A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Crohn's Disease (CD)
Crohn's Disease (CD)
About this trial
This is an interventional treatment trial for Crohn's Disease (CD) focused on measuring Drug Therapy
Eligibility Criteria
Inclusion Criteria:
- The participants has moderately to severely active CD, unresponsive or intolerant to their current standard of care (SOC).
- The participants weigh ≥10 kg at the time of screening and enrollment into the study.
- Participants with moderately to severely active Crohn's disease (CD) diagnosed at least 1 month before screening, defined by a Pediatric Crohn's Disease Activity Index (PCDAI) >30 and an simple endoscopic score for Crohn's Disease (SES-CD) >6 (or an SES-CD ≥4 if disease is confined to terminal ileum).
- Participants who have failed, lost response to, or been intolerant to treatment with at least 1 of the following agents: corticosteroids, immunomodulators (eg, azathioprine (AZA), 6-mercaptopurine (6-MP), methotrexate [MTX]), and/or tumor necrosis factor (TNF)-α antagonist therapy (eg, infliximab, adalimumab). This includes participants who are dependent on corticosteroids or exclusive or partial enteral nutrition to control symptoms and who are experiencing worsening of disease in the moderate-to-severe range when attempting to wean off corticosteroids or discontinue exclusive enteral nutrition.
- 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.
Exclusion Criteria:
- Participants who have received either (1) an investigational biologic (other than those listed in Exclusion Criterion #1) within 60 days or 5 half-lives before screening (whichever is longer); or (2) an approved biologic or biosimilar agent within 2 weeks before the first dose of study drug or at any time during the screening period.
- Participants with active cerebral/meningeal disease, signs/symptoms or history of progressive multifocal leukoencephalopathy (PML) or any other major neurological disorders including stroke, multiple sclerosis, brain tumor or neurodegenerative disease.
- The participants had a clinically significant infection (eg, pneumonia, pyelonephritis, coronavirus disease 2019 [COVID-19]) within 30 days prior to first dose of study drug.
- The participants has received any live vaccinations within 30 days prior to first dose.
- Participants who currently require surgical intervention or are anticipated to require surgical intervention for 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.
Active or latent tuberculosis (TB), as evidenced by a diagnostic TB test performed within 30 days of screening or during the screening Period that is positive, defined as:
- Positive QuantiFERON test or 2 successive indeterminate QuantiFERON tests, OR
- A TB skin test reaction ≥5 mm.
- The participants has chronic hepatitis B virus (HBV) infection or chronic hepatitis C virus (HCV) infection.
- The participants has any identified congenital or acquired immunodeficiency (eg, common variable immunodeficiency, human immunodeficiency virus [HIV] infection, organ transplantation).
- The participant has evidence of dysplasia or history of malignancy other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix.
- Participants with positive stool studies for ova and/or parasites or stool culture at screening visit.
- Participants with positive Clostridium difficile stool test at screening visit.
Sites / Locations
- Phoenix Childrens Hospital
- Cedars Sinai Medical Center
- Rady Childrens Hospital San Diego - PIN
- University of California San FranciscoRecruiting
- I.H.S Health LLCRecruiting
- Childrens Center For Digestive HealthcareRecruiting
- Advocate Children's Hospital Park RidgeRecruiting
- Riley Hospital For ChildrenRecruiting
- Johns Hopkins University
- Boston Children's Hospital
- MNGI Digestive Health, PARecruiting
- Mayo Clinic - PIN
- Goryeb Children's HospitalRecruiting
- The Steven and Alexandra Cohen Childrens Medical Center of New York - BRANY - PPDSRecruiting
- University of Rochester Medical Center PPDSRecruiting
- Stony Brook University Medical CenterRecruiting
- SUNY Upstate Medical Center
- University Hospitals Cleveland Medical Center
- Children's Hospital of Pittsburgh
- Hasbro Children's Hospital
- Texas Children's HospitalRecruiting
- Carilion Children's Tanglewood CenterRecruiting
- Children's Hospital at Westmead
- Queensland Childrens HospitalRecruiting
- Monash Health, Monash Medical Centre
- Royal Children's Hospital Melbourne - PIN
- UZ Antwerpen
- Universitair Ziekenhuis Brussel - PIN
- UZ Leuven
- University of Alberta Hospital
- British Columbia Children's Hospital
- London Health Sciences Centre
- Centre Hospitalier Universitaire Sainte-Justine
- Beijing Children Hospital,Capital Medical University
- Henan Children's Hospital(Zhengzhou Children's Hospital)
- Children's Hospital of Fudan University
- The Children's Hospital Zhejiang UniversitySchool of Medicine
- Klinika Za Djecje Bolesti ZagrebRecruiting
- University Hospital Center ZagrebRecruiting
- University Hospital Centre SplitRecruiting
- Fakultni nemocnice Kralovske Vinohrady
- Fakultni Thomayerova Nemocnice
- Fakultni nemocnice Ostrava
- Attikon University General HospitalRecruiting
- Children's Hospital "Agia Sofia"Recruiting
- Ippokratio General Hospital of Thessaloniki
- Ippokratio General Hospital of ThessalonikiRecruiting
- Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktato KorhazRecruiting
- Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai KozpontRecruiting
- Semmelweis Egyetem
- Schneider Childrens Medical Center of Israel Petah Tikvah PIN
- Tel Aviv Sourasky Medical Center PPDS
- Soroka University Medical Centre
- Rambam Medical Center - PPDS
- Carmel Medical Center
- Shaare Zedek Medical Center
- Hadassah Medical Center - PPDS
- AOU dell'Universita degli Studi della Campania Luigi Vanvitelli
- Azienda Ospedaliera Universitaria Federico II
- Azienda USL di Bologna
- Sapienza University of RomeRecruiting
- ASST di Monza - Azienda Ospedaliera San Gerardo
- Universita degli Studi di Padova
- Kurume University HospitalRecruiting
- Japanese Red Cross Kumamoto HospitalRecruiting
- Juntendo University HospitalRecruiting
- National Center for Child Health and DevelopmentRecruiting
- Kyungpook National University Chilgok hospitalRecruiting
- Gachon University Gil Medical CenterRecruiting
- Seoul National University HospitalRecruiting
- Samsung Medical Center - PPDSRecruiting
- Hospital of Lithuanian University of Health Sciences Kaunas ClinicsRecruiting
- Vilnius University Hospital Santaros KlinikosRecruiting
- Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu
- Instytut Centrum Zdrowia Matki Polki
- Uniwersytecki Szpital Dzieciecy
- WIP Warsaw IBD Point Profesor Kierkus
- Instytut Pomnik Centrum Zdrowia DzieckaRecruiting
- Korczowski Bartosz, Gabinet LekarskiRecruiting
- Copernicus Podmiot Leczniczy Sp. z o.o.
