EPRATUZUMAB ( DrugBank: Epratuzumab )


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57

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
1NCT02306629
(ClinicalTrials.gov)
November 201429/11/2014Study to Compare Properties of Epratuzumab When Given as an Injection Under the Skin or Directly Into the BloodAn Open-label, Parallel-group, Single-dose Escalation Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Pharmacodynamics of Subcutaneous Epratuzumab in Healthy Caucasian and Japanese SubjectsSystemic Lupus ErythematosusBiological: Epratuzumab sc;Biological: Epratuzumab ivUCB Biopharma S.P.R.L.Pharmaceutical Research Associates;Richmond Pharmacology Limited;ACM Global Europe;Eurofins Pharma Bioanalysis;The Doctors LaboratoryCompleted18 Years50 YearsBoth42Phase 1United Kingdom
2EUCTR2010-020859-30-IT
(EUCTR)
23/06/201206/03/2012Open-label study of long-term Epratuzumab treatment in subjects withSystemic Lupus Erythematosus (SLE)A phase 3, multicenter, open-label, extension study to asssess the safety and tolerability of Epratuzumab treatment in systemic lupus erythematosus subjects (EMBODY 4) - EMBODY 4 Systemic lupus erythematosus
MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Epratuzumab
Product Code: CDP3194
INN or Proposed INN: EPRATUZUMAB
Other descriptive name: NA
UCB Inc.NULLNot RecruitingFemale: yes
Male: yes
1400Phase 3United States;Estonia;Taiwan;Hong Kong;Spain;Ukraine;Lithuania;Russian Federation;Israel;United Kingdom;Italy;India;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Australia;Bulgaria;South Africa;Germany;Korea, Republic of
3EUCTR2010-020859-30-EE
(EUCTR)
15/06/201204/06/2012Open-label study of long-term Epratuzumab treatment in subjects with Systemic Lupus Erythematosus (SLE)A phase 3, multicenter, open-label, extension study to assess the safety and tolerability of Epratuzumab treatment in systemic lupus erythematosus subjects (EMBODY 4) - EMBODY 4 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: Body processes [G] - Immune system processes [G12]
Product Name: Epratuzumab
Product Code: CDP3194
INN or Proposed INN: Epratuzumab
UCB Inc.NULLNot RecruitingFemale: yes
Male: yes
1250Phase 3United States;Taiwan;Estonia;Hong Kong;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;South Africa;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Bulgaria;Germany
4EUCTR2010-018563-41-EE
(EUCTR)
09/04/201209/03/2012Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE)A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 1) - EMBODY 1 Systemic Lupus Erythmatosus
MedDRA version: 17.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Epratuzumab
Product Code: CDP3194
INN or Proposed INN: Epratuzumab
UCB Inc.NULLNot RecruitingFemale: yes
Male: yes
780Phase 3Estonia;Taiwan;Spain;Lithuania;Israel;Russian Federation;Italy;United Kingdom;India;Czech Republic;Mexico;Brazil;Belgium;Australia;Bulgaria;Germany;Korea, Republic of
5EUCTR2010-018563-41-LT
(EUCTR)
14/03/201214/02/2012Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE)A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 1) - EMBODY 1 Systemic Lupus Erythmatosus
MedDRA version: 17.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Epratuzumab
Product Code: CDP3194
INN or Proposed INN: Epratuzumab
UCB Inc.NULLNot RecruitingFemale: yes
Male: yes
780Phase 3Estonia;Taiwan;Spain;Lithuania;Israel;Russian Federation;Italy;United Kingdom;India;Czech Republic;Mexico;Brazil;Belgium;Australia;Bulgaria;Germany;Korea, Republic of
6NCT01534403
(ClinicalTrials.gov)
January 201213/2/2012Open Label Extension Study of Epratuzumab in Japanese Systemic Lupus Erythematosus (SLE) SubjectsA Phase 2, Multicenter, Open-label, Long-term, Extension Study to Assess the Safety of Epratuzumab Treatment in Japanese Subjects With Systemic Lupus ErythematosusSystemic Lupus ErythematosusBiological: EpratuzumabUCB PharmaNULLCompleted18 Years65 YearsBoth17Phase 2Japan
7EUCTR2010-020859-30-BG
(EUCTR)
