Long-term Safety With Vedolizumab Intravenous (IV) in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD)
A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn's Disease
6 other identifiers
interventional
59
7 countries
23
Brief Summary
The purpose of this study is to determine the safety profile of long-term vedolizumab IV treatment in pediatric participants with UC or CD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2018
Longer than P75 for phase_2
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 20, 2017
CompletedFirst Posted
Study publicly available on registry
June 22, 2017
CompletedStudy Start
First participant enrolled
July 30, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 3, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 17, 2025
CompletedResults Posted
Study results publicly available
March 13, 2026
CompletedMarch 13, 2026
February 1, 2026
6.7 years
June 20, 2017
January 14, 2026
February 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
AE defined as any untoward medical occurrence in clinical investigation participants administered drug; it does not necessarily have to have causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug whether or not it was considered related to the drug. TEAE was defined as an AE whose date of onset occurred on or after the first dose of study drug, or an already-present AE that worsened in intensity or frequency following the treatment start, occurring from the first dose of study drug to the day of last dose of study drug.
From first dose of study drug up to end of follow up (up to 6.8 years)
Secondary Outcomes (15)
Percentage of Participants With UC Who Achieved and Maintained Clinical Response Based on Complete Mayo Score
At Week 32
Percentage of Participants With CD Who Achieved and Maintained Clinical Response Based on Simple Endoscopic Score for Crohn's Disease (SES-CD) Score and Crohn's Disease Activity Index (CDAI) at Week 32
At Week 32
Time to Major Inflammatory Bowel Disease (IBD) - Related Events
Up to 6.8 years
Change From Baseline in IMPACT-III - Total Score
Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, and 312
Change From Baseline in IMPACT-III - Bowel Symptoms Domain Score
Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, and 312
- +10 more secondary outcomes
Study Arms (2)
Vedolizumab High Dose Group
EXPERIMENTALParticipants with UC or CD having baseline weight of greater than or equal to (\>=) 30 kilogram (kg) will receive vedolizumab 300 mg and participants with UC or CD having baseline weight of less than (\<) 30 kg will receive vedolizumab 200 mg, IV infusion, every 8 weeks until vedolizumab IV is commercially available for pediatric indication(s) in the participant's country or until other drug access programs become available (whichever comes first), the participant turns 18 years of age and can be transitioned to commercial drug (up to approximately 8 years).
Vedolizumab Low Dose Group
EXPERIMENTALParticipants with UC or CD having baseline weight of \>= 30 kg will receive vedolizumab 150 mg and participants with UC or CD having baseline weight of \< 30 kg will receive vedolizumab 100 mg IV infusion, every 8 weeks until vedolizumab IV is commercially available for pediatric indication(s) in the participant's country or until other drug access programs become available (whichever comes first), the participant turns 18 years of age and can be transitioned to commercial drug (up to approximately 8 years).
Interventions
Vedolizumab intravenous infusion
Eligibility Criteria
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.
You may not qualify if:
- 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.
- 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.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
- Takeda Development Center Americas, Inc.collaborator
Study Sites (23)
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Children's Hospital of Orange County
Orange, California, 92868, United States
University of California San Francisco
San Francisco, California, 94158, United States
Connecticut Children's Medical Center
Hartford, Connecticut, 06106-3322, United States
Nemours Childrens Specialty Care - Jacksonville
Jacksonville, Florida, 32207, United States
Children's Center for Digestive Healthcare
Atlanta, Georgia, 30342, United States
Columbia University Medical Center
New York, New York, 10031, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
Hopital Necker-Enfants Malades
Paris, Île-de-France Region, 75015, France
BAZ Megyei Korhaz es Egyetemi Oktatokorhaz
Miskolc, Borsod-Abauj Zemplen county, 3526, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Szeged, Csongrád megye, 6720, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, Hajdú-Bihar, 4032, Hungary
The Edmond and Lily Safra Children's Hospital - Sheba Medical Center
Ramat Gan, Tel Aviv, 52621, Israel
Carmel Medical Center
Haifa, 3436212, Israel
Shaare Zedek Medical Center
Jerusalem, 9103102, Israel
Schneider Children's Medical Center of Israel
Petach Tiqwa, 4920235, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906, Israel
Uniwersytecki Szpital Dzieciecy w Krakowie
Krakow, Lesser Poland Voivodeship, 30-663, Poland
Gabinet Lekarski Dr. Hab. N. Med. Bartosz Korczowski
Rzeszów, Podkarpackie Voivodeship, 35-302, Poland
Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi Osrodek Pediatryczny im Marii Konopnic
Lodz, Łódź Voivodeship, 91-738, Poland
Kharkiv Regional Clinical Children's Hospital
Kharkiv, 61093, Ukraine
Barts and The London NHS Trust
London, England, E1 1BB, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Takeda
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2017
First Posted
June 22, 2017
Study Start
July 30, 2018
Primary Completion
April 3, 2025
Study Completion
July 17, 2025
Last Updated
March 13, 2026
Results First Posted
March 13, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.