CC ( DrugBank: - )


13 diseases
告示番号疾患名(ページ内リンク)臨床試験数
28全身性アミロイドーシス3
46悪性関節リウマチ16
49全身性エリテマトーデス8
51全身性強皮症6
56ベーチェット病5
84サルコイドーシス3
85特発性間質性肺炎7
96クローン病15
97潰瘍性大腸炎9
98好酸球性消化管疾患20
162類天疱瘡(後天性表皮水疱症を含む。)1
202スミス・マギニス症候群1
271強直性脊椎炎20

28. 全身性アミロイドーシス


臨床試験数 : 267 薬物数 : 241 - (DrugBank : 77) / 標的遺伝子数 : 68 - 標的パスウェイ数 : 180
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2011-001787-22-IT
(EUCTR)
02/05/201212/01/2012Treatment with pomalidomide and dexamethasone for previously treated patients with AL amyloidosis.An open-label, phase II study of Pomalidomide and Dexamethasone (PDex) for previously treated patients with AL amyloidosis - PDex Previously treated AL amyloidosis
MedDRA version: 14.1;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: pomalidomide
Product Code: CC-4047
INN or Proposed INN: Pomalidomide
INN or Proposed INN: DEXAMETHASONE SODIUM SULFATE
OSPEDALE POLICLINICO S. MATTEONULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 2Italy
2NCT00166413
(ClinicalTrials.gov)
April 200512/9/2005Efficacy of CC-5013 (Revlimid or Lenalidomide) in Patients With Primary Systemic AmyloidosisA Phase II Trial of CC-5013 in Patients With Primary Systemic AmyloidosisAmyloidosisDrug: CC-5013Mayo ClinicNULLCompleted18 YearsN/ABoth38Phase 2United States
3NCT00091260
(ClinicalTrials.gov)
January 20047/9/2004CC-5013 With or Without Dexamethasone in Treating Patients With Primary Systemic AmyloidosisA Phase II Trial of the Immunomodulatory Drug CC-5013 for Patients With AL AmyloidosisMultiple MyelomaDrug: dexamethasone;Drug: lenalidomideVaishali SanchorawalaCelgene CorporationCompleted18 YearsN/AAll82Phase 2United States

46. 悪性関節リウマチ


臨床試験数 : 4,356 薬物数 : 2,567 - (DrugBank : 415) / 標的遺伝子数 : 192 - 標的パスウェイ数 : 228
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04428424
(ClinicalTrials.gov)
July 5, 202010/6/2020Study To Evaluate The Response To Enbrel And The Impact Of Rheumatoid Factor(RF) And Anti-Cyclic Citrullinated Peptide(Anti-CCP) In Rheumatoid Arthritis(RA) PatientsThe Impact of RF, and Anti-CCP on RA Patients in Response to EtanerceptArthritis, RheumatoidDrug: EnbrelPfizerNULLCompleted18 YearsN/AAll1Iraq
2NCT03225950
(ClinicalTrials.gov)
February 1, 201719/7/2017Interaction Between Immune Cells and Bacteria Associated With PeriodontitisInteraction Between Immune Cells and Bacteria Associated With PeriodontitisPeriodontal Diseases;Periodontitis;Aggressive Periodontitis;Immunologic Disease;Microbial Disease;Periodontal Pocket;Inflammation;Inflammation Gum;Dysbiosis;Rheumatoid Arthritis;Generalized Aggressive Periodontitis;Generalized Chronic Periodontitis;Chronic PeriodontitisOther: In vitro stimulation of blood with periodontitis-associated- and control bacteria;Diagnostic Test: Anti-CCP- and anti-P.g.-antibodies titers;Genetic: Analysis of selected single nucleotide polymorphisms (SNPs);Diagnostic Test: periodontitis-associated bacteria presenceUniversity of CopenhagenCopenhagen University Hospital, DenmarkCompleted19 Years60 YearsAll90Denmark
3NCT01975610
(ClinicalTrials.gov)
October 201329/10/2013Efficacy and Safety Study of CC-292 Versus Placebo as Co-therapy With Methotrexate in Active Rheumatoid ArthritisA Phase 2a, 4-Week Double-Blind, Proof-of-Concept Efficacy and Safety Study of CC-292 Versus Placebo as Co-therapy With Methotrexate in Active Rheumatoid ArthritisRheumatoid ArthritisDrug: CC-292;Drug: PlaceboCelgeneNULLCompleted18 Years80 YearsFemale47Phase 2United States
4EUCTR2011-002024-40-ES
(EUCTR)
16/02/201214/10/2011Proof-of-Concept Study with BMS-817399 to Treat Moderate to Severe Rheumatoid ArthritisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BMS-817399 in Adults with Active, Moderate to Severe Rheumatoid Arthritis and Inadequate Response to Methotrexate Rheumatoid Arthritis
MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: CCR1 Antagonist
Product Code: BMS-817399
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
172Phase 2United States;Mexico;Argentina;Spain;South Africa;Russian Federation;Korea, Republic of
5EUCTR2010-019926-15-CZ
(EUCTR)
27/01/201101/12/2010A Phase 2 placebo-controlled study to compare the effectiveness and safety of two doses of apremilast (CC-10004) in subjects with active rheumatoid arthritis, who have not responded to methotrexate treatmentA PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY, TO COMPARE THE EFFICACY AND SAFETY OF TWO DOSES OF APREMILAST (CC-10004) IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE Rheumatoid arthritis, a chronic systemic autoimmune inflammatory disease characterized by persisten synovial inflammations.
MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
210Phase 2United States;Czech Republic
6NCT01285310
(ClinicalTrials.gov)
December 9, 201019/11/2010Study of Apremilast to Evaluate the Safety and Effectiveness for Patients With Rheumatoid ArthritisA Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study, To Compare the Efficacy and Safety of Two Doses of Apremilast (CC-10004) in Subjects With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to MethotrexateRheumatoid ArthritisDrug: Apremilast 30 mg;Drug: Apremilast 20 mg;Drug: PlaceboAmgenNULLTerminated18 YearsN/AAll237Phase 2United States;Czechia;Poland;Spain;Czech Republic
7EUCTR2010-019964-36-DE
(EUCTR)
14/10/201009/06/2010A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of CCX354-C in Subjects with Rheumatoid Arthritis Partially Responsive to Methotrexate Therapy - CARAT-2A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of CCX354-C in Subjects with Rheumatoid Arthritis Partially Responsive to Methotrexate Therapy - CARAT-2 Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: CCX354-C
Product Code: CCX354-C
Other descriptive name: CCX354
Product Name: CCX354-C
Product Code: CCX354-C
Other descriptive name: CCX354
ChemoCentryx, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 2Czech Republic;Hungary;Belgium;Germany
8EUCTR2010-019964-36-CZ
(EUCTR)
08/09/201009/06/2010A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of CCX354-C in Subjects with Rheumatoid Arthritis Partially Responsive to Methotrexate Therapy - CARAT-2A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of CCX354-C in Subjects with Rheumatoid Arthritis Partially Responsive to Methotrexate Therapy - CARAT-2 Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: CCX354-C
Product Code: CCX354-C
Other descriptive name: CCX354
ChemoCentryx, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 2Hungary;Czech Republic;Belgium;Germany
9NCT01242917
(ClinicalTrials.gov)
September 201015/11/2010A Study to Evaluate the Safety and Efficacy of CCX354-C in Subjects With Rheumatoid Arthritis Partially Responsive to Methotrexate TherapyA Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of CCX354-C in Subjects With Rheumatoid Arthritis Partially Responsive to Methotrexate TherapyRheumatoid ArthritisDrug: CCX-354-C;Drug: Placebo;Drug: CCX354-CChemoCentryxNULLCompleted18 Years75 YearsBoth159Phase 2Belgium;Czech Republic;Germany;Hungary;Netherlands;Poland;Romania;Ukraine
10EUCTR2010-019964-36-BE
(EUCTR)
26/08/201020/05/2010A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of CCX354-C in Subjects with Rheumatoid Arthritis Partially Responsive to Methotrexate Therapy - CARAT-2A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of CCX354-C in Subjects with Rheumatoid Arthritis Partially Responsive to Methotrexate Therapy - CARAT-2 Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: CCX354-C
Product Code: CCX354-C
Other descriptive name: CCX354
ChemoCentryx, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 2Czech Republic;Hungary;Belgium;Germany
11EUCTR2010-019964-36-HU
(EUCTR)
14/07/201007/06/2010A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of CCX354-C in Subjects with Rheumatoid Arthritis Partially Responsive to Methotrexate Therapy - CARAT-2A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of CCX354-C in Subjects with Rheumatoid Arthritis Partially Responsive to Methotrexate Therapy - CARAT-2 Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: CCX354-C
Product Code: CCX354-C
Other descriptive name: CCX354
ChemoCentryx, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 2Hungary;Czech Republic;Belgium
12NCT01027728
(ClinicalTrials.gov)
December 20097/12/2009Study to Evaluate Safety and Efficacy of CCX 354-C in Subjects With Rheumatoid ArthritisA Randomized, Double-Blind, Placebo-Controlled, Phase I/II Study to Evaluate the Safety and Efficacy of CCX354-C in Subjects With Rheumatoid ArthritisRheumatoid ArthritisDrug: CCX 354-CChemoCentryxNULLCompleted18 Years75 YearsBoth24Phase 1/Phase 2Belgium;Romania
13ChiCTR-CCC-10001054
2008-01-012010-08-25Circulating Dickkopf-1 (DKK-1) is Correlated with Bone Erosion and Inflammation in Rheumatoid ArthritisCirculating Dickkopf-1 (DKK-1) is Correlated with Bone Erosion and Inflammation in Rheumatoid Arthritis ra1:none;2:Infliximab ;National Sciences Foundation of ChinaNULLCompleted2858Both1:39;2:39;China
14EUCTR2007-004694-26-BE
(EUCTR)
17/09/200710/09/2007A Comparative Study Of A 6-Month Infliximab (Remicade) Or Placebo Regimen In Undifferentiated Arthritis At High Risk For The Development Of Rheumatoid Arthritis : Clinical, Radiological (MRI) And Synovial Benefit P1200/001. - INFLIXIMAB (REMICADE) in UAA Comparative Study Of A 6-Month Infliximab (Remicade) Or Placebo Regimen In Undifferentiated Arthritis At High Risk For The Development Of Rheumatoid Arthritis : Clinical, Radiological (MRI) And Synovial Benefit P1200/001. - INFLIXIMAB (REMICADE) in UA Patient with undifferentiated arthritis and the presence of anti-CCP antibodies are at high risk to develop RA
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: Remicade
Product Name: REMICADE® (Infliximab)
Product Code: -
Saint-Luc Universitary HospitalNULLNot RecruitingFemale: yes
Male: yes
30Phase 3Belgium
15EUCTR2006-001428-38-GB
(EUCTR)
18/09/200629/09/2006Remission Induction in Very Early Rheumatoid Arthritis (RIVERA):a comparison of etanercept plus methotrexate plus steroid with standard therapy - RIVERARemission Induction in Very Early Rheumatoid Arthritis (RIVERA):a comparison of etanercept plus methotrexate plus steroid with standard therapy - RIVERA Patients with early inflamatory arthritis (duration of symptoms of < 12 weeks) who are at very high risk of the development of rheumatoid arthritis (seropositivity for Rheumatoid factor and anti-CCP antibody)Trade Name: Enbrel
Trade Name: Methorexate
Trade Name: Depo-Medrone
Trade Name: Salazopyrin En-Tabs
Trade Name: Plaquenil
University Hospitals Birmingham NHS Foundation TrustNULLNot RecruitingFemale: yes
Male: yes
20Phase 4United Kingdom
16NCT00076206
(ClinicalTrials.gov)
December 200315/1/2004Study Evaluating CCI-779 in Active Rheumatoid Arthritis on Concomitant Methotrexate TherapyA Double-Blind, Parallel, Placebo-Controlled, Randomized Study to Evaluate the Efficacy and Safety of 3 Different Oral Dose Levels (1, 2, And 4 Mg) of CCI-779 in Subjects With Active Rheumatoid Arthritis on Concomitant Methotrexate TherapyRheumatoid ArthritisDrug: CCI-779;Drug: PlaceboWyeth is now a wholly owned subsidiary of PfizerNULLTerminated18 Years75 YearsBothPhase 2United States

