Study of Vedolizumab in Patients With Moderate to Severe Crohn's Disease (GEMINI III)

This study has been completed.
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc. Identifier:
First received: October 18, 2010
Last updated: March 7, 2013
Last verified: March 2013

This phase 3, randomized, blinded, placebo-controlled study in patients with moderately to severely active Crohn's disease is designed to establish the efficacy and safety of vedolizumab for the induction of clinical response and remission.

After completing the study, patients may be eligible to enroll in a long term safety study with continued access to vedolizumab.

Condition Intervention Phase
Crohn's Disease
Drug: vedolizumab
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn's Disease

Resource links provided by NLM:

Further study details as provided by Millennium Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Proportion of patients in clinical remission in the tumor necrosis factor alpha antagonist therapy subpopulation [ Time Frame: Week 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients in clinical remission [ Time Frame: Week 6 and Week 10 ] [ Designated as safety issue: No ]
  • Proportion of patients with sustained clinical remission [ Time Frame: Week 6 and Week 10 ] [ Designated as safety issue: No ]
  • Proportion of patients with enhanced clinical response [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
  • Safety profile [ Time Frame: Through Week 22 ] [ Designated as safety issue: Yes ]
    Adverse events, serious adverse events, results of standard laboratory tests and results of 12-lead electrocardiograms (ECGs)

Enrollment: 416
Study Start Date: November 2010
Study Completion Date: April 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vedolizumab Drug: vedolizumab
Vedolizumab will be given as an intravenous (IV) infusion at weeks 0, 2 and 6
Other Name: MLN0002
Placebo Comparator: Placebo Other: Placebo
Placebo will be given as an intravenous (IV) infusion comprised of normal saline at weeks 0, 2 and 6


Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 18 to 80
  • Diagnosis of moderately to severely active Crohn's disease
  • Crohn's Disease involvement of the ileum and/or colon
  • Demonstrated, over the previous 5 year period, an inadequate response to, loss of response to, or intolerance of at least one conventional therapy as defined by the protocol
  • May be receiving a therapeutic dose of conventional therapies for IBD as defined by the protocol

Exclusion Criteria

  • Evidence of abdominal abscess at the initial screening visit
  • Extensive colonic resection, subtotal or total colectomy
  • History of >3 small bowel resections or diagnosis of short bowel syndrome
  • Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine
  • Have received non permitted therapies within either 30 or 60 days, depending on the medication, as stated in the protocol
  • Chronic hepatitis B or C infection; HIV infection
  • Active or latent tuberculosis
  Contacts and Locations
Please refer to this study by its identifier: NCT01224171

  Hide Study Locations
United States, Colorado
Gastroenterology of the Rockies
Lafayette, Colorado, United States, 80026
United States, Connecticut
Gastroenterology Center of Connecticut P.C.
Hamden, Connecticut, United States, 65180
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
University of Miami Miller School of Medicine
Miami, Florida, United States, 33136
Shafran Gastroenterology Center
Winter Park, Florida, United States, 32789
United States, Georgia
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States, 30342
Gastroenterology Associates of Central Georgia
Macon, Georgia, United States, 31201
Atlanta Gastroenterology Specialist PC
Suwanee, Georgia, United States, 30024
United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
United States, Kansas
Cotton O'Neil Digestive Health Center
Topeka, Kansas, United States, 66606
United States, Kentucky
University of Kentucky Medical Center
Lexington, Kentucky, United States, 40536
University Of Louisville
Louisville, Kentucky, United States, 40402
United States, Louisiana
Gastroenterology Associates
Baton Rouge, Louisiana, United States, 70809
Gastroenterology Research of New Orleans
Hammond, Louisiana, United States, 70403
United States, Maryland
Metropolitan Gastroenterology Group P.C.
Chevy Chase, Maryland, United States, 20815
Mid-Atlantic Medical Research Center
Hollywood, Maryland, United States, 20636
United States, Massachusetts
Massachusetts General Hospital Crohn's and Colitis Center
Boston, Massachusetts, United States, 02114
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Center for Digestive Health
Troy, Michigan, United States, 48098
Huron Gastroenterology Associates
Ypsilanti, Michigan, United States, 48197
United States, Minnesota
Minnesota Gastroenterology P.A.
Plymouth, Minnesota, United States, 55446
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63110
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New York
Long Island Clinical Research Associates
Great Neck, New York, United States, 11021
New York Presbyterian Hospital
New York, New York, United States, 10021
University of Rochester
Rochester, New York, United States, 14642
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Charlotte Gastroenterology and Hepatology P.L.L.C
Charlotte, North Carolina, United States, 28207
United States, Ohio
Consultants for Clinical Research Inc.
Cincinnati, Ohio, United States, 45219
United States, Oklahoma
Options Health Research
Tulsa, Oklahoma, United States, 74104
United States, Oregon
The Oregon Clinic-West Hills Gastroenterology
Portland, Oregon, United States, 97225
United States, South Carolina
Consultants in Gastroenterology
Columbia, South Carolina, United States, 29203
United States, Tennessee
Gastroenterology Center of the MidSouth PC
Germantown, Tennessee, United States, 38138
United States, Texas
Gastroenterology Clinic of San Antonio
San Antonio, Texas, United States, 78229
Digestive Health Specialists of Tyler
Tyler, Texas, United States, 75701
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
United States, Washington
University of Washington School of Medicine
Seattle, Washington, United States, 98195
United States, Wisconsin
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, United States, 53215
Medical College Of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Canada, Alberta
Zeidler Ledcor Center-Univerisity of Alberta
Edmonton, Alberta, Canada, T6G2X8
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Millennium Pharmaceuticals, Inc. Identifier: NCT01224171     History of Changes
Other Study ID Numbers: C13011
Study First Received: October 18, 2010
Last Updated: March 7, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases processed this record on April 17, 2014