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

  
7 trials found
No.TrialIDDate_
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PhaseCountries
1EUCTR2014-002184-14-NL
(EUCTR)
22/12/201503/09/2015Safety and Efficacy Study of a Biologic to Treat Systemic Lupus ErythomatosusA Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of lulizumab pegol vs. Placebo on a Background of Limited Standard of care in the Treatment of Subjects with Active Systemic Lupus Erythematosus Active Systemic Lupus Erythematosus
MedDRA version: 18.0;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: lulizumab pegol
Product Code: BMS-931699
INN or Proposed INN: lulizumab pegol
Other descriptive name: Anti-CD28dAb
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
350Phase 2United States;Taiwan;Spain;Chile;Colombia;Italy;France;Hungary;Mexico;Puerto Rico;Canada;Argentina;Poland;Brazil;Romania;South Africa;Netherlands;Germany;Korea, Republic of
2JPRN-JapicCTI-153077
21/10/201520/11/2015A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of lulizumab pegol of Subjects with Active Systemic Lupus ErythematosusA Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of lulizumab pegol vs. Placebo on a Background of Limited Standard of Care in the Treatment of Subjects with Active Systemic Lupus Erythematosus Systemic Lupus ErythematosusIntervention name : Lulizumab pegol
INN of the intervention : -
Dosage And administration of the intervention : Four treatments of lulizumab pegol will be administered along with placebo treatment:12.5 mg weekly, 12.5 mg every other week (EOW), 5 mg EOW and 1.25mg EOW, on a background of limited standard of care medications. The dose levels may be modified based on the interim analysis results.
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
Bristol-Myers Squibb K.K.NULLcomplete1870BOTH350Phase 2Japan, Asia except Japan, North America, South America, Europe
3EUCTR2014-002184-14-DE
(EUCTR)
26/02/201523/12/2014Safety and Efficacy Study of a Biologic to Treat Systemic Lupus ErythomatosusA Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of lulizumab pegol vs. Placebo on a Background of Limited Standard of care in the Treatment of Subjects with Active Systemic Lupus ErythematosusPharmacogenetics Blood Sample Amendment 01 - Site Specific- dated-20-Aug-2014 Active Systemic Lupus Erythematosus
MedDRA version: 19.0;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: lulizumab pegol
Product Code: BMS-931699
INN or Proposed INN: lulizumab pegol
Other descriptive name: Anti-CD28dAb
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
350Phase 2United States;Taiwan;Spain;Chile;Colombia;Italy;France;Hungary;Mexico;Puerto Rico;Canada;Argentina;Poland;Brazil;Romania;South Africa;Netherlands;Germany;Korea, Republic of
4EUCTR2014-002184-14-IT
(EUCTR)
24/02/201509/01/2015Safety and Efficacy Study of a Biologic to Treat Systemic Lupus ErythomatosusA Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of BMS-931699 vs. Placebo on a Background of Limited Standard of care in the Treatment of Subjects with Active Systemic Lupus Erythematosus Active Systemic Lupus Erythematosus
MedDRA version: 17.1;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: Anti-CD28dab
Product Code: BMS-931699
INN or Proposed INN: Lulizumab Pegol
Other descriptive name: Lulizumab Pegol
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
350Phase 2United States;Taiwan;Spain;Chile;Colombia;Italy;France;Hungary;Mexico;Puerto Rico;Canada;Argentina;Poland;Brazil;Romania;South Africa;Netherlands;Germany;Korea, Republic of
5EUCTR2014-002184-14-HU
(EUCTR)
16/02/201529/12/2014Safety and Efficacy Study of a Biologic to Treat Systemic Lupus ErythomatosusA Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of BMS-931699 vs. Placebo on a Background of Limited Standard of care in the Treatment of Subjects with Active Systemic Lupus ErythematosusPharmacogenetics Blood Sample Amendment 1 - Site Specific - dated-20-Aug-2014 Active Systemic Lupus Erythematosus
MedDRA version: 17.1;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: Anti-CD28dab
Product Code: BMS-931699
INN or Proposed INN: Anti-CD28dAb
Other descriptive name: Anti-CD28dAb
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
350Phase 2United States;Taiwan;Spain;Chile;Colombia;Italy;France;Hungary;Mexico;Puerto Rico;Canada;Argentina;Poland;Brazil;Romania;South Africa;Netherlands;Germany;Korea, Republic of
6EUCTR2014-002184-14-ES
(EUCTR)
26/12/201422/12/2014Safety and Efficacy Study of a Biologic to Treat Systemic Lupus ErythomatosusA Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of BMS-931699 vs. Placebo on a Background of Limited Standard of care in the Treatment of Subjects with Active Systemic Lupus Erythematosus Active Systemic Lupus Erythematosus
MedDRA version: 17.1;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: Anti-CD28dab
Product Code: BMS-931699
INN or Proposed INN: Anti-CD28dAb
Other descriptive name: Anti-CD28dAb
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
350Phase 2Hungary;Mexico;Puerto Rico;Canada;Argentina;Poland;Brazil;Romania;South Africa;Netherlands;Germany;Korea, Republic of;France;United States;Taiwan;Spain;Chile;Colombia;Italy
7NCT02265744
(ClinicalTrials.gov)
November 13, 201415/10/2014Safety and Efficacy Study of a Biologic to Treat Systemic Lupus ErythematosusA Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Lulizumab Pegol vs. Placebo on a Background of Limited Standard of Care in the Treatment of Subjects With Active Systemic Lupus ErythematosusLupusDrug: BMS-931699;Drug: Placebo matching BMS-931699Bristol-Myers SquibbNULLCompleted18 Years70 YearsAll730Phase 2United States;Argentina;Brazil;Canada;Chile;Colombia;France;Germany;Hungary;Italy;Japan;Korea, Republic of;Lebanon;Mexico;Netherlands;Peru;Poland;Puerto Rico;Romania;Russian Federation;South Africa;Spain;Taiwan;Qatar