49. 全身性エリテマトーデス


臨床試験数 : 993 薬物数 : 702 - (DrugBank : 184) / 標的遺伝子数 : 116 - 標的パスウェイ数 : 200
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1ChiCTR2000038519
2020-10-012020-09-23A study of T lymphocyte subsets in children with systemic lupus erythematosusA study of T lymphocyte subsets in children with systemic lupus erythematosus systemic lupus erythematosus in childrenGold Standard:anti-nuclear antibodies;Index test:WBC, CD4+T cells, CD4+CCR7+CD95+T cells, CD4+CD45RA-CCR7+T cells, CD4+CD45RA-CCR7-Tcells;Tianjin Children's HospitalNULLPending817BothTarget condition:100;Difficult condition:50N/AChina
2EUCTR2016-004574-17-FR
(EUCTR)
30/11/201728/11/2018A study to measure how safe CC-220 is and how well CC-220 works in people with lupus.A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLEBLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-220 IN SUBJECTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS SYSTEMIC LUPUS ERYTHEMATOSUS
MedDRA version: 20.0;Level: LLT;Classification code 10025134;Term: Lupus erythematosus;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: CC-220
INN or Proposed INN: CC-220
Other descriptive name: CC-220
Product Code: CC-220
INN or Proposed INN: CC-220
Other descriptive name: CC-220
Product Code: CC-220
INN or Proposed INN: CC-220
Other descriptive name: CC-220
Celgene CorporationNULLNot Recruiting Female: yes
Male: yes
280 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSerbia;United States;Spain;Russian Federation;Colombia;Italy;France;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Germany
3EUCTR2016-004574-17-BE
(EUCTR)
14/11/201707/06/2017A study to measure how safe CC-220 is and how well CC-220 works in people with lupus.A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLEBLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-220 IN SUBJECTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS SYSTEMIC LUPUS ERYTHEMATOSUS
MedDRA version: 20.0;Level: LLT;Classification code 10025134;Term: Lupus erythematosus;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: CC-220
INN or Proposed INN: CC-220
Other descriptive name: CC-220
Product Code: CC-220
INN or Proposed INN: CC-220
Other descriptive name: CC-220
Product Code: CC-220
INN or Proposed INN: CC-220
Other descriptive name: CC-220
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
280Phase 2United States;Serbia;Spain;Russian Federation;Colombia;Italy;France;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Germany
4EUCTR2016-004574-17-DE
(EUCTR)
27/09/201721/04/2017A study to measure how safe CC-220 is and how well CC-220 works in people with lupus.A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLEBLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-220 IN SUBJECTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS SYSTEMIC LUPUS ERYTHEMATOSUS
MedDRA version: 20.0;Level: LLT;Classification code 10025134;Term: Lupus erythematosus;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: CC-220
INN or Proposed INN: CC-220
Other descriptive name: CC-220
Product Code: CC-220
INN or Proposed INN: CC-220
Other descriptive name: CC-220
Product Code: CC-220
INN or Proposed INN: CC-220
Other descriptive name: CC-220
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
280Phase 2United States;Serbia;Spain;Russian Federation;Colombia;Italy;France;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Germany
5NCT03161483
(ClinicalTrials.gov)
July 6, 201718/5/2017A Study to Evaluate the Efficacy and Safety of CC-220 in Subjects With Active Systemic Lupus ErythematosusA PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-220 IN SUBJECTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUSLupus Erythematosus, SystemicDrug: CC-220;Other: PlaceboCelgeneNULLActive, not recruiting18 YearsN/AAll289Phase 2United States;Argentina;Belgium;Brazil;Canada;Colombia;France;Germany;Hungary;Italy;Mexico;Poland;Russian Federation;Serbia;Spain
6EUCTR2016-004574-17-HU
(EUCTR)
19/06/201713/04/2017A study to measure how safe CC-220 is and how well CC-220 works in people with lupus.A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLEBLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-220 IN SUBJECTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS SYSTEMIC LUPUS ERYTHEMATOSUS
MedDRA version: 21.1;Level: LLT;Classification code 10025134;Term: Lupus erythematosus;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: CC-220
INN or Proposed INN: CC-220
Other descriptive name: CC-220
Product Code: CC-220
INN or Proposed INN: CC-220
Other descriptive name: CC-220
Product Code: CC-220
INN or Proposed INN: CC-220
Other descriptive name: CC-220
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
280Phase 2Serbia;United States;Spain;Russian Federation;Colombia;Italy;France;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany
7EUCTR2016-004574-17-ES
(EUCTR)
08/06/201707/04/2017A study to measure how safe CC-220 is and how well CC-220 works in people with lupus.A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLEBLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-220 IN SUBJECTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS SYSTEMIC LUPUS ERYTHEMATOSUS
MedDRA version: 19.1;Level: LLT;Classification code 10025134;Term: Lupus erythematosus;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: CC-220
INN or Proposed INN: CC-220
Other descriptive name: CC-220
Product Code: CC-220
INN or Proposed INN: CC-220
Other descriptive name: CC-220
Product Code: CC-220
INN or Proposed INN: CC-220
Other descriptive name: CC-220
Celgene CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
280Phase 2Serbia;United States;Spain;Russian Federation;Colombia;Italy;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Germany
8NCT02185040
(ClinicalTrials.gov)
September 16, 20147/7/2014A Pilot Study of CC-220 to Treat Systemic Lupus Erythematosus.A Pilot, Phase 2, Randomized, Placebo-Controlled, Double-Blind, Study To Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Pharmacogenetics of CC-220 In Subjects With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: CC-220;Drug: PlaceboCelgeneNULLCompleted18 YearsN/AAll42Phase 2United States

