V565 ( DrugBank: - )


2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
96クローン病10
97潰瘍性大腸炎1

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
1EUCTR2016-002939-15-NL
(EUCTR)
18/04/201722/02/2017A clinical study testing the efficacy and safety of V565 in patients with Crohn's Disease A Phase 2 study to investigate the efficacy, safety, and tolerability of six weeks treatment with V565 in subjects with active Crohn’s disease. - A six week efficacy, safety and tolerability study of V565 in Crohn's disease (the HarbOR study). Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: V565
Product Code: V565
INN or Proposed INN: not applied for
Other descriptive name: V565
VHsquared LtdNULLNot Recruiting Female: yes
Male: yes
126 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Serbia;Slovakia;Ukraine;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Netherlands;Germany;Norway
2EUCTR2016-002939-15-DE
(EUCTR)
05/04/201702/11/2016A clinical study testing the efficacy and safety of V565 in patients with Crohn's Disease A Phase 2 study to investigate the efficacy, safety, and tolerability of six weeks treatment with V565 in subjects with active Crohn’s disease. - A six week efficacy, safety and tolerability study of V565 in Crohn's disease (the HarbOR study). Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: V565
Product Code: V565
INN or Proposed INN: not applied for
Other descriptive name: V565
VHsquared LtdNULLNot Recruiting Female: yes
Male: yes
126 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noNorway;Netherlands;Germany;Poland;Belgium;Canada;Hungary;Czech Republic;United Kingdom;Austria;Ukraine;Slovakia;United States
3EUCTR2016-002939-15-HU
(EUCTR)
29/03/201706/01/2017A clinical study testing the efficacy and safety of V565 in patients with Crohn's Disease A Phase 2 study to investigate the efficacy, safety, and tolerability of six weeks treatment with V565 in subjects with active Crohn’s disease. - A six week efficacy, safety and tolerability study of V565 in Crohn's disease (the HarbOR study). Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: V565
Product Code: V565
INN or Proposed INN: not applied for
Other descriptive name: V565
VHsquared LtdNULLNot Recruiting Female: yes
Male: yes
126 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Serbia;Slovakia;Ukraine;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Germany;Netherlands;Norway
4EUCTR2016-002939-15-NO
(EUCTR)
09/03/201720/03/2019A clinical study testing the efficacy and safety of V565 in patients with Crohn's Disease A Phase 2 study to investigate the efficacy, safety, and tolerability of six weeks treatment with V565 in subjects with active Crohn’s disease. - A six week efficacy, safety and tolerability study of V565 in Crohn's disease (the HarbOR study). Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: V565
Product Code: V565
INN or Proposed INN: not applied for
Other descriptive name: V565
VHsquared LtdNULLNot Recruiting Female: yes
Male: yes
126 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Serbia;Slovakia;Ukraine;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Norway;Germany;Netherlands
5EUCTR2016-002939-15-SK
(EUCTR)
16/02/201712/01/2017A clinical study testing the efficacy and safety of V565 in patients with Crohn's Disease A Phase 2 study to investigate the efficacy, safety, and tolerability of six weeks treatment with V565 in subjects with active Crohn’s disease. - A six week efficacy, safety and tolerability study of V565 in Crohn's disease (the HarbOR study). Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: V565
Product Code: V565
INN or Proposed INN: not applied for
Other descriptive name: V565
VHsquared LtdNULLNot Recruiting Female: yes
Male: yes
126 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Slovakia;Ukraine;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands;Norway
6EUCTR2016-002939-15-AT
(EUCTR)
07/02/201705/01/2017A clinical study testing the efficacy and safety of V565 in patients with Crohn's Disease A Phase 2 study to investigate the efficacy, safety, and tolerability of six weeks treatment with V565 in subjects with active Crohn’s disease. - A six week efficacy, safety and tolerability study of V565 in Crohn's disease (the HarbOR study). Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: V565
Product Code: V565
INN or Proposed INN: not applied for
Other descriptive name: V565
VHsquared LtdNULLNot Recruiting Female: yes
Male: yes
126 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Serbia;Slovakia;Ukraine;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Germany;Netherlands;Norway
7EUCTR2016-002939-15-CZ
(EUCTR)
24/01/201701/11/2016A clinical study testing the efficacy and safety of V565 in patients with Crohn's Disease.A Phase 2 study to investigate the efficacy, safety, and tolerability of six weeks treatment with V565 in subjects with active Crohn’s disease. - English A six week efficacy, safety and tolerability study of V565 in Crohn’s disease (HarbOR study) Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: V565
Product Code: V565
INN or Proposed INN: not applied for
Other descriptive name: V565
VHsquared LtdNULLNot RecruitingFemale: yes
Male: yes
126Phase 2United States;Slovakia;Ukraine;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands;Norway
8EUCTR2016-002939-15-GB
(EUCTR)
19/01/201724/07/2020A clinical study testing the efficacy and safety of V565 in patients with Crohn's DiseaseA Phase 2 study to investigate the efficacy, safety, and tolerability of six weeks treatment with V565 in subjects with active Crohn’s disease. - A six week efficacy, safety and tolerability study of V565 in Crohn's disease (the HarbOR study). Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: V565
Product Code: V565
INN or Proposed INN: not applied for
Other descriptive name: V565
VHsquared LtdNULLNot RecruitingFemale: yes
Male: yes
126Phase 2United States;Slovakia;Ukraine;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands;Norway
9NCT02976129
(ClinicalTrials.gov)
December 201623/11/2016A Six Week Efficacy, Safety and Tolerability Study of V565 in Crohn's DiseasePhase 2 Study to Investigate the Efficacy, Safety, and Tolerability of Six Weeks Treatment With V565 in Subjects With Active Crohn's DiseaseCrohn's DiseaseDrug: V565;Drug: PlaceboVHsquared Ltd.NULLUnknown status18 Years80 YearsAll126Phase 2United States;Austria;Canada;Czechia;Germany;Hungary;Netherlands;Norway;Poland;Serbia;Slovakia;Ukraine;United Kingdom;Czech Republic
10NCT03010787
(ClinicalTrials.gov)
September 201512/12/2016A First Time in Human Study in Healthy Volunteers and PatientsA Four Part, Phase 1, First Time in Human, Single Centre Study in Healthy Male Subjects, Patient Volunteers With Crohn's Disease and in Healthy Patient Volunteers With a Terminal IleostomyCrohn's DiseaseDrug: V565;Drug: PlaceboVHsquared Ltd.NULLCompleted18 Years65 YearsAll47Phase 1United Kingdom

97. 潰瘍性大腸炎


臨床試験数 : 2,527 薬物数 : 1,465 - (DrugBank : 259) / 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
1NCT03705117
(ClinicalTrials.gov)
May 23, 20179/10/2018Open-label V565 Target Engagement StudyAn Open-label Exploratory Study in Patient Volunteers With Ulcerative Colitis (UC), to Investigate Lamina Propria Presence and Evidence of Biological Effect of the Oral Domain Antibody V565Ulcerative ColitisBiological: V565VHsquared Ltd.NULLCompleted18 Years75 YearsAll5Phase 1United Kingdom