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 |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2016-002939-15-NL (EUCTR) | 18/04/2017 | 22/02/2017 | A 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] | VHsquared Ltd | NULL | Not Recruiting | Female: yes Male: yes | 126 | Phase 2 | United States;Serbia;Slovakia;Ukraine;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Netherlands;Germany;Norway | |||
| 2 | EUCTR2016-002939-15-DE (EUCTR) | 05/04/2017 | 02/11/2016 | A 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] | VHsquared Ltd | NULL | Not Recruiting | Female: yes Male: yes | 126 | Phase 2 | United States;Slovakia;Ukraine;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands;Norway | |||
| 3 | EUCTR2016-002939-15-HU (EUCTR) | 29/03/2017 | 06/01/2017 | A 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] | VHsquared Ltd | NULL | Not Recruiting | Female: yes Male: yes | 126 | Phase 2 | United States;Serbia;Slovakia;Ukraine;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Germany;Netherlands;Norway | |||
| 4 | EUCTR2016-002939-15-NO (EUCTR) | 09/03/2017 | 20/03/2019 | A 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] | VHsquared Ltd | NULL | Not Recruiting | Female: yes Male: yes | 126 | Phase 2 | United States;Serbia;Slovakia;Ukraine;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Norway;Germany;Netherlands | |||
| 5 | EUCTR2016-002939-15-SK (EUCTR) | 16/02/2017 | 12/01/2017 | A 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] | VHsquared Ltd | NULL | Not Recruiting | Female: yes Male: yes | 126 | Phase 2 | United States;Slovakia;Ukraine;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands;Norway | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | EUCTR2016-002939-15-AT (EUCTR) | 07/02/2017 | 05/01/2017 | A 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] | VHsquared Ltd | NULL | Not Recruiting | Female: yes Male: yes | 126 | Phase 2 | United States;Serbia;Slovakia;Ukraine;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Germany;Netherlands;Norway | |||
| 7 | EUCTR2016-002939-15-CZ (EUCTR) | 24/01/2017 | 01/11/2016 | A 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 126 | Phase 2 | United States;Slovakia;Ukraine;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands;Norway | ||
| 8 | EUCTR2016-002939-15-GB (EUCTR) | 19/01/2017 | 24/07/2020 | A 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 126 | Phase 2 | United States;Slovakia;Ukraine;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands;Norway | ||
| 9 | NCT02976129 (ClinicalTrials.gov) | December 2016 | 23/11/2016 | A Six Week Efficacy, Safety and Tolerability Study of V565 in Crohn's Disease | Phase 2 Study to Investigate the Efficacy, Safety, and Tolerability of Six Weeks Treatment With V565 in Subjects With Active Crohn's Disease | Crohn's Disease | Drug: V565;Drug: Placebo | VHsquared Ltd. | NULL | Unknown status | 18 Years | 80 Years | All | 126 | Phase 2 | United States;Austria;Canada;Czechia;Germany;Hungary;Netherlands;Norway;Poland;Serbia;Slovakia;Ukraine;United Kingdom;Czech Republic |
| 10 | NCT03010787 (ClinicalTrials.gov) | September 2015 | 12/12/2016 | A First Time in Human Study in Healthy Volunteers and Patients | A 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 Ileostomy | Crohn's Disease | Drug: V565;Drug: Placebo | VHsquared Ltd. | NULL | Completed | 18 Years | 65 Years | All | 47 | Phase 1 | United Kingdom |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT03705117 (ClinicalTrials.gov) | May 23, 2017 | 9/10/2018 | Open-label V565 Target Engagement Study | An 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 V565 | Ulcerative Colitis | Biological: V565 | VHsquared Ltd. | NULL | Completed | 18 Years | 75 Years | All | 5 | Phase 1 | United Kingdom |