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

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ClinicalTrials.gov Identifier: NCT02630966
Recruitment Status : Completed
First Posted : December 15, 2015
Last Update Posted : November 19, 2018
Sponsor:
Information provided by (Responsible Party):
Takeda

Brief Summary:
The purpose of this study is to evaluate 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).

Condition or disease Intervention/treatment Phase
Crohn Disease Drug: Vedolizumab Drug: Placebo Phase 4

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 will 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Double-Blind Phase 4 Study to Evaluate the Safety and Proportion of Subjects With Fistula Healing in 2 Dose Regimens of Entyvio (Vedolizumab IV) in the Treatment of Fistulizing Crohn's Disease (ENTERPRISE)
Actual Study Start Date : August 10, 2016
Actual Primary Completion Date : September 4, 2018
Actual Study Completion Date : November 14, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Vedolizumab

Arm Intervention/treatment
Experimental: 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, once, at Week 10.
Drug: Vedolizumab
Vedolizumab 300 mg IV
Other Names:
  • Entyvio
  • MLN0002
  • Kynteles

Drug: Placebo
0.9% sodium chloride used as vedolizumab placebo-matching IV

Experimental: Group 2: Vedolizumab 300 mg
Vedolizumab 300 mg, IV infusion, once, at Weeks 0, 2, 6, 10, 14, and 22.
Drug: Vedolizumab
Vedolizumab 300 mg IV
Other Names:
  • Entyvio
  • MLN0002
  • Kynteles




Primary Outcome Measures :
  1. Percentage of Participants with a Reduction of at Least 50% from Day 1 in the Number of Draining Perianal Fistulae at Week 30 [ Time Frame: Day 1, Week 30 ]
    Closed fistulae are no longer draining despite gentle finger compression


Secondary Outcome Measures :
  1. Percentage of Participants with a Reduction of at Least 50% from Day 1 in the Number of Draining Perianal Fistulae at Weeks 22 and 30 [ Time Frame: Weeks 22 and 30 ]
    Closed fistulae are no longer draining despite gentle finger compression.

  2. Percentage of Participants with 100% Perianal Fistulae Closure at Week 30 [ Time Frame: Week 30 ]
    Closed fistulae are no longer draining despite gentle finger compression.

  3. Time to First Perianal Fistulae Closure [ Time Frame: Up to Week 30 ]
    Closed fistulae are no longer draining despite gentle finger compression.

  4. Time to Last (100%) Perianal Fistulae Closure [ Time Frame: Up to Week 30 ]
    Closed fistulae are no longer draining despite gentle finger compression.

  5. Duration of Perianal Fistulae Response [ Time Frame: Up to Week 30 ]
    Duration of fistula response will be measured by number of days with/without drainage.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  9. Currently has more than 3 draining perianal fistulae. Note: Other protocol-defined inclusion/exclusion criteria may apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02630966


Locations
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United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212-1375
United States, Texas
Texas Digestive Disease Consultants
Southlake, Texas, United States, 76092
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Canada, Alberta
University of Calgary
Calgary, Alberta, Canada, T2N 4Z6
Canada, British Columbia
GIRI (GI Research Institute)
Vancouver, British Columbia, Canada, V6Z 2K5
France
CHRU de Lille - Hopital Claude Huriez
Lille cedex, France, 59037
Hopital l'Archet II
Nice Cedex 3, France, 06202
CHU de Rennes - Hopital de Pontchaillou
Rennes cedex 9, France, 35033
Hopital de Brabois
Vandoeuvre les Nancy, France, 54511
Italy
Azienda Ospedaliera S. Orsola-Malpighi
Bologna, Italy, 40138
Istituto Clinico Humanitas IRCCS
Milan, Italy, 20089
Netherlands
Academic Medical Center
Amsterdam, Netherlands, 1105 AZ
Leids Universitair Medisch Centrum
Leiden, Netherlands, 2333 ZA
Erasmus MC
Rotterdam, Netherlands, 3015 CE
Spain
Hospital Clinic Barcelona
Barcelona, Spain, 08036
Hospital Universitario y Politecnico La Fe
Valencia, Spain, 46026
United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom, NG7 2UH
John Radcliffe Hospital
Oxford, United Kingdom, OX3 9DU
Sponsors and Collaborators
Takeda
Investigators
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Study Director: Medical Director Clinical Science Takeda

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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02630966     History of Changes
Other Study ID Numbers: Vedolizumab-4003
2015-000852-12 ( EudraCT Number )
U1111-1174-2252 ( Registry Identifier: WHO )
First Posted: December 15, 2015    Key Record Dates
Last Update Posted: November 19, 2018
Last Verified: November 2018

Keywords provided by Takeda:
Drug therapy

Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Vedolizumab
Gastrointestinal Agents