Efficacy and Safety of Vedolizumab Subcutaneous (SC) as Maintenance Therapy in Crohn's Disease

Phase 3

Completed

• Conditions: Crohn's Disease

• Registration Number: JPRN-jRCT2080223331
• Lead Sponsor: Takeda Pharmaceutical Company Limited

Brief Summary

The results of Study SC-3031 demonstrate the efficacy and safety of vedolizumab SC as maintenance treatment for participants with moderately to severely active CD.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-28
• Study Completion: 2019-10-14
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 644

Inclusion Criteria

1. Diagnosis of CD established at least 3 months prior to screening by clinical and endoscopic evidence corroborated by a histopathology report.
2. Moderately to severely active CD as determined by a Crohn's Disease Activity Index (CDAI) score of 220 to 450 and 1 of the following:
- C-reactive protein (CRP) level >2.87 mg/L OR
- Ileocolonoscopy with photographic documentation of a minimum of 3 nonanastomotic ulcerations (each >0.5 cm in diameter) or 10 aphthous ulcerations (involving a minimum of 10 contiguous cm of intestine) consistent with CD OR
- Fecal calprotectin >250 microgram per gram (mcg/g) stool during the screening period in conjunction with computed tomography enterography (CTE), magnetic resonance enterography (MRE), contrast-enhanced small bowel radiography, or wireless capsule endoscopy revealing CD ulcerations (aphthae not sufficient).
3. CD involvement of the ileum and/or colon, at a minimum.
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 at Screening.
2. Extensive colonic resection, subtotal or total colectomy.
3. History of >3 small bowel resections or diagnosis of short bowel syndrome.
4. Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.
5. Prior exposure to investigational or approved non-biologic therapies (example, cyclosporine, tacrolimus, thalidomide, or tofacitinib) for the treatment of underlying disease within 30 days or 5 half-lives of screening (whichever is longer).
6. Prior exposure to any investigational or approved biologic or biosimilar agent within 60 days or 5 half-lives of screening (whichever is longer).
7. Prior exposure to vedolizumab.
8. Surgical intervention for CD required at any time during the study.
9. History or evidence of adenomatous colonic polyps that have not been removed, or of colonic mucosal dysplasia.
10. Suspected or confirmed diagnosis of ulcerative colitis, indeterminate colitis, ischaemic colitis, radiation colitis, diverticular disease associated with colitis, or microscopic colitis.
11. Active infections.
12. Chronic hepatitis B virus (HBV) or C (HCV) infection, tuberculosis (TB) (active or latent), or congenital or acquired immunodeficiency. HBV immune participants (ie, being hepatitis B surface antigen [HBsAg] negative and hepatitis B antibody positive) may, however, be included.
13. History of any major neurological disorders, including stroke, multiple sclerosis, brain tumor, or neurodegenerative disease.

Study & Design

• Study Type: Interventional
• Study Design: Not specified