51. 全身性強皮症


臨床試験数 : 525 薬物数 : 565 - (DrugBank : 148) / 標的遺伝子数 : 114 - 標的パスウェイ数 : 217
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01559129
(ClinicalTrials.gov)
August 9, 201219/3/2012Study of Pomalidomide (CC-4047) to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Effectiveness for Patients With Systemic Sclerosis With Interstitial Lung DiseaseA Phase 2, Proof-Of-Concept, Multicenter, Randomized, Double-Blind, Placebo- Controlled, Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Pomalidomide (CC-4047) in Subjects With Systemic Sclerosis With Interstitial Lung DiseaseScleroderma, Systemic;Sclerosis, Systemic;Systemic Scleroderma;Systemic Sclerosis;Interstitial Lung DiseaseDrug: Pomalidomide (CC-4047);Drug: PlaceboCelgeneNULLTerminated18 Years80 YearsAll23Phase 2United States;Australia;France;Germany;Italy;Poland;Russian Federation;Spain;Switzerland;United Kingdom
2EUCTR2010-023047-15-PL
(EUCTR)
17/07/201214/05/2012A study to see if pomalidomide is safe and works to treat patients with sclerosis affecting the skin on the whole body and that also have lung diseaseA Phase 2, Proof-of-Concept, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Pomalidomide (CC-4047) In Subjects with Systemic Sclerosis with Interstitial Lung Disease systemic sclerosis associated with interstitial lung disease
MedDRA version: 16.0;Level: LLT;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: Pomalidomide
Product Code: CC-4047
INN or Proposed INN: Pomalidomide
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
88Phase 2France;United States;Spain;Poland;Australia;Russian Federation;Germany;Italy;United Kingdom;Switzerland
3EUCTR2010-023047-15-IT
(EUCTR)
20/03/201228/12/2011A study to see if pomalidomide is safe and works to treat patients with sclerosis affecting the skin on the whole body and that also have lung diseaseA Phase 2, Proof-of-Concept, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Pomalidomide (CC-4047) in Subjects with Diffuse Cutaneous Systemic Sclerosis with Interstitial Lung Disease Diffuse cutaneous systemic sclerosis with interstitial lung disease
MedDRA version: 14.1;Level: LLT;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.1;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: Pomalidomide
Product Code: CC-4047
INN or Proposed INN: Pomalidomide
Other descriptive name: Pomalidomide
CELGENE CORPORATIONNULLNot RecruitingFemale: yes
Male: yes
88Phase 2United States;Poland;Spain;Australia;Germany;United Kingdom;Italy
4EUCTR2010-023047-15-DE
(EUCTR)
15/03/201208/12/2011A study to see if pomalidomide is safe and works to treat patients with sclerosis affecting the skin on the whole body and that also have lung diseaseA Phase 2 Proof-of-Concept, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Pomalidomide (CC-4047) In Subjects with Systemic Sclerosis with Interstitial Lung Disease systemic sclerosis associated with interstitial lung disease
MedDRA version: 16.1;Level: LLT;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Imnovid 1 mg hard capsules
INN or Proposed INN: Pomalidomide
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
88Phase 2France;United States;Poland;Spain;Australia;Russian Federation;Germany;Italy;United Kingdom;Switzerland;Sweden
5EUCTR2010-023047-15-GB
(EUCTR)
08/03/201215/12/2011A study to see if pomalidomide is safe and works to treat patients with sclerosis affecting the skin on the whole body and that also have lung diseaseA Phase 2, Proof-of-Concept, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Pomalidomide (CC-4047) In Subjects with Systemic Sclerosis with Interstitial Lung Disease systemic sclerosis associated with interstitial lung disease
MedDRA version: 17.0;Level: LLT;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Imnovid 1 mg hard capsules
INN or Proposed INN: Pomalidomide
Celgene CorporationNULLNot Recruiting Female: yes
Male: yes
88 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Poland;Spain;Australia;Russian Federation;Germany;Italy;Switzerland;United Kingdom
6EUCTR2010-023047-15-ES
(EUCTR)
02/03/201219/01/2012A study to see if pomalidomide is safe and works to treat patients with sclerosis affecting the skin on the whole body and that also have lung diseaseA Phase 2, Proof-of-Concept, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Pomalidomide (CC-4047) In Subjects with Diffuse Cutaneous Systemic Sclerosis with Interstitial Lung Disease diffuse cutaneous systemic sclerosis associated with interstitial lung disease
MedDRA version: 14.1;Level: LLT;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: Pomalidomida
Product Code: CC-4047
INN or Proposed INN: Pomalidomida
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
88Phase 2France;United States;Poland;Spain;Australia;Germany;Italy;United Kingdom;Switzerland;Sweden

56. ベーチェット病


臨床試験数 : 81 薬物数 : 107 - (DrugBank : 30) / 標的遺伝子数 : 36 - 標的パスウェイ数 : 116
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2014-002108-25-GR
(EUCTR)
06/07/201608/06/2016Study to test whether apremilast is better than placebo (inactive substance in the same form as the drug) for the treatment of active Behçet’s disease (oral ulcers). This study also tests how well the body tolerates apremilast. The study is conducted in several centers in different countries. A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY, FOLLOWED BY AN ACTIVE-TREATMENT PHASE TO EVALUATE THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) IN THE TREATMENT OF SUBJECTS WITH ACTIVE BEHÇET’S DISEASE SUBJECTS WITH ACTIVE BEHÇET’S DISEASE
MedDRA version: 19.0;Level: LLT;Classification code 10004212;Term: Behcet's disease;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: APREMILAST
Other descriptive name: APREMILAST
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: APREMILAST
Other descriptive name: APREMILAST
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: APREMILAST
Other descriptive name: APREMILAST
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
204Phase 3United States;France;Greece;Turkey;Israel;Germany;Japan;Italy;Korea, Republic of
2EUCTR2014-002108-25-DE
(EUCTR)
17/06/201525/11/2014Study to test whether apremilast is better than placebo (inactive substance in the same form as the drug) for the treatment of active Behçet’s disease (oral ulcers). This study also tests how well the body tolerates apremilast. The study is conducted in several centers in different countries. A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY, FOLLOWED BY AN ACTIVE-TREATMENT PHASE TO EVALUATE THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) IN THE TREATMENT OF SUBJECTS WITH ACTIVE BEHÇET’S DISEASE SUBJECTS WITH ACTIVE BEHÇET’S DISEASE
MedDRA version: 21.1;Level: LLT;Classification code 10004212;Term: Behcet's disease;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Otezla
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: APREMILAST
Other descriptive name: APREMILAST
Trade Name: Otezla
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: APREMILAST
Other descriptive name: APREMILAST
Trade Name: Otezla
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: APREMILAST
Other descriptive name: APREMILAST
Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
204Phase 3France;United States;Greece;Turkey;Israel;Germany;Japan;Italy;Korea, Republic of
3EUCTR2014-002108-25-IT
(EUCTR)
24/02/201513/05/2015Study to test whether apremilast is better than placebo (inactive substance in the same form as the drug) for the treatment of active Behçet’s disease (oral ulcers). This study also tests how well the body tolerates apremilast. The study is conducted in several centers in different countries. A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY, FOLLOWED BY AN ACTIVE-TREATMENT PHASE TO EVALUATE THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) IN THE TREATMENT OF SUBJECTS WITH ACTIVE BEHÇET’S DISEASE - NA SUBJECTS WITH ACTIVE BEHÇET’S DISEASE
MedDRA version: 18.0;Level: LLT;Classification code 10004212;Term: Behcet's disease;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: APREMILAST
Other descriptive name: APREMILAST
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: APREMILAST
Other descriptive name: APREMILAST
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: APREMILAST
Other descriptive name: APREMILAST
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
204Phase 3United States;France;Greece;Turkey;Israel;Germany;Japan;Italy;Korea, Republic of
4NCT02307513
(ClinicalTrials.gov)
December 30, 20142/12/2014A Phase 3 Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Active Behçet's DiseaseA Phase 3, Multicenter, Randomized, Doubleblind, Placebo-controlled, Parallel Group Study, Followed by an Active-treatment Phase to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in the Treatment of Subjects With Active Behcet's DiseaseBehçet's SyndromeDrug: Apremilast;Drug: PlaceboAmgenNULLCompleted18 YearsN/AAll207Phase 3United States;France;Germany;Greece;Israel;Italy;Japan;Korea, Republic of;Lebanon;Turkey
5NCT00866359
(ClinicalTrials.gov)
August 1, 200918/3/2009A Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in the Treatment of Behçet DiseaseA Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Followed by an Active-Treatment Extension to Evaluate the Efficacy and Safety of Apremilast(CC-10004) in the Treatment of Behçet DiseaseBehcet SyndromeDrug: Apremilast (CC-10004);Drug: PlaceboAmgenNULLCompleted18 YearsN/AAll111Phase 2United States;Turkey

84. サルコイドーシス


臨床試験数 : 149 薬物数 : 202 - (DrugBank : 78) / 標的遺伝子数 : 66 - 標的パスウェイ数 : 169
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02192489
(ClinicalTrials.gov)
November 1, 201415/7/2014A Phase 2 Study With CC-220 in Skin SarcoidosisA Phase 2A, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential, Dose-Ascending Study Of CC-220 In Subjects With Chronic Cutaneous SarcoidosisSarcoidosisDrug: CC-220 0.3 mg Daily;Drug: CC-220 0.6mg Daily;Drug: PlaceboCelgeneNULLWithdrawn18 YearsN/AAll0Phase 2NULL
2NCT02134717
(ClinicalTrials.gov)
January 201430/4/2014Impact of Chemokine Receptor 5 (CCR5) Inhibition on Sarcoidosis ImmunophenotypesAn Interventional Study of the Effect of CCR5 Inhibition With Maraviroc on Immune Cells in the the Lung and in Peripheral Blood of Patients With SarcoidosisSarcoidosisDrug: all subjects will receive maraviroc 300mg orally twice a day for 6 weeks;Procedure: Bronchoscopy with bronchoalveolar lavage;Procedure: venipunctures;Procedure: Skin biopsyKevin F. GibsonUniversity of PittsburghTerminated18 Years80 YearsAll3N/AUnited States
3NCT00794274
(ClinicalTrials.gov)
November 200819/11/2008The Efficacy and Safety of CC-10004 in Chronic Cutaneous SarcoidosisThe Efficacy and Safety of CC-10004 in Chronic Cutaneous SarcoidosisSarcoidosis;Cutaneous SarcoidosisDrug: CC-100004University of CincinnatiCelgene Corporation;Medical University of South CarolinaCompleted18 Years80 YearsBoth15Phase 2/Phase 3United States

