Phase 3b Extension Study of Vedolizumab in Paediatric Patients with UC or CD
Research type
Research Study
Full 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
IRAS ID
1005401
Contact name
Jenn Poole
Contact email
Sponsor organisation
Takeda Development Center Americas, Inc.
Eudract number
2021-000630-34
Clinicaltrials.gov Identifier
Research summary
Ulcerative Colitis (UC) is a long-term disease that can cause diarrhoea and lower abdominal (belly) pain. Crohn’s disease (CD) is a long-term disease that can cause diarrhoea, abdominal pain, fever, loss of appetite, weight loss, poor nourishment and rectal bleeding which may be persistent and lead to anaemia. In UC, the extent of disease at diagnosis is more widespread in the paediatric population than in adults. While the symptoms of UC are similar in both the paediatric and adult populations, paediatric patients usually present with more extensive disease. Less is known about the clinical course of long-term disease.
This is a long-term extension study with a purpose to determine the long-term safety of vedolizumab in paediatric patients with UC and CD who initiated vedolizumab treatment at 2 to 17 years of age, inclusive, in either Study MLN0002-3024 (UC patients) or MLN0002-3025 (CD patients).
Approximately 93 patients, from approximately 100 sites worldwide, who completed MLN0002-3024 or MLN0002-3025 study and at Week 54 of the parent study, have maintained a corticosteroid-free clinical response, will be eligible to enter this extension study. The Sponsor of this study is Takeda Development Center Americas, Inc.
The study duration may continue for up to 5 years, until patient withdrawal (e.g. due to loss of response at highest dose or investigator assessment of no benefit in continuing dose) or the sponsor decides to close the study, whichever comes first. Patients who reach adult age should be considered to transition to commercial drug and adult care setting as available in their country.
REC name
Wales REC 5
REC reference
22/WA/0286
Date of REC Opinion
22 Dec 2022
REC opinion
Further Information Favourable Opinion