18/11/201118/07/2011Open-label study of long-term Epratuzumab treatment in subjects with Systemic Lupus Erythematosus (SLE)A phase 3, multicenter, open-label, extension study to assess the safety and tolerability of Epratuzumab treatment in systemic lupus erythematosus subjects (EMBODY 4) - EMBODY 4 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: Body processes [G] - Immune system processes [G12]
Product Name: Epratuzumab
Product Code: CDP3194
INN or Proposed INN: Epratuzumab
UCB Inc.NULLNot RecruitingFemale: yes
Male: yes
1250Phase 3United States;Estonia;Taiwan;Hong Kong;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;South Africa;Korea, Republic of;Korea, Democratic People's Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Bulgaria;Germany
8EUCTR2010-020859-30-LT
(EUCTR)
10/10/201111/08/2011Open-label study of long-term Epratuzumab treatment in subjects with Systemic Lupus Erythematosus (SLE)A phase 3, multicenter, open-label, extension study to assess the safety and tolerability of Epratuzumab treatment in systemic lupus erythematosus subjects (EMBODY 4) - EMBODY 4 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: Body processes [G] - Immune system processes [G12]
Product Name: Epratuzumab
Product Code: CDP3194
INN or Proposed INN: Epratuzumab
UCB Inc.NULLNot RecruitingFemale: yes
Male: yes
1250Phase 3United States;Taiwan;Estonia;Hong Kong;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;South Africa;Korea, Democratic People's Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Bulgaria;Germany
9NCT01449071
(ClinicalTrials.gov)
October 20113/10/2011Study Evaluating the Pharmacokinetics and Safety of Epratuzumab in Japanese Systemic Lupus Erythematosus (SLE)A Phase1/2, Randomized, Parallel-group, Double-Blind, Placebo-Controlled, Multicenter Study of the Safety and Pharmacokinetics of One 12 Week Treatment Cycle of Epratuzumab in Japanese Systemic Lupus Erythematosus (SLE) Subjects With Moderate to Severe DiseaseSystemic Lupus ErythematosusBiological: Placebo;Biological: Epratuzumab 400 mg;Biological: Epratuzumab 1200 mg;Biological: Epratuzumab 100 mg;Biological: Epratuzumab 600 mgUCB PharmaNULLCompleted18 Years64 YearsBoth20Phase 1/Phase 2Japan
10EUCTR2010-018565-26-IT
(EUCTR)
15/09/201105/01/2012Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE)A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE EFFICACY AND SAFETY OF FOUR 12-WEEK TREATMENT CYCLES (48 WEEKS TOTAL) OF EPRATUZUMAB IN SYSTEMIC LUPUS ERYTHEMATOSUS SUBJECTS WITH MODERATE TO SEVERE DISEASE (EMBODY 2) - EMBODY 2 Systemic Lupus Erythmatosus
MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Epratuzumab
Product Code: CDP3194
INN or Proposed INN: EPRATUZUMAB
UCB Inc.NULLNot RecruitingFemale: yes
Male: yes
780Phase 3Hungary;Mexico;Canada;Spain;Brazil;Ukraine;South Africa;Russian Federation;Germany;United Kingdom;Italy;India
11EUCTR2010-018563-41-BG
(EUCTR)
02/09/201125/07/2011Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE)A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 1) - EMBODY 1 Systemic Lupus Erythmatosus
MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Epratuzumab
Product Code: CDP3194
INN or Proposed INN: Epratuzumab
UCB Inc.NULLNot RecruitingFemale: yes
Male: yes
780Phase 3Estonia;Taiwan;Spain;Lithuania;Russian Federation;Israel;Italy;United Kingdom;India;Czech Republic;Mexico;Brazil;Belgium;Australia;Bulgaria;Germany;Korea, Republic of
12EUCTR2010-020859-30-DE
(EUCTR)
31/08/201124/01/2011Open-label study of long-term Epratuzumab treatment in subjects with Systemic Lupus Erythematosus (SLE)A phase 3, multicenter, open-label, extension study to assess the safety and tolerability of Epratuzumab treatment in systemic lupus erythematosus subjects (EMBODY 4) - EMBODY 4 Systemic Lupus Erythematosus
MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Epratuzumab
Product Code: CDP3194
INN or Proposed INN: Epratuzumab
UCB Inc.NULLNot RecruitingFemale: yes
Male: yes
1400Phase 3United States;Estonia;Taiwan;Hong Kong;Spain;Ukraine;Lithuania;Russian Federation;Israel;Italy;United Kingdom;India;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Australia;Bulgaria;South Africa;Germany;Korea, Republic of
