50. Dermatomyositis Clinical trials / Disease details


Clinical trials : 194 Drugs : 244 - (DrugBank : 89) / Drug target genes : 50 - Drug target pathways : 151

  
7 trials found
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1EUCTR2018-003171-35-HU
(EUCTR)
13/02/202314/12/2022A study to evaluate the efficacy, safety, and pharmacokinetics of IgPro20 in adults with dermatomyositis (DM)A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults with Dermatomyositis (DM) – The RECLAIIM Study Dermatomyositis
MedDRA version: 20.0;Level: LLT;Classification code 10001403;Term: Adult dermatomyositis;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Hizentra
Product Name: human immunoglobulin G
Product Code: IgPro20
INN or Proposed INN: human immunoglobulin G
Other descriptive name: Hizentra
CSL Behring LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
126Phase 3Argentina;Russian Federation;Hungary;United States;Japan;Ukraine;United Kingdom;Switzerland;Spain;Belgium;European Union;Mexico;Italy;Australia;France;Germany
2EUCTR2018-003171-35-DE
(EUCTR)
20/01/202018/09/2019A study to evaluate the efficacy, safety, and pharmacokinetics of IgPro20 in adults with dermatomyositis (DM)A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults with Dermatomyositis (DM) – The RECLAIIM Study Dermatomyositis
MedDRA version: 20.0;Level: LLT;Classification code 10001403;Term: Adult dermatomyositis;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Hizentra
Product Name: human immunoglobulin G
Product Code: IgPro20
INN or Proposed INN: human immunoglobulin G
Other descriptive name: Hizentra
CSL Behring LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
126Phase 3United States;Spain;Ukraine;Russian Federation;Italy;Switzerland;United Kingdom;France;Mexico;European Union;Argentina;Belgium;Australia;Germany;Japan
3EUCTR2018-003171-35-BE
(EUCTR)
21/11/201918/09/2019A study to evaluate the efficacy, safety, and pharmacokinetics of IgPro20 in adults with dermatomyositis (DM)A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults with Dermatomyositis (DM) – The RECLAIIM Study Dermatomyositis
MedDRA version: 20.0;Level: LLT;Classification code 10001403;Term: Adult dermatomyositis;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Hizentra
Product Name: human immunoglobulin G
Product Code: IgPro20
INN or Proposed INN: human immunoglobulin G
Other descriptive name: Hizentra
CSL Behring LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
126Phase 3United States;Spain;Ukraine;Russian Federation;Italy;Switzerland;United Kingdom;France;Mexico;European Union;Argentina;Belgium;Australia;Germany;Japan
4EUCTR2018-003171-35-ES
(EUCTR)
14/11/201929/11/2019A study to evaluate the efficacy, safety, and pharmacokinetics of IgPro20 in adults with dermatomyositis (DM)A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults with Dermatomyositis (DM) Dermatomyositis
MedDRA version: 20.0;Level: LLT;Classification code 10001403;Term: Adult dermatomyositis;System Organ Class: 100000004858 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Hizentra
Product Name: human immunoglobulin G
Product Code: IgPro20
INN or Proposed INN: human immunoglobulin G
Other descriptive name: Hizentra
CSL Behring LLCNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
126 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Ukraine;Russian Federation;Switzerland;United Kingdom;France;European Union;Mexico;Canada;Argentina;Australia;Germany;Japan
5EUCTR2018-003171-35-IT
(EUCTR)
21/10/201922/01/2021A study to evaluate the efficacy, safety, and pharmacokinetics of IgPro20 in adults with dermatomyositis (DM)A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults with Dermatomyositis (DM) - NA Dermatomyositis
MedDRA version: 20.0;Level: LLT;Classification code 10001403;Term: Adult dermatomyositis;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Hizentra
Product Name: human immunoglobulin G
Product Code: [IgPro20]
INN or Proposed INN: human immunoglobulin G
Other descriptive name: Hizentra
CSL BEHRING GMBHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
126Phase 3United States;Spain;Ukraine;Russian Federation;Italy;Switzerland;United Kingdom;France;Mexico;European Union;Canada;Argentina;Australia;Germany;Japan
6NCT04044690
(ClinicalTrials.gov)
October 21, 20191/8/2019A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 in Adults With Dermatomyositis (DM)A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults With Dermatomyositis (DM) - The RECLAIIM StudyDermatomyositisDrug: human immunoglobulin G;Drug: PlaceboCSL BehringNULLRecruiting18 YearsN/AAll126Phase 3United States;Belgium;Czechia;France;Germany;Italy;Japan;Mexico;Netherlands;Poland;Russian Federation;Spain;Switzerland;Ukraine;United Kingdom;Australia
7EUCTR2018-003171-35-FR
(EUCTR)
24/09/201911/09/2019A study to evaluate the efficacy, safety, and pharmacokinetics of IgPro20 in adults with dermatomyositis (DM)A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults with Dermatomyositis (DM) Dermatomyositis
MedDRA version: 20.0;Level: LLT;Classification code 10001403;Term: Adult dermatomyositis;System Organ Class: 100000004858 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Hizentra
Product Name: human immunoglobulin G
Product Code: IgPro20
INN or Proposed INN: human immunoglobulin G
Other descriptive name: Hizentra
CSL Behring LLCNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
126 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;France;Mexico;European Union;Canada;Argentina;Ukraine;Australia;Russian Federation;Japan;United Kingdom;Switzerland