Ulcerative Colitis MedDRA version: 20.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856
Conditions
Interventions
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
Pharmaceutical Form: Powder for concentrate for solution for infusion
Sponsors
Takeda Development Centre Europe, Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The subject has a diagnosis of UC established at least 6 months prior to screening, by clinical and endoscopic evidence and corroborated by a histopathology report. 2. The subject has moderately to severely active UC as determined by a complete Mayo score of 6-12 with an endoscopic subscore =2 within 10 days prior to the first dose of study drug. 3. The subject has evidence of UC extending proximal to the rectum (=15 cm of involved colon). 4. The subject has demonstrated an inadequate response to, loss of response to, or intolerance of at least 1 of the following agents: immunomodulators, corticosteroids, or TNF-alpha antagonist. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 388 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 12
Exclusion criteria
Exclusion criteria: 1. The subject has evidence of abdominal abscess or toxic megacolon at the initial Screening Visit. 2. The subject has had extensive colonic resection, subtotal or total colectomy. 3. The subject has had ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine. 4. The subject has received any of the investigational or approved non-biologic therapies (eg, cyclosporine, tacrolimus, thalidomide, methotrexate or tofacitinib, except for those specifically listed in the protocol) for the treatment of underlying disease within 30 days or 5 half-lives of screening (whichever is longer). 5. The subject has received any investigational or approved biologic or biosimilar agent within 60 days or 5 half-lives of screening (which ever is longer). 6. The subject currently requires or is anticipated to require surgical intervention for UC during the study. 7. The subject has a history or evidence of adenomatous colonic polyps that have not been removed, or has a history or evidence of colonic mucosal dysplasia. 8. The subject has a suspected or confirmed diagnosis of Crohn’s entercolitis, indeterminate colitis, ischaemic colitis, radiation colitis, diverticular disease associated with colitis, or microscopic colitis. 9. The subject has evidence of an active infection during the Screening Period. 10. The subject has evidence of, or treatment for, C. difficile infection or other intestinal pathogen with 28 days prior to first dose of study drug. 11. The subject has chronic hepatitis B virus (HBV) infection* or chronic hepatitis C virus (HCV) infection. * HBV immune subjects (ie, being hepatitis B surface antigen [HBsAg] negative and hepatitis B antibody positive) may, however, be included. 12. The subject has active or latent TB as evidenced by the following: I. A positive diagnostic TB test within 30 days prior to screening or during the Screening Period, defined as: 1. A positive QuantiFERON test or 2 successive indeterminate QuantiFERON tests, (or, A positive T-SPOT TB test [Japan only]), OR, 2. A tuberculin skin test reaction >5 mm. Note: if subjects have received BCG vaccine then a QuantiFERON TB Gold test should be performed instead of the tuberculin skin test. OR ii. Chest X-ray within 3 months prior to Week 0 which is suspicious for pulmonary TB, and a positive or 2 successive indeterminate QuantiFERON tests (or, A positive T-SPOT TB test [Japan only]) within 30 days prior to Screening or during the Screening Period. Note: subjects with documented previously treated TB with a negative QuantiFERON test can be included in the study. 13. The subject has any identified congenital or acquired immunodeficiency (eg, common variable immunodeficiency, human immunodeficiency virus [HIV] infection, organ transplantation). 14. The subject has received any live vaccinations within 30 days prior to screening. 15. The subject had a clinically significant infection (eg, pneumonia, pyelonephritis) within 30 days prior to screening, or ongoing chronic infection. 16. The subject has used a topical (rectal) treatment with 5-aminosalicylic acid (5-ASA) or corticosteroid enemas/suppositories within 2 weeks of the administration o
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To assess the effect of vedolizumab SC maintenance treatment on clinical remission at Week 52 in subjects with moderately to severely active UC who achieved clinical response at Week 6 following administration of vedolizumab IV at Weeks 0 and 2.; Secondary Objective: • To determine the effect of vedolizumab SC maintenance treatment on mucosal healing at Week 52 in subjects who achieved clinical response at Week 6 following administration of vedolizumab IV at Weeks 0 and 2. • To determine the effect of vedolizumab SC maintenance treatment on durable clinical response at Week 52 in subjects who achieved clinical response at Week 6 following administration of vedolizumab IV at Weeks 0 and 2. • To determine the effect of vedolizumab SC maintenance treatment on durable clinical remission at Week 52 in subjects who achieved clinical response at Week 6 following administration of vedolizumab IV at Weeks 0 and 2. • To determine the effect of vedolizumab SC maintenance treatment on corticosteroid free remission at Week 52 in subjects who achieved clinical response at Week 6 following administration of vedolizumab IV at Weeks 0 and 2. ;Primary end point(s): • Proportion of subjects with clinical remission, defined as a complete Mayo score of =2 points and no individual subscore >1 point, at Week 52.;Timepoint(s) of evaluation of this end point: Week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Proportion of subjects with mucosal healing, defined as Mayo endoscopic subscore of =1 point, at Week 52. • Proportion of subjects with durable clinical response, defined as clinical response at Weeks 6 and 52, where clinical response is defined as a reduction in complete Mayo score of =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. • Proportion of subjects with durable clinical remission, defined as clinical remission at Weeks 6 and 52. • Proportion of subjects with corticosteroid-free remission, defined as subjects using oral corticosteroids at Baseline (Week 0) who have discontinued oral corticosteroids and are in clinical remission at Week 52. ; Timepoint(s) of evaluation of this end point: Week 52: Mucosal healing and corticosteroid-free remission. Week 6 and Week 52: Durable clinical response and durable clinical remission. | — |
Countries
Australia, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, Croatia, Czech Republic, Denmark, Estonia, France, Germany, Hungary, Israel, Italy, Japan, Korea, Republic of, Lithuania, Mexico, Netherlands, Poland, Romania, Russian Federation, Serbia, Slovakia, Spain, Sweden, Turkey, Ukraine, United Kingdom, United States
Contacts
Public ContactStudy Manager
Takeda Development Centre Europe Ltd
Outcome results
None listed