13NCT01408576
(ClinicalTrials.gov)
July 20111/8/2011Open Label Extension Study of Epratuzumab in Subjects With Systemic Lupus ErythematosusA Phase 3, Multicenter, Open-label, Extension Study to Assess the Safety and Tolerability of Epratuzumab Treatment in Systemic Lupus Erythematosus SubjectsSystemic Lupus ErythematosusDrug: EpratuzumabUCB PharmaNULLCompleted18 YearsN/AAll1250Phase 3United States;Australia;Belgium;Brazil;Bulgaria;Canada;Czechia;Estonia;France;Germany;Hong Kong;Hungary;Israel;Italy;Korea, Republic of;Lithuania;Mexico;Poland;Romania;Russian Federation;South Africa;Spain;Taiwan;Ukraine;United Kingdom;Czech Republic
14EUCTR2010-018563-41-IT
(EUCTR)
23/06/201120/03/2012Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE)A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE EFFICACY AND SAFETY OF FOUR 12-WEEK TREATMENT CYCLES (48 WEEKS TOTAL) OF EPRATUZUMAB IN SYSTEMIC LUPUS ERYTHEMATOSUS SUBJECTS WITH MODERATE TO SEVERE DISEASE (EMBODY 1) - EMBODY 1 Systemic Lupus Erythmatosus
MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Epratuzumab
Product Code: CDP3194
INN or Proposed INN: EPRATUZUMAB
UCB Inc.NULLNot RecruitingFemale: yes
Male: yes
780Phase 3Estonia;Taiwan;Spain;Lithuania;Russian Federation;Israel;United Kingdom;Italy;India;Czech Republic;Mexico;Brazil;Belgium;Australia;Bulgaria;Germany;Korea, Republic of
15EUCTR2010-018565-26-DE
(EUCTR)
21/06/201121/01/2011Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE)A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 2) - EMBODY 2 Systemic Lupus Erythmatosus
MedDRA version: 17.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Epratuzumab
Product Code: CDP3194
INN or Proposed INN: Epratuzumab
UCB Inc.NULLNot RecruitingFemale: yes
Male: yes
780Phase 3Hungary;Mexico;Canada;Spain;Brazil;Ukraine;Russian Federation;South Africa;Germany;Italy;United Kingdom;India
16EUCTR2010-018563-41-DE
(EUCTR)
21/06/201121/01/2011Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE)A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 1) - EMBODY 1 Systemic Lupus Erythmatosus
MedDRA version: 17.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Epratuzumab
Product Code: CDP3194
INN or Proposed INN: Epratuzumab
UCB Inc.NULLNot RecruitingFemale: yes
Male: yes
780Phase 3Estonia;Taiwan;Spain;Lithuania;Israel;Russian Federation;Italy;United Kingdom;India;Czech Republic;Mexico;Brazil;Belgium;Australia;Bulgaria;Germany;Korea, Republic of
17EUCTR2010-020859-30-BE
(EUCTR)
25/05/201119/11/2010Open-label study of long-term Epratuzumab treatment in subjects with Systemic Lupus Erythematosus (SLE)A phase 3, multicenter, open-label, extension study to asssess the safety and tolerability of Epratuzumab treatment in systemic lupus erythematosus subjects (EMBODY 4) - EMBODY 4 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: Body processes [G] - Immune system processes [G12]
Product Name: Epratuzumab
Product Code: CDP3194
INN or Proposed INN: Epratuzumab
UCB Inc.NULLNot RecruitingFemale: yes
Male: yes
1250Phase 3United States;Estonia;Taiwan;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Australia;South Africa;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Bulgaria;Germany
18EUCTR2010-018563-41-BE
(EUCTR)
25/05/201119/11/2010Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE)A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 1) - EMBODY 1 Systemic Lupus Erythmatosus
MedDRA version: 17.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Epratuzumab
Product Code: CDP3194
INN or Proposed INN: Epratuzumab
UCB Inc.NULLNot RecruitingFemale: yes
Male: yes
780Phase 3Estonia;Taiwan;Spain;Lithuania;Israel;Russian Federation;Italy;United Kingdom;India;Czech Republic;Mexico;Belgium;Brazil;Australia;Bulgaria;Germany;Korea, Republic of
19EUCTR2010-020859-30-GB
(EUCTR)
