Long-term Safety With Vedolizumab Intravenous (IV) in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD)
| Condition | Ulcerative Colitis, Crohn's Disease |
|---|---|
| Phase | Phase 2 |
| Sponsor | Takeda |
| Status | Completed |
| Enrollment | 59 participants |
| Interventions | Vedolizumab |
| Start date | Jul 30, 2018 |
| Completion date | Apr 3, 2025 |
| Results posted | Mar 13, 2026 |
Summary
The purpose of this study is to determine the safety profile of long-term vedolizumab IV treatment in pediatric participants with UC or CD.
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
| UC Participants (< 30 kg): Vedolizumab 100 mg | 100 percentage of participants |
|---|---|
| UC Participants (< 30 kg): Vedolizumab 200 mg | 83.3 percentage of participants |
| CD Participants (< 30 kg): Vedolizumab 100 mg | 100 percentage of participants |
| CD Participants (< 30 kg): Vedolizumab 200 mg | 100 percentage of participants |
| UC Participants (>=30 kg): Vedolizumab 150 mg | 100 percentage of participants |
| UC Participants (>=30 kg): Vedolizumab 300 mg | 100 percentage of participants |
Open in BENITIONS View on ClinicalTrials.gov
Other trials for this condition
- A Study of Guselkumab Subcutaneous Therapy in Participants With Moderately to Severely Act — Janssen Research & Development, LLC
- A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severe — Janssen Research & Development, LLC
- A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Crohn' — Janssen Research & Development, LLC
- A Phase 2a Safety and Efficacy Open-Label Study of Tulisokibart (MK-7240/PRA023) in Partic — Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- PDA001 for the Treatment of Adults With Moderate-to-Severe Crohn's Disease — Celularity Incorporated
- Loss of RESponse to Ustekinumab Treated by Dose Escalation — Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW