Efficacy and Safety of Vedolizumab Subcutaneously (SC) as Maintenance Therapy in Ulcerative Colitis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02611830
• Date of registration: 19/11/2015
• Prospective Registration: Yes
• Primary sponsor: Takeda
• Public title: Efficacy and Safety of Vedolizumab Subcutaneously (SC) as Maintenance Therapy in Ulcerative Colitis
• Scientific title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, With a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy
• Date of first enrolment: December 18, 2015
• Target sample size: 383
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02611830
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Colombia, Croatia, Czech Republic, Czechia, Denmark, Estonia, 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

• Name: Medical Director Clinical Science
• Affiliation: Takeda

Key inclusion & exclusion 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-a) antagonists

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 entercolitis, 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.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Colitis, Ulcerative

Intervention(s)

Drug: Vedolizumab 300 mg IV

Drug: Placebo SC

Drug: Placebo IV

Drug: Vedolizumab 108 mg SC

Primary Outcome(s)

Percentage of Participants Achieving Clinical Remission at Week 52 [Time Frame: Week 52]

Secondary Outcome(s)

Percentage of Participants Achieving Durable Clinical Remission at Week 6 and Week 52 [Time Frame: Weeks 6 and 52]

Percentage of Participants Achieving Durable Clinical Response at Week 6 and Week 52 [Time Frame: Baseline, Weeks 6 and 52]

Percentage of Participants Achieving Mucosal Healing at Week 52 [Time Frame: Week 52]

Percentage of Participants Achieving Corticosteroid-free Remission at Week 52 [Time Frame: Week 52]

Secondary ID(s)

16/LO/0089

JapicCTI-163222

MLN0002SC-3027

NL55501.056.15

2015-000480-14

163300410A0046

189732

U1111-1168-0813

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 23/01/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02611830