A Study of Vedolizumab in Children With Ulcerative Colitis (UC) or Crohn's Disease (CD)
NCT ID: NCT05442567
Last Updated: 2025-04-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
240 participants
INTERVENTIONAL
2023-05-16
2031-08-15
Brief Summary
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Detailed Description
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Treatment Cohort:
The drug being tested in this study is called vedolizumab, being studied to treat pediatric patients who have UC or CD.
Participants eligible for the Treatment Cohort can be administered vedolizumab intravenous (IV) at Week 54 visit of parent study or up to 1 week after Week 54 of the parent study based on the availability of test results needed to assess eligibility of the participant. At this study entry, participants will be administered the same blinded dose of vedolizumab IV that was received at Week 46 in the parent study and will then continue to receive vedolizumab IV at a frequency of once every 8 weeks (Q8W) in the following treatment groups:
* Participants 10 to ≤15 kilogram (kg), Vedolizumab 150 milligram (mg) (High dose)
* Participants 10 to ≤15 kg, Vedolizumab 100 mg (Low dose)
* Participants \>15 to \<30 kg, Vedolizumab 200 mg (High dose)
* Participants \>15 to \<30 kg, Vedolizumab 100 mg (Low dose)
* Participants ≥30 kg, Vedolizumab 300 mg (High dose)
* Participants ≥30 kg, Vedolizumab 150 mg (Low dose)
Blinding of dose group assignment of the parent study will continue until the respective parent study is unblinded in order to protect the blinding of the parent study.
The overall time to participate in the Treatment Cohort of this study is up to participant withdrawal, or until vedolizumab IV is commercially available for pediatric indication(s) in the participant's country or until other drug access programs become available, or Sponsor's decision for study closure, or for up to approximately 5 years, whichever comes first. Participants who complete or are discontinued from the study for any reason will complete the final safety/end of study (EOS) visit 18 weeks after their last dose of study drug.
Observational Cohort:
Participants who received at least 1 dose of study drug during parent study and early terminated or are not eligible for the Treatment Cohort of this study after completion of the Week 54 visit of parent study, will be enrolled in the Observational Cohort of this study as part of a long-term follow-up period to assess prespecified safety events of interest and will not receive continued treatment with vedolizumab IV.
The overall time to participate in the Observational Cohort is up to approximately 2 years.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment Cohort: Participants 10 to ≤15 kg, Vedolizumab 150 mg
Eligible participants from studies MLN0002-3024 or MLN0002-3025 weighing 10 to ≤15 kg will receive vedolizumab 150 mg, IV infusion, Q8W, (same as their Week 46 dose in parent study) in this study for up to approximately 5 years.
Vedolizumab IV
Vedolizumab IV infusion
Treatment Cohort: Participants 10 to ≤15 kg, Vedolizumab 100 mg
Eligible participants from studies MLN0002-3024 or MLN0002-3025 weighing 10 to ≤15 kg will receive vedolizumab 100 mg, IV infusion, Q8W, (same as their Week 46 dose in parent study) in this study for up to approximately 5 years.
Vedolizumab IV
Vedolizumab IV infusion
Treatment Cohort: Participants >15 to <30 kg, Vedolizumab 200 mg
Eligible participants from studies MLN0002-3024 or MLN0002-3025 weighing \>15 to \<30 kg will receive vedolizumab 200 mg, IV infusion, Q8W, (same as their Week 46 dose in parent study) in this study for up to approximately 5 years.
Vedolizumab IV
Vedolizumab IV infusion
Treatment Cohort: Participants >15 to <30 kg, Vedolizumab 100 mg
Eligible participants from studies MLN0002-3024 or MLN0002-3025 weighing \>15 to \<30 kg will receive vedolizumab 100 mg, IV infusion, Q8W, (same as their Week 46 dose in parent study) in this study for up to approximately 5 years.
Vedolizumab IV
Vedolizumab IV infusion
Treatment Cohort: Participants ≥30 kg, Vedolizumab 300 mg
Eligible participants from studies MLN0002-3024 or MLN0002-3025 weighing ≥30 kg will receive vedolizumab 300 mg, IV infusion, Q8W, (same as their Week 46 dose in parent study) in this study for up to approximately 5 years.
