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

  
2 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-002917-16-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
2EUCTR2020-002915-23-IT
(EUCTR)
11/12/202024/05/2021A study to assess the safety and efficacy of a subcutaneous formulation of efgartigimod PH20 SC in adults with Pemphigus (Vulgaris or Foliaceus)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 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]
Trade Name: Prednison 50 mg GALEN
Product Name: na
Product Code: [na]
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Prednison 5 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
Product Name: Efgartigimod PH20 SC
Product Code: [na]
INN or Proposed INN: EFGARTIGIMOD ALFA
Trade Name: Prednison 10 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