JNJ-40346527 ( DrugBank: JNJ-40346527 )


2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
46悪性関節リウマチ5
96クローン病6

46. 悪性関節リウマチ


臨床試験数 : 4,325 薬物数 : 2,671 - (DrugBank : 417) / 標的遺伝子数 : 185 - 標的パスウェイ数 : 223
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2011-004529-28-CZ
(EUCTR)
25/07/201203/04/2012A Study of the Efect of JNJ-40346527 and Placebo in Patients with Active Rheumatoid ArthritisA Phase 2a, Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Study of JNJ-40346527 in Subjects with Active Rheumatoid Arthritis Despite Disease-modifying Antirheumatic Drug Therapy - not available Rheumatoid Arthritis
MedDRA version: 15.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: JNJ-40346527-AAC - capsule - 50 mg
Product Code: JNJ-40346527
INN or Proposed INN: Not assigned
Other descriptive name: Not assigned
Janssen-Cilag International NVNULLNot RecruitingFemale: yes
Male: yes
90Phase 2Hungary;Czech Republic;Argentina;Poland;Malaysia;Bulgaria;Chile;Russian Federation;Korea, Republic of
2NCT01597739
(ClinicalTrials.gov)
July 201210/5/2012A Study of JNJ-40346527 in Patients With Active Rheumatoid Arthritis Despite Disease-modifying Antirheumatic Drug TherapyA Phase 2a, Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Study of JNJ-40346527 in Subjects With Active Rheumatoid Arthritis Despite Disease-modifying Antirheumatic Drug TherapyArthritis, RheumatoidDrug: JNJ-40346527;Drug: PlaceboJanssen Research & Development, LLCNULLCompleted18 Years80 YearsBoth96Phase 2Argentina;Bulgaria;Chile;Czech Republic;Hungary;Korea, Republic of;Poland;Russian Federation;Singapore;Ukraine
3EUCTR2011-004529-28-BG
(EUCTR)
01/06/201207/05/2012A Study of the Efect of JNJ-40346527 and Placebo in Patients with Active Rheumatoid ArthritisA Phase 2a, Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Study of JNJ-40346527 in Subjects with Active Rheumatoid Arthritis Despite Disease-modifying Antirheumatic Drug Therapy - not available Rheumatoid Arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: JNJ-40346527-AAC - capsule - 50 mg
Product Code: JNJ-40346527
INN or Proposed INN: Not assigned
Other descriptive name: Not assigned
Janssen-Cilag International NVNULLNot RecruitingFemale: yes
Male: yes
90Phase 2Hungary;Poland;Bulgaria
4EUCTR2011-004529-28-PL
(EUCTR)
14/05/201228/03/2012A Study of the Efect of JNJ-40346527 and Placebo in Patients with Active Rheumatoid ArthritisA Phase 2a, Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Study of JNJ-40346527 in Subjects with Active Rheumatoid Arthritis Despite Disease-modifying Antirheumatic Drug Therapy - not available Rheumatoid Arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: JNJ-40346527-AAC - capsule - 50 mg
Product Code: JNJ-40346527
INN or Proposed INN: Not assigned
Other descriptive name: Not assigned
Janssen-Cilag International NVNULLNot RecruitingFemale: yes
Male: yes
90Phase 2Hungary;Poland;Bulgaria
5EUCTR2011-004529-28-HU
(EUCTR)
18/04/201201/03/2012A Study of the Efect of JNJ-40346527 and Placebo in Patients with Active Rheumatoid ArthritisA Phase 2a, Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Study of JNJ-40346527 in Subjects with Active Rheumatoid Arthritis Despite Disease-modifying Antirheumatic Drug Therapy - not available Rheumatoid Arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: JNJ-40346527-AAC - capsule - 50 mg
Product Code: JNJ-40346527
INN or Proposed INN: Not assigned
Other descriptive name: Not assigned
Janssen-Cilag International NVNULLNot RecruitingFemale: yes
Male: yes
90Phase 2Czech Republic;Hungary;Argentina;Poland;Ukraine;Singapore;Chile;Bulgaria;Russian Federation;Korea, Republic of

