Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC
- Conditions
- lcerative ColitisMedDRA version: 18.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2015-000939-33-ES
- Lead Sponsor
- Takeda Development Centre Europe, Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 771
1.Has a diagnosis of ulcerative colitis established at least 6 months prior to screening by clinical and endoscopic evidence and corroborated by a histopathology report.
2.Has moderately to severely active ulcerative colitis as determined by a Mayo score of 6 to 12 with an endoscopic subscore greater than or equal to >=2 within 14 days prior to the randomization.
3.Has evidence of ulcerative colitis proximal to the rectum (>=15 centimeter [cm] of involved colon).
4.With extensive colitis (up to the hepatic flexure) or pancolitis of >8 years duration or left-sided colitis of >12 years duration must have documented evidence that a surveillance colonoscopy was performed within 12 months of the initial screening visit (may be performed during the Screening Period).
5.Has had previous treatment with tumor necrosis factor- alpha (TNF-alpha) antagonists without documented clinical response to treatment or is naïve to TNF-alpha antagonist therapy but is failing current treatment.
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 638
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
1.Clinical evidence of abdominal abscess or toxic megacolon at Screening.
2.The subject has had an 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 a diagnosis of Crohn's colitis or indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, or microscopic colitis.
5.The subject has received any of the following within 30 days of screening:
a.Non-biologic therapies other than those specifically listed in Section Permitted Medications For Treatment of UC.
b.An approved non-biologic therapy in an investigational protocol.
6.The subject has received any investigational or approved biologic or biosimilar agent within 60 days or 5 half lives prior to the screening (whichever is longer).
7.The subject has previously received natalizumab, efalizumab, adalimumab, or rituximab.
8.The subject has history or evidence of adenomatous colonic polyps that have not been removed, or colonic mucosal dysplasia.
9.Evidence of an active infection during Screening.
10.Evidence of, or treatment for, C. difficile or other intestinal pathogen within 28 days prior to the 1st dose of study drug.
11.The subject has chronic HBV or HCV infection.
12.The subject has active or latent TB, regardless of treatment history.
13.The subject has used a topical (rectal) treatment with (5-ASA) or corticosteroid enemas/suppositories within 2 weeks of the administration of the 1st dose of study drug.
14.The subject has a history of hypersensitivity or allergies to vedolizumab or adalimumab.
15.The subject has a positive PML subjective symptom checklist prior to the administration of the first dose of study drug.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine the effect of vedolizumab IV compared to adalimumab SC on clinical remission at Week 52.;<br> Secondary Objective: ? To evaluate the effect of vedolizumab IV compared to adalimumab SC on mucosal healing at Week 52.<br> ? To evaluate the effect of vedolizumab IV compared to adalimumab SC on corticosteroid-free remission at Week 52.<br> ;Primary end point(s): Proportion of subjects achieving 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 Outcome Measures
Name Time Method <br> Secondary end point(s): ? Proportion of subjects achieving mucosal healing (defined as Mayo endoscopic subscore ?1 point) at Week 52.<br> ? Proportion of subjects using oral corticosteroids at Baseline who have discontinued corticosteroids and are in clinical remission at Week 52.<br> ;Timepoint(s) of evaluation of this end point: Week 52