NCT02365649

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of an Active Drug for the Induction of Symptomatic and Endoscopic Remission in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Immunomodulators or Anti-TNF Therapy

Brief summary

To determine the efficacy and safety of multiple doses of an active drug in subjects with moderately to severely active Crohn's Disease with a history of inadequate response to or intolerance to Immunomodulators or anti-Tumor Necrosis Factor (TNF) therapy.

Interventional study

Status:
Completed
Conditions:
Crohn's Disease
Enrollment:
219 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M13-740
Allocation:
Randomized
Intervention model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Purpose:
Treatment

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Eligibility criteria

Participant attributes:
Male and Female

Age:

From 18 Years to 75 Years.

Inclusion Criteria:

1. Diagnosis of Crohn's disease (CD) for at least 90 days.

2. Crohn's Disease Activity Index (CDAI) greater than or equal to 220 and less than or
equal to 450.

3. Subject inadequately responded to or experience intolerance to previous treatment with
immunomodulators (e.g. azathioprine, 6-mercaptopurine, or methotrexate) and/or
anti-TNF agent (e.g., infliximab, adalimumab, or certolizumab pegol).

Exclusion Criteria:

1. Subjects with ulcerative colitis (UC), collagenous colitis or indeterminate colitis.

2. Subject who has had surgical bowel resections in the past 6 months or is planning
resection.

3. Subjects with an ostomy or ileoanal pouch.

4. Subject with symptomatic bowel stricture or abdominal or peri-anal abcess.

5. Subject who has short bowel syndrome.

6. Subject with recurring infections or active Tuberculosis (TB).

All the cities where the clinical studies are located

Edmonton - T6G 2X8
Vancouver - V5Z 1M9
Vancouver - V6Z 2K5
London - N6A 5A5
Sudbury - P3E 1H5
Vaughan - L4L 4Y7
Montreal - H3G 1A4
Winnipeg - R3A 1R9

Alberta

British Columbia

Manitoba

Quebec