Vedolizumab IV
Vedolizumab IV infusion
Treatment Cohort: Participants ≥30 kg, Vedolizumab 150 mg
Eligible participants from studies MLN0002-3024 or MLN0002-3025 weighing ≥30 kg will receive vedolizumab 150 mg, IV infusion, Q8W, (same as their Week 46 dose in parent study) in this study for up to approximately 5 years.
Vedolizumab IV
Vedolizumab IV infusion
Observational Cohort: Early Terminated Participants From Parent Studies
Participants will have assessment visits at Day 1 and Weeks 8, 34, 60, and 86 as part of a long-term follow-up period to assess prespecified safety events of interest and to monitor growth and pubertal development for approximately 2 years after their last dose of study drug in parent study.
No Intervention
Participants will not receive any intervention in the Observational Cohort.
Interventions
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Vedolizumab IV
Vedolizumab IV infusion
No Intervention
Participants will not receive any intervention in the Observational Cohort.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. The participant should have completed Study MLN0002-3024 or Study MLN0002-3025 and achieved corticosteroid-free clinical response at Week 54 (and has tapered off of steroids, as applicable, at least 12 weeks before Week 54) as defined by a reduction of partial Mayo score of ≥2 points and ≥25% from baseline for participants with UC, or by a decrease of pediatric Crohn's disease activity index (PCDAI) of ≥15 points for participants with CD and with total PCDAI ≤30.
2. A male participant who is sexually active with a female partner of childbearing potential agrees to use a barrier method of contraception (e.g., condom with or without spermicide) from signing of participant/parental informed consent and/or pediatric assent throughout the duration of the study and for 18 weeks after last dose. The female partner of a male participant should also be advised to use a highly effective method of contraception.
3. A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use a highly effective method of contraception from signing of participant/parental informed consent and/or pediatric assent throughout the duration of the study and 18 weeks after the last dose.
For Observational Cohort:
1\. The participant has received at least 1 dose of vedolizumab during Study MLN0002-3024 or Study MLN0002-3025 and early terminated OR completed the Week 54 visit of Study MLN0002-3024 or Study MLN0002-3025 but was not eligible to enroll in the treatment cohort of this study.
Exclusion Criteria
1. The participant currently requires major surgical intervention for UC or CD (e.g., bowel resection), or is anticipated to require major surgical intervention for UC or CD during the study.
2. The participant 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.
3. The participant has other serious comorbidities that will limit their ability to complete the study.
4. The participant is unable to comply with all study assessments.
5. The participant has hypersensitivity or allergies to any of the vedolizumab excipients.
6. The participant is lactating or pregnant.
2 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Phoenix Childrens Hospital -1919 E Thompson Rd
Phoenix, Arizona, United States
Rady Childrens Hospital San Diego - PIN
San Diego, California, United States
Childrens Center For Digestive Healthcare
Atlanta, Georgia, United States
Advocate Children's Hospital Park Ridge
Park Ridge, Illinois, United States
Johns Hopkins University
Baltimore, Maryland, United States
Boston Children's Hospital
Boston, Massachusetts, United States
MNGI Digestive Health PA-Plymouth
Minneapolis, Minnesota, United States
Mayo Clinic - PIN
Rochester, Minnesota, United States
Goryeb Children's Hospital
Morristown, New Jersey, United States
The Steven and Alexandra Cohen Childrens Medical Center of New York - BRANY - PPDS
New Hyde Park, New York, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Texas Children's Hospital
Houston, Texas, United States
Carilion Children's Tanglewood Center
Roanoke, Virginia, United States
Children's Hospital at Westmead
