300. IgG4関連疾患
［臨床試験数：31，薬物数：33（DrugBank：16），標的遺伝子数：11，標的パスウェイ数：81］
Searched query = "IgG4-related disease", "Autoimmune pancreatitis", "IgG4-related sclerosing cholangitis", "IgG4-related lacrimal gland, orbital, and salivary gland lesions", "IgG4-related kidney disease"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
| 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 | NCT04660565 (ClinicalTrials.gov) | January 2021 | 23/9/2020 | Belimumab Treatment for IgG4-related Disease | Belimumab Treatment for IgG4-related Disease, a Prospective, Open-label Clinical Trial | IgG4-related Disease | Drug: Prednisone and Belimumab;Drug: Prednisone | Peking Union Medical College Hospital | NULL | Recruiting | 18 Years | 75 Years | All | 60 | Phase 4 | China |
| 2 | NCT04602598 (ClinicalTrials.gov) | January 2021 | 20/10/2020 | Zanubrutinib in Patients With IgG4-Related Disease | A Phase II, Single-Site, Open-Label Study of Zanubrutinib in Patients With IgG4-Related Disease | IgG4 Related Disease | Drug: Zanubrutinib 80 MG | Matthew C. Baker | Stanford University | Not yet recruiting | 18 Years | 85 Years | All | 10 | Phase 2 | United States |
| 3 | NCT04540497 (ClinicalTrials.gov) | October 26, 2020 | 1/9/2020 | A Study of Inebilizumab Efficacy and Safety in IgG4- Related Disease | A Phase 3, Randomized, Double-blind, Multicenter, Placebo Controlled Study of Inebilizumab Efficacy and Safety in IgG4-Related Disease | IgG4 Related Disease | Drug: Inebilizumab;Other: Placebo | Viela Bio | NULL | Recruiting | 18 Years | N/A | All | 160 | Phase 3 | United States;Australia;Canada;China;France;Germany;Hong Kong;Hungary;Israel;Italy;Japan;Mexico;Netherlands;Poland;Spain;Turkey;Ukraine;United Kingdom |
| 4 | EUCTR2020-000417-33-HU (EUCTR) | 06/10/2020 | 06/08/2020 | Inebilizumab efficacy and safety in IgG4 related disease | 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] | Product Name: Inebilizumab INN or Proposed INN: INEBILIZUMAB Other descriptive name: afucosylated IgG1 kappa monoclonal antibody | Viela Bio, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 3 | United States;Spain;Ukraine;Israel;United Kingdom;Italy;India;France;Hungary;Mexico;Canada;Poland;Australia;Germany;Netherlands;China;Japan;Korea, Republic of | ||
| 5 | EUCTR2020-000417-33-DE (EUCTR) | 30/09/2020 | 24/06/2020 | Inebilizumab efficacy and safety in IgG4 related disease | 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] | Product Name: Inebilizumab INN or Proposed INN: INEBILIZUMAB Other descriptive name: afucosylated IgG1 kappa monoclonal antibody | Viela Bio, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 3 | United States;Spain;Ukraine;Israel;United Kingdom;Italy;India;France;Hungary;Mexico;Canada;Poland;Australia;Germany;Netherlands;China;Japan;Korea, Republic of | ||
| 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 |
| 6 | EUCTR2020-000417-33-PL (EUCTR) | 02/09/2020 | 30/06/2020 | Inebilizumab efficacy and safety in IgG4 related disease | 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] | Product Name: Inebilizumab INN or Proposed INN: INEBILIZUMAB Other descriptive name: afucosylated IgG1 kappa monoclonal antibody | Viela Bio, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 3 | United States;Spain;Ukraine;Israel;United Kingdom;Italy;India;France;Hungary;Mexico;Canada;Poland;Australia;Netherlands;Germany;China;Japan;Korea, Republic of | ||
| 7 | NCT04520451 (ClinicalTrials.gov) | August 21, 2020 | 11/8/2020 | Open Label Two-Arm Study to Evaluate Rilzabrutinib (PRN1008) in IgG4-Related Disease Patients | An Open Label, Two-Arm Study to Evaluate the Effect of Rilzabrutinib (PRN1008) on Safety and Disease Activity in Patients With IgG4-Related Disease | IgG4-Related Disease | Drug: rilzabrutinib;Drug: Glucocorticoids | Principia Biopharma Inc. | Massachusetts General Hospital | Recruiting | 18 Years | N/A | All | 25 | Phase 2 | United States |
| 8 | ChiCTR2000028918 | 2020-01-01 | 2020-01-07 | A randomized, double-blind controlled study of glucocorticoids combination with thalidomide in the treatment of IgG4-related diseases | Efficacy and safety of thalidomide in IgG4-related diseases | IgG4 related disease | control group:prednison combined with placebo;experimental group:prednison combined with thalidomide; | Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | NULL | Recruiting | 18 | 80 | Both | control group:51;experimental group:51; | Phase 4 | China |
