A Six Week Efficacy, Safety and Tolerability Study of V565 in Crohn's Disease
Completed · Phase 2 · Has a placebo group
Conditions studied: Crohn's Disease
In brief
The purpose of this study is to evaluate the efficacy and safety of V565 in participants with active Crohn's Disease (CD).
Key facts
- Study ID
- NCT02976129
- Run by
- VHsquared Ltd.
- People needed
- 125
- Starts
- 2016-12-01
- Expected to finish
- 2019-03-08
- Last updated by the study team
- 2021-12-22
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- History of Crohn's Disease of at least 3 months duration prior to screening
- Crohn's Disease Activity Index (CDAI) score of ≥220 to ≤450 during screening
- C-reactive protein (CRP) ≥5 mg/L (or, if CRP is normal, faecal calprotectin (FCP) ≥250 µg/g) at screening
- Permitted CD medication regimen expected to remain stable during the period of the study
You may not qualify if…
- Previous lack of response or current contra-indication to an anti-tumour necrosis factor α (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 inflammatory bowel disease other than Crohn's disease
- History of tuberculosis (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
Where it is running
- West Central Gastroenterology — Clearwater, Florida, United States
- Clinical Research of West Florida — Clearwater, Florida, United States
- Galiz Research, LLC — Miami Springs, Florida, United States
- Northwestern University — Evanston, Illinois, United States
- Clinical Trials of America — Mount Airy, North Carolina, United States
- Klinikum Klagenfurt am Wörtersee — Klagenfurt, Austria
- LKH - Universitatsklinikum — Salzburg, Austria
- AKH - Medizinische Universität Wien — Vienna, Austria
- Klinikum Wels Grieskirchen — Wels, Austria
- Queen Elizabeth II Health Sciences Centre — Halifax, Nova Scotia, Canada
- London Health Science Centre — London, Ontario, Canada
- LHSC - Victoria Hospital — London, Ontario, Canada
- Vojenska nemocnice Brno — Brno, Czechia
- Nemocnice Horovice — Hořovice, Czechia
- Hepato-Gastroenterologie HK — Hradec Králové, Czechia
- Poliklinika MEDICINA PLUS — Prague, Czechia
- Mediendo s.r.o. — Prague, Czechia
- Praxiszentrum Alte Maelzerei — Regensburg, Bavaria, Germany
- Klinikum der Johann Wolfgang Goethe-Universitaet — Frankfurt am Main, Hesse, Germany
- Universitaetsklinikum Carl Gustav Carus TU — Dresden, Saxony, Germany
- Universitaetsklinikum Schleswig-Holstein - Campus Kiel — Kiel, Schleswig, Germany
- Charite Universitaetsmedizin — Berlin, Germany
- Charite Universitaetsmedizin Berlin - Campus Charite Mitte — Berlin, Germany
- Staedisches Klinikum — Brandenburg, Germany
- Advanced Research Center, Inc. — Anaheim, California, United States
Full record on ClinicalTrials.gov
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