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

  
4 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2016-002950-19-DE
(EUCTR)
19/06/201712/04/2017A Phase II Study of M2951 in SLE A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study To Evaluate the Safety and Efficacy of M2951 in Subjects with Systemic Lupus Erythematosus (SLE) - N/A Systemic Lupus Erythematosus (SLE)
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Evobrutinib
Product Code: M2951
INN or Proposed INN: Evobrutinib
Other descriptive name: M2951
Merck KGaANULLNot Recruiting Female: yes
Male: yes
468 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Philippines;Taiwan;Russian Federation;Chile;Colombia;Italy;Mexico;Mauritius;Argentina;Poland;Brazil;Malaysia;Romania;Peru;South Africa;Bulgaria;Germany;Japan;Korea, Republic of
2EUCTR2016-002950-19-BG
(EUCTR)
27/04/201727/03/2017A Phase II Study of M2951 in SLEA Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study To Evaluate the Safety and Efficacy of M2951 in Subjects with Systemic Lupus Erythematosus (SLE) - N/A Systemic Lupus Erythematosus (SLE)
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Evobrutinib
Product Code: M2951
INN or Proposed INN: Evobrutinib
Other descriptive name: M2951
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
468Phase 2United States;Philippines;Taiwan;Russian Federation;Chile;Colombia;Italy;Mexico;Mauritius;Argentina;Poland;Brazil;Malaysia;Romania;Peru;South Africa;Bulgaria;Germany;Japan;Korea, Republic of
3EUCTR2016-002950-19-PL
(EUCTR)
25/04/201728/03/2017A Phase II Study of M2951 in SLEA Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study To Evaluate the Safety and Efficacy of M2951 in Subjects with Systemic Lupus Erythematosus (SLE) - N/A Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Evobrutinib
Product Code: M2951
INN or Proposed INN: Evobrutinib
Other descriptive name: M2951
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
468Phase 2United States;Philippines;Taiwan;Russian Federation;Chile;Colombia;Italy;Mexico;Mauritius;Argentina;Poland;Brazil;Malaysia;Romania;Peru;South Africa;Bulgaria;Germany;Japan;Korea, Republic of
4JPRN-JapicCTI-183957
20/1/201714/05/2018A Phase II Study of M2951 in Systemic Lupus Erythematosus (SLE)A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study To Evaluate the Safety and Efficacy of M2951 in Subjects With Systemic Lupus Erythematosus (SLE) Systemic Lupus ErythematosusIntervention name : M2951 (Other Name: Evobrutinib)
INN of the intervention : -
Dosage And administration of the intervention : M2951 low dose will be administered for 52 weeks in double-blind treatment period.

Intervention name : M2951 (Other Name: Evobrutinib)
INN of the intervention : -
Dosage And administration of the intervention : M2951 mid dose will be administered for 52 weeks in double-blind treatment period.

Intervention name : M2951 (Other Name: Evobrutinib)
INN of the intervention : -
Dosage And administration of the intervention : M2951 high dose will be administered for 52 weeks in double-blind treatment period.
Intervention name : M2951 (Other Name: Evobrutinib)
INN of the intervention : -
Dosage And administration of the intervention : M2951 will be administered for 104 weeks in open-lable extension period at a dose of 50 milligrams twice a day.
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : Placebo matched to M2951 will be administered for 52 weeks in double-blind treatment period.
Merck Biopharma Co., LtdMerck KGaAcomplete1875BOTH480Phase 2Japan, Asia except Japan, North America, South America, Europe, Africa