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A Study of Vedolizumab in Children With Ulcerative Colitis (UC) or Crohn's Disease (CD)
NCT05442567 · Takeda
In plain English
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Official title
A Phase 3b Extension Study to Evaluate the Long-term Safety of Vedolizumab Intravenous in Pediatric Patients With Ulcerative Colitis or Crohn's Disease
About this study
This multi-center trial is conducted worldwide. Up to 240 patients would be enrolled from Studies MLN0002-3024 \[participants with UC\] and MLN0002-3025 \[participants with CD\], either in the Treatment Cohort or in the Observational Cohort. Approximately 93 participants who have previously participated either in study MLN0002-3024 or MLN0002-3025, referred to as parent study, are expected to roll over to the MLN0002-3029 study in the treatment cohort.
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.
Eligibility criteria
Main Inclusion Criteria:
For Treatment Cohort:
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.
Main Exclusion Criteria:
For Treatment Cohort only:
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.
Study design
Enrollment target: 240 participants
Allocation: non_randomized
Masking: none
Age groups: child, adult, older_adult
Timeline
Starts: 2023-05-16
Estimated completion: 2031-08-15
Last updated: 2026-04-16
Interventions
Drug: Vedolizumab IVOther: No Intervention
Primary outcomes
- • Treatment Cohort: Number of Participants With at Least One Adverse Event (AE) (From first dose of study drug up to approximately 5 years)
- • Observational Cohort: Number of Participants With Prespecified Safety Events (Up to approximately 2 years)
Sponsor
Takeda · industry
Contacts & investigators
ContactTakeda Contact · contact · medinfoUS@takeda.com · +1-877-825-3327
InvestigatorStudy Director · study_director, Takeda
All locations (68)
Phoenix Childrens Hospital -1919 E Thompson RdRecruiting
Phoenix, Arizona, United States
Rady Childrens Hospital San Diego - PINNot Yet Recruiting
San Diego, California, United States
Childrens Center For Digestive HealthcareNot Yet Recruiting
Atlanta, Georgia, United States
Advocate Children's Hospital Park RidgeNot Yet Recruiting
Park Ridge, Illinois, United States
Johns Hopkins UniversityNot Yet Recruiting
Baltimore, Maryland, United States
Boston Children's HospitalNot Yet Recruiting
Boston, Massachusetts, United States
MNGI Digestive Health PA-PlymouthRecruiting
Minneapolis, Minnesota, United States
Mayo Clinic - PINNot Yet Recruiting
Rochester, Minnesota, United States
Goryeb Children's HospitalNot Yet Recruiting
Morristown, New Jersey, United States
The Steven and Alexandra Cohen Childrens Medical Center of New York - BRANY - PPDSNot Yet Recruiting
New Hyde Park, New York, United States
University Hospitals Cleveland Medical CenterNot Yet Recruiting
Cleveland, Ohio, United States
Children's Hospital of PittsburghNot Yet Recruiting
Pittsburgh, Pennsylvania, United States
Texas Children's HospitalNot Yet Recruiting
Houston, Texas, United States
Carilion Children's Tanglewood CenterNot Yet Recruiting
Roanoke, Virginia, United States
Children's Hospital at WestmeadRecruiting
Westmead, New South Wales, Australia
Queensland Childrens HospitalNot Yet Recruiting
South Brisbane, Queensland, Australia
Monash Health, Monash Medical CentreNot Yet Recruiting
Clayton, Victoria, Australia
Royal Children's Hospital Melbourne - PINRecruiting
Parkville, Victoria, Australia
UZ AntwerpenNot Yet Recruiting
Edegem, Antwerpen, Belgium
Universitair Ziekenhuis Brussel - PINNot Yet Recruiting
Jette, Brussels Capital, Belgium
UZ LeuvenRecruiting
Leuven, Vlaams Brabant, Belgium
University of Alberta HospitalNot Yet Recruiting
Edmonton, Alberta, Canada
British Columbia Children's HospitalNot Yet Recruiting
Vancouver, British Columbia, Canada
