A clinical study testing the efficacy and safety of V565 in patients with Crohn's Disease

Phase 1

• Conditions: Active Crohn's Disease; MedDRA version: 20.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2016-002939-15-SK
• Lead Sponsor: VHsquared Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-01-12
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 126

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 µg/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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 111
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

The main criteria for exclusion are:
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-TNFa therapy, or any contraindication to anti-TNFa 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 clinical trial of medicinal product
• Study Design: Not specified