85. 特発性間質性肺炎


臨床試験数 : 627 薬物数 : 443 - (DrugBank : 120) / 標的遺伝子数 : 99 - 標的パスウェイ数 : 212
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2018-004447-23-GB
(EUCTR)
20/05/201915/03/2019Efficacy and Safety Study with Inhaled RVT-1601 for the Treatment of Persistent Cough in Patients with Idiopathic Pulmonary Fibrosis (IPF)Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study with Inhaled RVT-1601 for the Treatment of Persistent Cough in Patients with Idiopathic Pulmonary Fibrosis (IPF): SCENIC Trial - SCENIC Trial RESPIVANT RVT1601-cc-04 Persistent cough in Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 21.1;Level: LLT;Classification code 10070801;Term: Persistent cough;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Cromolyn sodium [Disodium Cromoglycate]
Product Code: RVT-1601 (formerly, PA101B)
INN or Proposed INN: SODIUM CROMOGLICATE
Other descriptive name: SODIUM CROMOGLICATE
Respivant Sciences GmbHNULLNot RecruitingFemale: yes
Male: yes
180Phase 2United States;Czech Republic;Canada;Belgium;Turkey;Australia;Netherlands;Germany;New Zealand;Italy;United Kingdom
2EUCTR2016-003473-17-GB
(EUCTR)
14/09/201724/02/2017Investigation to Efficacy and Safety of CC-90001 in patients with Idiopathic Pulmonary FibrosisA Phase 2, 24-Week Randomized, Double-blind, Placebo-ControlledMulticenter Study, With an 80-Week Active Treatment Extension, toEvaluate the Efficacy and Safety of CC-90001 in Subjects with IdiopathicPulmonary Fibrosis IDIOPATHIC PULMONARY FIBROSIS
MedDRA version: 20.0;Level: LLT;Classification code 10067761;Term: Exacerbation of idiopathic pulmonary fibrosis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: CC-90001
INN or Proposed INN: Not available
Celgene CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
210Phase 2Colombia;Russian Federation;Romania;United States;United Kingdom;Greece;Canada;Turkey;Taiwan;Brazil;Australia;France;Germany
3NCT03142191
(ClinicalTrials.gov)
July 26, 201724/4/2017A Study to Evaluate the Efficacy and Safety of CC-90001 in Subjects With Idiopathic Pulmonary FibrosisA Phase 2, 24-Week, Randomized, Double-blind, Placebo-controlled, Multicenter Study, With an 80-Week Active Treatment Extension, to Evaluate the Efficacy and Safety of CC-90001 in Subjects With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary Fibrosis;Fibrosis;Idiopathic Interstitial Pneumonias;Pathologic Processes;Lung Diseases, Interstitial;Lung Diseases;Respiratory Tract DiseasesDrug: CC-90001;Other: PlaceboCelgeneNULLCompleted40 YearsN/AAll138Phase 2United States;Australia;Brazil;Canada;Colombia;Germany;Greece;Romania;Russian Federation;Taiwan;Turkey;Ukraine;United Kingdom;China
4EUCTR2016-003473-17-GR
(EUCTR)
05/05/201702/03/2017Investigation to Efficacy and Safety of CC-90001 in patients with Idiopathic Pulmonary FibrosisA Phase 2, 24-Week Randomized, Double-blind, Placebo-Controlled Multicenter Study, With an 80-Week Active Treatment Extension, to Evaluate the Efficacy and Safety of CC-90001 in Subjects with Idiopathic Pulmonary Fibrosis IDIOPATHIC PULMONARY FIBROSIS
MedDRA version: 20.0;Level: LLT;Classification code 10067761;Term: Exacerbation of idiopathic pulmonary fibrosis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: CC-90001Celgene CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
135Phase 2United States;Taiwan;Greece;Turkey;Russian Federation;Colombia;United Kingdom;France;Canada;Brazil;Romania;Australia;Germany
5NCT01203943
(ClinicalTrials.gov)
January 1, 201115/9/2010A Study to Characterize the Safety, PK and Biological Activity of CC-930 in Idiopathic Pulmonary Fibrosis (IPF)A Phase 2 Sequential, Ascending Dose Study to Characterize the Safety, Tolerability, Pharmacokinetic and Biological Activity of CC-930 in Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary Fibrosis;Pulmonary Fibrosis;Fibrosis;Interstitial Lung Disease;Lung Diseases, InterstitialDrug: CC-930;Other: PlaceboCelgeneNULLTerminated50 YearsN/AAll28Phase 2United States;Canada
6NCT01135199
(ClinicalTrials.gov)
June 201028/5/2010Pomalidomide for Cough in Patients With Idiopathic Pulmonary FibrosisSafety and Efficacy of Pomalidomide in the Treatment of Refractory Cough in Patients With Idiopathic Pulmonary Fibrosis (IPF): A Pilot StudyPulmonary FibrosisDrug: pomalidomide (CC-4047Stanford UniversityCelgene CorporationWithdrawn18 YearsN/ABoth0Phase 2United States
7EUCTR2006-002174-22-DE
(EUCTR)
08/11/200623/08/2006Influence of inhaled Aviptadil on CCL18 serum concentrations in patients with pulmonary fibrosis - Inhaled Aviptadil in pulmonary fibrosisInfluence of inhaled Aviptadil on CCL18 serum concentrations in patients with pulmonary fibrosis - Inhaled Aviptadil in pulmonary fibrosis Pulmonary Fibrosis categorized as UIP or NSIPProduct Name: Aviptadil, 66 microgram/mL
Other descriptive name: Vasoactive intestinal peptide
Mondobiotech Laboratories AnstaltNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Germany

