HLL2 ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
49全身性エリテマトーデス15

49. 全身性エリテマトーデス


臨床試験数 : 946 薬物数 : 722 - (DrugBank : 186) / 標的遺伝子数 : 117 - 標的パスウェイ数 : 199
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2007-002566-35-HU
(EUCTR)
09/06/200828/01/2008A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease. - SL0007A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease. - SL0007 systemic lupus erythematosus
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: epratuzumab
Product Code: CDP3194
INN or Proposed INN: epratuzumab
Other descriptive name: hLL2
UCB IncNULLNot RecruitingFemale: yes
Male: yes
210Phase 2Hungary;United Kingdom;Belgium;Spain;Lithuania
2EUCTR2007-002566-35-GB
(EUCTR)
19/03/200829/11/2007A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease. - SL0007A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease. - SL0007 systemic lupus erythematosus
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: epratuzumab
Product Code: CDP3194
INN or Proposed INN: epratuzumab
Other descriptive name: hLL2
UCB IncNULLNot RecruitingFemale: yes
Male: yes
210Phase 2Hungary;United Kingdom;Belgium;Spain;Lithuania
3EUCTR2007-002566-35-BE
(EUCTR)
25/02/200803/12/2007A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease. - SL0007A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease. - SL0007 systemic lupus erythematosus
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: epratuzumab
Product Code: CDP3194
INN or Proposed INN: epratuzumab
Other descriptive name: hLL2
UCB IncNULLNot RecruitingFemale: yes
Male: yes
210Phase 2Hungary;United Kingdom;Belgium;Spain;Lithuania
4EUCTR2007-002566-35-ES
(EUCTR)
14/02/200820/12/2007Estudio en fase IIb aleatorizado, doble ciego, controlado con placebo, de búsqueda de dosis y pauta posológica, para evaluar la seguridad y eficacia de epratuzumab en pacientes con lupus eritematoso sistémico con serología positiva y enfermedad activa.A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease. - SL0007Estudio en fase IIb aleatorizado, doble ciego, controlado con placebo, de búsqueda de dosis y pauta posológica, para evaluar la seguridad y eficacia de epratuzumab en pacientes con lupus eritematoso sistémico con serología positiva y enfermedad activa.A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease. - SL0007 Lupus eritematoso sistémicosystemic lupus erythematosus
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: epratuzumab
Product Code: CDP3194
INN or Proposed INN: epratuzumab
Other descriptive name: hLL2
UCB IncNULLNot RecruitingFemale: yes
Male: yes
210Phase 2Hungary;Belgium;Spain;Lithuania;United Kingdom
5EUCTR2007-002566-35-LT
(EUCTR)
11/02/200804/12/2007A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease. - SL0007A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease. - SL0007 systemic lupus erythematosus
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: epratuzumab
Product Code: CDP3194
INN or Proposed INN: epratuzumab
Other descriptive name: hLL2
UCB IncNULLNot RecruitingFemale: yes
Male: yes
210Phase 2Hungary;United Kingdom;Belgium;Spain;Lithuania
6EUCTR2005-000705-59-DE
(EUCTR)
11/04/200607/06/2005A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Trial of Epratuzumab in Patients with Acute Severe SLE Flares Excluding the Renal or Neurological Systems - Phase III Study of Epratuzumab in Severe Acute SLE FlaresA Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Trial of Epratuzumab in Patients with Acute Severe SLE Flares Excluding the Renal or Neurological Systems - Phase III Study of Epratuzumab in Severe Acute SLE Flares Systemic Lupus Erythematosus
Classification code 10042945
Product Name: Epratuzumab
Product Code: IMMU-103
Other descriptive name: hLL2 (trivial name or chemical description)
UCB Pharma, IncNULLNot RecruitingFemale: yes
Male: yes
510Phase 3Hungary;United Kingdom;Germany;Spain;Italy
7EUCTR2005-000705-59-HU
(EUCTR)
09/01/200612/10/2005A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Trial of Epratuzumab in Patients with Acute Severe SLE Flares Excluding the Renal or Neurological Systems. - Phase III Study of Epratuzumab in Severe Acute SLE Flares A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Trial of Epratuzumab in Patients with Acute Severe SLE Flares Excluding the Renal or Neurological Systems. - Phase III Study of Epratuzumab in Severe Acute SLE Flares Systemic Lupus Erythematosus
Classification code 10042945
Product Name: Epratuzumab
Product Code: IMMU-103
Other descriptive name: hLL2 (trivial name or chemical description)
Immunomedics, Inc.NULLNot RecruitingFemale: yes
Male: yes
510Phase 3Hungary;Slovakia;Spain;Germany;Italy;United Kingdom
8EUCTR2005-000706-31-DE
(EUCTR)
05/01/200628/06/2005A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Studyof Epratuzumab in Patients with Active Systemic Lupus Erythematosus - Phase III Study of Epratuzumab in Active SLEA Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Studyof Epratuzumab in Patients with Active Systemic Lupus Erythematosus - Phase III Study of Epratuzumab in Active SLE Systemic Lupus Erythematosus
