49. 全身性エリテマトーデス Systemic lupus erythematosus Clinical trials / Disease details


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

  
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
1EUCTR2021-004648-27-ES
(EUCTR)
21/03/202219/11/2021A Study of Enpatoran in Patients With Systemic Lupus Erythematosus andCutaneous Lupus ErythematosusA Phase II, Randomized, Double-Blind, Placebo Controlled Dose-Ranging, Parallel and Adaptive Study to Evaluate the Efficacy and Safety of Enpatoran in Systemic Lupus Erythematosus and in Cutaneous Lupus Erythematosus (Subacute Cutaneous Lupus Erythematosus and/or Discoid Lupus Erythematosus) Participants Receiving Standard of Care - WILLOW Systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE)
MedDRA version: 21.1;Level: PT;Classification code 10056509;Term: Cutaneous lupus erythematosus;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 21.1;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.1;Classification code 10057903;Term: Subacute cutaneous lupus erythematosus;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Enpatoran 25mg
Product Code: M5049
INN or Proposed INN: Enpatoran
Merck Healthcare KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
440Phase 2United States;Serbia;Philippines;Greece;Spain;Ukraine;Chile;Russian Federation;Colombia;Hungary;Mexico;Mauritius;Argentina;Poland;Brazil;Australia;Bulgaria;South Africa;China;Japan;Moldova, Republic of
2EUCTR2021-004648-27-BG
(EUCTR)
24/02/202212/01/2022A Study of Enpatoran in Patients With Systemic Lupus Erythematosus and Cutaneous Lupus ErythematosusA Phase II, Randomized, Double-Blind, Placebo Controlled Dose-Ranging, Parallel and Adaptive Study to evaluate the Efficacy and Safety of Enpatoran in Systemic Lupus Erythematosus and in Cutaneous Lupus Erythematosus (Subacute Cutaneous Lupus Erythematosus and/or Discoid Lupus Erythematosus) Participants Receiving Standard of Care - WILLOW Systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE)
MedDRA version: 21.1;Level: PT;Classification code 10056509;Term: Cutaneous lupus erythematosus;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 21.1;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.1;Classification code 10057903;Term: Subacute cutaneous lupus erythematosus;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Enpatoran 25mg
Product Code: M5049
INN or Proposed INN: Enpatoran
Merck Healthcare KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
440Phase 2United States;Serbia;Philippines;Greece;Spain;Ukraine;Chile;Russian Federation;Colombia;Hungary;Mexico;Mauritius;Argentina;Poland;Brazil;Australia;South Africa;Bulgaria;China;Japan;Moldova, Republic of