17/05/201109/02/2011Open-label study of long-term Epratuzumab treatment in subjects with Systemic Lupus Erythematosus (SLE)A phase 3, multicenter, open-label, extension study to asssess the safety and tolerability of Epratuzumab treatment in systemic lupus erythematosus subjects (EMBODY 4) - EMBODY 4 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: Body processes [G] - Immune system processes [G12]
Product Name: Epratuzumab
Product Code: CDP3194
INN or Proposed INN: Epratuzumab
UCB Inc.NULLNot Recruiting Female: yes
Male: yes
1250 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Estonia;Taiwan;Hong Kong;Spain;Ukraine;Russian Federation;Israel;Italy;India;France;Australia;South Africa;Korea, Republic of;Korea, Democratic People's Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Bulgaria;Germany
20EUCTR2010-018565-26-GB
(EUCTR)
13/05/201109/02/2011 Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE)A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 2) - EMBODY 2 Systemic Lupus Erythmatosus
MedDRA version: 16.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Epratuzumab
Product Code: CDP3194
INN or Proposed INN: Epratuzumab
UCB Inc.NULLNot Recruiting Female: yes
Male: yes
780 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noHungary;Mexico;Canada;Spain;Brazil;Ukraine;South Africa;Russian Federation;Germany;Italy;United Kingdom;India
21EUCTR2010-018563-41-GB
(EUCTR)
13/05/201109/02/2011 Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE)A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 1) - EMBODY 1 Systemic Lupus Erythmatosus
MedDRA version: 16.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Epratuzumab
Product Code: CDP3194
INN or Proposed INN: Epratuzumab
UCB Inc.NULLNot Recruiting Female: yes
Male: yes
780 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noEstonia;Taiwan;Spain;Lithuania;Israel;Russian Federation;Italy;United Kingdom;India;Czech Republic;Mexico;Brazil;Belgium;Australia;Bulgaria;Germany;Korea, Republic of
22EUCTR2010-020859-30-CZ
(EUCTR)
25/02/201126/01/2011Open-label study of long-term Epratuzumab treatment in subjects with Systemic Lupus Erythematosus (SLE)A phase 3, multicenter, open-label, extension study to assess the safety and tolerability of Epratuzumab treatment in systemic lupus erythematosus subjects (EMBODY 4) - EMBODY 4 Systemic Lupus Erythematosus
MedDRA version: 17.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Epratuzumab
Product Code: CDP3194
INN or Proposed INN: Epratuzumab
UCB Inc.NULLNot RecruitingFemale: yes
Male: yes
1400Phase 3United States;Estonia;Taiwan;Hong Kong;Spain;Ukraine;Lithuania;Russian Federation;Israel;Italy;United Kingdom;India;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Australia;Bulgaria;South Africa;Germany;Korea, Republic of
23EUCTR2010-018563-41-CZ
(EUCTR)
25/02/201126/01/2011Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE)A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 1) - EMBODY 1 Systemic Lupus Erythmatosus
MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Epratuzumab
Product Code: CDP3194
INN or Proposed INN: Epratuzumab
UCB Inc.NULLNot RecruitingFemale: yes
Male: yes
780Phase 3Estonia;Taiwan;Spain;Lithuania;Israel;Russian Federation;Italy;United Kingdom;India;Czech Republic;Mexico;Brazil;Belgium;Australia;Bulgaria;Germany;Korea, Republic of
24EUCTR2010-018565-26-ES
(EUCTR)
22/02/201123/12/2010Estudio en fase III, aleatorizado, doble ciego, controlado con placebo y multicéntrico sobre la eficacia y la seguridad de cuatro ciclos de tratamiento de 12 semanas (48 semanas) con epratuzumab en pacientes con lupus eritematoso sistémico moderado a intenso (EMBODY2). - EMBODY 2Estudio en fase III, aleatorizado, doble ciego, controlado con placebo y multicéntrico sobre la eficacia y la seguridad de cuatro ciclos de tratamiento de 12 semanas (48 semanas) con epratuzumab en pacientes con lupus eritematoso sistémico moderado a intenso (EMBODY2). - EMBODY 2 Lupus Sistémico Eritematoso
MedDRA version: 12.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: Epratuzumab
Product Code: CDP3194
INN or Proposed INN: Epratuzumab
UCB Inc.NULLNot RecruitingFemale: yes
Male: yes
780Hungary;Spain;Germany;Italy;United Kingdom
25EUCTR2010-020859-30-ES
