NCT03345849

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 Conventional and/or Biologic Therapies

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 participants with moderately and severely active Crohn's disease (CD).

Interventional study

Status:
Recruiting
Conditions:
Crohn's Disease
Enrollment:
501 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M14-433
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 one or more conventional and/or
biologic therapies (Oral locally acting steroids, Intravenous or oral corticosteroids,
Immunosuppressants), in the opinion of the investigator.

Note: Participants who have had inadequate response or intolerance to conventional therapy
who have received prior biologic may be enrolled; however, participants must have
discontinued the biologic for reasons other than inadequate response or intolerance (e.g.,
change of insurance, well controlled disease).

- 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 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 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

Edmonton - T6G 2X8

Edmonton - T6L 6K3

New Westminster - V3L 3W4

Vancouver - V6Z 2K5

Halifax - B3H 2Y9

London - N6A 5A5

North Bay - P1B 2H3

Oshawa - L1H 7K4

Ottawa - K1H 8L6

Sudbury - P3E 5M4

Vaughan - L4L 4Y7

Levis - G6V 3Z1

Montreal - H2X 0A9

Montréal - H3G 1A4

Sherbrooke - J1G 2E8