RecruitingCrohn's Disease

A Study of Vedolizumab Intravenous (IV) and Adalimumab or Vedolizumab and Ustekinumab in Adults With Crohn's Disease

Eligible age

18–70 yrs

Accepts

All genders

Locations

21 states

Healthy volunteers

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About this study

The main aim of this study is to learn about the effect of treatment with vedolizumab IV (vedolizumab) together with adalimumab or vedolizumab (VDZ) together with ustekinumab (UST) in adults with moderate to severe Crohn's Disease, and the effect of treatment with vedolizumab alone, after the dual targeted treatment. The study is conducted in two parts. In Part A, participants will receive the dual targeted treatment (vedolizumab together with either adalimumab or ustekinumab). In part B, participants will receive vedolizumab only. Part B will include participants who responded to the treatment in Part A. Each participant will be followed up for at least 26 weeks after the last dose of treatment.

Sponsor: Takeda

You may qualify if…

✓ Part A:
✓ 1. Has a confirmed diagnosis of CD at least 3 months before screening, based on endoscopy results.
✓ 2. Has moderately to severely active CD at Screening, defined as an SES-CD \>=6 (\>=4 if isolated ileal disease).
✓ 3. Has demonstrated at least 1 of the following (a, b, or c) to at least 1 IL antagonist or at least 1 tumor necrosis factor (TNF) antagonist, at doses approved for the treatment of CD:
✓ 1. Inadequate response after completing the full induction regimen;
✓ 2. Loss of response (recurrence of symptoms during scheduled maintenance dosing after prior clinical benefit); or
✓ 3. Intolerance (a significant adverse event that precluded further use, including but not limited to serious infection including opportunistic infections, malignancy, infusion-related and hypersensitivity reactions including anaphylaxis, and liver injury).
✓ Note: Participants with an inadequate response to \>2 classes of advanced therapies or \>1 agent in the same class are not eligible. Participants who discontinued a third class of advanced therapy for reasons other than inadequate response may be eligible after discussion with the Medical Monitor.

You may not qualify if…

✕ 1. CDAI score \> 450.
✕ 2. A current diagnosis of ulcerative colitis or indeterminate colitis.
✕ 3. Clinical evidence of an abdominal abscess.
✕ 4. Known fistula (other than perianal fistula) or phlegmon.
✕ 5. Known perianal fistula with abscess.
✕ 6. Ileostomy, colostomy, or severe, or symptomatic stenosis of the intestine.
✕ 7. Previous extensive bowel resection with 2 entire segments missing, of the following: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum.
✕ 8. Short bowel syndrome.