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A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease

NCT06100289 · Takeda
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Official title
An Open-Label, Phase 3 Study to Evaluate the Pharmacokinetics, Safety, and Immunogenicity of Vedolizumab Subcutaneous in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy
About this study
The drug being tested in this study is vedolizumab. Vedolizumab is being tested to treat pediatric participants with moderate to severe active UC or CD who achieved clinical response following open-label vedolizumab intravenous (IV) therapy. The study will look at the pharmacokinetics, safety, and immunogenicity of vedolizumab. The study will enroll approximately 70 patients. During the Induction Period participants will receive 3 doses of vedolizumab IV infusion at Day 1, Week 2, and Week 6 based on their weight at Baseline as: * Participants ≥30 kilograms (kg), Vedolizumab (High Dose) * Participants \>15 to \<30 kg, Vedolizumab (Medium Dose) * Participants ≥10 to ≤15 kg, Vedolizumab (Low Dose) At Week 14, participants who achieve clinical response will be assigned to one of the following groups, stratified by weight to receive vedolizumab 108 mg SC injection during the 20-week Maintenance Period: * Participants ≥30 kg, Vedolizumab 108 mg once every 2 weeks (Q2W) * Participants ≥10 to \<30 kg, Vedolizumab 108 mg once every 4 weeks (Q4W) This multi-center trial will be conducted globally. After the Week 34 end of treatment (EOT) visit assessments have been completed, participants may be eligible to receive continued treatment with vedolizumab SC in an extension study, whereas participants who do not qualify to receive continued treatment in the extension study or participants who discontinue from the study for any reason will complete the EOT visit, and the follow-up safety visit (18 weeks after last dose).
Eligibility criteria
Inclusion Criteria: 1. The participant weighs ≥10 kg at the time of screening and enrollment into the study. 2. Participants with UC or CD diagnosed at least 1 month before screening. Participants with moderately to severely active disease defined as: * Participants with UC: a modified Mayo score of 5 to 9 (sum of Mayo endoscopic subscore, stool frequency subscore, and rectal bleeding subscore) with a Mayo endoscopic subscore of ≥2 (with the presence of mucosal friability excluding an endoscopic subscore of 1 and mandating a score of at least 2). (The results of screening endoscopy should be applied.) * Participants with CD: a pediatric Crohn's disease activity index (PCDAI) \>30 and a simple endoscopic score for Crohn's disease (SES-CD) \>6 (or an SES-CD ≥4 if disease is confined to terminal ileum) at screening endoscopy. 3. Participants who have failed, lost response to, or been intolerant to treatment with at least 1 of the following agents: corticosteroids, immunomodulators (for example, azathioprine \[AZA\], 6-mercaptopurine \[6-MP\], methotrexate \[MTX\]), and/or tumor necrosis factor (TNF)-α antagonist therapy (for example, infliximab, adalimumab). 4. Participants with evidence of UC extending proximal to the rectum (that is, not limited to proctitis), at a minimum. 5. Participants with extensive colitis or pancolitis of \>8 years' duration or left-sided colitis of \>12 years' duration must have documented evidence of a negative surveillance colonoscopy within 12 months before screening. 6. Participants with vaccinations that are up-to-date based on the countrywide accepted schedule of childhood vaccines. Exclusion Criteria: 1. Participants who have had previous exposure to approved or investigational anti-integrins, including but not limited to, natalizumab, efalizumab, etrolizumab, or abrilumab (AMG 181); or mucosal addressin cell adhesion molecule-1 (MAdCAM-1) antagonists (ontamalimab), or rituximab. 2. Participants who have had prior exposure to vedolizumab. 3. Participants with hypersensitivity or allergies to vedolizumab or any of its excipients. 4. Participants with active cerebral/meningeal disease, signs/symptoms or history of progressive multifocal leukoencephalopathy (PML) or any other major neurological disorders. 5. The participant has received any live vaccinations within 30 days before first dose of study drug. 6. Participants who currently require surgical intervention or are anticipated to require surgical intervention for UC or CD during this study. 7. Participants who have had subtotal or total colectomy or have a jejunostomy, ileostomy, colostomy, ileo-anal pouch, known fixed stenosis of the intestine, short bowel syndrome, or \>3 small intestine resections. 8. Participants with a current diagnosis of indeterminate colitis. 9. Participants with clinical features suggesting monogenic very early-onset inflammatory bowel disease (IBD). 10. Participants with active or latent tuberculosis (TB). 11. Participants with evidence of positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Hepatitis B virus (HBV) immune subjects (that is, HBsAg negative and hepatitis B surface antibody \[anti-HBs\]-positive) may, however, be included. 12. The participant has any identified congenital or acquired immunodeficiency (for example, common variable immunodeficiency, human immunodeficiency virus \[HIV\] infection, organ transplantation). 13. Participants with positive stool studies for ova and/or parasites or stool culture at screening visit. 14. Participants with positive Clostridioides difficile (C difficile) stool test at screening visit.