(EUCTR)
22/02/201122/12/2010ESTUDIO EN FASE 3, MULTICÉNTRICO, ABIERTO Y DEEXTENSIÓN, PARA EVALUAR LA EFICACIA Y LATOLERABILIDAD DEL TRATAMIENTO CONEPRATUZUMAB EN PACIENTES CON LUPUSERITEMATOSO SISTÉMICO (EMBODY 4) - EMBODY 4ESTUDIO EN FASE 3, MULTICÉNTRICO, ABIERTO Y DEEXTENSIÓN, PARA EVALUAR LA EFICACIA Y LATOLERABILIDAD DEL TRATAMIENTO CONEPRATUZUMAB EN PACIENTES CON LUPUSERITEMATOSO SISTÉMICO (EMBODY 4) - EMBODY 4 Lupus eritematoso sistémico
MedDRA version: 12.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: Epratuzumab
Product Code: CDP3194
INN or Proposed INN: Epratuzumab
UCB Inc.NULLNot RecruitingFemale: yes
Male: yes
1250Estonia;Hungary;Czech Republic;Belgium;Spain;Lithuania;Bulgaria;Germany;Italy;United Kingdom
26EUCTR2010-018563-41-ES
(EUCTR)
21/02/201122/12/2010Estudio en fase 3, aleatorizado, doble ciego, controlado con placebo y multicéntrico sobre la eficacia y la seguridad de cuatro ciclos de tratamiento de 12 semanas (48 semanas) con epratuzumab en pacientes con lupus eritematoso sistémico moderado a intenso (EMBODY 1). //A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 1). - EMBODY 1Estudio en fase 3, aleatorizado, doble ciego, controlado con placebo y multicéntrico sobre la eficacia y la seguridad de cuatro ciclos de tratamiento de 12 semanas (48 semanas) con epratuzumab en pacientes con lupus eritematoso sistémico moderado a intenso (EMBODY 1). //A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 1). - EMBODY 1 Lupus eritematoso sistémico
MedDRA version: 12.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: Epratuzumab
Product Code: CDP3194
INN or Proposed INN: Epratuzumab
UCB Inc.NULLNot RecruitingFemale: yes
Male: yes
780Phase 3Estonia;Czech Republic;Belgium;Spain;Lithuania;Bulgaria;Germany;Italy;United Kingdom
27EUCTR2010-020859-30-HU
(EUCTR)
08/02/201110/02/2011Open-label study of long-term Epratuzumab treatment in subjects with Systemic Lupus Erythematosus (SLE)A phase 3, multicenter, open-label, extension study to assess the safety and tolerability of Epratuzumab treatment in systemic lupus erythematosus subjects (EMBODY 4) - EMBODY 4 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: Body processes [G] - Immune system processes [G12]
Product Name: Epratuzumab
Product Code: CDP3194
INN or Proposed INN: Epratuzumab
UCB Inc.NULLNot RecruitingFemale: yes
Male: yes
1250Phase 3United States;Estonia;Taiwan;Hong Kong;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Australia;South Africa;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Bulgaria;Germany
28EUCTR2010-018565-26-HU
(EUCTR)
16/01/201122/11/2010Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE)A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 2) - EMBODY 2 Systemic Lupus Erythmatosus
MedDRA version: 17.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Epratuzumab
Product Code: CDP3194
INN or Proposed INN: Epratuzumab
UCB Inc.NULLNot RecruitingFemale: yes
Male: yes
780Phase 3Hungary;Mexico;Canada;Spain;Brazil;Ukraine;Russian Federation;South Africa;Germany;Italy;United Kingdom;India
29NCT01261793
(ClinicalTrials.gov)
December 201014/12/2010Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus (SLE)A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of the Efficacy and Safety of Four 12-week Treatment Cycles (48 Weeks Total) of Epratuzumab in Systemic Lupus Erythematosus Subjects With Moderate to Severe DiseaseSystemic Lupus ErythematosusDrug: Placebo;Drug: EpratuzumabUCB PharmaNULLCompleted18 YearsN/AAll791Phase 3United States;Brazil;Canada;France;Germany;Hungary;India;Italy;Mexico;Poland;Romania;Russian Federation;South Africa;Spain;Ukraine;United Kingdom;Netherlands
30NCT01262365
(ClinicalTrials.gov)
December 201014/12/2010Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus ErythematosusA Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of the Efficacy and Safety of Four 12-week Treatment Cycles (48 Weeks Total) of Epratuzumab in Systemic Lupus Erythematosus Subjects With Moderate to Severe DiseaseSystemic Lupus ErythematosusDrug: Epratuzumab;Drug: PlaceboUCB PharmaNULLCompleted18 YearsN/AAll793Phase 3United States;Australia;Belgium;Brazil;Bulgaria;Czechia;Estonia;France;Germany;India;Israel;Italy;Korea, Republic of;Lithuania;Mexico;Puerto Rico;Romania;Russian Federation;Spain;Taiwan;United Kingdom;Czech Republic
