A Phase 2 study to investigate the efficacy, safety, and tolerability of six weeks treatment with V565 in subjects with active Crohn*s disease<br>

Phase 2

Completed

Conditions: Crohn's Disease
Enteritis Regionalis
10017969

Registration Number: NL-OMON47571

Lead Sponsor: VHsquared Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 6

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Proportion of responders at Day 42, defined as subjects achieving both CDAI 70-<br /><br>point reduction from Baseline OR CDAI score <150, AND a reduction of 40% from<br /><br>the baseline value of CRP or FCP </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Proportion of subjects achieving a 100-point reduction in CDAI score and a<br /><br>concomitant reduction of 50% in CRP or FCP at Day 42<br /><br>- Proportion of subjects achieving a 70-point reduction in CDAI score at Day 42<br /><br>- Proportion of subjects achieving a *100-point reduction in CDAI score at Day<br /><br>42<br /><br>- Proportion of subjects achieving a CDAI score of <150 CDAI at Day 42<br /><br>- Changes from Baseline in scores for PRO-2 at Day 14 and Day 42</p><br>