96. クローン病


臨床試験数 : 2,442 薬物数 : 1,278 - (DrugBank : 248) / 標的遺伝子数 : 142 - 標的パスウェイ数 : 209
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01611805
(ClinicalTrials.gov)
July 22, 201012/4/2012Japanese Phase I of GSK1605786A Placebo-Controlled, Four-Period Crossover, Single Ascending Oral Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of the CCR9 Receptor Antagonist GSK1605786 in Japanese Healthy Male SubjectCrohn's DiseaseDrug: GSK1605786;Drug: GSK1605786 PlaceboGlaxoSmithKlineNULLCompleted20 Years55 YearsMale30Phase 1Australia
2NCT01114607
(ClinicalTrials.gov)
May 5, 201029/4/2010A Study to Assess the Relative Bioavailability of Four New Formulations of GSK1605786 in Healthy SubjectsA Single Dose, Randomized, Five-Period Crossover Study to Assess the Relative Bioavailability of Four New Formulations of the CCR9 Receptor Antagonist GSK1605786A (CCX282) in Healthy Male and Female SubjectsCrohn's DiseaseDrug: GSK1605786 ChemoCentryx: formulation A;Drug: GSK1605786 GSK: formulation B;Drug: GSK1605786 GSK direct-fill: formulation C;Drug: GSK1605786 GSK modified-process: formulation D;Drug: GSK1605786 GSK tablet: formulation EGlaxoSmithKlineNULLCompleted18 Years55 YearsAll24Phase 1United States
3EUCTR2005-003827-38-AT
(EUCTR)
15/10/200715/10/2007A Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s DiseaseA Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s Disease Subjects will be enrolled suffering from active, moderate to severe Crohn´s disease with a history of small or large bowel disease, with or without colonic disease. Their screening Crohn´s Disease Activity Index (CDAI) shall be between 250 and 450 inclusive and their fasting serum CRP concentration shall be above 7.5 mg/L.Product Name: CCX282-B
Product Code: CCX282-B
ChemoCentryx, IncNULLNot RecruitingFemale: yes
Male: yes
400Hungary;Czech Republic;United Kingdom;Belgium;Denmark;France;Bulgaria;Austria;Sweden
4EUCTR2005-003827-38-FR
(EUCTR)
20/09/200723/07/2007A Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s DiseaseA Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s Disease Subjects will be enrolled suffering from active, moderate to severe Crohn´s disease with a history of small or large bowel disease, with or without colonic disease. Their screening Crohn´s Disease Activity Index (CDAI) shall be between 250 and 450 inclusive and their fasting serum CRP concentration shall be above 7.5 mg/L.Product Name: CCX282-B
Product Code: CCX282-B
ChemoCentryx, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Hungary;Czech Republic;United Kingdom;Belgium;Denmark;Bulgaria;France;Austria;Sweden
5EUCTR2005-003827-38-BE
(EUCTR)
19/09/200726/07/2007A Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s DiseaseA Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s Disease Subjects will be enrolled suffering from active, moderate to severe Crohn´s disease with a history of small or large bowel disease, with or without colonic disease. Their screening Crohn´s Disease Activity Index (CDAI) shall be between 250 and 450 inclusive and their fasting serum CRP concentration shall be above 7.5 mg/L.Product Name: CCX282-B
Product Code: CCX282-B
ChemoCentryx, IncNULLNot RecruitingFemale: yes
Male: yes
400Hungary;Czech Republic;United Kingdom;Denmark;Belgium;France;Bulgaria;Austria;Sweden
6EUCTR2005-003827-38-SE
(EUCTR)
19/09/200711/07/2007A Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s DiseaseA Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s Disease Subjects will be enrolled suffering from active, moderate to severe Crohn´s disease with a history of small or large bowel disease, with or without colonic disease. Their screening Crohn´s Disease Activity Index (CDAI) shall be between 250 and 450 inclusive and their fasting serum CRP concentration shall be above 7.5 mg/L.Product Name: CCX282-B
Product Code: CCX282-B
ChemoCentryx, IncNULLNot RecruitingFemale: yes
Male: yes
400Hungary;Czech Republic;United Kingdom;Belgium;Denmark;France;Bulgaria;Austria;Sweden
7EUCTR2005-003827-38-DE
(EUCTR)
15/03/200714/12/2006A Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s DiseaseA Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s Disease Subjects will be enrolled suffering from active, moderate to severe Crohn´s disease with a history of small bowel disease, with or without colonic disease. Their screening Crohn´s Disease Activity Index (CDAI) shall be between 250 and 450 inclusive and their fasting serum CRP concentration shall be above 7.5 mg/L.Product Name: CCX282-B
Product Code: CCX282-B
ChemoCentryx, IncNULLNot RecruitingFemale: yes
Male: yes
400France;Hungary;Czech Republic;Belgium;Austria;Denmark;Bulgaria;Germany;United Kingdom;Sweden
8EUCTR2005-003827-38-HU
(EUCTR)
13/03/200722/12/2006A Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s DiseaseA Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s Disease Subjects will be enrolled suffering from active, moderate to severe Crohn´s disease with a history of small bowel disease, with or without colonic disease. Their screening Crohn´s Disease Activity Index (CDAI) shall be between 250 and 450 inclusive and their fasting serum CRP concentration shall be above 7.5 mg/L.Product Name: CCX282-B
Product Code: CCX282-B
ChemoCentryx, IncNULLNot RecruitingFemale: yes
Male: yes
423Hungary;Czech Republic;United Kingdom;Belgium;Denmark;France;Bulgaria;Austria;Sweden
9EUCTR2005-003827-38-BG
(EUCTR)
09/03/200701/03/2007A Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s DiseaseA Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s Disease Subjects will be enrolled suffering from active, moderate to severe Crohn´s disease with a history of small bowel disease, with or without colonic disease. Their screening Crohn´s Disease Activity Index (CDAI) shall be between 250 and 450 inclusive and their fasting serum CRP concentration shall be above 7.5 mg/L.
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: CCX282-B
Product Code: CCX282-B
ChemoCentryx, IncNULLNot RecruitingFemale: yes
Male: yes
336Hungary;Czech Republic;United Kingdom;Belgium;Denmark;France;Bulgaria;Austria;Sweden
10EUCTR2005-003827-38-GB
(EUCTR)
02/05/200618/11/2005A Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s DiseaseA Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s Disease Subjects will be enrolled suffering from active, moderate to severe Crohn´s disease with a history of small or large bowel disease, with or without colonic disease. Their screening Crohn´s Disease Activity Index (CDAI) shall be between 250 and 450 inclusive and their fasting serum CRP concentration shall be above 7.5 mg/L.Product Name: CCX282-B
Product Code: CCX282-B
ChemoCentryx, IncNULLNot Recruiting Female: yes
Male: yes
598 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;Hungary;Czech Republic;Belgium;Austria;Denmark;Bulgaria;Germany;United Kingdom;Sweden
11NCT00306215
(ClinicalTrials.gov)
March 200621/3/2006A Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects With Moderate to Severe Crohn's DiseaseA Multinational, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects With Moderate to Severe Crohn's DiseaseCrohn's DiseaseDrug: CCX282-BChemoCentryxNULLCompleted18 YearsN/ABoth436Phase 2Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Czech Republic;Denmark;France;Germany;Hungary;Israel;Netherlands;Poland;South Africa;Sweden;United Kingdom
12EUCTR2005-003827-38-DK
(EUCTR)
27/02/200607/12/2005A Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s DiseaseA Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s Disease Subjects will be enrolled suffering from active, moderate to severe Crohn´s disease with a history of small or large bowel disease, with or without colonic disease. Their screening Crohn´s Disease Activity Index (CDAI) shall be between 250 and 450 inclusive and their fasting serum CRP concentration shall be above 7.5 mg/L.Product Name: CCX282-B
Product Code: CCX282-B
ChemoCentryx, IncNULLNot RecruitingFemale: yes
Male: yes
598Hungary;Czech Republic;United Kingdom;Belgium;Denmark;France;Bulgaria;Austria;Sweden
13EUCTR2005-003827-38-CZ
(EUCTR)
20/02/200615/12/2005A Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s DiseaseA Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s Disease Subjects will be enrolled suffering from active, moderate to severe Crohn´s disease with a history of small or large bowel disease, with or without colonic disease. Their screening Crohn´s Disease Activity Index (CDAI) shall be between 250 and 450 inclusive and their fasting serum CRP concentration shall be above 7.5 mg/L.Product Name: CCX282-B
Product Code: CCX282-B
ChemoCentryx, IncNULLNot RecruitingFemale: yes
Male: yes
400Hungary;United Kingdom;Czech Republic;Belgium;Denmark;France;Bulgaria;Austria;Sweden
14NCT00102921
(ClinicalTrials.gov)
August 20044/2/2005Safety and Activity Study of an Oral Medication to Treat Moderate to Severe Crohn’s DiseasePilot, Double-Blind, Placebo-Controlled, Parallel Group Study of the Safety Clinical Activity of CCX282-B in Patients With Moderate to Severe Crohn’s DiseaseCrohn DiseaseDrug: CCX282-BChemoCentryxNULLCompleted18 Years65 YearsBoth70Phase 2United States
15NCT00446433
(ClinicalTrials.gov)
March 20027/3/2007A Study to Evaluate CC-5013 in the Treatment of Adolescents and Adults With Moderately Severe Crohn's DiseaseA Multicenter, Randomized, Double-Blind, Placebo-Controlled,Parallel-Group Study to Evaluate the Safety and Efficacy of CC-5013 in the Treatment of Adolescents and Adults With Moderately Severe Crohn's DiseaseCrohn's DiseaseDrug: CC-5013Celgene CorporationNULLCompleted12 Years75 YearsBoth90Phase 2United States;France;Israel;United Kingdom

97. 潰瘍性大腸炎


臨床試験数 : 2,630 薬物数 : 1,459 - (DrugBank : 265) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1ChiCTR2000033953
2020-07-012020-06-18Effect of the probiotic on symptoms in patients with ulcerative colitis (UC)Effect of the probiotic on symptoms in patients with ulcerative colitis (UC) Ulcerative colitisPlacebo group:Maltodextrin;experimental group 1:Lactobacillus plantarum CCFM8610;experimental group 2:Lactobacillus plantarum N13;experimental group 3:Lactobacillus casei CCFM1059;Jiangnan UniversityNULLPendingBothPlacebo group:20;experimental group 1:20;experimental group 2:20;experimental group 3:20;China
2EUCTR2014-002981-64-BG
(EUCTR)
20/01/201625/09/2015Clinical trial that will compare the efficacy and safety of apremilast versus placebo, in patients with active ulcerative colitis, a chronic inflammatory of the colon of unknown originA PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) FOR TREATMENT OF SUBJECTS WITH ACTIVE ULCERATIVE COLITIS Subjects with active ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: APREMILAST
Other descriptive name: APREMILAST
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: APREMILAST
Other descriptive name: APREMILAST
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: APREMILAST
Other descriptive name: APREMILAST
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
165Phase 2United States;Slovakia;Ukraine;Russian Federation;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany;Netherlands;New Zealand
3EUCTR2014-002981-64-NL
(EUCTR)
12/10/201519/05/2015Clinical trial that will compare the efficacy and safety of apremilast versus placebo, in patients with active ulcerative colitis, a chronic inflammatory of the colon of unknown originA PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) FOR TREATMENT OF SUBJECTS WITH ACTIVE ULCERATIVE COLITIS Subjects with active ulcerative colitis
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: APREMILAST
Other descriptive name: APREMILAST
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: APREMILAST
Other descriptive name: APREMILAST
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: APREMILAST
Other descriptive name: APREMILAST
Celgene CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
165Phase 2United States;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Netherlands;Germany;New Zealand
4EUCTR2014-002981-64-DE
(EUCTR)
29/09/201508/06/2015Clinical trial that will compare the efficacy and safety of apremilast versus placebo, in patients with active ulcerative colitis, a chronic inflammatory of the colon of unknown originA PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) FOR TREATMENT OF SUBJECTS WITH ACTIVE ULCERATIVE COLITIS Subjects with active ulcerative colitis
MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: APREMILAST
Other descriptive name: APREMILAST
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: APREMILAST
Other descriptive name: APREMILAST
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: APREMILAST
Other descriptive name: APREMILAST
Celgene CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
165Phase 2United States;Slovakia;Ukraine;Russian Federation;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany;Netherlands;New Zealand
5EUCTR2014-002981-64-HU
(EUCTR)
14/09/201527/05/2015Clinical trial that will compare the efficacy and safety of apremilast versus placebo, in patients with active ulcerative colitis, a chronic inflammatory of the colon of unknown originA PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) FOR TREATMENT OF SUBJECTS WITH ACTIVE ULCERATIVE COLITIS Subjects with active ulcerative colitis
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: APREMILAST
Other descriptive name: APREMILAST
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: APREMILAST
Other descriptive name: APREMILAST
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: APREMILAST
Other descriptive name: APREMILAST
Celgene CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
165Phase 2United States;Slovakia;Ukraine;Turkey;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Poland;Australia;Bulgaria;Netherlands;Germany;New Zealand
6EUCTR2014-002981-64-IT
(EUCTR)
20/08/201505/11/2020Clinical trial that will compare the efficacy and safety of apremilast versus placebo, in patients with active ulcerative colitis, a chronic inflammatory of the colon of unknown originA Phase 2, randomized, placebo-controlled, multicenter study to investigate the efficacy and safety of apremilast (CC-10004) for treatment of subjects with active ulcerative colitis - na Subjects with active ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: APREMILAST
Other descriptive name: APREMILAST
Product Name: Apremilast
Product Code: [CC-10004]
INN or Proposed INN: Apremilast
Other descriptive name: APREMILAST
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: APREMILAST
Other descriptive name: APREMILAST
CELGENE CORPORATIONNULLNot RecruitingFemale: yes
Male: yes
165Phase 2United States;Czechia;Slovakia;Spain;Ukraine;Turkey;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany;Netherlands;New Zealand
7EUCTR2014-002981-64-CZ
(EUCTR)
13/08/201505/05/2015Clinical trial that will compare the efficacy and safety of apremilast versus placebo, in patients with active ulcerative colitis, a chronic inflammatory of the colon of unknown originA PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) FOR TREATMENT OF SUBJECTS WITH ACTIVE ULCERATIVE COLITIS Subjects with active ulcerative colitis
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: APREMILAST
Other descriptive name: APREMILAST
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: APREMILAST
Other descriptive name: APREMILAST
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: APREMILAST
Other descriptive name: APREMILAST
Celgene CorporationNULLNot Recruiting Female: yes
Male: yes
165 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Slovakia;Ukraine;Russian Federation;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany;Netherlands;New Zealand
8NCT02289417
(ClinicalTrials.gov)
January 8, 201510/11/2014Efficacy and Safety Study of Apremilast to Treat Active Ulcerative ColitisA Phase 2, Randomized, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of Apremilast (CC-10004) for Treatment of Subjects With Active Ulcerative ColitisUlcerative ColitisDrug: Apremilast;Drug: PlaceboAmgenNULLCompleted18 YearsN/AAll170Phase 2United States;Australia;Bulgaria;Canada;Czechia;France;Germany;Hungary;Italy;Netherlands;New Zealand;Poland;Russian Federation;Ukraine;Czech Republic
9NCT01434576
(ClinicalTrials.gov)
December 20111/9/2011Study to Evaluate the Pharmacodynamics and Safety of HGS1025 in Patients With Ulcerative ColitisA Phase 1b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Pharmacodynamics and Safety of HGS1025, a Human Monoclonal Anti-CCR5 Antibody, in Subjects With Ulcerative ColitisUlcerative ColitisBiological: HGS1025;Drug: PlaceboHuman Genome Sciences Inc.NULLWithdrawn18 YearsN/ABoth0Phase 1NULL

