Colitis, Ulcerative
Conditions
Interventions
investigational material(s)
Generic name etc : Vedolizumab Intravenous (IV), Vedolizumab Subcutaneous (SC), Placebo IV
INN of investigational material : Vedolizumab
Therapeutic category code : 239 Oth
Sponsors
Takeda Pharmaceutical Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosis of ulcerative colitis (UC) established at least 6 months prior to screening, by clinical and endoscopic evidence and corroborated by a histopathology report. 2. Moderately to severely active UC as determined by a complete Mayo score of 6-12 (with an endoscopic subscore >=2) 3. Evidence of UC extending proximal to the rectum (>=15 cm of involved colon). 4. Inadequate response with, loss of response to, or intolerance to corticosteroids, immunomodulators, or Tumor Necrosis Factor-alpha (TNF-alpha) antagonists
Exclusion criteria
Exclusion criteria: 1. Evidence of abdominal abscess or toxic megacolon at the initial Screening Visit. 2. Extensive colonic resection, subtotal or total colectomy. 3. Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine. 4. 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). 5. Prior exposure to any investigational or approved biologic or biosimilar agent within 60 days or 5 half-lives of screening (whichever is longer). 6. Prior exposure to vedolizumab 7. Surgical intervention for UC required at any time during the study. 8. History or evidence of adenomatous colonic polyps that have not been removed or has a history or evidence of colonic mucosal dysplasia. 9. Suspected or confirmed diagnosis of Crohn's enterocolitis, indeterminate colitis, ischaemic colitis, radiation colitis, diverticular disease associated with colitis, or microscopic colitis. 10. Active infections 11. 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. 12. History of any major neurological disorders, including stroke, multiple sclerosis, brain tumor, demyelinating or neurodegenerative disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Percentage of Participants Achieving Clinical Remission at Week 52 Timeframe: Week 52 Clinical remission is defined as a complete Mayo score = 1 point. The Mayo score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 subscores: rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment. Each subscore is scored on a scale from 0 to 3 and the complete Mayo score ranges from 0 to 12 (higher scores indicate greater disease activity). | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy Percentage of Participants Achieving Mucosal Healing at Week 52 Timeframe: Week 52 Mucosal healing is defined as Mayo endoscopic subscore ==3 points and >=30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of >=1 point or absolute rectal bleeding subscore of =) 1 point. The Mayo score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 subscores: rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment. Each subscore is scored on a scale from 0 to 3 and the complete Mayo score ranges from 0 to 12 (higher scores indicate greater disease activity). efficacy Percentage of Participants Achieving Corticosteroid-free Remission at Week 52 Timeframe: Week 52 Corticosteroid-free remission is defined as participants using oral corticosteroids at Baseline (Week 0) who have discontinued oral corticosteroids and are in clinical remission at Week 52. Clinical remission is defined as a complete Mayo score of = 1 point. The Mayo score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 subscores: rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment. Each subscore is scored on a scale from 0 to 3 and the complete Mayo score ranges from 0 to 12 (higher scores indicate greater disease activity). | — |
Countries
Japan, Japan, Refer to "Other" section
Outcome results
None listed