TBC ( DrugBank: - )


3 diseases
告示番号疾患名(ページ内リンク)臨床試験数
85特発性間質性肺炎1
94原発性硬化性胆管炎2
96クローン病1

85. 特発性間質性肺炎


臨床試験数 : 598 薬物数 : 435 - (DrugBank : 116) / 標的遺伝子数 : 100 - 標的パスウェイ数 : 210
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2017-004919-39-DE
(EUCTR)
20/11/201816/07/2018A study to test the safety, tolerability, biological activity, and pharmacokinetics of the drug ND-L02-s0201 compared with a placebo in patients with Idiopathic Pulmonary Fibrosis (IPF)A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Biological Activity, and PK of ND-L02-s0201 in Subjects with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: ND-L02-s0201 for injection
INN or Proposed INN: TBC
Nitto Denko CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 2Japan;United Kingdom;Germany;United States

94. 原発性硬化性胆管炎


臨床試験数 : 142 薬物数 : 113 - (DrugBank : 37) / 標的遺伝子数 : 19 - 標的パスウェイ数 : 139
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-002945-39-ES
(EUCTR)
20/01/202219/10/2021A study to look at how well study drug CM-101 works in people with disease of the liver and gallbladder characterized by inflammation and scarring of the bile ductsA Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Clinical Trial Evaluating the Safety and Efficacy of CM-101 in Subjects with Primary Sclerosing Cholangitis - The SPRING study Primary Sclerosing Cholangitis
MedDRA version: 20.1;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: CM-101
Product Code: CM-101
INN or Proposed INN: TBC
Other descriptive name: Humanised IgG1 monoclonal antibody against human eotaxin-2
ChemomAb LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
45Phase 2Spain;Israel;United Kingdom
2EUCTR2019-002945-39-GB
(EUCTR)
15/04/202014/11/2019A study to look at how well study drug CM-101 works in people with disease of the liver and gallbladder characterized by inflammation and scarring of the bile ductsA Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Clinical Trial Evaluating the Safety and Efficacy of CM-101 in Subjects with Primary Sclerosing Cholangitis - The SPRING study Primary Sclerosing Cholangitis
MedDRA version: 20.1;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: CM-101
Product Code: CM-101
INN or Proposed INN: TBC
Other descriptive name: Humanised IgG1 monoclonal antibody against human eotaxin-2
ChemomAb LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
45Phase 2Israel;United Kingdom

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 : 170 - 標的パスウェイ数 : 215
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-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