98. 好酸球性消化管疾患


臨床試験数 : 172 薬物数 : 149 - (DrugBank : 39) / 標的遺伝子数 : 38 - 標的パスウェイ数 : 135
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-jRCT2031210574
28/07/202222/01/2022A PHASE 3, MULTICENTER, MULTINATIONAL, OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY OF CC-93538 IN ADULT AND ADOLESCENT SUBJECTS WITH EOSINOPHILIC ESOPHAGITISA PHASE 3, MULTICENTER, MULTINATIONAL, OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY OF CC-93538 IN ADULT AND ADOLESCENT SUBJECTS WITH EOSINOPHILIC ESOPHAGITIS eosinophilic esophagitisAll subjects will be administered CC-93538 at a dose of
360 mg SC once weekly.
Zhang ChangliangNULLPending>= 12age old<= 75age oldBoth22Phase 3Belgium;Australia;Argentina;Japan;United States of America;Canada;United Kingdom;Italy;Israel;Portugal;Germany;Switzerland;Poland;Spain;Austria
2EUCTR2020-004335-24-ES
(EUCTR)
17/05/202224/03/2022A study to evaluate the long-term safety of CC-93538 in adult and adolescent patients who have eosinophilic esophagitisA PHASE 3, MULTICENTER, MULTINATIONAL, OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY OF CC-93538 IN ADULT AND ADOLESCENT SUBJECTS WITH EOSINOPHILIC ESOPHAGITIS EOSINOPHILIC ESOPHAGITIS
MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Product Name: Cendakimab
Product Code: CC-93538
INN or Proposed INN: Cendakimab
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
259Phase 3United States;Portugal;Spain;Austria;Israel;Switzerland;United Kingdom;Italy;Canada;Argentina;Belgium;Poland;Australia;Germany;Japan
3EUCTR2020-004335-24-PL
(EUCTR)
24/03/202209/12/2021A study to evaluate the long-term safety of CC-93538 in adult and adolescent patients who have eosinophilic esophagitisA PHASE 3, MULTICENTER, MULTINATIONAL, OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY OF CC-93538 IN ADULT AND ADOLESCENT SUBJECTS WITH EOSINOPHILIC ESOPHAGITIS EOSINOPHILIC ESOPHAGITIS
MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Product Name: Cendakimab
Product Code: CC-93538
INN or Proposed INN: Cendakimab
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
269Phase 3Portugal;United States;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;Canada;Argentina;Poland;Belgium;Australia;Germany;Japan
4NCT05214768
(ClinicalTrials.gov)
March 4, 202212/1/2022A Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Japanese Participants With Eosinophilic GastroenteritisA Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Induction and Maintenance Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Japanese Subjects With Eosinophilic GastroenteritisEosinophilic GastroenteritisDrug: CC-93538;Drug: PlaceboCelgeneNULLRecruiting12 Years75 YearsAll45Phase 3Japan
5JPRN-jRCT2021210067
04/03/202202/02/2022A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLEBLIND,PLACEBO-CONTROLLED INDUCTION AND MAINTENANCE STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-93538 IN ADULT AND ADOLESCENT JAPANESE SUBJECTS WITH EOSINOPHILIC GASTROENTERITISA PHASE 3, MULTICENTER, RANDOMIZED, DOUBLEBLIND,PLACEBO-CONTROLLED INDUCTION AND MAINTENANCE STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-93538 IN ADULT AND ADOLESCENT JAPANESE SUBJECTS WITH EOSINOPHILIC GASTROENTERITIS Eosinophilic gastroenteritisCC-93538 is administered subcutaneously at a dose of 360 mg weekly in adults and adolescents of 12 years of age or older.After 16 weeks after the initial administration,a dose of 360 mg is administered subcutaneously weekly or bi-weekly.During the OLE phase,360 mg will be administered subcutaneously weekly.Zhang ChangliangNULLRecruiting>= 12age old<= 75age oldBoth45Phase 3Japan
6EUCTR2020-004335-24-PT
(EUCTR)
24/02/202203/12/2021A study to evaluate the long-term safety of CC-93538 in adult and adolescent patients who have eosinophilic esophagitisA PHASE 3, MULTICENTER, MULTINATIONAL, OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY OF CC-93538 IN ADULT AND ADOLESCENT SUBJECTS WITH EOSINOPHILIC ESOPHAGITIS EOSINOPHILIC ESOPHAGITIS
MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Product Name: Cendakimab
Product Code: CC-93538
INN or Proposed INN: Cendakimab
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
259Phase 3United States;Portugal;Spain;Austria;Israel;United Kingdom;Italy;Switzerland;Canada;Argentina;Belgium;Poland;Australia;Germany;Japan
7EUCTR2020-004335-24-IT
(EUCTR)
08/02/202229/10/2021A study to evaluate the long-term safety of CC-93538 in adult and adolescent patients who have eosinophilic esophagitisA Phase 3, Multicenter, Multinational, Open-Label Extension Study to evaluate the Long-Term Safety of CC-93538 in adult and adolescent subjects with Eosinophilic Esophagitis - - EOSINOPHILIC ESOPHAGITIS
MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Trade Name: Cendakimab
Product Name: Cendakimab
Product Code: [CC-93538]
INN or Proposed INN: Cendakimab
CELGENE INTERNATIONAL II SàRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
259Phase 3United States;Portugal;Spain;Austria;Israel;United Kingdom;Italy;Switzerland;Canada;Argentina;Belgium;Poland;Australia;Germany;Japan
8EUCTR2020-004335-24-DE
(EUCTR)
14/01/202230/07/2021A study to evaluate the long-term safety of CC-93538 in adult and adolescent patients who have eosinophilic esophagitisA PHASE 3, MULTICENTER, MULTINATIONAL, OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY OF CC-93538 IN ADULT AND ADOLESCENT SUBJECTS WITH EOSINOPHILIC ESOPHAGITIS EOSINOPHILIC ESOPHAGITIS
MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Product Name: Cendakimab
Product Code: CC-93538
INN or Proposed INN: Cendakimab
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
259Phase 3United States;Portugal;Spain;Austria;Israel;United Kingdom;Italy;Switzerland;Canada;Argentina;Belgium;Poland;Australia;Germany;Japan
9EUCTR2020-004336-16-ES
(EUCTR)
12/01/202212/01/2022A study to evaluate the efficacy and safety of CC-93538 in adult and adolescent patients who have eosinophilic esophagitisA Phase 3, Multi-Center, Multi-National, Randomized, Double-Blind, Placebo-Controlled Induction and Maintenance Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Subjects with Eosinophilic Esophagitis EOSINOPHILIC ESOPHAGITIS
MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Product Name: Cendakimab
Product Code: CC-93538
INN or Proposed INN: Cendakimab
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
399Phase 3United States;Portugal;Czechia;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;Canada;Argentina;Belgium;Poland;Australia;Germany;Japan;New Zealand
10EUCTR2020-004336-16-DE
(EUCTR)
29/09/202101/02/2021A study to evaluate the efficacy and safety of CC-93538 in adult and adolescent patients who have eosinophilic esophagitisA Phase 3, Multi-Center, Multi-National, Randomized, Double-Blind, Placebo-Controlled Induction and Maintenance Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Subjects with Eosinophilic Esophagitis EOSINOPHILIC ESOPHAGITIS
MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Product Name: Cendakimab
Product Code: CC-93538
INN or Proposed INN: Cendakimab
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
399Phase 3United States;Portugal;Czechia;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;Canada;Argentina;Belgium;Poland;Australia;Germany;Japan;New Zealand
11EUCTR2020-004336-16-PT
(EUCTR)
24/09/202101/04/2021A study to evaluate the efficacy and safety of CC-93538 in adult and adolescent patients who have eosinophilic esophagitisA Phase 3, Multi-Center, Multi-National, Randomized, Double-Blind, Placebo-Controlled Induction and Maintenance Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Subjects with Eosinophilic Esophagitis EOSINOPHILIC ESOPHAGITIS
MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Product Name: Cendakimab
Product Code: CC-93538
INN or Proposed INN: Cendakimab
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
399Phase 3United States;Portugal;Czechia;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;Canada;Argentina;Belgium;Poland;Australia;Germany;Japan;New Zealand
12NCT04991935
(ClinicalTrials.gov)
September 14, 202128/7/2021Safety Study of CC-93538 in Adult and Adolescent Participants With Eosinophilic EsophagitisA Phase 3, Multicenter, Multinational, Open-Label Extension Study to Evaluate the Long-Term Safety of CC-93538 in Adult and Adolescent Subjects With Eosinophilic EsophagitisEosinophilic EsophagitisDrug: CC-93538CelgeneNULLRecruiting12 Years75 YearsAll259Phase 3United States;Argentina;Australia;Austria;Belgium;Canada;Germany;Israel;Italy;Japan;Poland;Portugal;Spain;Switzerland;United Kingdom
13EUCTR2020-004336-16-AT
(EUCTR)
01/08/202122/03/2021A study to evaluate the efficacy and safety of CC-93538 in adult and adolescent patients who have eosinophilic esophagitisA Phase 3, Multi-Center, Multi-National, Randomized, Double-Blind, Placebo-Controlled Induction and Maintenance Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Subjects with Eosinophilic Esophagitis EOSINOPHILIC ESOPHAGITIS
MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Product Name: Cendakimab
Product Code: CC-93538
INN or Proposed INN: Cendakimab
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
399Phase 3Switzerland;Italy;Canada;Argentina;Belgium;Poland;Australia;Germany;Japan;New Zealand;United Kingdom;United States;Portugal;Czechia;Spain;Austria;Israel
14EUCTR2020-004336-16-PL
(EUCTR)
21/07/202112/05/2021A study to evaluate the efficacy and safety of CC-93538 in adult and adolescent patients who have eosinophilic esophagitisA Phase 3, Multi-Center, Multi-National, Randomized, Double-Blind, Placebo-Controlled Induction and Maintenance Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Subjects with Eosinophilic Esophagitis EOSINOPHILIC ESOPHAGITIS
MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Product Name: Cendakimab
Product Code: CC-93538
INN or Proposed INN: Cendakimab
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
399Phase 3Portugal;United States;Czechia;Spain;Austria;Israel;United Kingdom;Italy;Switzerland;Canada;Argentina;Belgium;Poland;Australia;Germany;Japan;New Zealand
15JPRN-jRCT2051200140
01/07/202119/02/2021A Phase 3, Multicenter, Multinational, Randomized, Double-Blind, Placebo-Controlled Induction and Maintenance Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Subjects with Eosinophilic EsophagitisA Phase 3, Multicenter, Multinational, Randomized, Double-Blind, Placebo-Controlled Induction and Maintenance Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Subjects with Eosinophilic Esophagitis Eosinophilic esophagitisCC-93538 is administered subcutaneously at a dose of 360 mg weekly in adults and adolescent 12 years of age or older. After 24 weeks after the initial dose, a dose of 360 mg is administered subcutaneously weekly or biweekly.Zhang ChangliangNULLRecruiting>= 12age old<= 75age oldBoth33Phase 3United States of America;Canada;UK;Italy;Israel;Portugal;Germany;Switzerland;Poland;Spain;Austria;Belgium;Australia;Argentina;Japan
16EUCTR2020-004336-16-IT
(EUCTR)
17/06/202108/06/2021A study to evaluate the efficacy and safety of CC-93538 in adult and adolescent patients who have eosinophilic esophagitisA phase 3, multicenter, multinational, randomized, double-blind, placebo-controlled induction and maintenance study to evaluate the efficacy and safety of CC-93538 in adult and adolescent subjects with eosinophilic esophagitis - - EOSINOPHILIC ESOPHAGITIS
MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Product Name: Cendakimab
Product Code: [CC-93538]
INN or Proposed INN: Cendakimab
CELGENE INTERNATIONAL II SàRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
399Phase 3United States;Portugal;Czechia;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;Canada;Argentina;Belgium;Poland;Australia;Germany;Japan;New Zealand
17NCT04753697
(ClinicalTrials.gov)
February 22, 20215/2/2021A Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Participants With Eosinophilic EsophagitisA Multi-Center, Multi-National, Randomized, Double-Blind, Placebo-Controlled Induction and Long-term Controlled Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Subjects With Active Eosinophilic Esophagitis.Eosinophilic EsophagitisDrug: CC-93538;Other: PlaceboCelgeneNULLRecruiting12 Years75 YearsAll399Phase 3United States;Argentina;Australia;Austria;Belgium;Canada;Germany;Israel;Italy;Japan;Poland;Portugal;Spain;Switzerland;United Kingdom;Puerto Rico
18EUCTR2020-004336-16-BE
(EUCTR)
07/05/2021A study to evaluate the efficacy and safety of CC-93538 in adult and adolescent patients who have eosinophilic esophagitisA Phase 3, Multi-Center, Multi-National, Randomized, Double-Blind, Placebo-Controlled Induction and Maintenance Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Subjects with Eosinophilic Esophagitis EOSINOPHILIC ESOPHAGITIS
MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Product Name: Cendakimab
Product Code: CC-93538
INN or Proposed INN: Cendakimab
Celgene International II SàrlNULLNAFemale: yes
Male: yes
399Phase 3United States;Portugal;Czechia;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;Canada;Argentina;Belgium;Poland;Australia;Germany;Japan;New Zealand
19EUCTR2020-004335-24-AT
(EUCTR)
18/11/2021A study to evaluate the long-term safety of CC-93538 in adult and adolescent patients who have eosinophilic esophagitisA PHASE 3, MULTICENTER, MULTINATIONAL, OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY OF CC-93538 IN ADULT AND ADOLESCENT SUBJECTS WITH EOSINOPHILIC ESOPHAGITIS EOSINOPHILIC ESOPHAGITIS
MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Product Name: Cendakimab
Product Code: CC-93538
INN or Proposed INN: Cendakimab
Celgene International II SàrlNULLNAFemale: yes
Male: yes
259Phase 3United States;Portugal;Spain;Austria;Israel;United Kingdom;Italy;Switzerland;Canada;Argentina;Belgium;Poland;Australia;Germany;Japan
20EUCTR2020-004335-24-BE
(EUCTR)
24/12/2021A study to evaluate the long-term safety of CC-93538 in adult and adolescent patients who have eosinophilic esophagitisA PHASE 3, MULTICENTER, MULTINATIONAL, OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY OF CC-93538 IN ADULT AND ADOLESCENT SUBJECTS WITH EOSINOPHILIC ESOPHAGITIS EOSINOPHILIC ESOPHAGITIS
MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Product Name: Cendakimab
Product Code: CC-93538
INN or Proposed INN: Cendakimab
Celgene International II SàrlNULLNAFemale: yes
Male: yes
259Phase 3Portugal;Spain;Austria;Israel;United Kingdom;Italy;United States;Switzerland;Canada;Argentina;Belgium;Poland;Australia;Germany;Japan

