NCT03345836

A Study of the Efficacy and Safety of an Active Drug in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy

Brief summary

The objective of this study is to evaluate the efficacy and safety of an active drug compared to placebo as induction therapy in subjects with moderately and severely active Crohn's disease (CD).

Interventional study

Status:
Completed
Conditions:
Crohn's Disease
Enrollment:
625 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M14-431
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:

- Confirmed diagnosis of CD for at least 3 months prior to Baseline.

- Confirmed diagnosis of moderate to severe CD as assessed by stool frequency (SF),
abdominal pain (AP) score.

- Evidence of mucosal inflammation based on the Simplified Endoscopic Score for Crohn's
disease (SES-CD) on an endoscopy confirmed by a central reader.

- Demonstrated an inadequate response or intolerance to any biologic therapy for
infliximab, adalimumab, certolizumab pegol, vedolizumab, and ustekinumab.

- If female, participant must meet the contraception recommendations.

Exclusion Criteria:

- Participant with a current diagnosis of ulcerative colitis or indeterminate colitis.

- Participant not on stable doses of CD related antibiotics, oral aminosalicylates,
corticosteroids or methotrexate (MTX).

- Participant with the following ongoing known complications of CD: abscess (abdominal
or peri-anal), symptomatic bowel strictures, fulminant colitis, toxic megacolon, or
any other manifestation that might require surgery while enrolled in the study.

- Participant with ostomy or ileoanal pouch.

- Participant diagnosed with conditions that could interfere with drug absorption
including but not limited to short gut or short bowel syndrome.

- Screening laboratory and other analyses show abnormal results.

All the cities where the clinical studies are located

Calgary - T2N 4Z6
Edmonton - T5R 1W2
New Westminster - V3L 3W4
Vancouver - V6Z 2K5
Halifax - B3H 2Y9
North Bay - P1B 2H3
Oshawa - L1H 7K4
Ottawa - K1H 8L6
Sudbury - P3A 1W8
Vaughan - L4L 4Y7
Levis - G6V 3Z1
Montreal - H2X 0A9
Montreal - H3G 1A4
Sherbrooke - J1G 2E8