London Health Sciences CentreNot Yet Recruiting
London, Ontario, Canada
Beijing Children Hospital,Capital Medical UniversityNot Yet Recruiting
Beijing, Beijing Municipality, China
Henan Children's Hospital (Zhengzhou Children's Hospital)Recruiting
Zhengzhou, Henan, China
Children's Hospital of Fudan UniversityRecruiting
Shanghai, Shanghai Municipality, China
The Children's Hospital Zhejiang UniversitySchool of MedicineNot Yet Recruiting
Hangzhou, Zhejiang, China
Klinika Za Djecje Bolesti ZagrebRecruiting
Zagreb, City of Zagreb, Croatia
Attikon University General HospitalNot Yet Recruiting
Athens, Attica, Greece
Children's Hospital "Agia Sofia"Not Yet Recruiting
Athens, Greece
Ippokratio General Hospital of ThessalonikiRecruiting
Thessaloniki, Greece
Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktato KorhazNot Yet Recruiting
Miskolc, Borsod-Abauj Zemplen county, Hungary
Semmelweis EgyetemRecruiting
Budapest, Hungary
Schneider Childrens Medical Center of Israel Petah Tikvah PINNot Yet Recruiting
Petah Tikva, Central District, Israel
Hadassah Medical Center - PPDSRecruiting
Jerusalem, Jerusalem, Israel
Rambam Medical Center - PPDSRecruiting
Haifa, Israel
Carmel Medical CenterNot Yet Recruiting
Haifa, Israel
Shaare Zedek Medical CenterNot Yet Recruiting
Jerusalem, Israel
Tel Aviv Sourasky Medical Center PPDSRecruiting
Tel Aviv, Israel
AOU dell'Universita degli Studi della Campania Luigi VanvitelliNot Yet Recruiting
Naples, Campania, Italy
Azienda Ospedaliera Universitaria Federico IINot Yet Recruiting
Naples, Campania, Italy
Azienda USL di BolognaRecruiting
Bologna, Emilia-Romagna, Italy
Sapienza University of RomeNot Yet Recruiting
Rome, Lazio, Italy
Fondazione IRCCS San Gerardo dei Tintori - ASST di Monza A. O. San GerardoRecruiting
Monza, Lombardy, Italy
Universita degli Studi di PadovaNot Yet Recruiting
Padova, Veneto, Italy
Kurume University HospitalNot Yet Recruiting
Kurume-Shi, Hukuoka, Japan
Japanese Red Cross Kumamoto HospitalNot Yet Recruiting
Kumamoto, Kumamoto, Japan
Juntendo University HospitalNot Yet Recruiting
Bunkyo-Ku, Tokyo, Japan
National Center for Child Health and DevelopmentNot Yet Recruiting
Setagaya-Ku, Tokyo, Japan
Uniwersytecki Szpital DzieciecyNot Yet Recruiting
Krakow, Lesser Poland Voivodeship, Poland
WIP Warsaw IBD Point Profesor KierkusNot Yet Recruiting
Warsaw, Masovian Voivodeship, Poland
Instytut Pomnik Centrum Zdrowia DzieckaNot Yet Recruiting
Warsaw, Masovian Voivodeship, Poland
Korczowski Bartosz, Gabinet LekarskiNot Yet Recruiting
Rzeszów, Podkarpackie Voivodeship, Poland
Gornoslaskie Centrum Zdrowia Dziecka Im. Sw. Jana Pawla II Spsk Nr 6 Sum W KatowicachNot Yet Recruiting
Katowice, Silesian Voivodeship, Poland
Twoja Przychodnia SCMRecruiting
Szczecin, West Pomeranian Voivodeship, Poland
SPZOZ Centralny Szpital Kliniczny UM w LodziNot Yet Recruiting
Lodz, Poland
Instytut Centrum Zdrowia Matki PolkiNot Yet Recruiting
Lodz, Łódź Voivodeship, Poland
Narodny ustav detskych chorobNot Yet Recruiting
Bratislava, Slovakia
Kyungpook National University Chilgok hospitalNot Yet Recruiting
Daegu, Daegu Gwang'yeogsi, South Korea
Gachon University Gil Medical CenterNot Yet Recruiting
Incheon, Incheon Gwang'yeogsi, South Korea
Seoul National University HospitalNot Yet Recruiting
Seoul, South Korea
Samsung Medical Center - PPDSNot Yet Recruiting
Seoul, South Korea
Great Ormond Street Hospital (GOSH)Not Yet Recruiting
London, London, City of, United Kingdom
Noahs Ark Childrens Hospital for Wales - PPDS - PINNot Yet Recruiting
Cardiff, South Glamorgan, United Kingdom
Birmingham Children's Hospital NHS Foundation TrustNot Yet Recruiting
Birmingham, West Midlands, United Kingdom
Barts Health NHS TrustNot Yet Recruiting
London, United Kingdom
Royal Manchester Children's Hospital - PPDSNot Yet Recruiting
Manchester, United Kingdom