ClinicaliQ Trial Snapshot
- A Study of Vedolizumab in Children With Ulcerative Colitis (UC) or Crohn’s Disease (CD) — Recruiting • Phase III • Respiratory / COPD / Asthma • NCT05442567.
- What is being tested: Long-term safety and efficacy of vedolizumab (an anti-α4β7 integrin monoclonal antibody) as maintenance therapy in paediatric patients with moderate-to-severe ulcerative colitis or Crohn's disease, through an extension protocol of completed phase III trials.
- Patient eligibility overview: Children who completed participation in either parent study MLN0002-3024 or MLN0002-3025 and demonstrated clinical benefit or tolerance to vedolizumab; inclusion restricted to those with documented UC or CD diagnoses requiring ongoing biologic therapy.
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
The study is an extension of two parent studies (MLN0002-3024 [NCT04779307] and MLN0002-3025 [NCT04779320]). Participants must have participated in one of the previous studies. The purpose of this study is to collect the long-term safety of vedolizumab in children with UC or CD.
Eligibility Snapshot
- Main Inclusion Criteria: For Treatment Cohort: 1. The participant should have completed Study MLN0002-3024 or Study MLN0002-3025 and achieved corticosteroid-free clinical response at Week 54 (and has tapered off of steroids, as applicable, at least 12 weeks before Week 54) as defined by a reduction of partial Mayo score of ≥2 points and ≥25% from baseline for participants with UC, or by a decrease of pediatric Crohn's disease activity index (PCDAI) of ≥15 points for participants with CD and with total PCDAI ≤30. 2. A male participant who is sexually active with a female partner of childbearing potential agrees to use a barrier method of contraception (e.g., condom with or without spermicide) from signing of participant/parental informed consent and/or pediatric assent throughout the duration of the study and for 18 weeks after last dose. The female partner of a male participant should also be advised to use a highly effective method of contraception. 3. A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use a highly effective method of contraception from signing of participant/parental informed consent and/or pediatric assent throughout the duration of the study and 18 weeks after the last dose.…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.