162. 類天疱瘡(後天性表皮水疱症を含む。)


臨床試験数 : 90 薬物数 : 122 - (DrugBank : 47) / 標的遺伝子数 : 34 - 標的パスウェイ数 : 144
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2018-002564-10-NL
(EUCTR)
23/04/201923/04/2019PDE4 inhibitor (apremilast) in pemphigoid.Short-term safety, efficacy and mode of action of apremilast in mild to moderate cutaneous pemphigoid: a phase IIa open label single arm study. - SAMP trial Pemphigoid;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]Trade Name: Otezla
Product Name: Apremilast
Product Code: CC-10004
Universitair Medisch Centrum GroningenNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
10 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noNetherlands

202. スミス・マギニス症候群


臨床試験数 : 9 薬物数 : 10 - (DrugBank : 5) / 標的遺伝子数 : 4 - 標的パスウェイ数 : 7
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT00506259
(ClinicalTrials.gov)
July 17, 200721/7/2007Treatment Strategies for Children With Smith-Magenis SyndromeA Phase One Treatment Trial of the Circadian Sleep Disturbance in Smith-Magenis Syndrome (SMS)Developmental Delay Disorders;Chromosome Deletion;Mental Retardation;Sleep Disorders, Circadian Rhythm;Self Injurious BehaviorDrug: dTR Melatonin (NIH CC PDS);Device: Phototherapy (Bright Light);Drug: Melatonin CRNational Human Genome Research Institute (NHGRI)NULLCompleted3 Years45 YearsAll23Phase 1United States

