A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD)

Official title

A Phase 3b Extension Study to Evaluate the Long-term Safety of Vedolizumab Subcutaneous in Pediatric Subjects With Ulcerative Colitis or Crohn's Disease

Overview

The main aim of this study is to learn about medical problems (adverse events) if vedolizumab subcutaneously (SC) is given to a child or teenager with UC or CD for a long time. Other aims are to understand if the long time use of vedolizumab SC has an impact on the time period until hospital visits because of bowel swelling (inflammation) are needed and has an impact on the quality of life of children and teenagers who received vedolizumab SC. In this study, participants who responded well to the treatment with vedolizumab SC in the parent study (VedolizumabSC-3003 \[NCT06100289\]) will continue to be treated with vedolizumab SC. Participants who did not respond well to the treatment with vedolizumab SC in the parent study or who received corticosteroids in the last 4 weeks of the parent study will not receive vedolizumab SC in this study but will be followed for up to 2 years after the last treatment with vedolizumab SC in the parent study. During the study, participants will visit their study clinic several times.

Detailed description

The drug being tested in this study is Vedolizumab SC. Vedolizumab SC is being tested to treat pediatric participants with moderate to severe active UC or CD. This study will look at the long-term safety profile in pediatric participants who take vedolizumab SC.

The study will enroll approximately 70 participants. This extension study consists of a treatment cohort and an observational cohort. Participants will continue receiving the same dose and frequency of vedolizumab SC that was received at the last dose of the parent study VedolizumabSC-3003 (NCT06100289).

For the Treatment cohort participants will be randomized (1:1) to receive vedolizumab in either a prefilled syringe (PFS) as part of an autoinjector pen (PFS+AI) or a PFS with a needle safety device (PFS+NSD):

* Treatment Cohort: Vedolizumab 108 milligram (mg) PFS+AI * Treatment Cohort: Vedolizumab 108 mg PFS+NSD

This multi-center trial will be conducted globally. The overall time to participate in this study is up to 2 years from the first dose in the study. Participants in the treatment cohort will have a follow-up safety visit of 18 weeks after their last dose of study drug. Participants who will not be eligible for the treatment cohort will be enrolled in the observational cohort and will be followed for approximately 2 years after the last dose of vedolizumab SC received during Study VedolizumabSC-3003 (NCT06100289).

Interventions

• Drug Vedolizumab SC
  Vedolizumab subcutaneous injection.
• Other No Intervention
  As this is an observational cohort, no intervention will be administered.

Primary outcome measures

• Treatment Cohort: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time frame: First dose of the study drug until 18 weeks of follow-up after last dose (up to Week 138)]
• Treatment Cohort: Number of Participants With Adverse Events of Special Interests (AESIs) [Time frame: First dose of the study drug until 18 weeks of follow-up after last dose (up to Week 138)]
• Observational Cohort: Number of Participants With Prespecified Safety Events [Time frame: Up to Week 86]

Secondary outcome measures (2)

• Treatment Cohort: Time to Major Inflammatory Bowel Disease (IBD)-related Events [Time frame: Up to Week 120]
• Treatment Cohort: Change from Baseline in IMPACT-III Scores [Time frame: Baseline, every 24 weeks in this study (up to Week 120)]

Eligibility criteria

Inclusion Criteria for Treatment Cohort 1. Has completed Week 34 of Study VedolizumabSC-3003 (NCT06100289) and achieved clinical response at Week 34 and was corticosteroid-free for at least the last 4 weeks (Week 30 to Week 34). Clinical response for participants with UC is defined as a reduction of partial Mayo score of >=2 points and >= 25 percentage (%) from baseline (from VedolizumabSC-3003 \[NCT06100289\]), including a >=1-point decrease in the Mayo stool frequency subscore and a >=1-point reduction in the rectal bleeding subscore or absolute rectal bleeding subscore of less than or equal to (<=) 1 point. Clinical response for participants with CD is defined as a pediatric Crohn's disease activity index (PCDAI) <=30 with a reduction in the PCDAI of >=15 points from baseline (from VedolizumabSC-3003 \[NCT06100289\]).

