Trials / Completed
CompletedNCT02976129
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 125 (actual)
- Sponsor
- VHsquared Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the efficacy and safety of V565 in participants with active Crohn's Disease (CD).
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | V565 | Daily dosing of V565 three times a day orally for 6 weeks |
| DRUG | Placebo | Daily dosing of placebo three times a day orally for 6 weeks |
Timeline
- Start date
- 2016-12-01
- Primary completion
- 2019-03-08
- Completion
- 2019-03-08
- First posted
- 2016-11-29
- Last updated
- 2021-12-22
- Results posted
- 2021-12-22
Locations
94 sites across 13 countries: United States, Austria, Canada, Czechia, Germany, Hungary, Netherlands, Norway, Poland, Serbia, Slovakia, Ukraine, United Kingdom
Source: ClinicalTrials.gov record NCT02976129. Inclusion in this directory is not an endorsement.