Westmead, New South Wales, Australia
Queensland Childrens Hospital
South Brisbane, Queensland, Australia
Monash Health, Monash Medical Centre
Clayton, Victoria, Australia
Royal Children's Hospital Melbourne - PIN
Parkville, Victoria, Australia
UZ Antwerpen
Edegem, Antwerpen, Belgium
Universitair Ziekenhuis Brussel - PIN
Jette, Brussels Capital, Belgium
UZ Leuven
Leuven, Vlaams Brabant, Belgium
University of Alberta Hospital
Edmonton, Alberta, Canada
British Columbia Children's Hospital
Vancouver, British Columbia, Canada
London Health Sciences Centre
London, Ontario, Canada
Beijing Children Hospital,Capital Medical University
Beijing, Beijing Municipality, China
Henan Children's Hospital (Zhengzhou Children's Hospital)
Zhengzhou, Henan, China
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China
The Children's Hospital Zhejiang UniversitySchool of Medicine
Hangzhou, Zhejiang, China
Klinika Za Djecje Bolesti Zagreb
Zagreb, City of Zagreb, Croatia
Attikon University General Hospital
Athens, Attica, Greece
Children's Hospital "Agia Sofia"
Athens, , Greece
Ippokratio General Hospital of Thessaloniki
Thessaloniki, , Greece
Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktato Korhaz
Miskolc, Borsod-Abauj Zemplen county, Hungary
Semmelweis Egyetem
Budapest, , Hungary
Schneider Childrens Medical Center of Israel Petah Tikvah PIN
Petah Tikva, Central District, Israel
Hadassah Medical Center - PPDS
Jerusalem, Jerusalem, Israel
Rambam Medical Center - PPDS
Haifa, , Israel
Carmel Medical Center
Haifa, , Israel
Shaare Zedek Medical Center
Jerusalem, , Israel
Tel Aviv Sourasky Medical Center PPDS
Tel Aviv, , Israel
AOU dell'Universita degli Studi della Campania Luigi Vanvitelli
Napoli, Campania, Italy
Azienda Ospedaliera Universitaria Federico II
Napoli, Campania, Italy
Azienda USL di Bologna
Bologna, Emilia-Romagna, Italy
Sapienza University of Rome
Rome, Lazio, Italy
Fondazione IRCCS San Gerardo dei Tintori - ASST di Monza A. O. San Gerardo
Monza, Lombardy, Italy
Universita degli Studi di Padova
Padua, Veneto, Italy
Kurume University Hospital
Kurume-Shi, Hukuoka, Japan
Japanese Red Cross Kumamoto Hospital
Kumamoto, Kumamoto, Japan
Juntendo University Hospital
Bunkyo-Ku, Tokyo, Japan
National Center for Child Health and Development
Setagaya-Ku, Tokyo, Japan
Uniwersytecki Szpital Dzieciecy
Krakow, Lesser Poland Voivodeship, Poland
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, Masovian Voivodeship, Poland
Instytut Pomnik Centrum Zdrowia Dziecka
Warsaw, Masovian Voivodeship, Poland
Korczowski Bartosz, Gabinet Lekarski
Rzeszów, Podkarpackie Voivodeship, Poland
Gornoslaskie Centrum Zdrowia Dziecka Im. Sw. Jana Pawla II Spsk Nr 6 Sum W Katowicach
Katowice, Silesian Voivodeship, Poland
Twoja Przychodnia SCM
Szczecin, West Pomeranian Voivodeship, Poland
SPZOZ Centralny Szpital Kliniczny UM w Lodzi
Lodz, , Poland
Instytut Centrum Zdrowia Matki Polki
Lodz, Łódź Voivodeship, Poland
Narodny ustav detskych chorob
Bratislava, , Slovakia
Kyungpook National University Chilgok hospital
Daegu, Daegu Gwang'yeogsi, South Korea
Gachon University Gil Medical Center
Incheon, Incheon Gwang'yeogsi, South Korea
Seoul National University Hospital
Seoul, , South Korea
Samsung Medical Center - PPDS
Seoul, , South Korea
Great Ormond Street Hospital (GOSH)
London, London, City of, United Kingdom
Noahs Ark Childrens Hospital for Wales - PPDS - PIN
Cardiff, South Glamorgan, United Kingdom
Birmingham Children's Hospital NHS Foundation Trust
Birmingham, West Midlands, United Kingdom
Barts Health NHS Trust
London, , United Kingdom
Royal Manchester Children's Hospital - PPDS
Manchester, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Related Links
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To obtain more information about this study, click this link.
Other Identifiers
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2023-509046-36-00
Identifier Type: CTIS
Identifier Source: secondary_id
jRCT2071230036
Identifier Type: REGISTRY
Identifier Source: secondary_id
MLN0002-3029
Identifier Type: -
Identifier Source: org_study_id
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