Effect of Intravenous (IV) Vedolizumab on Mucosal Healing in Crohn's Disease

Recruiting in Palo Alto (17 mi)

+73 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Takeda

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate endoscopic remission at Week 26 as assessed by ileocolonoscopy.

Research Team

Medical Director Clinical Science

Principal Investigator

Takeda

Eligibility Criteria

Inclusion Criteria

Has a diagnosis of moderately to severely active Crohn's disease (CD) at least 3 months prior to enrollment, with a Crohn's Disease Activity Index (CDAI) score of 220-450 during the Screening Period, a simple endoscopic score for Crohn's Disease (SES-CD) score of ≥7 and presence of at least one mucosal ulceration documented by recorded ileocolonoscopy at Screening assessed by the central reader.

Has CD with involvement of the ileum and/or colon that can be assessed by ileocolonoscopy.

Is male or female and aged 18 to 80 years, inclusive.

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Treatment Details

Interventions

Vedolizumab (Monoclonal Antibodies)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Vedolizumab 300 mgExperimental Treatment1 Intervention

Part A: Vedolizumab 300 mg, intravenously (IV), once on Day 1 and Weeks 2, 6, 14 and 22, followed by Part B: Vedolizumab 300 mg, intravenously (IV), once at Weeks 30, 38, and 46.

Vedolizumab is already approved in Canada, Japan for the following indications: