Crohn's Disease
Conditions
Sponsors
Takeda Pharmaceutical Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Percentage of Participants Achieving Clinical Remission at Week 52 Time Frame: Week 52 Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score =<150 at Week 52. | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy Percentage of Participants Achieving Enhanced Clinical Response at Week 52 Timeframe; Baseline and Week 52 Enhanced clinical response is defined as a decrease from Baseline of >=100 points in the CDAI score at Week 52. efficacy Percentage of Participants Achieving Corticosteroid-free Remission Timeframe; Baseline and Week 52 Corticosteroid-free remission is defined as participants using oral corticosteroids at Baseline (Week 0) who have discontinued oral corticosteroids and are in clinical remission at Week 52. Clinical remission is defined as a CDAI score <=150 at Week 52. efficacy Percentage of TNF-alpha Antagonist Naive Participants Achieving Clinical Remission at Week 52 Timeframe; Baseline and Week 52 Clinical Remission defined as CDAI score <=150, at Week 52. | — |
Countries
Japan, Refer to "Other"section
Outcome results
None listed