| 9 | NCT04125511 (ClinicalTrials.gov) | November 1, 2019 | 28/8/2019 | Characterizing IgG4-RD With 68Ga-FAPI PET/CT | Characterizing IgG4-related Disease With 68Ga-FAPI PET/CT | IgG4-related Disease | Drug: 68Ga-FAPI | Peking Union Medical College Hospital | NULL | Recruiting | 18 Years | 90 Years | All | 100 | Early Phase 1 | China |
| 10 | NCT04124861 (ClinicalTrials.gov) | October 15, 2019 | 13/2/2019 | Withdraw Drug in Stable IgG4-Related Disease | Evaluation 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 China | Autoimmune Diseases | Drug: Drug free, IS monotherapy and GC combined with IS | Peking Union Medical College Hospital | Chinese PLA General Hospital;Peking University People's Hospital;The People's Hospital of Hebei Province;Shengjing Hospital;Tongji Hospital | Not yet recruiting | 18 Years | 70 Years | All | 138 | N/A | NULL |
| 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 |
| 11 | EUCTR2017-002214-31-NL (EUCTR) | 23/07/2019 | 09/08/2018 | Study 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. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | United States;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Netherlands;Germany;Sweden | ||
| 12 | EUCTR2017-002214-31-IT (EUCTR) | 26/02/2019 | 04/11/2020 | Study 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 INC | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Hungary;Canada;Belgium;Poland;Germany;Netherlands;Sweden | ||
| 13 | NCT03669861 (ClinicalTrials.gov) | November 13, 2018 | 4/6/2018 | Safety and Efficacy of Abatacept in IgG4-Related Disease | A Prospective, Open-label, Single Center Abatacept in IgG4-Related Disease 10-patient Proof-of-concept Study | IgG4-related Disease | Drug: Abatacept | Massachusetts General Hospital | Bristol-Myers Squibb | Active, not recruiting | 18 Years | N/A | All | 10 | Phase 2 | United States |
| 14 | JPRN-UMIN000030735 | 2018/01/15 | 15/01/2018 | Diagnostic accuracy of contrast enhanced endoscopic ultrasonography in pancreatbiliary disease | Diagnostic 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 tumor | Contrast enhanced endoscopic ultrasonography using perflubutane MRI enhanced CT endoscopic ultrasonography without perflubutane | Department of EndoscopyThe Jikei University School of Medicine | NULL | Complete: follow-up complete | 20years-old | 100years-old | Male and Female | 786 | Not selected | Japan |
| 15 | NCT03368274 (ClinicalTrials.gov) | September 1, 2017 | 20/9/2017 | To Evaluate the Clinical Efficacy of Iguratimod in the Treatment of IgG4 Related Disease (IgG4-RD) With Mild Symptom | To Evaluate the Clinical Efficacy of Iguratimod in the Treatment of IgG4 Related Disease (IgG4-RD) With Mild Symptom | IgG4-related Disease | Drug: T 614 | Wen Zhang | NULL | Unknown status | 18 Years | 70 Years | All | 30 | Phase 4 | China |
| 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 |
| 16 | JPRN-UMIN000022633 | 2016/06/06 | 06/06/2016 | Efficacy and safety of low-dose steroid treatment in asymptomatic patients with autoimmune pancreatitis. | autoimmune pancreatitis | Steroid 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 University | NULL | Pending | 20years-old | Not applicable | Male and Female | 20 | Not selected | Japan | |
| 17 | NCT02797665 (ClinicalTrials.gov) | May 2016 | 6/6/2016 | Treatment of Obstructive Jaundice in Autoimmune Pancreatitis and/or Immunoglobulin G4-related Sclerosing Cholangitis by Corticosteroids | Autoimmune Pancreatitis;IgG4-related Sclerosing Cholangitis;Obstructive Jaundice | Drug: corticosteroids;Procedure: biliary stent | Peking Union Medical College Hospital | NULL | Recruiting | 18 Years | N/A | All | 30 | N/A | China | |
| 18 | NCT02705638 (ClinicalTrials.gov) | April 2016 | 7/3/2016 | Treatment of IgG4-Related Disease With Revlimid and Rituximab | Treatment of IgG4-Related Disease With Revlimid and Rituximab: The TIGR2 Trial | Immunoglobulin G Subclass 4 Related Disease;IgG4-related Disease;Autoimmune Pancreatitis;IgG4-related Sclerosing Cholangitis;Retroperitoneal Fibrosis | Drug: Rituximab;Drug: Lenalidomide | Mayo Clinic | Celgene Corporation | Completed | 18 Years | N/A | All | 6 | Phase 1 | United States |
| 19 | NCT02725476 (ClinicalTrials.gov) | March 2016 | 4/3/2016 | Study 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 Disease | IgG4-RD | Biological: XmAb5871 | Xencor, Inc. | Massachusetts General Hospital | Completed | 18 Years | 80 Years | All | 20 | Phase 2 | United States |
