Long-term Safety With Vedolizumab Intravenous (IV) in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD)

Completed · Phase 2

Conditions studied: Ulcerative Colitis, Crohn's Disease

In brief

The purpose of this study is to determine the safety profile of long-term vedolizumab IV treatment in pediatric participants with UC or CD.

Key facts

Study ID

NCT03196427

Run by

Takeda

People needed

59

Starts

2018-07-30

Expected to finish

2025-07-17

Last updated by the study team

2026-05-13

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Is male or female with UC or CD and was between 2 to 17 years, inclusive, at the time of randomization for Study MLN0002-2003.
• (Note: A participant remains eligible to participate in this study after they reach 18 years of age if they continue to meet the inclusion criteria and do not meet any exclusion criteria.)
• Has completed Study MLN0002-2003 and, at Week 22, achieved clinical response as defined by a reduction of partial Mayo score of >=2 points and >=25% from Baseline, or a reduction of the Paediatric Ulcerative Colitis Activity Index (PUCAI) of >=20 points from baseline for participants with UC; or a reduction of the CDAI as defined by a >=70-point decrease from Baseline or a decrease of Pediatric Crohn's Disease Activity Index (PCDAI) of >=15 points for participants with CD.
• May be receiving a therapeutic dose of the following drugs:
• Oral 5-aminosalicylic acid (5-ASA) compounds.
• Oral corticosteroid therapy (prednisone or equivalent steroid at a dose less than or equal to [<=] 50 milligram per day [mg/day]) provided the participant was receiving this medication during prior participation in MLN0002-2003.
• Topical (rectal) treatment with 5-ASA or corticosteroids.
• Probiotics (example, Saccharomyces boulardii).
• Antidiarrheals (example, loperamide, diphenoxylate with atropine) for control of chronic diarrhea.
• Antibiotics used for the treatment of CD (i.e., ciprofloxacin, metronidazole).
• Azathioprine (AZA) or 6-mercaptopurine (6-MP) or methotrexate (MTX), provided the participant was receiving this medication during prior participation in MLN0002-2003.
• The participant's vaccinations are up to date as per inclusion criteria number 10 in MLN0002-2003.

You may not qualify if…

• Is female and is lactating or pregnant.
• Has hypersensitivity or allergies to vedolizumab or any of its excipients.
• Has withdrawn from Study MLN0002-2003.
• Has developed any new unstable or uncontrolled cardiovascular, heart failure moderate to severe (New York Class Association III or IV), pulmonary, hepatic, renal, gastrointestinal (GI), genitourinary, hematological, coagulation, immunological, endocrine/metabolic, neurological, or other medical disorder that, in the opinion of the investigator, would confound the study results or compromise participant safety.
• Has a positive progressive multifocal leukoencephalopathy (PML) subjective symptom checklist prior to the administration of the first dose of study drug.
• Currently requires major surgical intervention for UC or CD (example, bowel resection), or is anticipated to require major surgical intervention for UC or CD during the study.
• Has other serious comorbidities that will limit his or her ability to complete the study.

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Children's Hospital of Orange County — Orange, California, United States
• University of California San Francisco — San Francisco, California, United States
• Connecticut Children's Medical Center — Hartford, Connecticut, United States
• Nemours Childrens Specialty Care - Jacksonville — Jacksonville, Florida, United States
• Children's Center for Digestive Healthcare — Atlanta, Georgia, United States
• Columbia University Medical Center — New York, New York, United States
• Texas Children's Hospital — Houston, Texas, United States
• Seattle Children's Hospital — Seattle, Washington, United States
• Hopital Necker-Enfants Malades — Paris, Île-de-France Region, France
• BAZ Megyei Korhaz es Egyetemi Oktatokorhaz — Miskolc, Borsod-Abauj Zemplen county, Hungary
• Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont — Szeged, Csongrád megye, Hungary
• Debreceni Egyetem Klinikai Kozpont — Debrecen, Hajdú-Bihar, Hungary
• The Edmond and Lily Safra Children's Hospital - Sheba Medical Center — Ramat Gan, Tel Aviv, Israel
• Carmel Medical Center — Haifa, Israel
• Shaare Zedek Medical Center — Jerusalem, Israel
• Schneider Children's Medical Center of Israel — Petach Tiqwa, Israel
• Tel Aviv Sourasky Medical Center — Tel Aviv, Israel
• Uniwersytecki Szpital Dzieciecy w Krakowie — Krakow, Lesser Poland Voivodeship, Poland
• Gabinet Lekarski Dr. Hab. N. Med. Bartosz Korczowski — Rzeszów, Podkarpackie Voivodeship, Poland
• Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi Osrodek Pediatryczny im Marii Konopnic — Lodz, Łódź Voivodeship, Poland
• Kharkiv Regional Clinical Children's Hospital — Kharkiv, Ukraine
• Barts and The London NHS Trust — London, England, United Kingdom

Full record on ClinicalTrials.gov

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