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Purpose

Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most often affecting the bowels. It can cause many different symptoms including abdominal pain, diarrhea, tiredness, and weight loss. This study will assess how safe and effective risankizumab subcutaneous (SC) induction treatment is in treating moderately to severely active CD in adult participants. Risankizumab is an approved drug for adults with CD. This study comprises of a Period A, a Period B, and a Period C. In Period A, participants are placed in 1 of 2 groups to receive either risankizumab SC Dose A or Placebo. In Period B, based on response, participants will receive risankizumab SC Dose B or Placebo. Participants who do not have improvement in CD symptoms at Week 12 will receive risankizumab SC Dose C and participants with worsening CD symptoms in period B will receive risankizumab SC. In Period C, eligible participants will receive open-label risankizumab SC Dose D. Approximately 276 adult participants with a diagnosis of moderately to severely active CD will be enrolled in approximately 250 sites globally. Participants will receive SC induction treatment of risankizumab or matching placebo for up to 24 weeks in Period A and B followed by an open-label risankizumab extension in Period C for 52 weeks. The duration of the study will be approximately 93 weeks.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Biopsy-confirmed diagnosis of CD for at least 3 months prior to Baseline. - Participant meets the following disease activity criteria: 1. Moderate to severe CD as assessed by CDAI 2. Endoscopic evidence of mucosal inflammation as documented by a SES-CD - Participant has demonstrated intolerance, loss of response or inadequate response to conventional or advanced therapies for CD.

Exclusion Criteria

  • Participants with a current diagnosis of ulcerative colitis or indeterminate colitis. - Participants with unstable doses of concomitant Crohn's disease therapy. - Participants with prior exposure to p19 inhibitors. - Participants with complications of Crohn's disease. - Participants having an ostomy or ileoanal pouch.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Period A: Risankizumab Dose A 		Participants randomized to receive risankizumab Dose A administered by subcutaneous (SC) injection for up to 12 weeks during Period A.
  • Drug: Risankizumab SC
    subcutaneous (SC) injection
    Other names:
    • ABBV-066
    • SKYRIZI
Placebo Comparator
Period A: Placebo 		Participants randomized to receive placebo for risankizumab administered by Subcutaneous (SC) injection for up to 12 weeks during Period A.
  • Drug: Placebo for risankizumab
    subcutaneous (SC) injection
Experimental
Period B: Risankizumab Dose B 		Participants randomized to receive risankizumab Dose A in Period A that achieved adequate response to receive risankizumab Dose B administered by subcutaneous (SC) injection for up to 12 weeks.
  • Drug: Risankizumab SC
    subcutaneous (SC) injection
    Other names:
    • ABBV-066
    • SKYRIZI
Placebo Comparator
Period B: Placebo 		Participants randomized to receive placebo risankizumab in Period A that achieved adequate response to continue to receive placebo for risankizumab administered by Subcutaneous (SC) injection for up to 12 weeks in Period B.
  • Drug: Placebo for risankizumab
    subcutaneous (SC) injection
Experimental
Period B: Risankizumab Dose C 		Participants with inadequate response in Period A to receive Dose C administered by Subcutaneous (SC) injection for up to 12 weeks during Period B.
  • Drug: Risankizumab SC
    subcutaneous (SC) injection
    Other names:
    • ABBV-066
    • SKYRIZI
Experimental
Period C: Open-Label Risankizumab Dose D 		Participants who complete the Period B Week 24 visit to receive open-label risankizumab Dose D administered by subcutaneous (SC) injection for up to 52 weeks during Period C.
  • Drug: Risankizumab SC
    subcutaneous (SC) injection
    Other names:
    • ABBV-066
    • SKYRIZI

Recruiting Locations

Massachusetts General Hospital /Id# 261051
Boston, Massachusetts 02114

More Details

Status
Recruiting
Sponsor
AbbVie

Study Contact

ABBVIE CALL CENTER
844-663-3742
abbvieclinicaltrials@abbvie.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.