Vedolizumab IV 300 mg in the Treatment of Fistulizing Crohn's Disease

Phase 1

• Conditions: Fistulizing Crohn’s Disease (CD); MedDRA version: 20.0 Level: LLT Classification code 10075465 Term: Fistulizing Crohn's disease System Organ Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2015-000852-12-FR
• Lead Sponsor: Takeda Development Centre Europe, Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-15
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

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

Inclusion Criteria

-Adult subjects, aged 18 to 80 years, inclusive, with moderately to severely active CD and 1 to 3 draining perianal fistula(e) of at least 2 weeks duration.
-Subjects who have historically failed (ie, had an inadequate response with, lost response to, or was intolerant to) infliximab for treatment of their underlying CD or fistulizing CD.
-Noncutting seton placement as part of standard of care within 1 to 4 weeks prior to randomization.
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 107
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 19

Exclusion Criteria

-Subjects who have perianal abscesses greater than 2 cm or an abscess that the investigator feels requires drainage based on either clinical assessment or MRI.
-Subjects who have a CDAI score greater than 400.
-Subjects who have ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.
-Subjects who have significant anal or rectal stenosis.
-Subjects who have any evidence of an active infection (eg, sepsis, cytomegalovirus, or listeriosis) during screening, other than related to the fistula(e).
-Subjects who have a positive progressive multifocal leukoencephalopathy (PML) subjective checklist.
-Subjects who have received any investigational or approved biologic or biosimilar agent within 60 days or 5 half-lives of randomization (whichever is longer).
-Subjects who have had prior exposure to vedolizumab, natalizumab, efalizumab, or rituximab.
- Subjects who have active or latent tuberculosis.
- Subjects who have a known history of hepatitis B virus (HBV), hepatitis C virus (HCV), acquired human immunodeficiency virus (HIV), or are found to be seropositive at Screening.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified