NCT03104413

A Study to Assess the Efficacy and Safety of an Active Drug in Participants With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment

Brief summary

The objective of Study M15-991 is to evaluate the efficacy and safety of an active drug versus
placebo during induction therapy in participants with moderately to severely active CD.

Interventional study

Status:
Completed
Conditions:
Crohn's Disease
Enrollment:
618 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M15-991
Allocation:
Randomized
Intervention model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Purpose:
Treatment

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Eligibility criteria

Participant attributes:
Male and Female

Age:

From 16 Years to 80 Years.

Inclusion Criteria:

- Male or female aged >=18 to <= 80 years, or minimum age of adult consent according to
local regulations, at the Baseline Visit. Where locally permissible, participants 16
to < 18 years of age who meet the definition of Tanner stage 5 for development at the
Baseline Visit.

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

- Crohn's disease activity index (CDAI) score 220 - 450 at Baseline.

- Confirmed diagnosis of moderate to severe CD as assessed by stool frequency (SF),
abdominal pain (AP) score, and Simple Endoscopic Score for Crohn's Disease (SES-CD).

- Demonstrated intolerance or inadequate response to biologic therapy for CD.

- If female, participant must meet the contraception recommendations.

Exclusion Criteria:

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

- Participants with unstable doses of concomitant Crohn's disease therapy.

- Receipt of Crohn's disease approved biologic agents (infliximab, adalimumab,
certolizumab, vedolizumab, natalizumab within 8 weeks prior to Baseline or ustekinumab
within 12 weeks prior to Baseline), or any investigational biologic or other agent or
procedure within minimally 35 days or 5 half-lives prior to Baseline, whichever is
longer.

- Prior exposure to p19 inhibitors (e.g., risankizumab).

- Complications of Crohn's disease.

- Having an ostomy or ileoanal pouch.

- Known active Coronavirus Disease 2019 (COVID-19) infection.

All the cities where the clinical studies are located

Calgary - T2N 4Z6
Edmonton - T6G 2X8
Edmonton - T5R 1W2
New Westminster - V3L 3W4
Vancouver - V6Z 2K5
Victoria - V8V 3M9
Halifax - B3K 6R8
Halifax - B3H 2Y9
London - N6A 5A5
North Bay - P1B 2H3
Sudbury - P3E 5M4
Vaughan - L4L 4Y7
Greenfield Park - J4V 2H1
Montreal - H1T 2M4
Montreal - H3G 1A4
Montreal - H2X 0A9