Study design
Enrollment target: 70 participants
Allocation: non_randomized
Masking: none
Age groups: child
Timeline
Starts: 2025-01-22
Estimated completion: 2027-06-30
Last updated: 2025-09-19
Interventions
Drug: Vedolizumab IVDrug: Vedolizumab SC
Primary outcomes
  • Ctrough,ss: Steady-state Median Observed Plasma Concentration at the End of a Dosing Interval for Vedolizumab at Week 34 (Predose at Week 34)
  • Cavg,ss: Average Serum Concentration at Steady-state for Vedolizumab at Week 34 (Multiple time points prior to Week 34; pre-dose at Week 34)
Sponsor
Takeda · industry
Contacts & investigators
ContactTakeda Contact · contact · medinfoUS@takeda.com · +1-877-825-3327
InvestigatorStudy Director · study_director, Takeda
All locations (57)
VVCRD Clinical ResearchTerminated
Garden Grove, California, United States
Loma Linda University School of MedicineActive Not Recruiting
Loma Linda, California, United States
Children's Hospital Of Orange CountyActive Not Recruiting
Orange, California, United States
Stanford Children's HealthActive Not Recruiting
Palo Alto, California, United States
Advocate Children's HospitalActive Not Recruiting
Park Ridge, Illinois, United States
Children's Hospital of MichiganRecruiting
Detroit, Michigan, United States
Atlantic Health SystemActive Not Recruiting
Morristown, New Jersey, United States
New York Presbyterian Hospital, Weill Cornell Medical CollegeActive Not Recruiting
New York, New York, United States
Cleveland Clinic FoundationActive Not Recruiting
Cleveland, Ohio, United States
The University of Oklahoma Health Sciences CenterActive Not Recruiting
Oklahoma City, Oklahoma, United States
Medical University of South CarolinaActive Not Recruiting
North Charleston, South Carolina, United States
Cliniques Universitaires Saint-LucRecruiting
Brussels, Belgium
Centre Hospitalier Chretien MontLegiaActive Not Recruiting
Liège, Belgium
University Hospital "Saint George"Active Not Recruiting
Plovdiv, Bulgaria
Specialized Hospital for Active Treatment of Children Diseases "Prof. Dr. Ivan Mitev" EADActive Not Recruiting
Sofia, Bulgaria
Hvidovre University HospitalActive Not Recruiting
Hvidovre, Capital Region, Denmark
H.C Andersens HospitalActive Not Recruiting
Odense, Denmark
Childrens Health IrelandActive Not Recruiting
Dublin, Ireland
Azienda Ospedaliera Universitaria Gaetano Martino MessinaActive Not Recruiting
Messina, Italy
V. Buzzi HospitalActive Not Recruiting
Milan, Italy
Unita Operativa Complessa Di Pediatria MedicaActive Not Recruiting
Pescara, Italy
IRCCS Ospedale Pediatrico Bambino GesuActive Not Recruiting
Rome, Italy
Kurume University HospitalActive Not Recruiting
Kurume, Fukuoka, Japan
Juntendo University HospitalRecruiting
Bunkyo-ku, Tokyo, Japan
