RecruitingRecruiting
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: 2033-02-07
Last updated: 2026-05-07
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 (98)
University of South Alabama (USA) Physicians GroupNot Yet Recruiting
Mobile, Alabama, United States
Phoenix Childrens Hospital - Thomas Rd - PINRecruiting
Phoenix, Arizona, United States
Cedars Sinai Medical Center - 127 San Vicente BlvdWithdrawn
Los Angeles, California, United States
Rady Children's Hospital - San Diego - PINNot Yet Recruiting
San Diego, California, United States
University of California San FranciscoWithdrawn
San Francisco, California, United States
I.H.S Health LLC-Kissimmee-445 W Oak StWithdrawn
Kissimmee, Florida, United States
Childrens Center For Digestive HealthcareNot Yet Recruiting
Atlanta, Georgia, United States
Advocate Children's Hospital - Park Ridge - PINRecruiting
Park Ridge, Illinois, United States
Riley Hospital For Children - PINWithdrawn
Indianapolis, Indiana, United States
Johns Hopkins UniversityWithdrawn
Baltimore, Maryland, United States
Boston Children's Hospital - PINWithdrawn
Boston, Massachusetts, United States
MNGI Digestive Health PA-PlymouthTerminated
Minneapolis, Minnesota, United States
Mayo Clinic - PINTerminated
Rochester, Minnesota, United States
Goryeb Children's HospitalTerminated
Morristown, New Jersey, United States
Cohen Children's Medical Center Northwell - BRANY - PPDS - PINWithdrawn
New Hyde Park, New York, United States
University of Rochester Medical Center - PPDSWithdrawn
Rochester, New York, United States
Stony Brook University Medical CenterWithdrawn
Stony Brook, New York, United States
University Hospitals Cleveland Medical Center - 11100 Euclid AveNot Yet Recruiting
Cleveland, Ohio, United States
UPMC Children's Hospital of Pittsburgh - Adolescent Medicine (Oakland) - PINWithdrawn
Pittsburgh, Pennsylvania, United States
Hasbro Children's Hospital - PINWithdrawn
Providence, Rhode Island, United States
Texas Children's Hospital - Baylor - PINNot Yet Recruiting
Houston, Texas, United States
Carilion Children's Tanglewood CenterRecruiting
Roanoke, Virginia, United States
Children's Hospital at WestmeadRecruiting
Westmead, New South Wales, Australia
Queensland Childrens HospitalRecruiting
South Brisbane, Queensland, Australia
Monash Health, Monash Medical CentreNot Yet Recruiting
Clayton, Victoria, Australia
Royal Children's Hospital Melbourne - PINRecruiting
Parkville, Victoria, Australia
UZ Antwerpen - PINRecruiting
Edegem, Antwerpen, Belgium
UZ Brussel - PINRecruiting
Jette, Brussels Capital, Belgium
UZ LeuvenRecruiting
Leuven, Vlaams Brabant, Belgium
University of Alberta HospitalWithdrawn
Edmonton, Alberta, Canada
British Columbia Children's Hospital - 4480 Oak StWithdrawn
Vancouver, British Columbia, Canada
London Health Sciences Centre -800 Commissioners Rd ETerminated
London, Ontario, Canada
Centre Hospitalier Universitaire Sainte-JustineWithdrawn
Montreal, Quebec, Canada
Beijing Children's Hospital, Capital Medical University - PINNot Yet Recruiting
Beijing, Beijing Municipality, China
Henan Children's Hospital Zhengzhou Children's Hospital - Zhengdong CampusRecruiting
Zhengzhou, Henan, China
Hunan Children's HospitalRecruiting
Changsha, Hunan, China
Children's Hospital of Fudan UniversityRecruiting
Shanghai, Shanghai Municipality, China
The Children's Hospital Zhejiang University School of Medicine - Binjiang CampusRecruiting
Hangzhou, Zhejiang, China
Children's Hospital ZagrebRecruiting
Zagreb, City of Zagreb, Croatia
University Hospital Center ZagrebWithdrawn
Zagreb, City of Zagreb, Croatia
University Hospital of Split-Spinciceva 1Withdrawn
Split, Croatia
Fakultni nemocnice Kralovske VinohradyWithdrawn
Prague, Praha, Hlavni Mesto, Czechia
Fakultni Thomayerova NemocniceWithdrawn
Prague, Praha, Hlavni Mesto, Czechia
University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARARecruiting
Athens, Attica, Greece
Children's Hospital Agia SofiaRecruiting
Athens, Greece
General Hospital of Thessaloniki ''Hippokratio''Withdrawn
Thessaloniki, Greece
General Hospital of Thessaloniki ''Hippokratio''Recruiting
Thessaloniki, Greece
Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi OktatokorhazRecruiting
Miskolc, Borsod-Abauj Zemplen county, Hungary
Szegedi Tudomanyegyetem, SZAKK, Borgyogyaszati es Allergologiai KlinikaWithdrawn
Szeged, Csongrád megye, Hungary
Clinexpert Obuda EgeszsegcentrumaTerminated
Budapest, Hungary
Semmelweis Egyetem, Pulmonologiai KlinikaRecruiting
Budapest, Hungary
Tel Aviv Sourasky Medical Center Ichilov - PPDSRecruiting
Jerusalem, Jerusalem, Israel
Shaare Zedek Medical CenterRecruiting
Jerusalem, Jerusalem, Israel
Soroka University Medical CentreWithdrawn
Beersheba, Israel
Rambam Health Care Campus PPDSRecruiting
Haifa, Israel
Carmel Medical CenterRecruiting
Haifa, Israel
Hadassah Medical Center- Ein Kerem - PPDSRecruiting
Jerusalem, Israel
Schneider Childrens Medical Center of Israel Petah Tikvah PINTerminated
Petah Tikva, Israel
Azienda Ospedaliera Universitaria Federico IIRecruiting
Naples, Campania, Italy
Azienda Ospedaliera Universitaria Luigi Vanvitelli - Piazza Luigi Miraglia 2Recruiting
Naples, Campania, Italy
Azienda USL di BolognaRecruiting
Bologna, Emilia-Romagna, Italy
Sapienza University of RomeRecruiting
Rome, Lazio, Italy
Fondazione IRCCS San Gerardo dei TintoriTerminated
Monza, Lombardy, Italy
Azienda Ospedaliero Universitaria A MeyerTerminated
Florence, Tuscany, Italy
Universita degli Studi di PadovaWithdrawn
Padova, Veneto, Italy
Kurume University HospitalRecruiting
Kurume-Shi, Hukuoka, Japan
Japanese Red Cross Kumamoto HospitalRecruiting
Kumamoto, Kumamoto, Japan
Saitama Children's Medical Center-1397-1 yamaneRecruiting
Hidaka, Saitama, Japan
Juntendo University HospitalRecruiting
Bunkyo-Ku, Tokyo, Japan
National Center for Child Health and DevelopmentRecruiting
Setagaya-Ku, Tokyo, Japan
Hospital of Lithuanian University of Health Sciences Kaunas ClinicsWithdrawn
Kaunas, Kaunas County, Lithuania
Vilnius University Hospital Santaros KlinikosWithdrawn
Vilnius, Vilnius County, Lithuania
Uniwersytecki Szpital Dzieciecy w KrakowieRecruiting
Krakow, Lesser Poland Voivodeship, Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu-ul.Ludwika Pasteura 4Withdrawn
Wroclaw, Lower Silesian Voivodeship, Poland
WIP Warsaw IBD Point Profesor KierkusRecruiting
Warsaw, Masovian Voivodeship, Poland
Instytut Pomnik Centrum Zdrowia DzieckaRecruiting
Warsaw, Masovian Voivodeship, Poland
Korczowski Bartosz, Gabinet LekarskiRecruiting
Rzeszów, Podkarpackie Voivodeship, Poland
Copernicus Podmiot Leczniczy Sp. z o.o. - al. Jana Pawla II 50Withdrawn
Gdansk, Pomeranian Voivodeship, Poland
Gornoslaskie Centrum Zdrowia Dziecka Im. Sw. Jana Pawla II Spsk Nr 6 Sum W KatowicachWithdrawn
Katowice, Silesian Voivodeship, Poland
Twoja Przychodnia SCM - SlowackiegoRecruiting
Szczecin, West Pomeranian Voivodeship, Poland
SPZOZ Centralny Szpital Kliniczny UM w Lodzi - ul. Pomorska 251Recruiting
Lodz, Poland
Instytut Centrum Zdrowia Matki PolkiRecruiting
Lodz, Łódź Voivodeship, Poland
Narodny ustav detskych chorobWithdrawn
Bratislava, Slovakia
Kyungpook National University Chilgok hospitalRecruiting
Daegu, Daegu Gwang'yeogsi, South Korea
Gachon University Gil Medical CenterTerminated
Incheon, Incheon Gwang'yeogsi, South Korea
Seoul National University HospitalRecruiting
Seoul, South Korea
Samsung Medical CenterRecruiting
Seoul, South Korea
Hospital de SaguntoWithdrawn
Sagunto, Valencia, Spain
Hospital Sant Joan de Deu - PINWithdrawn
Barcelona, Spain
Hospital Infantil Universitario Nino Jesus - PINWithdrawn
Madrid, Spain
Hospital Regional Universitario de Malaga Hospital Materno-InfantilWithdrawn
Málaga, Spain
Hospital Universitario Virgen del Rocio - PPDSWithdrawn
Seville, Spain
Great Ormond Street HospitalWithdrawn
London, London, City of, United Kingdom
Noahs Ark Childrens Hospital for Wales - PINWithdrawn
Cardiff, South Glamorgan, United Kingdom
King's College HospitalWithdrawn
London, Surrey, United Kingdom
Birmingham Women's and Children's NHS Foundation TrustRecruiting
Birmingham, Warwickshire, United Kingdom
Barts Health NHS Trust - PPDSNot Yet Recruiting
London, United Kingdom
Royal Manchester Children's Hospital - PPDS - PINWithdrawn
Manchester, United Kingdom