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

Phase 3

Completed

• Conditions: Colitis, Ulcerative

• Registration Number: JPRN-jRCT2080223167
• Lead Sponsor: Takeda Pharmaceutical Company Limited

Brief Summary

The results of Study SC-3027 demonstrate that vedolizumab SC is an effective and well-tolerated maintenance treatment for participants with moderately to severely active UC and the treatment effects with SC are consistent with IV maintenance therapy. Except for injection site reactions, the safety and immunogenicity of vedolizumab SC was similar to vedolizumab IV in this study.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-08
• Study Completion: 2018-08-21
• Results First Posted: 2018-11-29
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 383

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
efficacy<br>Percentage of Participants Achieving Clinical Remission at Week 52<br>Timeframe: Week 52<br>Clinical remission is defined as a complete Mayo score =< 2 points and no individual subscore > 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).