Phase 3
Completed N=383
Efficacy and Safety of Vedolizumab Subcutaneously (SC) as Maintenance Therapy in Ulcerative Colitis
Colitis, Ulcerative
Source: ClinicalTrials.gov NCT02611830 ↗
Enrolled (actual)
383
Serious AEs
10.4%
Results posted
Jan 2020
Primary outcomePrimary: Percentage of Participants Achieving Clinical Remission at Week 52 — 14.3; 46.2; 42.6 percentage of participants — p=<0.001
◆ Published Evidence
Highly cited
314citations · ~52 / year
Efficacy and Safety of Vedolizumab Subcutaneous Formulation in a Randomized Trial of Patients With Ulcerative Colitis.
Summary
The purpose of this study is to assess the effect of vedolizumab subcutaneous (vedolizumab SC) maintenance treatment on clinical remission at Week 52 in participants with moderately to severely active ulcerative colitis (UC) who achieved clinical response following administration of vedolizumab intravenous (vedolizumab IV) induction therapy.
Linked Publications (3)
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Efficacy and Safety of Vedolizumab Subcutaneous Formulation in a Randomized Trial of Patients With Ulcerative Colitis.
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Efficacy and safety of a new vedolizumab subcutaneous formulation in Japanese patients with moderately to severely active ulcerative colitis.
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Efficacy of vedolizumab during intravenous induction therapy in ulcerative colitis and Crohn's disease: post hoc analysis of patient-reported outcomes from the VISIBLE 1 and 2 studies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Clinical Remission at Week 52 |
14.3; 46.2; 42.6 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving Mucosal Healing at Week 52 |
21.4; 56.6; 53.7 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving Durable Clinical Response at Week 6 and Week 52 |
28.6; 64.2; 72.2 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving Durable Clinical Remission at Week 6 and Week 52 |
5.4; 15.1; 16.7 | 0.076 |
| SECONDARY Percentage of Participants Achieving Corticosteroid-free Remission at Week 52 |
8.3; 28.9; 28.6 | 0.067 |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of ulcerative colitis (UC) established at least 6 months prior to screening, by clinical and endoscopic evidence and corroborated by a histopathology report.
- Moderately to severely active UC as determined by a complete Mayo score of 6-12 (with an endoscopic subscore ≥2)
- Evidence of UC extending proximal to the rectum (≥15 cm of involved colon).
- Inadequate response with, loss of response to, or intolerance to corticosteroids, immunomodulators, or Tumor Necrosis Factor-alpha (TNF-α) antagonists
Exclusion Criteria
- Evidence of abdominal abscess or toxic megacolon at the initial Screening Visit.
- Extensive colonic resection, subtotal or total colectomy.
- Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.
- Prior exposure to investigational or approved non-biologic therapies (eg, cyclosporine, tacrolimus, thalidomide, methotrexate or tofacitinib) for the treatment of underlying disease within 30 days or 5 half-lives of screening (whichever is longer).
- Prior exposure to any investigational or approved biologic or biosimilar agent within 60 days or 5 half-lives of screening (whichever is longer).
- Prior exposure to vedolizumab
- Surgical intervention for UC required at any time during the study.
- History or evidence of adenomatous colonic polyps that have not been removed or has a history or evidence of colonic mucosal dysplasia.
- Suspected or confirmed diagnosis of Crohn's entercolitis, indeterminate colitis, ischaemic colitis, radiation colitis, diverticular disease associated with colitis, or microscopic colitis.
- Active infections
- Chronic hepatitis B virus (HBV) infection or chronic hepatitis C virus (HCV) infection, HIV or tuberculosis (active or latent), identified congenital or acquired immunodeficiency. HBV immune participants (ie, being hepatitis B surface antigen [HBsAg] negative and hepatitis B antibody positive) may, however, be included.
- History of any major neurological disorders, including stroke, multiple sclerosis, brain tumor, demyelinating or neurodegenerative disease.
Data sourced from ClinicalTrials.gov (NCT02611830) and the linked publication. 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.