Phase 4
Completed N=150
A Study of Vedolizumab in People With Ulcerative Colitis and Crohn's Disease
Ulcerative Colitis · Crohn Disease
Source: ClinicalTrials.gov NCT04804540 ↗
Enrolled (actual)
150
Serious AEs
5.3%
Results posted
Feb 2025
Primary outcomePrimary: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) — 54; 29; 6; 2 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Vedolizumab is a medicine that helps to reduce inflammation and pain in the digestive system. In this study, people with ulcerative colitis or Crohn's disease will be treated with vedolizumab. The main aim of the study is to check for side effects from vedolizumab.
At the first visit, the study doctor will check who can take part. Participants will receive vedolizumab slowly through a vein (infusion). Participants will regularly visit the clinic for up to 46 weeks for more infusions of Vedolizumab. During these visits, the study doctor will check if there are any side effects from this treatment.
Participants will visit the clinic for a final check-up up to 16 weeks after their final infusion of Vedolizumab. Clinic staff will arrange a phone call 6 months after their final infusion of Vedolizumab for a further check-up.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) |
54; 29; 6; 2; 4; 0 | — |
| PRIMARY Number of Participants With Adverse Drug Reactions (ADRs) and Unexpected ADRs |
5; 0; 2; 0 | — |
| SECONDARY Percentage of UC Participants With Clinical Response at Weeks 14, 30 and 46 |
54.9; 62.7; 73.5 | — |
| SECONDARY Percentage of CD Participants With Clinical Response at Weeks 14, 30 and 46 |
72.9; 70.8; 68.8 | — |
| SECONDARY Percentage of UC Participants With Clinical Remission at Weeks 14, 30 and 46 |
39.2; 43.1; 52.0 | — |
| SECONDARY Percentage of CD Participants With Clinical Remission at Weeks 14, 30 and 46 |
47.9; 45.8; 56.3 | — |
| SECONDARY Percentage of UC and CD Participants Who Discontinued Vedolizumab |
25.5; 27.1 | — |
| SECONDARY Percentage of UC Participants With Mucosal Healing at Week 46 |
22.5 | — |
| SECONDARY Percentage of CD Participants With Mucosal Healing at Week 46 |
8.3 | — |
| SECONDARY Percentage of UC Participants With Endoscopic Response at Week 46 |
21.6 | — |
| SECONDARY Percentage of CD Participants With Endoscopic Response at Week 46 |
12.5 | — |
| SECONDARY Change From Baseline in Patient-reported Quality of Life (Short Inflammatory Bowel Disease Questionnaire [SIBDQ]) Scores at Weeks 14, 30, and 46 |
8.4; 8.3; 12.9; 8.4; 13.0; 10.6 | — |
Eligibility Criteria
Inclusion Criteria
- Has a diagnosis of moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD) at least 3 months prior to screening, with a Full Mayo Score of 6-12 for UC and a Harvey Bradshaw Index (HBI) score of >=8 for CD at the time of enrolment.
- Has demonstrated, an inadequate response to, loss of response to, or intolerance to at least 1 of the following agents:
- Conventional therapy
- TNF-α alpha antagonist
Exclusion Criteria
- Has undergone an ileostomy, colostomy, or has known fixed symptomatic stenosis of the intestine.
- Has active or latent tuberculosis (TB).
- Has had a prior exposure to vedolizumab or a history of hypersensitivity or allergies to vedolizumab, natalizumab, efalizumab, or rituximab.
- Has a positive progressive multifocal leukoencephalopathy (PML) subjective symptom checklist during screening or prior to the administration of study drug on Day 1.
Data sourced from ClinicalTrials.gov (NCT04804540). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.