96. クローン病


臨床試験数 : 2,400 薬物数 : 1,391 - (DrugBank : 267) / 標的遺伝子数 : 168 - 標的パスウェイ数 : 214
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2017-003017-25-PL
(EUCTR)
23/03/201819/12/2017Clinical Study to Evaluate the Efficacy and Safety of PRV-6527 an Inhibitor of Colony Stimulating Factor-1 Receptor, in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Efficacy and Safety of Oral PRV-6527 (JNJ-40346527), an Inhibitor of Colony Stimulating Factor-1 Receptor, in Subjects with Moderately to Severely Active Crohn’s Disease - PRovention INvestigation in Crohn’s DiseasE (PRINCE) Moderately to Severely Active Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856
MedDRA version: 22.1;Classification code 10011403;Term: Crohn's disease aggravated;System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: JNJ-40346527-AAC
Product Code: PRV-6527 (JNJ-40346527)
Other descriptive name: JNJ-40346527-AAC
Provention Bio, Inc.NULLNot RecruitingFemale: yes
Male: yes
90Phase 2Hungary;Spain;Poland;Ukraine;Austria;Russian Federation;Germany
2NCT03854305
(ClinicalTrials.gov)
March 20, 201823/2/2019Phase 2a Study of PRV-6527 in Subjects With Moderately to Severely Active Crohn's DiseasePhase 2a Multicenter Randomized Double-Blind Placebo-Controlled Parallel Study to Evaluate the Efficacy and Safety of Oral PRV-6527 (JNJ-40346527), an Inhibitor of CSF-1 Receptor, in Subjects With Moderately to Severely Active Crohn'sCrohn's DiseaseDrug: PRV-6527;Drug: PlaceboProvention Bio, Inc.NULLCompleted18 Years75 YearsAll93Phase 2Austria;Germany;Hungary;Poland;Russian Federation;Spain;Ukraine
3EUCTR2017-003017-25-DE
(EUCTR)
20/03/201822/02/2018Clinical Study to Evaluation the Efficacy and Safety of PRV-6527 an Inhibitor of Colony Stimulating Factor-1 Receptor, in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Efficacy and Safety of Oral PRV-6527 (JNJ-40346527), an Inhibitor of Colony Stimulating Factor-1 Receptor, in Subjects with Moderately to Severely Active Crohn’s Disease - PRovention INvestigation in Crohn’s DiseasE (PRINCE) Moderately to severely Active Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10011403;Term: Crohn's disease aggravated;System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: JNJ-40346527-AAC
Product Code: PRV-6527 (JNJ-40346527)
Other descriptive name: JNJ-40346527-AAC
Provention Bio, Inc.NULLNot Recruiting Female: yes
Male: yes
90 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noHungary;Poland;Spain;Ukraine;Austria;Russian Federation;Germany
4EUCTR2017-003017-25-ES
(EUCTR)
14/03/201815/12/2017Clinical Study to Evaluate the Efficacy and Safety of PRV-6527, an Inhibitor of Colony Stimulating Factor-1 Receptor, in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Efficacy and Safety of Oral PRV-6527 (JNJ-40346527), an Inhibitor of Colony Stimulating Factor-1 Receptor, in Subjects with Moderately to Severely Active Crohn’s Disease - PRovention INvestigation in Crohn’s DiseasE (PRINCE) Moderately to severely Active Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10011403;Term: Crohn's disease aggravated;System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: JNJ-40346527-AAC
Product Code: PRV-6527 (JNJ-40346527)
INN or Proposed INN: TBC
Other descriptive name: JNJ-40346527-AAC
Provention Bio, Inc.NULLNot Recruiting Female: yes
Male: yes
90 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noHungary;Poland;Spain;Ukraine;Austria;Russian Federation;Germany
5EUCTR2017-003017-25-AT
(EUCTR)
06/02/201811/12/2017Clinical Study to Evaluation the Efficacy and Safety of PRV-6527 an Inhibitor of Colony Stimulating Factor-1 Receptor, in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Efficacy and Safety of Oral PRV-6527 (JNJ-40346527), an Inhibitor of Colony Stimulating Factor-1 Receptor, in Subjects with Moderately to Severely Active Crohn’s Disease - PRovention INvestigation in Crohn’s DiseasE (PRINCE) Moderately to severely Active Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10011403;Term: Crohn's disease aggravated;System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: JNJ-40346527-AAC
Product Code: PRV-6527 (JNJ-40346527)
Other descriptive name: JNJ-40346527-AAC
Provention Bio, Inc.NULLNot Recruiting Female: yes
Male: yes
90 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noHungary;Poland;Spain;Ukraine;Austria;Russian Federation;Germany
6EUCTR2017-003017-25-HU
(EUCTR)
08/01/201813/11/2017Clinical Study to Evaluation the Efficacy and Safety of PRV-6527 an Inhibitor of Colony Stimulating Factor-1 Receptor, in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Efficacy and Safety of Oral PRV-6527 (JNJ-40346527), an Inhibitor of Colony Stimulating Factor-1 Receptor, in Subjects with Moderately to Severely Active Crohn’s Disease - PRovention INvestigation in Crohn’s DiseasE (PRINCE) Moderately to severely Active Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10011403;Term: Crohn's disease aggravated;System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: JNJ-40346527-AAC
Product Code: PRV-6527(JNJ-40346527)
Other descriptive name: JNJ-40346527-AAC
Provention Bio, Inc.NULLNot Recruiting Female: yes
Male: yes
90 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noHungary;Poland;Spain;Ukraine;Austria;Russian Federation;Germany