Inclusion Criteria for Observational Cohort

1\. Has received at least 1 dose of vedolizumab during Study VedolizumabSC-3003 (NCT06100289) and early terminated OR completed the Week 34 clinic visit of Study VedolizumabSC-3003 (NCT06100289) but was not eligible to enroll in the treatment cohort of this study.

Exclusion Criteria for Treatment Cohort

• Has hypersensitivity or allergies to vedolizumab or any of its excipients.
• The participant currently requires major surgical intervention for UC or CD (example, bowel resection), or is anticipated to require major surgical intervention for UC or CD during the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 14 centers

• Phoenix Childrens Hospital — Phoenix
• Loma Linda University — Loma Linda
• Children's Hospital of Orange County — Orange
• Stanford Children's Health — Palo Alto
• Advocate Children's Hospital Park Ridge — Park Ridge
• Childrens Hospital of Michigan — Detroit
• Atlantic Health - Morristown Medical Center — Morristown
• New York Presbyterian Hospital — New York
• … and 6 more centers

Italy · 4 centers

• Azienda Ospedaliera Universitaria Gaetano Martino, Messina — Messina
• ASST Fatebenefratelli Sacco - Ospedale dei Bambini Vittore Buzzi - INCIPIT - PIN — Milan
• Unita Operativa Complessa Di Pediatria Medica — Pescara
• Bambin Gesu Hospital - Ospedale Pediatrico Bambin Gesu — Roma

Poland · 4 centers

• Korczowski Bartosz, Gabinet Lekarski — Rzeszów
• WIP Warsaw IBD Point Profesor Kierkus — Warsaw
• Instytut Pomnik - Centrum Zdrowia Dziecka — Warsaw
• SPSK Nr 1 im. Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego — Zabrze

South Korea · 4 centers

• Kyungpook National University Chilgok hospital — Daegu
• Severance Hospital, Yonsei University Health System — Seoul
• Seoul National University Hospital — Seoul
• Samsung Medical Center — Seoul

Spain · 4 centers

• Hospital Arquitecto Marcide de Ferrol — Ferrol
• Hospital Universitario 12 de Octubre — Madrid
• Hospital Universitario Virgen Macarena — Seville
• Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital L — Valencia

Japan · 3 centers

• Kurume University Hospital — Kurume-shi
• Juntendo University Hospital — Bunkyo-ku
• National Center for Child Health and Development — Setagaya-ku

Portugal · 3 centers

• Hospitais da Universidade de Coimbra — Coimbra
• Hospital St Maria- Centro Hospitalar de Lisboa, Norte EPE — Lisbon
• Centro Hospitalar do Porto - Hospital de Santo Antonio — Porto

Romania · 3 centers

• Victor Gomoiu Clinical Hospital for Children — Bucharest
• Pius Brinzeu Emergency Clinical County Hospital — Timișoara
• Grigore Alexandrescu Emergency Clinical Hospital for Children — Bucharest

Serbia · 3 centers

• University Children's Clinic — Belgrade
• Mother and Child Health Care Institute of Serbia Dr Vukan Cupic — Belgrade
• Institute for Children and Youth Health Care of Vojvodina — Novi Sad

Switzerland · 3 centers

• University Hospital of Bern — Bern
• Centre Hospitalier Universitaire Vaudois — Lausanne
• University Children's Hospital Zurich — Zurich

Taiwan · 3 centers

• Changhua Christian Medical Foundation - Changhua Christian Children's Hospital — Changhua
• Kaohsiung Medical University - Chung-Ho Memorial Hospital — Kaohsiung City
• National Taiwan University Hospital — Zhongzheng

Belgium · 2 centers

• Cliniques Universitaires Saint-Luc — Brussels
• Centre Hospitalier Chretien MontLegia — Liège

Bulgaria · 1 center

• UMHAT Sv. Georgi, EAD — Plovdiv

Denmark · 1 center

• Hvidovre Hospital — Hvidovre

Ireland · 1 center

• Childrens Health Ireland at Crumlin - PIN — Crumlin

Netherlands · 1 center

• Radboud Universitair Medisch Centrum — Nijmegen

Identifiers

NCT: NCT06405087 · VedolizumabSC-3004 · 2023-508804-39-00 · jRCT2031250519

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