Crohn's Disease Enteritis Regionalis
Conditions
Interventions
Each dose will consist of three capsules of V565 (three 185-mg capsules, total
dose 555 mg) or placebo. Study drug will be administered orally TID. The
subjects will be instructed to take the capsul
enteritis regionalis
Inflammatory Bowel Disease
Targeted Anti-TNF
Sponsors
VHsquared Ltd
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. History of CD (confirmed by ileocolonoscopy) of at least three months duration prior to Visit 1 2. CDAI score of *220 to *450 during Screening 3. CRP *5 mg/L (or, if CRP is normal, FCP* 250 *g/g ) at Screening 4. Active CD of ileum and/or colon as determined by the baseline ileocolonoscopy 5. Female subjects must not be pregnant and male and female subjects must agree to use effective contraception throughout the study and for 90 days after the last dose of study drug. 6. Subject must have failed or experienced intolerance to at least one of the following: aminosalicylates, corticosteroids; immunosuppressants
Exclusion criteria
Exclusion criteria: 1. CD of mouth, stomach, oesophagus or duodenum which, in the opinion of the Investigator, is likely to be causing symptoms 2. Known history of or suspicion of ulcerative colitis, indeterminate colitis, microscopic colitis, ischaemic co litis or radiation-induced colitis, based on medical history, endoscopy and/or histological findings. 3. Any gastrointestinal (GI) manifestations of CD that might affect the evaluation of efficacy 4. Prior primary efficacy failure of o r secondary loss of response to anti-TNF* therapy, or any contraindication to anti-TNF* therapy 5. The use of medications prior to the study or during the study with the potential to affect the evaluation of efficacy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of responders at Day 42, defined as subjects achieving both CDAI *70- point reduction from Baseline OR CDAI score | — |
Secondary
| Measure | Time frame |
|---|---|
| - Proportion of subjects achieving a *100-point reduction in CDAI score and a concomitant reduction of 50% in CRP or FCP at Day 42 - Proportion of subjects achieving a *70-point reduction in CDAI score at Day 42 - Proportion of subjects achieving a *100-point reduction in CDAI score at Day 42 - Proportion of subjects achieving a CDAI score of | — |
Countries
Austria, Canada, Czechia, Germany, Hungary, Netherlands, Norway, Poland, Serbia, Slovakia, Ukraine, United Kingdom, United States of America
Outcome results
None listed