NCT02630966

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).

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2016

Typical duration for phase_4

Geographic Reach
7 countries

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 15, 2015

Completed
8 months until next milestone

Study Start

First participant enrolled

August 10, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 4, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2018

Completed
11 months until next milestone

Results Posted

Study results publicly available

September 25, 2019

Completed
Last Updated

November 19, 2019

Status Verified

November 1, 2019

Enrollment Period

2.1 years

First QC Date

December 11, 2015

Results QC Date

September 4, 2019

Last Update Submit

November 5, 2019

Conditions

Crohn's Disease

Keywords

Drug therapyFistulizing Crohn´s diseasePerianal Fistula

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With at Least 50% Reduction From Baseline in the Number of Draining Perianal Fistulae (of Those Draining at Baseline)

    Closed fistulae are no longer draining despite gentle finger compression.

    Baseline, Week 30

Secondary Outcomes (5)

  • Percentage of Participants With at Least 50% Reduction of From Baseline in the Number of Draining Perianal Fistulae (of Those Draining at Baseline) at Both Weeks 22 and 30

    Weeks 22 and 30

  • Percentage of Participants With 100% Perianal Fistulae Closure (of the Fistulae Draining at Baseline)

    Week 30

  • Time to First Perianal Fistulae Closure (of Those Fistulae Draining at Baseline)

    Up to Week 30

  • Time to Last (100%) Perianal Fistulae Closure (of Those Fistulae Draining at Baseline)

    Up to Week 30

  • Duration of Perianal Fistulae Response (of Those Fistulae Draining at Baseline)

    Up to Week 30

Study Arms (2)

Group 1: Vedolizumab IV 300 mg + Placebo

EXPERIMENTAL

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.

Drug: VedolizumabDrug: Placebo

Group 2: Vedolizumab 300 mg

EXPERIMENTAL

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

Drug: Vedolizumab

Interventions

VedolizumabDRUG

Vedolizumab 300 mg IV infusion

Also known as: Entyvio, MLN0002, Kynteles
Group 1: Vedolizumab IV 300 mg + PlaceboGroup 2: Vedolizumab 300 mg
PlaceboDRUG

0.9% sodium chloride IV infusion

Group 1: Vedolizumab IV 300 mg + Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
  • 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.
  • Has a diagnosis of CD established at least 3 months prior to randomization by clinical and endoscopic evidence and corroborated by a histopathology report.
  • 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.
  • 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.
  • If the participant had noncutting perianal seton placement as part of standard care, seton must be removed by Week 14 of the study.

You may not qualify if:

  • Has a diagnosis of ulcerative colitis or indeterminate colitis.
  • 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.
  • Has a Crohn's Disease Activity Index (CDAI) score \>400.
  • Has an ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.
  • Has significant anal or rectal stenosis.
  • Has active or latent tuberculosis (TB), regardless of treatment history.
  • Has evidence of active Clostridium difficile (C. difficile) infection or is having treatment for C. difficile infection or other intestinal pathogens during Screening.
  • Has current rectovaginal fistula.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212-1375, United States

Location

Texas Digestive Disease Consultants

Southlake, Texas, 76092, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

University of Calgary

Calgary, Alberta, T2N 4Z6, Canada

Location

GIRI (GI Research Institute)

Vancouver, British Columbia, V6Z 2K5, Canada

Location

CHRU de Lille - Hopital Claude Huriez

Lille, 59037, France

Location

Hopital l'Archet II

Nice, 06202, France

Location

CHU de Rennes - Hopital de Pontchaillou

Rennes, 35033, France

Location

Hopital de Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

Azienda Ospedaliera S. Orsola-Malpighi

Bologna, 40138, Italy

Location

Istituto Clinico Humanitas IRCCS

Milan, 20089, Italy

Location

Academic Medical Center

Amsterdam, 1105 AZ, Netherlands

Location

Leids Universitair Medisch Centrum

Leiden, 2333 ZA, Netherlands

Location

Erasmus MC

Rotterdam, 3015 CE, Netherlands

Location

Hospital Clinic Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario y Politecnico La Fe

Valencia, 46026, Spain

Location

Nottingham University Hospitals NHS Trust

Nottingham, NG7 2UH, United Kingdom

Location

John Radcliffe Hospital

Oxford, OX3 9DU, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 34597729DERIVED

MeSH Terms

Conditions

Crohn Disease

Interventions

vedolizumab

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Limitations and Caveats

Takeda decided to close enrollment after randomizing 34 participants.Decision was taken due to challenges in recruitment and was not related to any safety concerns.Participants randomized before enrollment closure continued participation as planned.

Results Point of Contact

Title
Medical Director
Organization
Takeda
trialdisclosures@takeda.com
877-825-3327

Study Officials

  • Medical Director Clinical Science

    Takeda

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2015

First Posted

December 15, 2015

Study Start

August 10, 2016

Primary Completion

September 4, 2018

Study Completion

November 14, 2018

Last Updated

November 19, 2019

Results First Posted

September 25, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will share

Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

Locations

GB(2)ES(2)US(3)NL(3)CA(2)IT(2)FR(4)