31EUCTR2007-002589-37-GB
(EUCTR)
17/07/200804/01/2008A Phase IIb, Multi-center, Open-label, Follow-up Study to Assess the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease Who Participated in Study SL0007. - SL0008A Phase IIb, Multi-center, Open-label, Follow-up Study to Assess the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease Who Participated in Study SL0007. - SL0008 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
UCB IncNULLNot Recruiting Female: yes
Male: yes
175 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noHungary;Spain;Belgium;Lithuania;United Kingdom
32EUCTR2007-002589-37-HU
(EUCTR)
09/06/200829/01/2008A Phase IIb, Multi-center, Open-label, Follow-up Study to Assess the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease Who Participated in Study SL0007. - SL0008A Phase IIb, Multi-center, Open-label, Follow-up Study to Assess the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease Who Participated in Study SL0007. - SL0008 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
UCB IncNULLNot RecruitingFemale: yes
Male: yes
175Phase 2Hungary;United Kingdom;Belgium;Spain;Lithuania
33EUCTR2007-002566-35-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
34NCT00660881
(ClinicalTrials.gov)
May 200815/4/2008Open-label Study of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients With Active DiseaseA Phase IIb Multi-Center, Open-label, Follow-up Study to Assess Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients With Active Disease Who Participated in Study SL0007Systemic Lupus ErythematosusBiological: EpratuzumabUCB PharmaNULLCompleted18 YearsN/ABoth210Phase 2United States;Belgium;Brazil;Hong Kong;Hungary;India;Lithuania;Poland;Spain;Ukraine;United Kingdom
35EUCTR2007-002589-37-BE
(EUCTR)
10/04/200830/01/2008Open-label Study of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients With Active DiseaseA Phase IIb, Multi-center, Open-label, Follow-up Study to Assess the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease Who Participated inStudy SL0007. Systemic Lupus Erythematosus
MedDRA version: 14.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Epratuzumab
Product Code: CDP3194
INN or Proposed INN: Epratuzumab
UCB IncNULLNot RecruitingFemale: yes
Male: yes
203Phase 2Hungary;Hong Kong;Brazil;Spain;Poland;Belgium;Ukraine;Lithuania;United Kingdom;India
36EUCTR2007-002589-37-LT
(EUCTR)
02/04/200808/01/2008Open-label Study of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients With Active DiseaseA Phase IIb, Multi-center, Open-label, Follow-up Study to Assess the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease Who Participated in Study SL0007. - SL0008 Systemic Lupus Erythematosus
MedDRA version: 14.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: epratuzumab
Product Code: CDP3194
INN or Proposed INN: epratuzumab
UCB IncNULLNot RecruitingFemale: yes
Male: yes
175Phase 2India;Hungary;United Kingdom;Ukraine;Belgium;Spain;Hong Kong;Poland;Brazil;Lithuania
37EUCTR2007-002589-37-ES
(EUCTR)
26/03/200807/02/2008Estudio en fase IIb de seguimiento abierto, multicéntrico para evaluar la seguridad y la eficacia del epratuzumab en pacientes con lupus eritematoso sistémico activo con serología positiva que participaron en el estudio SL0007A Phase IIb, Multi-center, Open-label, Follow-up Study to Assess the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease Who Participated in Study SL0007. - SL0008Estudio en fase IIb de seguimiento abierto, multicéntrico para evaluar la seguridad y la eficacia del epratuzumab en pacientes con lupus eritematoso sistémico activo con serología positiva que participaron en el estudio SL0007A Phase IIb, Multi-center, Open-label, Follow-up Study to Assess the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease Who Participated in Study SL0007. - SL0008 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
