ClinicaliQ Trial Snapshot
- A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Crohn’s Disease (CD) — Recruiting • Phase III • Respiratory / COPD / Asthma • NCT04779320.
- What is being tested: Vedolizumab, an anti-inflammatory biologic agent targeting gut-specific integrin α4β7, is being evaluated for efficacy and safety in paediatric patients (children and teenagers) with moderate to severe Crohn's disease.
- Patient eligibility overview: The study recruits children and adolescents diagnosed with moderate to severe Crohn's disease; specific age ranges, disease activity thresholds, and prior treatment history will determine individual eligibility for enrolment.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
Vedolizumab is a medicine that helps to reduce inflammation and pain in the digestive system. In this study, children and teenagers with moderate to severe Crohn's disease will be treated with vedolizumab. The main aim of the study is to check if participants achieve remission after treatment with the vedolizumab. Remission means symptoms improve or disappear and an endoscopy shows no signs of inflammation. Participants will receive 3 infusions of vedolizumab over 6 weeks. Then, those who have a clinical response will receive either a high dose or low dose…
Eligibility Snapshot
- Main Inclusion Criteria: 1. The participants has moderately to severely active CD, unresponsive or intolerant to their current standard of care (SOC). 2. The participants weigh ≥10 kg at the time of screening and enrollment into the study.
- Participants with Crohn's disease (CD) diagnosed at least 1 month before screening. Participants with moderately to severely active CD 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) 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 (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…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.