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

NCT ID: NCT02630966

Last Updated: 2019-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-10
• Study Completion Date: 2018-11-14

Brief Summary

The purpose of this study is to evaluate the percentage of participants with perianal fistula healing at Week 30 in 2 different dose regimens of vedolizumab intravenous (IV) 300 milligram (mg) in participants with fistulizing Crohn's disease (CD).

Detailed Description

The drug being tested in this study is called vedolizumab IV. Vedolizumab IV is being tested to treat people who have fistulizing CD. This study will look at fistula healing in people who take vedolizumab IV.

The study is planned to enroll approximately 100 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):

• Group 1: Vedolizumab IV 300 mg dose at Weeks 0, 2, 6, 14 and 22, and a placebo infusion at Week 10 (dummy inactive infusion - this is a solution that looks like the study drug but has no active ingredient).
• Group 2: Vedolizumab IV 300 mg dose at Weeks 0, 2, 6, 10, 14 and 22.

This multi-center trial will be conducted worldwide. The overall time to participate in this study from screening to 18 weeks after the last dose is 44 weeks. Participants will make multiple visits to the clinic, and will be contacted by telephone 6 months after last dose of study drug for a follow-up assessment.

Conditions

Crohn's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Group 1: Vedolizumab IV 300 mg + Placebo

Vedolizumab 300 mg, IV infusion, once, at Weeks 0, 2, 6, 14, and 22, and vedolizumab placebo-matching, IV infusion once, at Week 10 to maintain the blind.

Group Type: EXPERIMENTAL

Vedolizumab

Intervention Type: DRUG

Vedolizumab 300 mg IV infusion

Placebo

Intervention Type: DRUG

0.9% sodium chloride IV infusion

Group 2: Vedolizumab 300 mg

Vedolizumab 300 mg, IV infusion, once, at Weeks 0, 2, 6, 10, 14, and 22.

Group Type: EXPERIMENTAL

Vedolizumab

Intervention Type: DRUG

Vedolizumab 300 mg IV infusion

Interventions

Vedolizumab

Vedolizumab 300 mg IV infusion

Intervention Type: DRUG

Placebo

0.9% sodium chloride IV infusion

Intervention Type: DRUG

Other Intervention Names

Entyvio; MLN0002; Kynteles

Eligibility Criteria

Inclusion Criteria

1. In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.

2. The participant or, when applicable, the participant's legally acceptable representative has signed and dated a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.

3. Has a diagnosis of CD established at least 3 months prior to randomization by clinical and endoscopic evidence and corroborated by a histopathology report.

4. Has a diagnosis of a minimum of 1 perianal draining fistula of at least 2 weeks duration as a complication of moderately to severely active CD, as identified on magnetic resonance image (MRI) at Screening. Other types of fistulae (enterocutaneous, abdominal) except rectovaginal fistulae are permitted, but the number of perianal draining fistulae is limited to 3.

5. All countries except France: The participant, historically, had an inadequate response with, lost response to, or was intolerant to either conventional therapy or a tumor necrosis factor-alpha (TNF-α) antagonist for their underlying CD (does not require treatment failure for currently active draining fistula).

France only: The participant, 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.

6. If the participant had noncutting perianal seton placement as part of standard care, seton must be removed by Week 14 of the study.

Exclusion Criteria

1. Has a diagnosis of ulcerative colitis or indeterminate colitis.

2. Has a perianal abscess greater than (>) 2 centimeter (cm) or an abscess that the investigator feels requires drainage based on either clinical assessment or MRI.

3. Has a Crohn's Disease Activity Index (CDAI) score >400.

4. Has an ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.

5. Has significant anal or rectal stenosis.

6. Has active or latent tuberculosis (TB), regardless of treatment history.

7. Has evidence of active Clostridium difficile (C. difficile) infection or is having treatment for C. difficile infection or other intestinal pathogens during Screening.

8. Has current rectovaginal fistula.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director Clinical Science

Role: STUDY_DIRECTOR

Takeda

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Texas Digestive Disease Consultants

Southlake, Texas, United States

Virginia Mason Medical Center

Seattle, Washington, United States

University of Calgary

Calgary, Alberta, Canada

GIRI (GI Research Institute)

Vancouver, British Columbia, Canada

CHRU de Lille - Hopital Claude Huriez

Lille, , France

Hopital l'Archet II

Nice, , France

CHU de Rennes - Hopital de Pontchaillou

Rennes, , France

Hopital de Brabois

Vandœuvre-lès-Nancy, , France

Azienda Ospedaliera S. Orsola-Malpighi

Bologna, , Italy

Istituto Clinico Humanitas IRCCS

Milan, , Italy

Academic Medical Center

Amsterdam, , Netherlands

Leids Universitair Medisch Centrum

Leiden, , Netherlands

Erasmus MC

Rotterdam, , Netherlands

Hospital Clinic Barcelona

Barcelona, , Spain

Hospital Universitario y Politecnico La Fe

Valencia, , Spain

Nottingham University Hospitals NHS Trust

Nottingham, , United Kingdom

John Radcliffe Hospital

Oxford, , United Kingdom

Countries

United States; Canada; France; Italy; Netherlands; Spain; United Kingdom

References

Schwartz DA, Peyrin-Biroulet L, Lasch K, Adsul S, Danese S. Efficacy and Safety of 2 Vedolizumab Intravenous Regimens for Perianal Fistulizing Crohn's Disease: ENTERPRISE Study. Clin Gastroenterol Hepatol. 2022 May;20(5):1059-1067.e9. doi: 10.1016/j.cgh.2021.09.028. Epub 2021 Sep 29.

Reference Type: DERIVED

PMID: 34597729 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2015-000852-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1174-2252

Identifier Type: REGISTRY

Identifier Source: secondary_id

Vedolizumab-4003

Identifier Type: -

Identifier Source: org_study_id