An Open-label Study of Vedolizumab (MLN0002) in Participants With Ulcerative Colitis and Crohn's Disease
Launched by TAKEDA · Nov 13, 2008
Trial Information
Current as of June 20, 2025
Completed
Keywords
ClinConnect Summary
The drug being tested in this study is called vedolizumab. Vedolizumab is being tested to treat people who have ulcerative colitis or Crohn's disease. This study will determine the safety profile of long-term vedolizumab treatment.
The study enrolled 2243 patients. Participants who received either placebo or vedolizumab 300 mg IV infusion every 4 or 8 weeks in previous vedolizumab studies received:
• Vedolizumab 300 mg
All participants received vedolizumab intravenous infusion every 4 weeks for approximately up to 510 weeks.
This multicenter trial is being conducted worldwide. The overa...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Previous treatment in Study C13004 (NCT00619489), Study C13006 (NCT00783718), Study C13007 (NCT00783692), or Study C13011 (NCT01224171) that, in the opinion of the investigator, was well tolerated OR b. Moderate to severe Crohn's disease or ulcerative colitis which has not been previously treated with vedolizumab (MLN0002)
- • 2. May be receiving a therapeutic dose of conventional therapies for Crohn's disease or ulcerative colitis as defined by the protocol
- Exclusion Criteria:
- • 1. Development of any new, unstable, or uncontrolled disease
About Takeda
Takeda Pharmaceutical Company Limited is a global, research-driven biopharmaceutical organization committed to advancing patient care through innovative therapies. Founded in 1781 and headquartered in Osaka, Japan, Takeda focuses on key therapeutic areas including oncology, gastroenterology, neuroscience, and rare diseases. With a strong emphasis on research and development, Takeda leverages cutting-edge science and technology to deliver transformative medicines that address unmet medical needs. The company is dedicated to sustainability and ethical practices, ensuring that its clinical trials uphold the highest standards of safety and efficacy while fostering collaboration with healthcare professionals and communities worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Decatur, Georgia, United States
Tyler, Texas, United States
Tel Aviv, , Israel
San Antonio, Texas, United States
Miami, Florida, United States
Charlotte, North Carolina, United States
Louisville, Kentucky, United States
Chevy Chase, Maryland, United States
Richmond, Virginia, United States
Richmond, Virginia, United States
Birmingham, Alabama, United States
Ann Arbor, Michigan, United States
Leuven, , Belgium
Edmonton, Alberta, Canada
New York, New York, United States
Leuven, , Belgium
Milwaukee, Wisconsin, United States
Portland, Oregon, United States
Saskatoon, Saskatchewan, Canada
Ann Arbor, Michigan, United States
Atlanta, Georgia, United States
Milwaukee, Wisconsin, United States
San Francisco, California, United States
Birmingham, Alabama, United States
Seoul, , Korea, Republic Of
Hamden, Connecticut, United States
Rochester, New York, United States
Jacksonville, Florida, United States
Littleton, Colorado, United States
Portland, Oregon, United States
Germantown, Tennessee, United States
Charlottesville, Virginia, United States
Macon, Georgia, United States
Lafayette, Louisiana, United States
Halle, , Germany
Jacksonville, Florida, United States
San Diego, California, United States
Lafayette, Colorado, United States
Baton Rouge, Louisiana, United States
Troy, Michigan, United States
Winter Park, Florida, United States
Charlotte, North Carolina, United States
Topeka, Kansas, United States
Adelaide, South Australia, Australia
San Francisco, California, United States
Szekszard, , Hungary
Kuala Lumpur, , Malaysia
Thornton, Colorado, United States
Decatur, Georgia, United States
San Diego, California, United States
Miami, Florida, United States
Atlanta, Georgia, United States
Rochester, Minnesota, United States
Cheektowaga, New York, United States
Elkin, North Carolina, United States
Edmonton, Alberta, Canada
Praha, , Czechia
Halle, Saint, Germany
Seoul, , Korea, Republic Of
Patients applied
Trial Officials
Medical Monitor Clinical Science
Study Director
Takeda
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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