271. 強直性脊椎炎


臨床試験数 : 574 薬物数 : 359 - (DrugBank : 68) / 標的遺伝子数 : 41 - 標的パスウェイ数 : 146
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-004108-37-CZ
(EUCTR)
14/10/202109/03/2021A study to determine how effective and safe the drug CC-99677 is for patients with active Ankylosing SpondylitisA Phase 2 Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of CC-99677 in Subjects with Active Ankylosing Spondylitis Ankylosing Spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: CC-99677 60mg Capsule
INN or Proposed INN: 146368
Other descriptive name: CC-99677
Product Code: CC-99677 30mg Capsule
INN or Proposed INN: 146368
Other descriptive name: CC-99677
Celgene CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
256Phase 2United States;Czechia;Czech Republic;Canada;Spain;Poland;Turkey;Romania;Russian Federation;Germany
2EUCTR2019-004108-37-PL
(EUCTR)
13/09/202101/04/2021A study to determine how effective and safe the drug CC-99677 is for patients with active Ankylosing SpondylitisA Phase 2 Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of CC-99677 in Subjects with Active Ankylosing Spondylitis Ankylosing Spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: CC-99677 60mg Capsule
INN or Proposed INN: 146368
Other descriptive name: CC-99677
Product Code: CC-99677 30mg Capsule
INN or Proposed INN: 146368
Other descriptive name: CC-99677
Celgene CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
256Phase 2United States;Czechia;Czech Republic;Canada;Spain;Poland;Turkey;Romania;Russian Federation;Germany
3NCT04947579
(ClinicalTrials.gov)
August 25, 202123/6/2021A Study of CC-99677 in Participants With Active Ankylosing SpondylitisA Phase 2 Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of CC-99677 in Subjects With Active Ankylosing SpondylitisSpondylitis, AnkylosingDrug: CC-99677;Other: PlaceboCelgeneNULLTerminated18 Years65 YearsAll167Phase 2United States;China;Czechia;Germany;Poland;Romania;Spain;Turkey;Canada;Russian Federation
4EUCTR2019-004108-37-DE
(EUCTR)
09/07/202118/02/2021A study to determine how effective and safe the drug CC-99677 is for patients with active Ankylosing SpondylitisA Phase 2 Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of CC-99677 in Subjects with Active Ankylosing Spondylitis Ankylosing Spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: CC-99677 60mg Capsule
INN or Proposed INN: 146368
Other descriptive name: CC-99677
Product Code: CC-99677 30mg Capsule
INN or Proposed INN: 146368
Other descriptive name: CC-99677
Celgene CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
256Phase 2United States;Czechia;Czech Republic;Canada;Spain;Poland;Turkey;Romania;Russian Federation;Germany
5EUCTR2011-001555-37-EE
(EUCTR)
19/04/201319/03/2013Phase 3 study to evaluate safety and effectiveness of oral Apremilast (CC-10004) in patients with ankylosing spondylitisA phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of apremilast (CC-10004) in the treatment of active ankylosing spondylitis Ankylosing spondylitis (AS)
MedDRA version: 18.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Celgene CorporationNULLNot Recruiting Female: yes
Male: yes
456 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Estonia;Slovakia;Spain;Austria;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;South Africa;Bulgaria;Netherlands;Germany;Sweden
6EUCTR2011-001555-37-NL
(EUCTR)
05/12/201215/05/2012Phase 3 study to evaluate safety and effectiveness of oral Apremilast (CC-10004) in patients with ankylosing spondylitisA phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of apremilast (CC-10004) in the treatment of active ankylosing spondylitis Ankylosing spondylitis (AS)
MedDRA version: 14.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Celgene CorporationNULLNot Recruiting Female: yes
Male: yes
456 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Estonia;Slovakia;Spain;Austria;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;South Africa;Bulgaria;Germany;Netherlands;Sweden
7EUCTR2011-001555-37-BG
(EUCTR)
14/11/201214/08/2012Phase 3 study to evaluate safety and effectiveness of oral Apremilast (CC-10004) in patients with ankylosing spondylitisA phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of apremilast (CC-10004) in the treatment of active ankylosing spondylitis Ankylosing spondylitis (AS)
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Celgene CorporationNULLNot Recruiting Female: yes
Male: yes
456 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Estonia;Slovakia;Spain;Austria;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;Bulgaria;South Africa;Netherlands;Germany;Sweden
8EUCTR2011-001555-37-DE
(EUCTR)
20/09/201208/05/2012Phase 3 study to evaluate safety and effectiveness of oral Apremilast (CC-10004) in patients with ankylosing spondylitisA phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of apremilast (CC-10004) in the treatment of active ankylosing spondylitis Ankylosing spondylitis (AS)
MedDRA version: 18.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Celgene CorporationNULLNot Recruiting Female: yes
Male: yes
456 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Estonia;Slovakia;Spain;Austria;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;South Africa;Bulgaria;Netherlands;Germany;Sweden
9EUCTR2011-001555-37-GB
(EUCTR)
04/09/201216/04/2012Phase 3 study to evaluate safety and effectiveness of oral Apremilast (CC-10004) in patients with ankylosing spondylitisA phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of apremilast (CC-10004) in the treatment of active ankylosing spondylitis Ankylosing spondylitis (AS)
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Celgene CorporationNULLNot Recruiting Female: yes
Male: yes
456 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Estonia;Slovakia;Spain;Austria;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;South Africa;Bulgaria;Netherlands;Germany;Sweden
10EUCTR2011-001555-37-CZ
(EUCTR)
14/08/201230/05/2012Phase 3 study to evaluate safety and effectiveness of oral Apremilast (CC-10004) in patients with ankylosing spondylitisA phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of apremilast (CC-10004) in the treatment of active ankylosing spondylitis Ankylosing spondylitis (AS)
MedDRA version: 19.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
456Phase 3United States;Estonia;Slovakia;Spain;Austria;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;South Africa;Bulgaria;Netherlands;Germany;Sweden
11EUCTR2011-001555-37-SE
(EUCTR)
09/08/201229/05/2012Phase 3 study to evaluate safety and effectiveness of oral Apremilast (CC-10004) in patients with ankylosing spondylitisA phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of apremilast (CC-10004) in the treatment of active ankylosing spondylitis Ankylosing spondylitis (AS)
MedDRA version: 19.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Celgene CorporationNULLNot Recruiting Female: yes
Male: yes
456 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Estonia;Slovakia;Spain;Austria;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;South Africa;Bulgaria;Netherlands;Germany;Sweden
12EUCTR2011-001555-37-SK
(EUCTR)
31/07/201215/05/2012Phase 3 study to evaluate safety and effectiveness of oral Apremilast (CC-10004) in patients with ankylosing spondylitisA phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of apremilast (CC-10004) in the treatment of active ankylosing spondylitis Ankylosing spondylitis (AS)
MedDRA version: 14.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Celgene CorporationNULLNot Recruiting Female: yes
Male: yes
456 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Estonia;Slovakia;Spain;Austria;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;South Africa;Bulgaria;Netherlands;Germany;Sweden
13EUCTR2011-001555-37-ES
(EUCTR)
23/07/201228/05/2012Phase 3 study to evaluate safety and effectiveness of oral Apremilast (CC-10004) in patients with ankylosing spondylitisA phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of apremilast (CC-10004) in the treatment of active ankylosing spondylitis Ankylosing spondylitis (AS)
MedDRA version: 14.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Celgene CorporationNULLNot Recruiting Female: yes
Male: yes
456 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Estonia;Slovakia;Spain;Austria;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;South Africa;Bulgaria;Netherlands;Germany;Sweden
14EUCTR2011-001555-37-AT
(EUCTR)
03/07/201230/05/2012Phase 3 study to evaluate safety and effectiveness of oral Apremilast (CC-10004) in patients with ankylosing spondylitisA phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of apremilast (CC-10004) in the treatment of active ankylosing spondylitis Ankylosing spondylitis (AS)
MedDRA version: 19.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
456Phase 3United States;Estonia;Slovakia;Spain;Austria;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;South Africa;Bulgaria;Netherlands;Germany;Sweden
15EUCTR2011-001555-37-PL
(EUCTR)
30/06/201229/05/2012Phase 3 study to evaluate safety and effectiveness of oral Apremilast (CC-10004) in patients with ankylosing spondylitisA phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of apremilast (CC-10004) in the treatment of active ankylosing spondylitis Ankylosing spondylitis (AS)
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Celgene CorporationNULLNot Recruiting Female: yes
Male: yes
456 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Estonia;Slovakia;Spain;Austria;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;South Africa;Bulgaria;Netherlands;Germany;Sweden
16EUCTR2011-001555-37-HU
(EUCTR)
13/06/201202/05/2012Phase 3 study to evaluate safety and effectiveness of oral Apremilast (CC-10004) in patients with ankylosing spondylitisA phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of apremilast (CC-10004) in the treatment of active ankylosing spondylitis Ankylosing spondylitis (AS)
MedDRA version: 14.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
456Phase 3United States;Estonia;Slovakia;Spain;Austria;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Romania;Australia;South Africa;Bulgaria;Netherlands;Germany;Sweden
17EUCTR2011-001555-37-FR
(EUCTR)
06/06/201223/08/2012Phase 3 study to evaluate safety and effectiveness of oral Apremilast (CC-10004) in patients with ankylosing spondylitisA phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of apremilast (CC-10004) in the treatment of active ankylosing spondylitis Ankylosing spondylitis (AS)
MedDRA version: 14.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Celgene CorporationNULLNot Recruiting Female: yes
Male: yes
456 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Estonia;Slovakia;Spain;Austria;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;South Africa;Bulgaria;Netherlands;Germany;Sweden
18NCT01583374
(ClinicalTrials.gov)
May 2, 201220/4/2012Study of Apremilast to Treat Subjects With Active Ankylosing SpondylitisA PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) IN THE TREATMENT OF ACTIVE ANKYLOSING SPONDYLITISAnkylosing SpondyloarthritisDrug: Apremilast tablet 20 mg;Drug: Apremilast tablet 30 mg BID;Drug: PlaceboAmgenNULLCompleted18 YearsN/AAll490Phase 3United States;Australia;Austria;Bulgaria;Canada;Czechia;Estonia;France;Germany;Hungary;Netherlands;Poland;Romania;Russian Federation;Slovakia;Spain;Sweden;United Kingdom;Czech Republic
19NCT00944658
(ClinicalTrials.gov)
August 200920/7/2009Spondylitis Trial of Apremilast for Better Rheumatic TherapyRandomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004)in the Treatment of Ankylosing Spondylitis (AS)Ankylosing SpondylitisDrug: Apremilast;Drug: Placebo (sugar pill)Imperial College LondonCelgene CorporationCompleted18 YearsN/AAll38Phase 2United Kingdom
20EUCTR2008-004229-40-GB
(EUCTR)
09/03/200922/11/2010Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in the Treatment of Ankylosing Spondylitis (AS) - START - Spondylitis Trial of Apremilast for better Rheumatic TherapyRandomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in the Treatment of Ankylosing Spondylitis (AS) - START - Spondylitis Trial of Apremilast for better Rheumatic Therapy Ankylosing Spondylitis
MedDRA version: 9.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Imperial College LondonNULLNot RecruitingFemale: yes
Male: yes
United Kingdom