoscopic ultrasonography in pancreatbiliary disease - A clinical trial of contrast enhanced endoscopic ultrasonography in the pancreatobiliary disease Pancreas tumor, Chronic pancreatitis, Autoimmune pancreatitis, Gallblader polyp, Biliary tract tumorContrast enhanced endoscopic ultrasonography using perflubutane
MRI
enhanced CT
endoscopic ultrasonography without perflubutane
Department of EndoscopyThe Jikei University School of MedicineNULLComplete: follow-up complete20years-old100years-oldMale and Female786Not selectedJapan
20NCT03368274
(ClinicalTrials.gov)
September 1, 201720/9/2017To Evaluate the Clinical Efficacy of Iguratimod in the Treatment of IgG4 Related Disease (IgG4-RD) With Mild SymptomTo Evaluate the Clinical Efficacy of Iguratimod in the Treatment of IgG4 Related Disease (IgG4-RD) With Mild SymptomIgG4-related DiseaseDrug: T 614Wen ZhangNULLUnknown status18 Years70 YearsAll30Phase 4China
21JPRN-UMIN000022633
2016/06/0606/06/2016Efficacy and safety of low-dose steroid treatment in asymptomatic patients with autoimmune pancreatitis. autoimmune pancreatitisSteroid treatment (total 56 weeks)

Induction ~ 4 weeks : Prednisolone 10mg/day
4 weeks ~ 48 weeks : Prednisolone 5mg/day
48 weeks ~ 52 weeks : Prednisolone 2.5mg/day
52 weeks ~ 56 weeks : Prednisolone 1mg/day
Osaka UniversityNULLPending20years-oldNot applicableMale and Female20Not selectedJapan
22NCT02797665
(ClinicalTrials.gov)
May 20166/6/2016Treatment of Obstructive Jaundice in Autoimmune Pancreatitis and/or Immunoglobulin G4-related Sclerosing Cholangitis by CorticosteroidsAutoimmune Pancreatitis;IgG4-related Sclerosing Cholangitis;Obstructive JaundiceDrug: corticosteroids;Procedure: biliary stentPeking Union Medical College HospitalNULLRecruiting18 YearsN/AAll30N/AChina
23NCT02705638
(ClinicalTrials.gov)
April 20167/3/2016Treatment of IgG4-Related Disease With Revlimid and RituximabTreatment of IgG4-Related Disease With Revlimid and Rituximab: The TIGR2 TrialImmunoglobulin G Subclass 4 Related Disease;IgG4-related Disease;Autoimmune Pancreatitis;IgG4-related Sclerosing Cholangitis;Retroperitoneal FibrosisDrug: Rituximab;Drug: LenalidomideMayo ClinicCelgene CorporationCompleted18 YearsN/AAll6Phase 1United States
24NCT02703194
(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
25NCT02725476
(ClinicalTrials.gov)
March 20164/3/2016Study to Evaluate the Effect of XmAb®5871 on Disease Activity in Patients With IgG4-Related Disease (RD)An Open-label, Single-arm, Pilot Study to Evaluate the Effect of XmAb®5871 on Disease Activity in Patients With IgG4-Related DiseaseIgG4-RDBiological: XmAb5871Xencor, Inc.Massachusetts General HospitalCompleted18 Years80 YearsAll20Phase 2United States
26JPRN-UMIN000019908
2016/01/0101/01/2016Preliminary study of [11C]methionine PET/CT in the diagnosis of IgG4 related disease IgG4 related disease[11C]methionine PET/CT, [18F]FDG PET/CTSaitama Medical University International Medical CenterSaitama Medical University HospitalComplete: follow-up complete20years-oldNot applicableMale and Female30Not selectedJapan
27NCT02458196
(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
28NCT01758393
(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
29NCT01665196
(ClinicalTrials.gov)
September 201213/8/201218F-FDG PET/CT for IgG4-Related DiseaseEvaluation of 18F-FDG PET/CT in Diagnosis and Response Assessment of Patients With IgG4-Related DiseaseAutoimmune DiseaseDrug: 18F-FDGPeking Union Medical College HospitalNULLRecruiting18 Years75 YearsAll100Early Phase 1China
30NCT02899039
(ClinicalTrials.gov)
