IPP-201101 ( 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22

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
1EUCTR2017-004060-35-HU
(EUCTR)
12/03/201810/01/2018An open-label study to evaluate the safety and tolerability of 200-mcg Dose of IPP-201101 in Patients With SLEAn open-label study of the safety and tolerability of repeated administration of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 20.0;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: IPP-201101
Product Code: IPP-201101
INN or Proposed INN: IPP-201101
ImmuPharmaNULLNot Recruiting Female: yes
Male: yes
75 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Hungary;Mauritius
2NCT03427151
(ClinicalTrials.gov)
February 27, 20188/12/2017Study of Repeated Administration of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus ErythematosusAn Open-label Study of the Safety and Tolerability of Repeated Administration of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus ErythematosusLupus Erythematosus, SystemicDrug: IPP-201101ImmuPharmaNULLCompleted18 YearsN/AAll62Phase 3United States;Czechia;France;Germany;Hungary;Mauritius;Puerto Rico;Poland
3EUCTR2015-003341-25-GB
(EUCTR)
17/10/201622/09/2016A study to evaluate the effectiveness and safety of the study drug, when patients are given a 200-mcg dosage of IPP-201101 plus standard of care in patients with systemic lupus erythematosus.A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus - A study to evaluate the effectiveness and safety of the study drug for patients with SLE. 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: Body processes [G] - Immune system processes [G12]
Product Code: IPP-201101
INN or Proposed INN: IPP-201101
ImmuPharma SANULLNot Recruiting Female: yes
Male: yes
200 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Hungary;Germany;United Kingdom
4EUCTR2015-003341-25-DE
(EUCTR)
29/07/201617/03/2016A study to evaluate the effectiveness and safety of the study drug, when patients are given a 200-mcg dosage of IPP-201101 plus standard of care in patients with systemic lupus erythematosus.A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus - A study to evaluate the effectiveness and safety of the study drug for patients with SLE. 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: Body processes [G] - Immune system processes [G12]
Product Code: IPP-201101
INN or Proposed INN: IPP-201101
ImmuPharma SANULLNot Recruiting Female: yes
Male: yes
200 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Hungary;Germany;United Kingdom
5EUCTR2015-003341-25-IT
(EUCTR)
06/07/201619/01/2021Uno studio per valutare l'efficacia e la sicurezza del farmaco in studio, quando ai pazienti ¿ dato un dosaggio di 200 mcg di IPP-201101 pi¿ standard di cura, in pazienti con lupus eritematoso sistemico.A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus - A study to evaluate the effectiveness and safety of the study drug for patients with SLE. Systemic Lupus Erythematosus
MedDRA version: 21.1;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 Code: IPP-201101IMMUPHARMANULLNot RecruitingFemale: yes
Male: yes
200Phase 3France;Hungary;Germany;United Kingdom;Italy
6EUCTR2015-003341-25-HU
(EUCTR)
02/05/201607/03/2016A study to evaluate the effectiveness and safety of the study drug, when patients are given a 200-mcg dosage of IPP-201101 plus standard of care in patients with systemic lupus erythematosus.A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus - A study to evaluate the effectiveness and safety of the study drug for patients with SLE. Systemic Lupus Erythematosus
MedDRA version: 18.1;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 Code: IPP-201101
INN or Proposed INN: IPP-201101
ImmuPharma SANULLNot RecruitingFemale: yes
Male: yes
200Phase 3France;United States;Hungary;Germany
7EUCTR2015-003341-25-FR
(EUCTR)
24/02/201620/04/2016A study to evaluate the effectiveness and safety of the study drug, when patients are given a 200-mcg dosage of IPP-201101 plus standard of care in patients with systemic lupus erythematosus.A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus - A study to evaluate the effectiveness and safety of the study drug for patients with SLE. 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: Body processes [G] - Immune system processes [G12]
Product Code: IPP-201101
INN or Proposed INN: IPP-201101
ImmuPharma SANULLNot RecruitingFemale: yes
Male: yes
200Phase 3United States;France;Hungary;Germany
8NCT02504645
(ClinicalTrials.gov)
March 201517/7/2015A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus ErythematosusA 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus ErythematosusLupus Erythematosus, SystemicDrug: IPP-201101;Drug: Placebo;Other: Standard of CareImmuPharmaNULLCompleted18 Years70 YearsAll202Phase 3United States;Czechia;France;Germany;Hungary;Mauritius;Poland;Puerto Rico;Czech Republic;Italy
9EUCTR2010-019293-32-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
10EUCTR2010-019293-32-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
11EUCTR2010-018383-16-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
12EUCTR2010-018383-16-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
13EUCTR2010-019293-32-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
14EUCTR2010-019293-32-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
15EUCTR2010-018383-16-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
16EUCTR2010-019293-32-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
17EUCTR2010-018383-16-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
18EUCTR2010-019293-32-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
19EUCTR2010-018383-16-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
20EUCTR2010-018383-16-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
21EUCTR2010-018383-16-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
22EUCTR2007-004892-21-BG
(EUCTR)
16/04/200815/04/2008A Phase IIb, Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety, Tolerability and Efficacy of Two Doses of Subcutaneous IPP-201101 Plus Standard of Care, Versus Placebo Plus Standard of Care in Subjects with Systemic Lupus Erythematosus (SLE)A Phase IIb, Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety, Tolerability and Efficacy of Two Doses of Subcutaneous IPP-201101 Plus Standard of Care, Versus Placebo Plus Standard of Care in Subjects with Systemic Lupus Erythematosus (SLE) Systemic Lupus Erythematosus (SLE)
MedDRA version: 9.1;Level: HLT;Classification code 10025135;Term: Lupus erythematosus (incl subtypes)
Product Code: IPP-201101
INN or Proposed INN: IPP - 201101
Other descriptive name: P 140
IMMUPHARMA SANULLNot RecruitingFemale: yes
Male: yes
296Phase 2Bulgaria;Spain