35. 天疱瘡 Pemphigus Clinical trials / Disease details


臨床試験数 : 99 薬物数 : 124 - (DrugBank : 36) / 標的遺伝子数 : 23 - 標的パスウェイ数 : 169

  
12 trials found
No.TrialIDDate_
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PhaseCountries
1NCT04598477
(ClinicalTrials.gov)
July 15, 20218/10/2020A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod PH20 SC in Adults With Pemphigus (Vulgaris or Foliaceus)An Open-Label, Multicenter, Follow-up Trial of ARGX-113-1904 to Evaluate the Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Patients With PemphigusPemphigus Vulgaris;Pemphigus FoliaceusBiological: efgartigimod PH20 SC;Drug: prednisoneargenxNULLRecruiting18 YearsN/AAll213Phase 3United States;Australia;Bulgaria;China;France;Georgia;Germany;Greece;Hungary;India;Israel;Italy;Japan;Poland;Romania;Russian Federation;Serbia;Spain;Turkey;Ukraine;United Kingdom
2EUCTR2020-002917-16-DE
(EUCTR)
25/01/202131/08/2020A study to assess the safety and efficacy of a subcutaneous formulation of efgartigimod PH20 SC in adults with Pemphigus (Vulgaris or Foliaceus)An Open-Label, Multicenter, Follow-up Trial of ARGX-113-1904 to Evaluate the Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Patients with Pemphigus (ADDRESS+) - ADDRESS+ Pemphigus Vulgaris or Pemphigus Foliaceus
MedDRA version: 20.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858
MedDRA version: 20.0;Classification code 10057069;Term: Pemphigus foliaceus;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod PH20 SC
INN or Proposed INN: EFGARTIGIMOD ALFA
Other descriptive name: ARGX-113
Product Name: Efgartigimod PH20 SC
INN or Proposed INN: EFGARTIGIMOD ALFA
Other descriptive name: ARGX-113
argenx BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3Serbia;United States;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;United Kingdom;Italy;India;France;Hungary;Poland;Romania;Australia;Georgia;Bulgaria;Germany;Japan
3EUCTR2020-002917-16-FR
(EUCTR)
21/01/202110/11/2020A study to assess the safety and efficacy of a subcutaneous formulation of efgartigimod PH20 SC in adults with Pemphigus (Vulgaris or Foliaceus)An Open-Label, Multicenter, Follow-up Trial of ARGX-113-1904 to Evaluate the Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Patients with Pemphigus - ADDRESS+ Pemphigus Vulgaris or Pemphigus Foliaceus
MedDRA version: 20.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858
MedDRA version: 20.0;Classification code 10057069;Term: Pemphigus foliaceus;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod PH20 SC
INN or Proposed INN: EFGARTIGIMOD ALFA
Other descriptive name: ARGX-113
argenx BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3United States;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;United Kingdom;Italy;India;France;Hungary;Poland;Romania;Australia;Bulgaria;Georgia;Germany;Japan
4EUCTR2020-002917-16-IT
(EUCTR)
17/12/202024/05/2021A study to assess the safety and efficacy of a subcutaneous formulation of efgartigimod PH20 SC in adults with Pemphigus (Vulgaris or Foliaceus)An Open-Label, Multicenter, Follow-up Trial of ARGX-113-1904 to Evaluate the Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Patients with Pemphigus - ADDRESS+ Pemphigus Vulgaris or Pemphigus Foliaceus
MedDRA version: 20.0;Level: LLT;Classification code 10057069;Term: Pemphigus foliaceus;System Organ Class: 100000004858
MedDRA version: 20.0;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod PH20 SC
Product Code: [na]
INN or Proposed INN: EFGARTIGIMOD ALFA
Other descriptive name: ARGX-113
Trade Name: Prednison 5 mg GALEN
Product Name: na
Product Code: [na]
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Prednison 10 mg GALEN
Product Name: na
Product Code: [na]
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Prednison20 mg GALEN
Product Name: na
Product Code: [na]
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Prednison 50 mg GALEN
Product Name: na
Product Code: [na]
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
ARGENX BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3United States;Greece;Spain;Ukraine;Turkey;Israel;Russian Federation;United Kingdom;Italy;India;France;Hungary;Poland;Romania;Australia;Georgia;Bulgaria;Germany;Japan
5EUCTR2020-002917-16-GR
(EUCTR)
03/12/202015/10/2020A study to assess the safety and efficacy of a subcutaneous formulation of efgartigimod PH20 SC in adults with Pemphigus (Vulgaris or Foliaceus)An Open-Label, Multicenter, Follow-up Trial of ARGX-113-1904 to Evaluate the Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Patients with Pemphigus - ADDRESS+ Pemphigus Vulgaris or Pemphigus Foliaceus
MedDRA version: 20.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858
MedDRA version: 20.0;Classification code 10057069;Term: Pemphigus foliaceus;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod PH20 SC
INN or Proposed INN: EFGARTIGIMOD ALFA
Other descriptive name: ARGX-113
argenx BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3United States;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;United Kingdom;Italy;India;France;Hungary;Poland;Romania;Australia;Bulgaria;Georgia;Germany;Japan
6EUCTR2020-002915-23-FR
(EUCTR)
02/12/202009/09/2020A study to assess the safety and efficacy of a subcutaneous formulation of efgartigimod PH20 SC in adults with Pemphigus (Vulgaris or Foliaceus)A Randomized, Double-Blinded, Placebo-Controlled Trial to Investigate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 SC in Adult Patients With Pemphigus (Vulgaris or Foliaceus) (ADDRESS) - ADDRESS Pemphigus Vulgaris or Pemphigus Foliaceus