| 20 | NCT02703194 (ClinicalTrials.gov) | March 2016 | 27/2/2016 | Leflunomide for Maintenance of Remission in IgG4 Related Disease | A Study of Safety and Efficacy of Leflunomide for Maintenance of Remission in IgG4 Related Disease | Immunoglobulin G4 Related Sclerosing Disease | Drug: Prednisone;Drug: Leflunomide | Chinese PLA General Hospital | NULL | Completed | 18 Years | 80 Years | All | 68 | Phase 4 | China |
| 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 |
| 21 | JPRN-UMIN000019908 | 2016/01/01 | 01/01/2016 | Preliminary study of [11C]methionine PET/CT in the diagnosis of IgG4 related disease | IgG4 related disease | [11C]methionine PET/CT, [18F]FDG PET/CT | Saitama Medical University International Medical Center | Saitama Medical University Hospital | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 30 | Not selected | Japan | |
| 22 | NCT02458196 (ClinicalTrials.gov) | April 2015 | 15/4/2015 | Study of Treatment Response on IgG4 Related Disease (IgG4RD) | A Randomized Trial of Treatment in Patients With IgG4-Related Disease | Autoimmune Disease | Drug: Prednisone;Drug: Prednisone and Mycophenolate mofetil | Peking Union Medical College Hospital | NULL | Recruiting | 18 Years | 70 Years | All | 60 | Phase 2 | China |
| 23 | NCT01758393 (ClinicalTrials.gov) | December 2012 | 24/12/2012 | Glucocorticoids in Patients With IgG4-RD | A Randomized Trial of Glucocorticoids in Patients With IgG4-Related Disease | IgG4-related Disease | Drug: Prednisone | Peking Union Medical College Hospital | NULL | Recruiting | 18 Years | 70 Years | Both | 40 | Phase 2;Phase 3 | China |
| 24 | NCT01665196 (ClinicalTrials.gov) | September 2012 | 13/8/2012 | 18F-FDG PET/CT for IgG4-Related Disease | Evaluation of 18F-FDG PET/CT in Diagnosis and Response Assessment of Patients With IgG4-Related Disease | Autoimmune Disease | Drug: 18F-FDG | Peking Union Medical College Hospital | NULL | Recruiting | 18 Years | 75 Years | All | 100 | Early Phase 1 | China |
| 25 | NCT02899039 (ClinicalTrials.gov) | July 2012 | 2/9/2016 | Follicular Helper T Cells: Biological Marker and Involvement in the Physiopathology of the IgG4-related Disease | Follicular Helper T Cells: Biological Marker and Involvement in the Physiopathology of the IgG4-related Disease | IgG4-related Disease | Biological: extra blood draw samples | Assistance Publique Hopitaux De Marseille | NULL | Completed | 18 Years | N/A | Both | 75 | N/A | France |
| 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 |
| 26 | NCT01584388 (ClinicalTrials.gov) | April 2012 | 22/4/2012 | Rituximab in IgG4-RD: A Phase 1-2 Trial | Rituximab (RTX) for IgG4-related Disease (IgG4-RD): a Prospective,Open-label Trial | Retroperitoneal Fibrosis;Autoimmune Pancreatitis;Sialadenitis;Pseudotumor | Drug: Rituximab | Massachusetts General Hospital | Genentech, Inc. | Completed | 18 Years | N/A | All | 30 | Phase 1;Phase 2 | United States |
| 27 | JPRN-UMIN000003804 | 2010/05/01 | 25/06/2010 | Randomized 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 pancreatitis | Prednisolone 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 Tokyo | NULL | Recruiting | 20years-old | Not applicable | Male and Female | 20 | Not applicable | Japan | |
| 28 | NCT00588367 (ClinicalTrials.gov) | April 2006 | 24/12/2007 | CT Pancreas Perfusion | CT Perfusion of Pancreatic Cancer and Chronic Pancreatitis: Feasibility Study | Pancreatic Ductal Adenocarcinoma;Chronic Pancreatitis;Autoimmune Pancreatitis | Device: Mayo Interactive Breath Hold Monitor | Mayo Clinic | NULL | Completed | 18 Years | N/A | Both | 30 | N/A | United States |
| 29 | EUCTR2017-002214-31-SE (EUCTR) | 17/10/2018 | Study 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. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | United States;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands;Sweden | |||
| 30 | EUCTR2017-002214-31-GB (EUCTR) | 03/08/2018 | Study 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. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands;Sweden;United States;Spain;Israel;United Kingdom | |||
| 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 |
| 31 | EUCTR2017-002214-31-BE (EUCTR) | 22/10/2018 | Study 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. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | United States;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands;Sweden |