UCB IncNULLNot RecruitingFemale: yes
Male: yes
175Phase 2Hungary;Belgium;Spain;Lithuania;United Kingdom
38EUCTR2007-002566-35-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
39EUCTR2007-002566-35-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
40EUCTR2007-002566-35-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
41EUCTR2007-002566-35-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
42NCT00624351
(ClinicalTrials.gov)
January 200815/2/2008Study of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus (SLE) Patients With Active DiseaseA 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 (SLE) Patients With Active DiseaseSystemic Lupus ErythematosusBiological: Epratuzumab;Other: PlaceboUCB PharmaNULLCompleted18 YearsN/ABoth227Phase 2United States;Belgium;Brazil;Hong Kong;Hungary;India;Lithuania;Poland;Spain;Ukraine;United Kingdom
43NCT00382837
(ClinicalTrials.gov)
January 200729/9/2006Study of Epratuzumab in Systemic Lupus ErythematosusA Phase III Multi-Center, OpenLabel, Follow-Up Study to Assess the Safety & Efficacy of Epratuzumab in Patients With Acute Severe SLE Flares Excluding the Renal or Neurologic SystemsSystemic Lupus ErythematosusDrug: EpratuzumabUCB PharmaNULLWithdrawn18 YearsN/ABoth0Phase 3United States;Belgium;Brazil;Canada;Czech Republic;France;Germany;Hungary;Italy;Netherlands;Slovakia;Spain;United Kingdom
44NCT00383513
(ClinicalTrials.gov)
June 200629/9/2006Study of Epratuzumab in Systemic Lupus ErythematosusAn Open-Label Re-treatment Trial for Patients Previously Randomized Into the SL0003 and SL0004, Randomized, Double-blind, Placebo-controlled, Multi-center Studies of Epratuzumab in Patients With Systemic Lupus ErythematosusSystemic Lupus ErythematosusBiological: EpratuzumabUCB PharmaNULLCompleted18 YearsN/ABoth29Phase 2United States;Belgium;Brazil;Canada;Czech Republic;France;Germany;Italy;Netherlands;Spain;United Kingdom
45EUCTR2005-000705-59-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
46EUCTR2005-000705-59-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
47EUCTR2005-000706-31-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
48EUCTR2005-000705-59-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
49EUCTR2005-000706-31-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
50EUCTR2005-000706-31-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
51EUCTR2005-000706-31-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
52EUCTR2005-000705-59-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
53NCT00111306
(ClinicalTrials.gov)
June 200519/5/2005Study of Epratuzumab in Systemic Lupus ErythematosusA Phase III, Randomized, Double-Blind. Placebo-Controlled, Multi-Center Study of Systemic Lupus Erythematosus With Acute Severe SLE Flares Excluding Renal or Neurological SystemsSystemic Lupus ErythematosusDrug: epratuzumabUCB PharmaNULLTerminated18 YearsN/ABoth510Phase 3United States;Belgium;Hungary;Netherlands;Spain;United Kingdom
54EUCTR2005-000706-31-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
55NCT00383214
(ClinicalTrials.gov)
May 200529/9/2006Study of Epratuzumab in Systemic Lupus Erythematosus (SLE)A Phase III, Randomized, Double Blind, Placebo Controlled, Multi-Center Study of Epratuzumab in Patients With Active Systemic Lupus Erythematosus.Systemic Lupus ErythematosusDrug: Epratuzumab;Other: PlaceboUCB PharmaNULLTerminated18 YearsN/ABoth54Phase 3United States;Belgium;Brazil;Canada;Czech Republic;France;Germany;Italy;Netherlands;Spain;United Kingdom
56NCT00113971
(ClinicalTrials.gov)
April 200510/6/2005Pharmacokinetics Study of Epratuzumab in Systemic Lupus Erythematosus (SLE)A Randomized Phase II Pharmacokinetics/Pharmacodynamics Study of Epratuzumab in Patients With Systemic Lupus ErythematosusLupus Erythematosus, SystemicDrug: epratuzumabUCB PharmaNULLTerminated18 YearsN/ABoth20Phase 2United States
57NCT00011908
(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