An Efficacy and Safety Study of Vedolizumab Intravenous (IV) Compared to Adalimumab Subcutaneous (SC) in Participants With Ulcerative Colitis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02497469
• Date of registration: 10/07/2015
• Prospective Registration: No
• Primary sponsor: Takeda
• Public title: An Efficacy and Safety Study of Vedolizumab Intravenous (IV) Compared to Adalimumab Subcutaneous (SC) in Participants With Ulcerative Colitis
• Scientific title: A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis
• Date of first enrolment: June 29, 2015
• Target sample size: 771
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02497469
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Belgium, Bosnia and Herzegovina, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Czechia, Denmark, Estonia, Finland, France, Germany, Hong Kong, Hungary, Israel, Italy, Korea, Republic of, Latvia, Lithuania, Mexico, Netherlands, Norway, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Sweden, Taiwan, Turkey, Ukraine, United Kingdom, United States

Contacts

• Name: Medical Director
• Affiliation: Takeda

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Has a diagnosis of ulcerative colitis established at least 3 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. The participant:

1. Has had previous treatment with tumor necrosis factor- alpha (TNF-alpha)
antagonists without documented clinical response to treatment (example, due to
lack of response [primary nonresponders], loss of response, or intolerance
[secondary nonresponders]), or

2. Has previously used a TNF-alpha antagonists (except adalimumab), and discontinued
its use due to reasons other than safety, or

3. Is naïve to TNF-alpha antagonist therapy but is failing current treatment
(example, corticosteroids, 5-aminosalicylate [5-ASA], or immunomodulators).

Exclusion Criteria:

1. Clinical evidence of abdominal abscess or toxic megacolon at Screening.

2. Has had an extensive colonic resection, subtotal or total colectomy.

3. Has had ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.

4. Has a diagnosis of Crohn's colitis or indeterminate colitis, ischemic colitis,
radiation colitis, diverticular disease associated with colitis, or microscopic
colitis.

5. Has received any of the following for the treatment of underlying disease within 30
days of randomization:

1. Non-biologic therapies (example, cyclosporine, tacrolimus, thalidomide) other
than those specifically listed in Section Permitted Medications For Treatment of
UC.

2. An approved non-biologic therapy in an investigational protocol.

6. 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. Has previously received natalizumab, efalizumab, adalimumab, AMG-181, anti-mucosal
addressin cell adhesion molecule-1 antibodies, or rituximab.

8. Has previously received vedolizumab.

9. Has history or evidence of adenomatous colonic polyps that have not been removed, or
colonic mucosal dysplasia.

10. Evidence of an active infection during Screening.

11. Evidence of, or treatment for, Clostridium difficile (C. difficile) or other
intestinal pathogen within 28 days prior to the 1st dose of study drug.

12. Has chronic hepatitis B virus (HBV) infection* or chronic hepatitis C virus (HCV)
infection (* HBV immune participants, ie, being hepatitis B surface antigen [HBsAg],
may participate).

13. Has active or latent TB, regardless of treatment history.

14. 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.

15. Has a positive progressive multifocal leukoencephalopathy (PML) subjective symptom
checklist prior to the administration of the first dose of study drug.



Age minimum: 18 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Colitis, Ulcerative

Intervention(s)

Drug: Vedolizumab

Drug: Adalimumab

Drug: Adalimumab placebo

Drug: Vedolizumab placebo

Primary Outcome(s)

Percentage of Participants Who Achieved Clinical Remission [Time Frame: Week 52]

Secondary Outcome(s)

Percentage of Participants Who Achieved Mucosal Healing [Time Frame: Week 52]

Percentage of Participants Who Used Oral Corticosteroids at Baseline Who Discontinued Corticosteroids and Were in Clinical Remission [Time Frame: Week 52]

Secondary ID(s)

MLN0002-3026

NL54690.056.15

U1111-1168-6713

2015-000939-33

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 10/10/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02497469