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Effect of Intravenous (IV) Vedolizumab on Mucosal Healing in Crohn's Disease | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

An Open-Label Phase 3b Study to Assess Mucosal Healing in Subjects With Moderately to Severely Active Crohn's Disease Treated With Vedolizumab IV

NCT02425111•Takeda

View on ClinicalTrials.gov

Summary

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

Detailed Description

The drug being tested in this study is called vedolizumab. Vedolizumab is being tested to treat people who have Crohn's disease. This study will look at mucosal healing in people who take vedolizumab. The study will enroll approximately 100 patients and will be conducted in 2 Parts. Part A will consist of a 26-week treatment period and all participants will receive vedolizumab 300 mg intravenously (IV) on Day 1 and at Weeks 2, 6, 14 and 22. Part B will consist of a 26-week extension treatment period and all participants will receive vedolizumab 300 mg IV at Weeks 30, 38, and 46. This multi-center trial will be conducted worldwide. The overall time to participate in this study is approximately 70 weeks for Parts A, B and 18-Week Follow-up combined. Participants will make multiple visits to the clinic. All participants included in the study will also have a 6 month safety follow-up telephone call following his/her last dose of study drug.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
•2. Signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
•3. 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.
•4. Has CD with involvement of the ileum and/or colon that can be assessed by ileocolonoscopy.
•5. Is male or female and aged 18 to 80 years, inclusive.
•6. A male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 18 weeks after last dose.
•7. A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study and for 18 weeks after last dose.
•8. Has demonstrated an inadequate response to, loss of response to, or intolerance of at least 1 of the following agents as defined below:
•* Immunomodulators:
•i. Has signs and symptoms of persistently active disease despite a history of at least one 12-week regimen of oral azathioprine (≥1.5 mg/kg) or 6-mercaptopurine (≥0.75 mg/kg), OR ii. Has a history of intolerance (including but not limited to nausea/vomiting, abdominal pain, pancreatitis, liver function test abnormalities, lymphopenia, thiopurine S-methyltransferase non wild type \[where wild type is defined as thiopurine S-methyltransferase (TPMT)\*1/\*1\], infection) to at least 1 immunomodulator.
+8 more criteria

Exclusion Criteria

•1. Has received a diagnosis of ulcerative colitis or indeterminate colitis.
•2. Has clinical evidence of abdominal abscess.
•3. Has a history of \>3 small bowel resections or diagnosis of short bowel syndrome.
•4. Has extensive colonic resection, ie, subtotal or total colectomy with \<15 cm colon remaining.
•5. Has ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.
•6. Has a history or evidence of adenomatous colonic polyps that have not been removed.
•7. Has a history or evidence of colonic mucosal dysplasia.
•8. Has intolerance or contraindication to undergo ileocolonoscopy.
•9. Has active or latent tuberculosis, regardless of treatment history, as evidenced by any of the following:
•a. History of tuberculosis (TB). b. A diagnostic TB test performed during screening that is positive, as defined by: i. A positive QuantiFERON® test or 2 successive indeterminate QuantiFERON tests OR ii. A tuberculin skin test reaction ≥10 mm (≥5 mm in participants receiving the equivalent of \>15 mg/day prednisone).
+30 more criteria

Locations (79)

La Jolla, California, United States

Hamden, Connecticut, United States

Gainesville, Florida, United States

Inverness, Florida, United States

Maitland, Florida, United States

Miami, Florida, United States

Winter Park, Florida, United States

Macon, Georgia, United States

Suwanee, Georgia, United States

Topeka, Kansas, United States

Key Dates

Start Date

March 30, 2015

Primary Completion Date

June 2, 2017

Completion Date

February 21, 2018

Last Updated

September 14, 2018

Enrollment

101

ACTUAL participants

Conditions

Crohn's Disease

Interventions

Vedolizumab

DRUG

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

NCT06226883

Inflammatory Bowel DiseasesCrohn's Disease

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RECRUITINGPHASE3

An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease

NCT07184931

Crohn's Disease

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 14, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease

DB-3Q bmMSC-EVs in Patients With Perianal Fistulizing Crohn's Disease

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Safety of Allogeneic Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) to Treat Perianal Fistulas w/ Crohn's Disease