SEQUENCE

Study Comparing Intravenous (IV)/Subcutaneous (SC) Risankizumab to IV/SC Ustekinumab to Assess Change in Crohn's Disease Activity Index (CDAI) in Adult Participants With Moderate to Severe Crohn's Disease (CD)

Brief summary

Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. This study will evaluate how well risankizumab works compared to ustekinumab. This study will assess change in Crohn's Disease Activity Index (CDAI). Risankizumab is an investigational drug being developed for the treatment of Crohn's Disease (CD). Ustekinumab is an approved drug for the treatment of moderate and severe CD. Participants are randomly assigned to one of the three treatment groups. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to ustekinumab. Around 508 adult participants with moderate to severe CD will be enrolled in approximately 307 sites worldwide. In Part 1, participants assigned to risankizumab will receive intravenous (IV) doses of risankizumab at Week 0, 4,8 and subcutaneous (SC) doses every 8 weeks thereafter through Week 48. Participants assigned to ustekinumab will receive intravenous (IV) dose of ustekinumab at Week 0 and subcutaneous (SC) doses every 8 weeks thereafter through Week 48. In Part 2, participants who received risankizumab in Part 1 and completed the Week 48 visit will continue to receive SC risankizumab for up to an additional 220 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Interventional study

Status:
Active, not recruiting
Conditions:
Crohn's Disease (CD)
Enrollment:
527 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M20-259
Allocation:
Randomized
Intervention model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Purpose:
Treatment

 

Eligibility criteria

Participant attributes:
Male and Female

Age:

From 18 Years to 80 Years.

Inclusion Criteria:

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

- Demonstrated intolerance or inadequate response to one or more anti-tumor necrosis
factor (TNF) therapies.

Exclusion Criteria:

- Current diagnosis of ulcerative colitis or indeterminate colitis.

- Receipt of CD approved biologic agents prior to Baseline (as detailed in protocol), or
any investigational biologic or other agent or procedure prior to Baseline (as
detailed in protocol).

- Prior exposure to p19 and/or p40 inhibitors (e.g., risankizumab and ustekinumab).

- Currently know complications of CD (strictures, short bowel, etc).

All the cities where the clinical studies are located

Calgary - T2N 4Z6
Edmonton - T5R 1W2
New Westminster - V3L 3W4
Victoria - V8V 3M9
Halifax - B3H 2Y9
London - N6A 5W9
North Bay - P1B 2H3
Toronto - M5G 1X5
Greenfield Park - J4V 2H1
Montreal - H4A 3J1
Quebec City - G6V 3Z1
Quebec City - G6V 3Z1
Sherbrooke - J1H 5N4

More information about this study

clinicaltrials.gov