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Purpose

Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine).This study will evaluate how safe and effective risankizumab is compared to vedolizumab in treating adult participants with moderate to severe UC who are naive to targeted therapies (TaTs). Risankizumab and vedolizumab are approved medications for moderate to severe UC in multiple countries. Participants who meet the eligibility criteria will be randomized in a 1:1 ratio to receive open label risankizumab or vedolizumab. Approximately 530 adult participants with moderate to severe UC who are naïve to targeted therapies (TaTs) will be enrolled at 285 sites worldwide. For participants randomized to risankizumab, drug will be administered intravenous(IV) during the induction period followed by subcutaneous injection during the maintenance period. Participants randomized to vedolizumab will receive drug IV throughout the study. The duration of the study is approximately 69 weeks for participants randomized to risankizumab and 71 weeks for participants randomized to vedolizumab. This includes up to a 35-day screening period followed by a treatment period of 44 weeks for risankizumab and 46 weeks for vedolizumab. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular outpatient visits during the study. The effect and safety of the treatment will be checked by medical assessments, evaluation of side effects and completing questionnaires.

Condition

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Participant has confirmed diagnosis of Ulcerative Colitis (UC) for at least 3 months prior to Baseline. - Participant has active UC with an modified Mayo Score (mMS) of 5 to 9 points and endoscopic subscore of 2 to 3 (confirmed by central reader). - Participant has demonstrated intolerance or inadequate response to one or more of the following categories of drugs: aminosalicylates, oral locally acting steroids, systemic steroids (prednisone or equivalent), and immunomodulators.

Exclusion Criteria

  • Participant has received any targeted therapies (TaTs) for UC, including but not limited to infliximab, etanercept, adalimumab, natalizumab, golimumab, ozanimod, ustekinumab, etrolizumab, vedolizumab, tofacitinib, filgotinib, etrasimod, guselkumab, mirikizumab, upadacitinib, and risankizumab. - Participant with a current diagnosis of Crohn's disease (CD) or Irritable Bowel Disease (IBD)-unclassified or a history of radiation colitis or ischemic colitis. - Currently known complications of UC such as: fulminant colitis and/or toxic megacolon, acute severe UC, previous colectomy (total or subtotal), or any other manifestation that might require surgery while in the study - Active systemic infection/clinically important infection during the last 2 weeks prior to Baseline Visit as assessed by the investigator.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Risankizumab Group 		An induction dose of risankizumab intravenous (IV) will be administered at Baseline and Weeks 4 and 8. Starting at Week 12, participants will then receive either a lower or higher subcutaneous (SC) risankizumab maintenance dose, followed by the same dose every 8 weeks with the last dose at Week 44.
  • Drug: Risankizumab
    Intravenous (IV) Infusion
  • Drug: Risankizumab
    Subcutaneous (SC) injection
Active Comparator
Vedolizumab Group 		Vedolizumab IV will be administered at Baseline, Weeks 2 and 6, and every 8 weeks with the last dose of vedolizumab IV at Week 46.
  • Drug: Vedolizumab
    Intravenous (IV) infusion

Recruiting Locations

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.