Phase 4 N=150 Treatment

A Study of Vedolizumab in People With Ulcerative Colitis and Crohn's Disease

Ulcerative Colitis · Crohn Disease

Bottom Line

View on ClinicalTrials.gov: NCT04804540 ↗

Enrolled (actual)

150

Serious AEs

5.3%

Results posted

Feb 2025

Primary outcome: Primary: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) — 54; 29; 6; 2 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Vedolizumab IV (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Takeda
Primary completion: Feb 2024

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	—

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.

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.

View full record on ClinicalTrials.gov →

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.