A Six Week Efficacy, Safety and Tolerability Study of V565 in Crohn's Disease (HarbOR)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02976129|
Recruitment Status : Unknown
Verified October 2018 by VHsquared Ltd..
Recruitment status was: Recruiting
First Posted : November 29, 2016
Last Update Posted : October 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Crohn's Disease||Drug: V565 Drug: Placebo||Phase 2|
This study will be a multiple-site, double-blind, placebo-controlled, parallel-group study in approximately 126 subjects with a confirmed diagnosis of CD for at least three months and have CD involving the ileum and/or colon. Following a screening period of up to 28 days, subjects will be randomly allocated into one of two treatment arms: either V565 or placebo using a 2:1 active:placebo ratio for a treatment period of 6 weeks.
Subjects will be treated with study drug as an add-on to any permitted stable medications already being taken for CD.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||126 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Phase 2 Study to Investigate the Efficacy, Safety, and Tolerability of Six Weeks Treatment With V565 in Subjects With Active Crohn's Disease|
|Study Start Date :||December 2016|
|Estimated Primary Completion Date :||December 2018|
V565 TID PO for 6 weeks
Daily dosing of V565 three times a day orally for 6 weeks
Placebo Comparator: Placebo
Placebo TID PO for 6 weeks
Daily dosing of placebo three times a day orally for 6 weeks
- CDAI and Inflammatory Markers [ Time Frame: Day 42 ]Proportion of responders at Day 42
- Change from baseline in PRO-2 [ Time Frame: Day 42 ]
- Changes in endoscopic appearance [ Time Frame: Day 42 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02976129
|Contact: VHsquared Information||+44 (0)1223 firstname.lastname@example.org|
|Study Director:||Suhail Nurbhai, MBChB MRCP||VHsquared Ltd.|