Classification code 10042945
Product Name: Epratuzumab
Product Code: IMMU-103
Other descriptive name: hLL2 (trivial name or chemical description)
UCB Pharma Inc.NULLNot RecruitingFemale: yes
Male: yes
300Phase 3United Kingdom;Germany;Spain;Italy
9EUCTR2005-000705-59-SK
(EUCTR)
14/10/200529/07/2005A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Trial of Epratuzumab in Patients with Acute Severe SLE Flares Excluding the Renal or Neurological Systems. - Phase III Study of Epratuzumab in Severe Acute SLE FlaresA Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Trial of Epratuzumab in Patients with Acute Severe SLE Flares Excluding the Renal or Neurological Systems. - Phase III Study of Epratuzumab in Severe Acute SLE Flares Systemic Lupus Erythematosus
Classification code 10042945
Product Name: Epratuzumab
Product Code: IMMU-103
Other descriptive name: hLL2 (trivial name or chemical description)
Immunomedics, Inc.NULLNot RecruitingFemale: yes
Male: yes
510Phase 3Hungary;Slovakia;Spain;Germany;Italy;United Kingdom
10EUCTR2005-000706-31-IT
(EUCTR)
15/09/200530/09/2005A Phase III, Randomized, Double-Blind, Placebo Controlled, Multi-Center Study of Epratuzumab in Patients with Active Systemic LupusErythematosusA Phase III, Randomized, Double-Blind, Placebo Controlled, Multi-Center Study of Epratuzumab in Patients with Active Systemic LupusErythematosus improvement of signs and symptoms of Active Systemic Lupus Erythematosus
MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: Epatuzumab
Product Code: hLL2,IMMU-103
IMMUNOMEDICSNULLNot RecruitingFemale: yes
Male: yes
Phase 3Germany;United Kingdom;Spain;Italy
11EUCTR2005-000706-31-ES
(EUCTR)
25/07/200523/05/2006A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Studyof Epratuzumab in Patients with Active Systemic Lupus Erythematosus - Phase III Study of Epratuzumab in Active SLEA Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Studyof Epratuzumab in Patients with Active Systemic Lupus Erythematosus - Phase III Study of Epratuzumab in Active SLE Systemic Lupus Erythematosus
Classification code 10042945
Product Name: Epratuzumab
Product Code: IMMU-103
INN or Proposed INN: Epratuzumab
Other descriptive name: hLL2 (trivial name or chemical description)
Immunomedics, Inc.NULLNot RecruitingFemale: yes
Male: yes
300Phase 3Belgium;Spain;Germany;Italy;United Kingdom
12EUCTR2005-000706-31-BE
(EUCTR)
29/06/200526/07/2005A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Studyof Epratuzumab in Patients with Active Systemic Lupus Erythematosus - Phase III Study of Epratuzumab in Active SLEA Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Studyof Epratuzumab in Patients with Active Systemic Lupus Erythematosus - Phase III Study of Epratuzumab in Active SLE Systemic Lupus Erythematosus
Classification code 10042945
Product Name: Epratuzumab
Product Code: IMMU-103
Other descriptive name: hLL2 (trivial name or chemical description)
UCB Pharma Inc.NULLNot RecruitingFemale: yes
Male: yes
300Phase 3Spain;Belgium;Germany;Italy;United Kingdom
13EUCTR2005-000705-59-GB
(EUCTR)
07/06/200519/04/2005A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Trial of Epratuzumab in Patients with Acute Severe SLE Flares Excluding the Renal or Neurological Systems - Phase III Study of Epratuzumab in Severe Acute SLE FlaresA Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Trial of Epratuzumab in Patients with Acute Severe SLE Flares Excluding the Renal or Neurological Systems - Phase III Study of Epratuzumab in Severe Acute SLE Flares Systemic Lupus Erythematosus
Classification code 10042945
Product Name: Epratuzumab
Product Code: IMMU-103
Other descriptive name: hLL2 (trivial name or chemical description)
Immunomedics, Inc.NULLNot RecruitingFemale: yes
Male: yes
510Phase 3Hungary;Germany;United Kingdom;Spain;Italy
14EUCTR2005-000706-31-GB
(EUCTR)
13/05/200519/04/2005A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Studyof Epratuzumab in Patients with Active Systemic Lupus Erythematosus - Phase III Study of Epratuzumab in Active SLEA Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Studyof Epratuzumab in Patients with Active Systemic Lupus Erythematosus - Phase III Study of Epratuzumab in Active SLE Systemic Lupus Erythematosus
Classification code 10042945
Product Name: Epratuzumab
Product Code: IMMU-103
Other descriptive name: hLL2 (trivial name or chemical description)
Immunomedics, Inc.NULLNot RecruitingFemale: yes
Male: yes
300Phase 3Germany;United Kingdom;Spain;Italy
15NCT00011908
(ClinicalTrials.gov)
February 20013/3/2001Humanized LL2IGG to Treat Systemic Lupus ErythematosusA Phase I Clinical Trial of Immunotherapy With Humanized LL2 IgG (Epratuzumab) in Patients With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: hLL2 (Epratuzumab)National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NULLCompletedN/AN/ABoth20Phase 1United States