CEP-33457 ( 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
1EUCTR2010-019293-32-BE
(EUCTR)
10/05/201119/07/2010A clinical study to evaluate the tolerability of repeated doses of CEP-33457 administered in patients with a chronic autoimmune disease (Lupus)An Open-Label Long-Term Study of the Safety and Tolerability of Repeated administration of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 75 Patients With Systemic Lupus Erythematosus (SLE)
MedDRA version: 14.0;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: Lupuzor
Product Code: CEP-33457
INN or Proposed INN: Forigerimod
Other descriptive name: IPP-201101, P140
Cephalon, Inc.NULLNot RecruitingFemale: yes
Male: yes
130Phase 3United States;Portugal;Hungary;Czech Republic;Spain;Poland;Belgium;Ukraine;Germany
2EUCTR2010-019293-32-DE
(EUCTR)
10/02/201116/07/2010A clinical study to evaluate the tolerability of repeated doses of CEP-33457 administered in patients with a chronic autoimmune disease (Lupus)An Open-Label Long-Term Study of the Safety and Tolerability of Repeated administration of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 75 Patients With Systemic Lupus Erythematosus (SLE)
MedDRA version: 14.1;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: Lupuzor
Product Code: CEP-33457
INN or Proposed INN: Forigerimod
Other descriptive name: IPP-201101, P140
Cephalon, Inc.NULLNot RecruitingFemale: yes
Male: yes
130United States;Portugal;Hungary;Czech Republic;Spain;Poland;Belgium;Ukraine;Germany
3NCT01240694
(ClinicalTrials.gov)
December 201015/10/2010A Long-Term Study of the Safety and Tolerability of Repeated Administration of CEP-33457 in Patients With Systemic Lupus ErythematosusAn Open-Label Long-Term Study of the Safety and Tolerability of Repeated Administration of CEP-33457 in Patients With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: LupuzorCephalonNULLTerminated18 Years70 YearsAll136Phase 3United States;Belgium;Czechia;France;Germany;Hungary;Poland;Portugal;Spain;Ukraine;United Kingdom;Czech Republic
4EUCTR2010-018383-16-BE
(EUCTR)
10/11/201019/07/2010A clinical study to evaluate the effectiveness and tolerability of a 200mcg dose of CEP-33457 in patients with a chronic autoimmune disease (Lupus).A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 47 Patients With Systemic Lupus Erythematosus (SLE)
MedDRA version: 14.0;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: Lupuzor
Product Code: CEP-33457
INN or Proposed INN: Forigerimod
Other descriptive name: IPP-201101, P140
Cephalon, Inc.NULLNot RecruitingFemale: yes
Male: yes
220Phase 2France;United States;Portugal;Hungary;Czech Republic;Spain;Poland;Belgium;Ukraine;Germany
5EUCTR2010-019293-32-PT
(EUCTR)
01/10/201026/07/2010A clinical study to evaluate the tolerability of repeated doses of CEP-33457 administered in patients with a chronic autoimmune disease (Lupus)An Open-Label Long-Term Study of the Safety and Tolerability of Repeated administration of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 75 Patients With Systemic Lupus Erythematosus (SLE)
MedDRA version: 14.1;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: Lupuzor
Product Code: CEP-33457
INN or Proposed INN: Forigerimod
Other descriptive name: IPP-201101, P140
Cephalon, Inc.NULLNot RecruitingFemale: yes
Male: yes
130United States;Portugal;Hungary;Czech Republic;Belgium;Spain;Poland;Ukraine;Germany
6EUCTR2010-018383-16-PT
(EUCTR)
01/10/201023/07/2010A clinical study to evaluate the effectiveness and tolerability of a 200mcg dose of CEP-33457 in patients with a chronic autoimmune disease (Lupus).A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 47 Patients With Systemic Lupus Erythematosus (SLE)
MedDRA version: 13.1;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: Lupuzor
Product Code: CEP-33457
INN or Proposed INN: Forigerimod
Other descriptive name: IPP-201101, P140
Cephalon, Inc.NULLNot RecruitingFemale: yes
Male: yes
220France;United States;Portugal;Hungary;Czech Republic;Belgium;Spain;Poland;Ukraine;Germany
7EUCTR2010-019293-32-ES
(EUCTR)
28/09/201021/07/2010Estudio abierto a largo plazo de la seguridad y la tolerabilidad de la administración repetida de CEP-33457 en pacientes con lupus eritematoso sistémico.An Open-Label Long-Term Study of the Safety and Tolerability of Repeated administration of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 75Estudio abierto a largo plazo de la seguridad y la tolerabilidad de la administración repetida de CEP-33457 en pacientes con lupus eritematoso sistémico.An Open-Label Long-Term Study of the Safety and Tolerability of Repeated administration of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 75 Pacientes con lupus eritematoso sístemico (LES). Patients With Systemic Lupus Erythematosus (SLE)
MedDRA version: 12.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: Lupuzor
Product Code: CEP-33457
INN or Proposed INN: rigerimod
Other descriptive name: IPP-201101, P140
Cephalon, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Portugal;Czech Republic;Hungary;Spain;Germany
