A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease
- Conditions
- Crohn's DiseaseUlcerative Colitis
- Interventions
- Registration Number
- NCT06100289
- Lead Sponsor
- Takeda
- Brief Summary
The main aim of this study is to learn how the body of a child or teenager with moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD) processes vedolizumab (pharmacokinetics) given just under the skin subcutaneously (SC).
The participants will be treated with vedolizumab for up to 34 weeks.
During the study, participants will visit their study clinic several times.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 70
-
The participant weighs ≥10 kg at the time of screening and enrollment into the study.
-
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.
-
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).
-
Participants with evidence of UC extending proximal to the rectum (that is, not limited to proctitis), at a minimum.
-
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.
-
Participants with vaccinations that are up-to-date based on the countrywide accepted schedule of childhood vaccines.
- 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.
- Participants who have had prior exposure to vedolizumab.
- Participants with hypersensitivity or allergies to vedolizumab or any of its excipients.
- Participants with active cerebral/meningeal disease, signs/symptoms or history of progressive multifocal leukoencephalopathy (PML) or any other major neurological disorders.
- The participant has received any live vaccinations within 30 days before first dose of study drug.
- Participants who currently require surgical intervention or are anticipated to require surgical intervention for UC or CD during this study.
- 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.
- Participants with a current diagnosis of indeterminate colitis.
- Participants with clinical features suggesting monogenic very early-onset inflammatory bowel disease (IBD).
- Participants with active or latent tuberculosis (TB).
- 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.
- The participant has any identified congenital or acquired immunodeficiency (for example, common variable immunodeficiency, human immunodeficiency virus [HIV] infection, organ transplantation).
- Participants with positive stool studies for ova and/or parasites or stool culture at screening visit.
- Participants with positive Clostridioides difficile (C difficile) stool test at screening visit.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Maintenance Period: Participants ≥30 kg, Vedolizumab 108 mg SC Q2W Vedolizumab SC Participants with clinical response at Week 14 weighing ≥30 kg will receive vedolizumab 108 mg, SC injection, Q2W from Week 14 to Week 32 in the Maintenance Period. Maintenance Period: Participants ≥10 to <30 kg, Vedolizumab 108 mg SC Q4W Vedolizumab SC Participants with clinical response at Week 14 weighing ≥10 to \<30 kg will receive vedolizumab 108 mg, SC injection, Q4W from Week 14 to Week 30 in the Maintenance Period. Induction Period: Participants ≥30 kg, Vedolizumab (High Dose) IV Vedolizumab IV Participants weighing ≥30 kg will receive vedolizumab (High Dose) IV infusion, at Day 1, Weeks 2 and 6 in the Induction Period. Induction Period: Participants >15 to <30 kg, Vedolizumab (Medium Dose) IV Vedolizumab IV Participants weighing \>15 to \<30 kg will receive vedolizumab (Medium Dose), IV infusion, at Day 1, Weeks 2 and 6 in the Induction Period. Induction Period: Participants ≥10 to ≤15 kg, Vedolizumab (Low Dose) IV Vedolizumab IV Participants weighing ≥10 to ≤15 kg will receive vedolizumab (Low Dose), IV infusion, at Day 1, Weeks 2 and 6 in the Induction Period.
