A Study of Long-term Effects of Vedolizumab Subcutaneous in Adults With Ulcerative Colitis and Crohn's Disease

Completed · Phase 3

Conditions studied: Colitis, Ulcerative, Crohn's Disease

In brief

The main aim of the study is to check for long-term side effects of Vedolizumab Subcutaneous (also known as Vedolizumab SC) in people with ulcerative colitis (UC) and Crohn's disease (CD). Vedolizumab SC will be given as an injection just under the skin. This type of injection is called a subcutaneous injection or SC for short. Another aim of the study is to collect information on whether the participant's condition remains under control or improves during and after treatment with Vedolizumab SC. Participants who previously took part in studies MLN0002SC-3027 or MLN0002SC-3031 will be invited to visit the study clinic. At this visit, the study doctor will check if each participant can take part in this study. For those who can take part, participants will receive a subcutaneous injection of vedolizumab SC either once a week or once every 2 weeks. How often each participant receives vedolizumab SC will depend on their results from the previous study and on how active their condition is. Participants might be able to self-inject vedolizumab SC after being trained by the study doctors. During this study, the dose of vedolizumab SC might be increased for participants whose condition worsens. Participants will continue treatment with vedolizumab SC until it is approved in their particular country, the participant decides to stop treatment, or the sponsor stops the study. If the sponsor stops the study before vedolizumab SC is approved in all countries, the sponsor will make sure all affected participants will have access to vedolizumab SC outside of the study. After their final dose of vedolizumab SC, participants will visit the clinic 18 weeks later for a final check-up. Then, the clinic will telephone the participants 6 months after their final dose of vedolizumab SC to check if they have any health problems.

Key facts

Study ID

NCT02620046

Run by

Takeda

People needed

746

Starts

2016-04-15

Expected to finish

2024-06-12

Last updated by the study team

2025-04-03

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Prior participation in Study MLN0002SC-3027 or MLN0002SC-3031, and, in the opinion of the investigator, tolerated the study drug well. Early withdrawal from Study MLN0002SC-3027 or MLN0002SC-3031 must have been due to treatment failure during the Maintenance Period.

You may not qualify if…

• Surgical intervention for IBD during or after participation in Study MLN0002SC-3027 or MLN0002SC-3031, or at any time during this study.
• Chronic or severe infection, or, any new, unstable, or uncontrolled cardiovascular, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, neurologic, oncologic, or other medical disorder developed during or after participation in a prior vedolizumab study that, in the opinion of the investigator, would confound the study results or compromise participant safety.
• Withdrawal from Study MLN0002SC-3027 or MLN0002SC-3031 due to a study-drug related adverse event (AE).

Where it is running

• Arkansas Primary Care Clinic, PA — Little Rock, Arkansas, United States
• Rocky Mountain Clinical Research, LLC — Wheat Ridge, Colorado, United States
• Medical Research Center of Connecticut, LLC — Hamden, Connecticut, United States
• Middlesex Gastroenterology Associates — Middletown, Connecticut, United States
• Nature Coast Clinical Research, LLC — Inverness, Florida, United States
• Florida Center for Gastroenterology — Largo, Florida, United States
• L & L Research Choices, Inc. — Miami, Florida, United States
• Gastroenterology Group of Naples — Naples, Florida, United States
• BRCR Medical Center, Inc. — Pembroke Pines, Florida, United States
• Shafran Gastroenterology Center — Winter Park, Florida, United States
• Florida Medical Clinic, P.A. — Zephyrhills, Florida, United States
• Atlanta Gastroenterology Associates — Atlanta, Georgia, United States
• Gastroenterology Associates of Central Georgia — Macon, Georgia, United States
• Atlanta Gastroenterology Specialists, PC — Suwanee, Georgia, United States
• Grand Teton Research Group, PLL — Idaho Falls, Idaho, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Carle Foundation Hospital — Urbana, Illinois, United States
• Cotton-O'Neil Clinical Research Center, Digestive Health — Topeka, Kansas, United States
• Tri-State Gastroenterology Associates — Crestview Hills, Kentucky, United States
• Research Concierge, LLC — Owensboro, Kentucky, United States
• Gastroenterology Associates, LLC — Baton Rouge, Louisiana, United States
• Lafayette General Medical Center — Lafayette, Louisiana, United States
• Louisiana Research Center, LLC — Shreveport, Louisiana, United States
• Metropolitan Gastroenterology Group, PC, Chevy Chase Clinical Research — Chevy Chase, Maryland, United States
• Arizona Arthritis & Rheumatology Research, PLLC — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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