July 20122/9/2016Follicular Helper T Cells: Biological Marker and Involvement in the Physiopathology of the IgG4-related DiseaseFollicular Helper T Cells: Biological Marker and Involvement in the Physiopathology of the IgG4-related DiseaseIgG4-related DiseaseBiological: extra blood draw samplesAssistance Publique Hopitaux De MarseilleNULLCompleted18 YearsN/ABoth75N/AFrance
31NCT01584388
(ClinicalTrials.gov)
April 201222/4/2012Rituximab in IgG4-RD: A Phase 1-2 TrialRituximab (RTX) for IgG4-related Disease (IgG4-RD): a Prospective,Open-label TrialRetroperitoneal Fibrosis;Autoimmune Pancreatitis;Sialadenitis;PseudotumorDrug: RituximabMassachusetts General HospitalGenentech, Inc.Completed18 YearsN/AAll30Phase 1/Phase 2United States
32JPRN-UMIN000003804
2010/05/0125/06/2010Randomized controlled trial which examines whether resuming steroid can prevent clinical relapse in the patients with asymptomatic high levels of serum IgG after ceasing steroid therapy for autoimmune pancreatitis autoimmune pancreatitisPrednisolone at a dose of 10mg/day is started. The dose is taperd by 2.5mg every 8-10 weeks until reaching 5mg/day.
Maintenance therapy at a dose of 5 mg/day is continued.
Resuming or increasing prednisolone is not planned. Patients during the course of tapering prednisolone continue to taper the dose until its complete cessation.
Department of Gastroenterology, University of TokyoNULLRecruiting20years-oldNot applicableMale and Female20Not applicableJapan
33NCT00588367
(ClinicalTrials.gov)
April 200624/12/2007CT Pancreas PerfusionCT Perfusion of Pancreatic Cancer and Chronic Pancreatitis: Feasibility StudyPancreatic Ductal Adenocarcinoma;Chronic Pancreatitis;Autoimmune PancreatitisDevice: Mayo Interactive Breath Hold MonitorMayo ClinicNULLCompleted18 YearsN/ABoth30N/AUnited States
34EUCTR2017-002214-31-GB
(EUCTR)
03/08/2018Study to Evaluate The Safety And Effectiveness of XmAb®5871 In Patients With IgG4-Related Disease (INDIGO)A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of XmAb®5871 in Patients with IgG4-Related Disease (INDIGO) IgG4-Related Disease
MedDRA version: 20.0;Level: LLT;Classification code 10071581;Term: IgG4 related sclerosing disease;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: XmAb5871
INN or Proposed INN: XmAb5871
Other descriptive name: XMAB5871
Xencor, Inc.NULLNot RecruitingFemale: yes
Male: yes
240Phase 3Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands;Sweden;United States;Spain;Israel;United Kingdom
35EUCTR2017-002214-31-BE
(EUCTR)
22/10/2018Study to Evaluate The Safety And Effectiveness of XmAb®5871 In Patients With IgG4-Related Disease (INDIGO)A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of XmAb®5871 in Patients with IgG4-Related Disease (INDIGO) IgG4-Related Disease
MedDRA version: 20.0;Level: LLT;Classification code 10071581;Term: IgG4 related sclerosing disease;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: XmAb5871
INN or Proposed INN: XmAb5871
Other descriptive name: XMAB5871
Xencor, Inc.NULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands;Sweden
36EUCTR2017-002214-31-SE
(EUCTR)
17/10/2018Study to Evaluate The Safety And Effectiveness of XmAb®5871 In Patients With IgG4-Related Disease (INDIGO)A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of XmAb®5871 in Patients with IgG4-Related Disease (INDIGO) IgG4-Related Disease
MedDRA version: 20.0;Level: LLT;Classification code 10071581;Term: IgG4 related sclerosing disease;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: XmAb5871
INN or Proposed INN: XmAb5871
Other descriptive name: XMAB5871
Xencor, Inc.NULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands;Sweden