Purpose

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

Condition

Eligibility

Eligible Ages
Between 16 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Risankizumab Dose 1 (Induction Period 1)
Participants randomized to receive risankizumab dose 1 in Induction Period 1.
  • Drug: risankizumab IV
    risankizumab administered as intravenous (IV) infusion.
    Other names:
    • ABBV-066 BI 655066
    • SKYRIZI
Experimental
Risankizumab Dose 2 (Induction Period 1)
Participants randomized to receive risankizumab dose 2 in Induction Period 1.
  • Drug: risankizumab IV
    risankizumab administered as intravenous (IV) infusion.
    Other names:
    • ABBV-066 BI 655066
    • SKYRIZI
Placebo Comparator
Placebo (Induction Period 1)
Participants randomized to receive placebo for risankizumab in Induction Period 1.
  • Drug: placebo for risankizumab IV
    placebo for risankizumab administered as intravenous (IV) infusion.
Experimental
Risankizumab Dose 1 (Induction Period 2)
Participants who received placebo in Period 1 and participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Period 2.
  • Drug: risankizumab IV
    risankizumab administered as intravenous (IV) infusion.
    Other names:
    • ABBV-066 BI 655066
    • SKYRIZI
Experimental
Risankizumab Dose 2 (Induction Period 2)
Participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Period 2.
  • Drug: risankizumab SC
    risankizumab administered by subcutaneous (SC) injection
    Other names:
    • ABBV-066 BI 655066
    • SKYRIZI
Experimental
Risankizumab Dose 3 (Induction period 2)
Participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Period 2.
  • Drug: risankizumab SC
    risankizumab administered by subcutaneous (SC) injection
    Other names:
    • ABBV-066 BI 655066
    • SKYRIZI

More Details

Status
Completed
Sponsor
AbbVie

Study Contact

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.