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Percentage of Participants with Positive Antivedolizumab Antibody (AVA) Baseline up to 18 weeks after last dose of study drug (up to Week 50) Percentage of Participants with Positive Neutralizing AVA Baseline up to 18 weeks after last dose of study drug (up to Week 50)
Trial Locations
- Locations (57)
Hospital Arquitecto Marcide de Ferrol
🇪🇸Ferrol, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Universidad de Sevilla - Hospital Universitario Virgen Macarena
🇪🇸Sevilla, Spain
VVCRD Clinical Research
🇺🇸Garden Grove, California, United States
Loma Linda University School of Medicine
🇺🇸Loma Linda, California, United States
Children's Hospital Of Orange County
🇺🇸Orange, California, United States
Stanford Children's Health
🇺🇸Palo Alto, California, United States
Advocate Children's Hospital
🇺🇸Park Ridge, Illinois, United States
Children's Hospital of Michigan
🇺🇸Detroit, Michigan, United States
Morristown Medical Center
🇺🇸Morristown, New Jersey, United States
The New York Presbyterian Hospital, Weill Cornell Medical College
🇺🇸New York, New York, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
The University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Medical University of South Carolina
🇺🇸North Charleston, South Carolina, United States
Hospital UCL Saint Luc
🇧🇪Brussels, Belgium
Centre Hospitalier Chretien MontLegia
🇧🇪Liege, Belgium
UMHAT Sveti Georgi EAD
🇧🇬Plovdiv, Bulgaria
Specialized Hospital for Active Treatment of Children's diseases Prof Ivan Mitev
🇧🇬Sofia, Bulgaria
Hvidovre University Hospital
🇩🇰Hvidovre, Hovedstaden, Denmark
Childrens Health Ireland
🇮🇪Dublin, Ireland
Azienda Ospedaliera Universitaria Gaetano Martino Messina
🇮🇹Messina, Italy
Ospedale dei Bambini Vittore Buzzi
🇮🇹Milan, Italy
Unita Operativa Complessa Di Pediatria Medica
🇮🇹Pescara, Italy
IRCCS Ospedale Pediatrico Bambino Gesu
🇮🇹Rome, Italy
Kurume University Hospital
🇯🇵Kurume, Fukuoka, Japan
National Center for Child Health and Development (NCCHD)
🇯🇵Setagaya-Ku Tokyo, Tokyo-to, Japan
Juntendo University Hospital
🇯🇵Bunkyo-ku, Tokyo, Japan
Kyungpook National University Chilgok Hospital (KNUCH)
🇰🇷Daegu, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Radboud University Medical Center
🇳🇱Nijmegen, Gelderland, Netherlands
Instytut Pomnik - Centrum Zdrowia Dziecka
🇵🇱Warsaw, Mazowieckie, Poland
SPSK Nr 1 im. Prof. S. Szyszko SUM w Katowicach
🇵🇱Zabrze, Slaskie, Poland
Uniwersytecki Szpital Dzieciecy W Krakowie
🇵🇱Krakow, Poland
Korczowski Bartosz, Gabinet Lekarski
🇵🇱Rzeszow, Poland
WIP Warsaw IBD Point Profesor Kierkus
🇵🇱Warsaw, Poland
Hospitais da Universidade de Coimbra
🇵🇹Coimbra, Portugal
Hospital St Maria- Centro Hospitalar de Lisboa, Norte EPE
🇵🇹Lisboa, Portugal
Centro Hospitalar Universitario do Porto - Hospital de Santo Antonio
🇵🇹Porto, Portugal
Emergency County Clinical Hospital Pius Brinzeu
🇷🇴Timisoara, Timis, Romania
Children's Clinical Hospital Dr. Victor Gomoiu
🇷🇴Bucharest, Romania
Emergency Clinical Hospital for Children Grigore Alexandrescu
🇷🇴Bucharest, Romania
University Children's Clinic
🇷🇸Belgrade, Serbia
Institut Za Zdravstvenu Zastitu Majke I Deteta Srbije Dr Vukan Cupic
🇷🇸Belgrade, Serbia
Institute for Childand YouthHealth Care of Vojvodina
🇷🇸Novi Sad, Serbia
Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)
🇪🇸Valencia, Spain
Inselspital - Universitatsspital Bern - Kinderklinik Bern
🇨🇭Bern, Switzerland
Centre Hospitalier Universitaire Vaudois (CHUV)
🇨🇭Lausanne, Switzerland
Kantonsspital Luzern
🇨🇭Luzern 16, Switzerland
Children's Hospital Zurich
🇨🇭Zurich, Switzerland
Changhua Christian Medical Foundation - Changhua Christian Childrens Hospital
🇨🇳Changhua, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
🇨🇳Kaohsiung, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Koc University Hospital
🇹🇷Istanbul, Zeytinburnu, Turkey
Istanbul University, Istanbul Medical Faculty
🇹🇷Istanbul, Turkey
Dokuz Eylul University Medical Faculty
🇹🇷Izmir, Turkey