Purpose

The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2. The objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.

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 at the Baseline Visit. Where locally permissible, subjects 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit
  • Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to Baseline.
  • Active UC as assessed by adapted Mayo Score
  • Demonstrated intolerance or inadequate response to one or more biologic therapies
  • Females must be postmenopausal for more than 2 years or surgically sterile or practicing specific forms of birth control.

Exclusion Criteria

  • Subject with a current diagnosis of Crohn's disease (CD), inflammatory bowel disease-unclassified (IBD-U) or a history of radiation colitis or ischemic colitis.
  • Subject receiving prohibited medications and treatment.
  • Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.
  • Subject with currently known complications of UC (e.g., megacolon).

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Substudy 1, Induction 2: Double-blind Risankizumab Dose 2
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Induction 2.
  • Drug: risankizumab SC
    risankizumab subcutaneous (SC) injection
    Other names:
    • ABBV-066
    • BI 655066
Experimental
Substudy 2, Induction 1: Open-label Risankizumab Dose 2
Participants randomized to receive risankizumab dose 2 administered by intravenous (IV) infusion.
  • Drug: risankizumab IV
    risankizumab intravenous (IV) infusion
    Other names:
    • ABBV-066
    • BI 655066
Experimental
Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)
Participants who received placebo with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.
  • Drug: risankizumab IV
    risankizumab intravenous (IV) infusion
    Other names:
    • ABBV-066
    • BI 655066
Experimental
Substudy 2, Induction 2: Double-blind Risankizumab Dose 3
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Induction 2.
  • Drug: risankizumab SC
    risankizumab subcutaneous (SC) injection
    Other names:
    • ABBV-066
    • BI 655066
Experimental
Substudy 1, Induction 1: Double-blind Risankizumab Dose 1
Participants randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion.
  • Drug: risankizumab IV
    risankizumab intravenous (IV) infusion
    Other names:
    • ABBV-066
    • BI 655066
Experimental
Substudy 1, Induction 1: Double-blind Risankizumab Dose 2
Participants randomized to receive risankizumab dose 2 administered by intravenous (IV) infusion.
  • Drug: risankizumab IV
    risankizumab intravenous (IV) infusion
    Other names:
    • ABBV-066
    • BI 655066
Experimental
Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)
Participants who received placebo with inadequate response in Induction 1 receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.
  • Drug: risankizumab IV
    risankizumab intravenous (IV) infusion
    Other names:
    • ABBV-066
    • BI 655066
Experimental
Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.
  • Drug: risankizumab IV
    risankizumab intravenous (IV) infusion
    Other names:
    • ABBV-066
    • BI 655066
Experimental
Substudy 2, Induction 1: Double-blind Risankizumab Dose 1
Participants randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion.
  • Drug: risankizumab IV
    risankizumab intravenous (IV) infusion
    Other names:
    • ABBV-066
    • BI 655066
Experimental
Substudy 1, Induction 1: Double-blind Risankizumab Dose 3
Participants randomized to receive risankizumab dose 3 administered by intravenous (IV) infusion.
  • Drug: risankizumab IV
    risankizumab intravenous (IV) infusion
    Other names:
    • ABBV-066
    • BI 655066
Placebo Comparator
Substudy 1, Induction 1: Double-blind Placebo
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
  • Drug: placebo for risankizumab
    placebo for risankizumab
Experimental
Substudy 2, Induction 2: Double-blind Risankizumab Dose 2
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Induction 2.
  • Drug: risankizumab SC
    risankizumab subcutaneous (SC) injection
    Other names:
    • ABBV-066
    • BI 655066
Experimental
Substudy 1, Induction 2: Double-blind Risankizumab Dose 3
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Induction 2.
  • Drug: risankizumab SC
    risankizumab subcutaneous (SC) injection
    Other names:
    • ABBV-066
    • BI 655066
Placebo Comparator
Substudy 2, Induction 1: Double-blind Placebo
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
  • Drug: risankizumab IV
    risankizumab intravenous (IV) infusion
    Other names:
    • ABBV-066
    • BI 655066
  • Drug: placebo for risankizumab
    placebo for risankizumab
Experimental
Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.
  • Drug: risankizumab IV
    risankizumab intravenous (IV) infusion
    Other names:
    • ABBV-066
    • BI 655066
Experimental
Substudy 1, Induction 1: Open-label Risankizumab Dose 3
Participants receive risankizumab dose 3 administered by intravenous (IV) infusion.
  • Drug: risankizumab IV
    risankizumab intravenous (IV) infusion
    Other names:
    • ABBV-066
    • BI 655066

Recruiting Locations

Vanderbilt Univ Med Ctr /ID# 160580
Nashville, Tennessee 37232-0011

More Details

NCT ID
NCT03398148
Status
Recruiting
Sponsor
AbbVie

Study Contact

ABBVIE CALL CENTER
847.283.8955
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.