Effect of Vedolizumab IV in subjects with Crohn's Disease

Phase 1

Conditions: Crohn's Disease
Therapeutic area: Diseases [C] - Immune System Diseases [C20]
MedDRA version: 19.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disorders

Registration Number: EUCTR2014-003509-13-PL

Lead Sponsor: Takeda Development Centre Europe Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

- The subject has a diagnosis of moderately to severely active CD at least 3 months prior to enrollment, with a CDAI score of 220-450 during the Screening Period, a SES-CD score of =7 and presence of at least one mucosal ulceration documented by recorded ileocolonoscopy at Screening assessed by the central reader.
- The subject has CD with involvement of the ileum and/or colon that can be assessed by ileocolonoscopy.
- The subject has demonstrated an inadequate response to, loss of response to, or intolerance of at least 1 of the following agents as defined below:
? Immunomodulators:
i. The subject has signs and symptoms of persistently active disease despite a history of at least one 12-week regimen of oral azathioprine (=1.5 mg/kg) or
6-mercaptopurine (=0.75 mg/kg), OR
ii. The subject has a history of intolerance (including but not limited to nausea/ vomiting, abdominal pain, pancreatitis, liver function test abnormalities, lymphopenia, thiopurine S-methyltransferase non wild type [where wild type is
defined as TPMT*1/*1], infection) to at least 1 immunomodulator.
? TNF-? antagonists:
i. The subject has signs and symptoms of persistently active disease despite a history of at least 1 induction with:
a) Infliximab: 4-week regimen of 5 mg/kg, 2 doses at 2 weeks apart, OR
b) Adalimumab: 2-week regimen of 160 mg on Day 1 and 80 mg on Day 15, OR
c) Certolizumab: 4-week regimen of 400 mg initially at Weeks 0, 2, 4 OR
ii. The subject has recurrence of symptoms during maintenance dosing following
prior clinical benefit (discontinuation despite clinical benefit does not qualify), OR
iii. The subject has a history of intolerance of infliximab, adalimumab, or
certolizumab, including but not limited to, infusion-related reaction,
demyelination, congestive heart failure, or infection.
? Corticosteroids
i. Signs and symptoms of persistently active disease despite a history of at least one
4-week induction regimen that included a dose equivalent to prednisone 30 mg
daily orally for 2 weeks or IV for 1 week, OR
ii. Signs and symptoms of persistently active disease despite treatment with
budesonide 9 mg daily or 6 mg daily for maintenance, OR
iii. At least one failed attempt to taper corticosteroids to below a dose equivalent to prednisone 10 mg daily orally, OR
iv. History of intolerance to corticosteroids (including, but not limited to, Cushing’s
syndrome, osteopenia/osteoporosis, hyperglycemia, insomnia, and infection).
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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

- The subject has active or latent tuberculosis, regardless of treatment history, as evidenced by any of the following:
a) History of TB.
b) A diagnostic TB test performed during screening that is positive, as defined by:
i. A positive QuantiFERON® test or 2 successive indeterminate QuantiFERON tests OR
ii. A tuberculin skin test reaction =10 mm (=5 mm in patients receiving the equivalent of >15 mg/day prednisone)
- The subject has chronic hepatitis B (HBV) or hepatitis C (HCV) infection.
- The subject has any identified congenital or acquired immunodeficiency (eg, common variable immunodeficiency, human immunodeficiency virus [HIV] infection, organ transplantation).
- The subject has evidence of active C. difficile infection or is having treatment for C. difficile infection or other intestinal pathogens during Screening.
- The subject has evidence of an active infection during Screening.
- The subject has received any investigational compound within 60 days of enrollment.
- The subject has received any biologics within 60 days of enrollment.
- The subject has received any live vaccinations within 30 days prior to enrollment.
- The subject has a positive PML subjective symptom checklist during screening and prior to the administration of study drug on Day 1.