A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Crohn*s Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 9

Inclusion Criteria

1. The subject has a diagnosis of CD established at least 3 months prior to screening, by clinical and endoscopic evidence and corroborated by a histopathology report.
2. The subject has moderately to severely active CD.
3. The subject has CD involvement of the ileum and/or colon, at a minimum.
4. The subject has extensive colitis or pancolitis of >8 years duration or limited colitis of >12 years duration must have documented evidence that a surveillance colonoscopy was performed within 12 months of the initial screening visit.
5. Subjects with a family history of colorectal cancer, personal history of increased colorectal cancer risk, age >50 years, or other known risk factors must be up-to-date on colorectal cancer surveillance at screening.
6. The subject has demonstrated an inadequate response to, loss of response to, or intolerance of at least 1 of the following agents: immunomodulators, corticosteroids, or TNF-alpha antagonists.

Exclusion Criteria

1. The subject has evidence of abdominal abscess at the initial Screening Visit.
2. The subject has had extensive colonic resection, subtotal or total colectomy.
3. The subject has a history of >3 small bowel resections or diagnosis of short bowel syndrome.
4. The subject has received tube feeding, defined formula diets, or parenteral alimentation within 28 days prior to the administration of the first dose of study drug.
5. The subject has ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.
6. The subject has received any of the investigational or approved nonbiologic therapies (eg, cyclosporine, tacrolimus, thalidomide, methotrexate, or tofacitinib except for those specifically listed in the protocol) for the treatment of underlying disease within 30 days or 5 half-lives of screening (which ever is longer).
7. The subject has received any investigational or approved biologic or biosimilar agent within 60 days or 5 half-lives of screening (which ever is longer).
8. The subject has used topical (rectal) treatment with 5-ASA or corticosteroid enemas/suppositories within 2 weeks of the administration of the first dose of study drug.
9. The subject requires currently or is anticipated to require surgical intervention for CD during the study.
10. The subject has a history or evidence of adenomatous colonic polyps that have not been removed.
11. The subject has a history or evidence of colonic mucosal dysplasia.
12. The subject has a suspected or confirmed diagnosis of ulcerative colitis, indeterminate colitis, ischaemic colitis, radiation colitis, diverticular disease associated with colitis, or microscopic colitis.
13. The subject has evidence of an active infection during the Screening Period.
14. The subject has evidence of, or treatment for, C. difficile infection or other intestinal pathogen with 28 days prior to first dose of study drug.
15. The subject has chronic hepatitis B virus (HBV) infection* or chronic hepatitis C virus (HCV) infection. * HBV immune subjects (ie, being hepatitis B surface antigen [HBsAg] negative and hepatitis B surface antibody [HBsAb] positive) may, however, be included.
16. The subject has active or latent TB as evidenced by the following:
i. A positive diagnostic TB test within 30 days prior to screening or during the screening period, defined as: 1. A positive QuantiFERON test or 2 successive indeterminate QuantiFERON tests, (or, A positive T-SPOT TB test [Japan only]), OR,
Vedolizumab SC 2. A tuberculin skin test reaction *5 mm.
Note: if subjects have received BCG vaccine then a QuantiFERON TB Gold text should be performed instead of the tuberculin skin text
ii. Chest X-ray within 3 months prior to Week 0 which is suspicious for pulmonary TB, and a positive or 2 successive indeterminate QuantiFERON tests (or, A positive T-SPOT TB test [Japan only]) within 30 days prior to Screening or during the Screening Period.
Note: subjects with documented previously treated TB with a negative QuantiFERON text can be included in the study.
17. The subject has any identified congenital or acquired immunodeficiency (eg, common variable immunodeficiency, human immunodeficiency virus [HIV] infection, organ transplantation).
18. The subject has received any live vaccinations within 30 days prior to screening.
19. The subject has clinically significant infection (eg, pneumonia, pyelonephritis) within 30 da

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint for the study is the proportion of subjects with clinical<br /><br>remission, defined as CDAI score *150, at Week 52.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints for this study are:<br /><br>* Proportion of subjects with enhanced clinical response, defined as a 100<br /><br>point decrease in CDAI score from Baseline (Week 0), at Week 52.<br /><br> Proportion of subjects with corticosteroid-free remission, defined as<br /><br>subjects using oral corticosteroids at Baseline (Week 0) who have discontinued<br /><br>oral corticosteroids and are in clinical remission at Week 52.<br /><br>* Proportion of TNF-alpha antagonist naïve subjects who achieved clinical<br /><br>remission, defined as CDAI score *150, at Week 52.</p><br>