National Center for Child Health and Development (NCCHD)Active Not Recruiting
Setagaya-Ku, Tokyo, Japan
Radboud University Medical CenterActive Not Recruiting
Nijmegen, Netherlands
Instytut Pomnik - Centrum Zdrowia DzieckaRecruiting
Warsaw, Masovian Voivodeship, Poland
Uniwersytecki Szpital Dzieciecy W KrakowieActive Not Recruiting
Krakow, Poland
Korczowski Bartosz, Gabinet LekarskiRecruiting
Rzeszów, Poland
Medical Network Sp. Z.o.o. WIP Warsaw IBD Point Profesor KierkusRecruiting
Warsaw, Poland
SPSK Nr 1 im. Prof. S. Szyszko SUM w KatowicachActive Not Recruiting
Zabrze, Poland
Hospital Pediatrico - Unidade Local de Saude de CoimbraActive Not Recruiting
Coimbra, Portugal
Hospital St Maria- Centro Hospitalar de Lisboa, Norte EPEActive Not Recruiting
Lisbon, Portugal
Centro Materno Infantil do Norte - Unidade Local de Saude de Santo AntonioActive Not Recruiting
Porto, Portugal
"Emergency County Clinical Hospital ""Pius Brinzeu"""Active Not Recruiting
Timișoara, Timiș County, Romania
Dr Victor Gomoiu Clinical Children HospitalRecruiting
Bucharest, Romania
Spitalul Clinic de Urgenta Pentru Copii ,,Grigore Alexandrescu,Recruiting
Bucharest, Romania
University Children's HospitalRecruiting
Belgrade, Serbia
Mother and child helath care Institute of Serbia dr Vukan CupicActive Not Recruiting
Belgrade, Serbia
Institute for Childand YouthHealth Care of VojvodinaActive Not Recruiting
Novi Sad, Serbia
Kyungpook National University Chilgok Hospital (KNUCH)Active Not Recruiting
Daegu, South Korea
Seoul National University HospitalRecruiting
Seoul, South Korea
Severance Hospital, Yonsei University Health SystemRecruiting
Seoul, South Korea
Samsung Medical CenterRecruiting
Seoul, South Korea
Complejo Hospitalario Universitario de FerrolActive Not Recruiting
Ferrol, Spain
Hospital Universitario 12 de OctubreActive Not Recruiting
Madrid, Spain
Hospital U. Virgen MacarenaRecruiting
Seville, Spain
Hospital Univesritario y Politecnico La Fe. Av Fernando abril Martorell106. Valencia 46026. SpainActive Not Recruiting
Valencia, Spain
Centre Hospitalier Universitaire Vaudois (CHUV)Active Not Recruiting
Lausanne, Canton of Vaud, Switzerland
Inselspital, Universitatsspital Bern, Kinderklinik, Julie-von-Jenner-HausActive Not Recruiting
Bern, Switzerland
Universitats-KinderspitalRecruiting
Zurich, Switzerland
National Taiwan University Children's HospitalRecruiting
Taipei, Zhongzheng Dist, Taiwan
Changhua Christian HospitalActive Not Recruiting
Changhua, Taiwan
Kaohsiung Medical University Chung-Ho Memorial HospitalActive Not Recruiting
Kaohsiung City, Taiwan
Koc University HospitalSuspended
Istanbul, Zeytinburnu, Turkey (Türkiye)
Istanbul University, Istanbul Medical FacultySuspended
Istanbul, Turkey (Türkiye)
Dokuz Eylul University Medical FacultySuspended
Izmir, Turkey (Türkiye)