Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years - 80 Years|
Inclusion Criteria:- History of Crohn's Disease of at least 3 months duration prior to screening - CDAI score of ≥220 to ≤450 during screening - CRP ≥5 mg/L (or, if CRP is normal, FCP ≥250 µg/g) at screening - Permitted CD medication regimen expected to remain stable during the period of the study
Exclusion Criteria:- Previous lack of response or current contra-indication to an anti-TNFα agent - Certain complications of Crohn's Disease that would make it hard to assess response to study drug - Known history or suspicion of IBD other than Crohn's disease - History of TB or latent TB infection that has not been treated - Any significant illness or condition which would preclude effective participation in the study - GI infection as demonstrated by presence of enteric pathogens - Pregnant or lactating women - Abdominal surgery in the previous 6 months - Unsuitable for inclusion in the study in the opinion of the investigator or sponsor for any reason that may compromise the subject's safety or confound data interpretation
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Suhail Nurbhai, MBChB MRCP|
|Principal Investigator Affiliation||VHsquared Ltd.|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Countries||Austria, Canada, Czechia, Germany, Hungary, Netherlands, Norway, Poland, Serbia, Slovakia, Ukraine, United Kingdom, United States|
The disease, disorder, syndrome, illness, or injury that is being studied.
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.
V565 TID PO for 6 weeks
Placebo Comparator: Placebo
Placebo TID PO for 6 weeks
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
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.