MedDRA version: 20.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858
MedDRA version: 20.0;Classification code 10057069;Term: Pemphigus foliaceus;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod PH20 SC
INN or Proposed INN: EFGARTIGIMOD ALFA
Other descriptive name: ARGX-113
argenx BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3United States;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;United Kingdom;Italy;India;France;Hungary;Poland;Romania;Australia;Bulgaria;Georgia;Germany;Japan
7EUCTR2020-002917-16-BG
(EUCTR)
30/11/202003/11/2020A study to assess the safety and efficacy of a subcutaneous formulation of efgartigimod PH20 SC in adults with Pemphigus (Vulgaris or Foliaceus)An Open-Label, Multicenter, Follow-up Trial of ARGX-113-1904 to Evaluate the Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Patients with Pemphigus (ADDRESS+) - ADDRESS+ Pemphigus Vulgaris or Pemphigus Foliaceus
MedDRA version: 20.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858
MedDRA version: 20.0;Classification code 10057069;Term: Pemphigus foliaceus;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod PH20 SC
INN or Proposed INN: EFGARTIGIMOD ALFA
Other descriptive name: ARGX-113
Product Name: Efgartigimod PH20 SC
INN or Proposed INN: EFGARTIGIMOD ALFA
Other descriptive name: ARGX-113
argenx BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3Serbia;Portugal;United States;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;United Kingdom;Italy;India;France;Hungary;Poland;Croatia;Romania;Australia;Georgia;Bulgaria;Netherlands;Germany;China;Japan
8EUCTR2020-002917-16-HU
(EUCTR)
17/11/202028/09/2020A study to assess the safety and efficacy of a subcutaneous formulation of efgartigimod PH20 SC in adults with Pemphigus (Vulgaris or Foliaceus)An Open-Label, Multicenter, Follow-up Trial of ARGX-113-1904 to Evaluate the Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Patients with Pemphigus - ADDRESS+ Pemphigus Vulgaris or Pemphigus Foliaceus
MedDRA version: 20.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858
MedDRA version: 20.0;Classification code 10057069;Term: Pemphigus foliaceus;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod PH20 SC
INN or Proposed INN: EFGARTIGIMOD ALFA
Other descriptive name: ARGX-113
argenx BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3United States;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;United Kingdom;Italy;India;France;Hungary;Poland;Romania;Australia;Bulgaria;Georgia;Germany;Japan
9EUCTR2017-002333-40-DE
(EUCTR)
31/01/201814/07/2017A study to evaluate the safety and efficacy of ARGX-113 in patients with Mild to Moderate Pemphigus Vulgaris or Foliaceus)An Open-label, Non-controlled, Phase II Study to Evaluate the Safety, Pharmacodynamics, Pharmacokinetics, Efficacy and Conditions of Use of ARGX-113 in Patients with Mild to Moderate Pemphigus (Vulgaris or Foliaceus) Pemphigus (Vulgaris or Foliaceus)
MedDRA version: 20.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858
MedDRA version: 20.0;Classification code 10057069;Term: Pemphigus foliaceus;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: ARGX-113
Product Code: ARGX-113
INN or Proposed INN: efgartigimod
argenx BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
22Phase 2Hungary;Ukraine;Romania;Israel;Germany;Italy
10EUCTR2017-002333-40-IT
(EUCTR)
05/01/201829/01/2021A study to evaluate the safety and efficacy of ARGX-113 in patients with Mild to Moderate Pemphigus (Vulgaris or Foliaceus)An Open-label, Non-controlled, Phase II Study to Evaluate the Safety, Pharmacodynamics, Pharmacokinetics, Efficacy and Conditions of Use of ARGX-113 in Patients with Mild to Moderate Pemphigus (Vulgaris or Foliaceus) - A study to evaluate the safety and efficacy of ARGX-113 in patients with Mild to Moderate Pemphigus Pemphigus (Vulgaris or Foliaceus)
MedDRA version: 20.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858
MedDRA version: 20.0;Classification code 10057069;Term: Pemphigus foliaceus;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: ARGX-113
Product Code: [ARGX-113]
INN or Proposed INN: efgartigimod
ARGEN-X BVBANULLNot RecruitingFemale: yes
Male: yes
22Phase 2Hungary;Ukraine;Romania;Israel;Germany;Italy
11NCT03334058
(ClinicalTrials.gov)
October 18, 201723/10/2017A Study to Evaluate the Safety, PD, PK and Efficacy of ARGX-113 in Patients With PemphigusAn Open-label, Non-controlled, Phase II Study to Evaluate the Safety, Pharmacodynamics, Pharmacokinetics, Efficacy and Conditions of Use of ARGX-113 in Patients With Mild to Moderate Pemphigus (Vulgaris and Foliaceus)Pemphigus Vulgaris;Pemphigus FoliaceusDrug: ARGX-113argenxNULLCompleted18 YearsN/AAll34Phase 2Germany;Hungary;Israel;Italy;Ukraine
12EUCTR2017-002333-40-HU
(EUCTR)
20/09/201720/07/2017A study to evaluate the safety and efficacy of ARGX-113 in patients with Mild to Moderate Pemphigus (Vulgaris or Foliaceus)An Open-label, Non-controlled, Phase II Study to Evaluate the Safety, Pharmacodynamics, Pharmacokinetics, Efficacy and Conditions of Use of ARGX-113 in Patients with Mild to Moderate Pemphigus (Vulgaris or Foliaceus) Pemphigus (Vulgaris or Foliaceus)
MedDRA version: 20.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858
MedDRA version: 20.0;Classification code 10057069;Term: Pemphigus foliaceus;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: ARGX-113
Product Code: ARGX-113
INN or Proposed INN: efgartigimod
argenx BVBANULLNot RecruitingFemale: yes
Male: yes
12Phase 2Hungary;Ukraine;Romania;Israel;Germany;Italy