- Gornoslaskie Centrum Zdrowia Dziecka Im. Sw. Jana Pawla II Spsk Nr 6 Sum W Katowicach
- Twoja Przychodnia SCMRecruiting
- SPZOZ Centralny Szpital Kliniczny UM w Lodzi
- Research Center of Children's Health
- Russian Children's Clinical Hospital of the Ministry of Health of Russia
- Kazan State Medical University
- Krasnoyarsk State Medical University n.a. V.F. Voyno-Ysenetskiy
- Privolzhsky Research Medical University
- Medical Company Hepatolog, LLC
- Detska fakultna nemocnica s poliklinikou Banska BystricaRecruiting
- Narodny ustav detskych chorob
- Hospital Sant Joan de Deu - PINRecruiting
- Hospital de SaguntoRecruiting
- Hospital Infantil Universitario Nino Jesus - PINRecruiting
- Hospital Regional Universitario de Malaga - Hospital Materno InfantilRecruiting
- Hospital Universitario Virgen del Rocio - PPDSRecruiting
- Municipal Non-profit Enterprise of Kharkiv Regional Council Regional Childrens Clinical Hospital
- Clinic of SI National Scientific Center of Radiological Medicine of NAMS of Ukraine
- State Institution Institute of Pediatrics, Obstetrics and Gynecology of NAMS Ukraine
- Kings College Hospital
- Great Ormond Street Hospital (GOSH)
- Noahs Ark Childrens Hospital for Wales - PPDS - PIN
- Birmingham Children's Hospital NHS Foundation Trust
- Barts Health NHS Trust
- Royal Manchester Children's Hospital - PPDS
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Induction Period: 10 to 15 kg, Vedolizumab 150 mg
Induction Period: >15 to <30 kg, Vedolizumab 200 mg
Induction Period: ≥30 kg, Vedolizumab 300 mg
Maintenance Period: 10 to 15 kg Vedolizumab 150 mg
Maintenance Period: 10 to 15 kg Vedolizumab 100 mg
Maintenance Period: >15 to <30 kg, Vedolizumab 200 mg
Maintenance Period: >15 to <30 kg Vedolizumab 100 mg
Maintenance Period: ≥30 kg, Vedolizumab 300 mg
Maintenance Period: ≥30 kg: Vedolizumab 150 mg
Vedolizumab 150 mg, intravenous (IV) infusion, at Day 1, Weeks 2 and 6 in Induction Period. Participants with CD having Baseline weight of 10 to 15 kg will be included in this arm group.
Vedolizumab 200 mg, IV infusion, at Day 1, Weeks 2 and 6 in Induction Period. Participants with CD having Baseline weight of >15 to <30 kg will be included in this arm group.
Vedolizumab 300 mg, IV infusion, at Day 1, Weeks 2 and 6 in Induction Period. Participants with CD having Baseline weight of ≥30 kg will be included in this arm group.
Vedolizumab 150 mg, IV infusion, once every 8 weeks (Q8W) from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of 10 to 15 kg who achieved clinical response at Week 14 randomized to this high dose arm group will receive vedolizumab 150 mg.
Vedolizumab 100 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of 10 to 15 kg who achieved clinical response at Week 14 randomized to this low dose arm group will receive vedolizumab 100 mg.
Vedolizumab 200 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of >15 to <30 kg who achieved clinical response at Week 14 randomized to this high dose arm group will receive vedolizumab 200 mg.
Vedolizumab 100 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of >15 to <30 kg who achieved clinical response at Week 14 randomized to this low dose arm group will receive vedolizumab 100 mg.
Vedolizumab 300 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of ≥30 kg who achieved clinical response at Week 14 randomized to this high dose arm group will receive vedolizumab 300 mg.
Vedolizumab 150 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of ≥30 kg who achieved clinical response at Week 14 randomized to this low dose arm group will receive vedolizumab 150 mg.