Purpose

The purpose of this study is to evaluate safety and efficacy of risankizumab in participants with ulcerative colitis (UC) in participants who responded to induction treatment with risankizumab in a prior AbbVie study of risankizumab in UC. This study consists of three sub-studies and a Continuous Treatment Extension (CTE): Substudy 1 is a 52-week, randomized, double-blind, placebo-controlled maintenance study; Substudy 2 is 52-week, randomized, exploratory maintenance study; and Substudy 3 is an open-label long-term extension study for participants who completed Substudy 1 or 2, or participants who responded to induction treatment in Study M16-067 with no final endoscopy due to the Covid-19 pandemic or due to the geopolitical conflict in Ukraine and surrounding impacted regions. The CTE is an open-label extension for Substudy 3 completers to ensure continuous treatment with risankizumab until such time that risankizumab becomes commercially available and/or the subject can access treatment locally or can transition to a Continued Treatment for Trial Participants Open-Label Extension study.

Condition

Eligibility

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

Inclusion Criteria

  • Participants who have completed Study M16-067 and have achieved clinical response as defined in the protocol.

Exclusion Criteria

  • Participants who have a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of chinese hamster ovary (CHO) or had an adverse event (AE) during Studies M16-067 that in the Investigator's judgment makes the participant unsuitable for this study. - Participant is considered by the Investigator, for any reason, to be an unsuitable candidate for the study. - Participant is not in compliance with prior and concomitant medication requirements throughout Studies M16-067.

Study Design

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

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Substudy 1: Double-blind Placebo
Participants randomized to receive placebo for risankizumab administered by subcutaneous (SC) injection.
  • Drug: placebo for risankizumab
    subcutaneous (SC) injection
Experimental
Substudy 1: Double-blind Risankizumab Dose 1
Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection.
  • Drug: risankizumab
    subcutaneous (SC) injection
    Other names:
    • ABBV-066
    • BI 655066
    • SKYRIZI
Experimental
Substudy 1: Double-blind Risankizumab Dose 2
Participants randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection.
  • Drug: risankizumab
    subcutaneous (SC) injection
    Other names:
    • ABBV-066
    • BI 655066
    • SKYRIZI
Experimental
Substudy 2: Open-label (OL) Clinical Assessment Risankizumab
Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection.
  • Drug: risankizumab
    subcutaneous (SC) injection
    Other names:
    • ABBV-066
    • BI 655066
    • SKYRIZI
Experimental
Substudy 2: OL Therapeutic Drug Monitoring Risankizumab
Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection.
  • Drug: risankizumab
    subcutaneous (SC) injection
    Other names:
    • ABBV-066
    • BI 655066
    • SKYRIZI
Experimental
Substudy 3: OL Extension Risankizumab
Participants who completed Sub-study 1 or 2 receive open-label risankizumab in Sub-study 3.
  • Drug: risankizumab
    subcutaneous (SC) injection
    Other names:
    • ABBV-066
    • BI 655066
    • SKYRIZI
Experimental
OL Continuous Treatment Extension - Dose 1
Participants who complete Sub-study 3 and continue to tolerate and derive benefit from receiving risankizumab, will continue to receive risankizumab based on their assignment during Sub-study 3. Participants completing Sub-study 3 without receiving risankizumab rescue therapy in any sub-study will receive risankizumab Dose 1 administered by subcutaneous (SC) injection.
  • Drug: risankizumab
    subcutaneous (SC) injection
    Other names:
    • ABBV-066
    • BI 655066
    • SKYRIZI
Experimental
OL Continuous Treatment Extension - Dose 2
Participants who complete Sub-study 3 and continue to tolerate and derive benefit from receiving risankizumab, will continue to receive risankizumab based on their assignment during Sub-study 3. Participants completing Sub-study 3 and received risankizumab rescue therapy in any sub-study will receive risankizumab Dose 2 administered by subcutaneous (SC) injection.
  • Drug: risankizumab
    subcutaneous (SC) injection
    Other names:
    • ABBV-066
    • BI 655066
    • SKYRIZI

More Details

Status
Active, not recruiting
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.