8EUCTR2010-018383-16-DE
(EUCTR)
17/09/201016/07/2010A clinical study to evaluate the effectiveness and tolerability of a 200mcg dose of CEP-33457 in patients with a chronic autoimmune disease (Lupus).A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 47 Patients With Systemic Lupus Erythematosus (SLE)
MedDRA version: 14.0;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: Lupuzor
Product Code: CEP-33457
INN or Proposed INN: Forigerimod
Other descriptive name: IPP-201101, P140
Cephalon, Inc.NULLNot RecruitingFemale: yes
Male: yes
220United States;Portugal;France;Hungary;Czech Republic;Spain;Poland;Belgium;Ukraine;Germany
9EUCTR2010-019293-32-CZ
(EUCTR)
19/08/201022/07/2010A clinical study to evaluate the tolerability of repeated doses of CEP-33457 administered in patients with a chronic autoimmune disease (Lupus)An Open-Label Long-Term Study of the Safety and Tolerability of Repeated administration of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 75 Patients With Systemic Lupus Erythematosus (SLE)
MedDRA version: 14.0;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: Lupuzor
Product Code: CEP-33457
INN or Proposed INN: Forigerimod
Other descriptive name: IPP-201101, P140
Cephalon, Inc.NULLNot RecruitingFemale: yes
Male: yes
130Poland;United States;Portugal;Hungary;Czech Republic;Belgium;Spain;Ukraine;Germany
10EUCTR2010-018383-16-HU
(EUCTR)
16/08/201020/07/2010A clinical study to evaluate the effectiveness and tolerability of a 200mcg dose of CEP-33457 in patients with a chronic autoimmune disease (Lupus).A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 47 Patients With Systemic Lupus Erythematosus (SLE)
MedDRA version: 14.0;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: Lupuzor
Product Code: CEP-33457
INN or Proposed INN: Forigerimod
Other descriptive name: IPP-201101, P140
Cephalon, Inc.NULLNot RecruitingFemale: yes
Male: yes
220Portugal;Hungary;Germany;Czech Republic;Ukraine;Belgium;France;Spain;United States;Poland
11EUCTR2010-019293-32-HU
(EUCTR)
16/08/201021/07/2010An Open-Label Long-Term Study of the Safety and Tolerability of Repeated administration of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 75 Patients With Systemic Lupus Erythematosus (SLE)
MedDRA version: 12.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: Lupuzor
Product Code: CEP-33457
INN or Proposed INN: rigerimod
Other descriptive name: IPP-201101, P140
Cephalon, Inc.NULLNot RecruitingFemale: yes
Male: yes
130Portugal;Hungary;Czech Republic;Spain
12EUCTR2010-018383-16-CZ
(EUCTR)
13/08/201022/07/2010A clinical study to evaluate the effectiveness and tolerability of a 200mcg dose of CEP-33457 in patients with a chronic autoimmune disease (Lupus).A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 47 Patients With Systemic Lupus Erythematosus (SLE)
MedDRA version: 14.0;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: Lupuzor
Product Code: CEP-33457
INN or Proposed INN: Forigerimod
Other descriptive name: IPP-201101, P140
Cephalon, Inc.NULLNot RecruitingFemale: yes
Male: yes
220France;United States;Portugal;Hungary;Czech Republic;Belgium;Spain;Poland;Ukraine;Germany
13EUCTR2010-018383-16-ES
(EUCTR)
10/08/201020/07/2010Estudio aleatorizado, doble ciego, con grupos paralelos y controlado con placebo para evaluar la eficacia y la seguridad de una dosis de 200 µg de CEP-33457 en pacientes con lupus eritematoso sistémico.A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 47Estudio aleatorizado, doble ciego, con grupos paralelos y controlado con placebo para evaluar la eficacia y la seguridad de una dosis de 200 µg de CEP-33457 en pacientes con lupus eritematoso sistémico.A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 47 Pacientes con lupus eritematoso sistémico (LES). Patients With Systemic Lupus Erythematosus (SLE)
MedDRA version: 13;Level: LLT;Classification code 10042945;Term: Lupus eritematoso sistémico
Product Name: Lupuzor
Product Code: CEP-33457
INN or Proposed INN: rigerimod
Other descriptive name: IPP-201101, P140
Cephalon, Inc.NULLNot RecruitingFemale: yes
Male: yes
220Phase 2France;Portugal;Czech Republic;Hungary;Belgium;Spain;Germany
14EUCTR2010-018383-16-FR
(EUCTR)
05/08/201029/07/2010A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 47A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 47 Patients With Systemic Lupus Erythematosus (SLE)
MedDRA version: 12.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: Lupuzor
Product Code: CEP-33457
INN or Proposed INN: rigerimod
Other descriptive name: IPP-201101, P140
Cephalon, Inc.NULLNot RecruitingFemale: yes
Male: yes
220Phase 2Portugal;France;Czech Republic;Hungary;Spain;Belgium;Germany
15NCT01135459
(ClinicalTrials.gov)
June 20101/6/2010A Study to Evaluate the Efficacy and Safety of CEP-33457 in Patients With Systemic Lupus ErythematosusA Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: Lupuzor;Drug: PlaceboCephalonNULLCompleted18 Years70 YearsBoth183Phase 2United States;Belgium;Czech Republic;France;Germany;Hungary;Poland;Portugal;Spain;Ukraine;United Kingdom