XmAb5871 ( DrugBank: - )


2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
49全身性エリテマトーデス1
300IgG4関連疾患6

49. 全身性エリテマトーデス


臨床試験数 : 993 薬物数 : 702 - (DrugBank : 184) / 標的遺伝子数 : 116 - 標的パスウェイ数 : 200
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02725515
(ClinicalTrials.gov)
February 16, 20168/1/2016A Study of the Effect of XmAb®5871 in Patients With Systemic Lupus ErythematosusA Randomized, Double-Blinded, Placebo-Controlled Study of the Effect of XmAb®5871 on Systemic Lupus Erythematosus Disease ActivitySystemic Lupus ErythematosusBiological: XmAb5871;Biological: Placebo to match XmAb5871Xencor, Inc.PPD;ICON plcCompleted18 Years65 YearsAll105Phase 2United States

300. IgG4関連疾患


臨床試験数 : 40 薬物数 : 47 - (DrugBank : 21) / 標的遺伝子数 : 18 - 標的パスウェイ数 : 141
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2017-002214-31-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
2EUCTR2017-002214-31-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
3NCT02725476
(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
4EUCTR2017-002214-31-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
5EUCTR2017-002214-31-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
6EUCTR2017-002214-31-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