Summary

for people ages 16-80 (full criteria)
at La Jolla, California and other locations
study started
estimated completion:

Description

Summary

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.

Keywords

Ulcerative Colitis (UC) ABBV-066 BI 655066 Colitis Ulcer Colitis, Ulcerative risankizumab IV rizankizumab SC Substudy 1, Induction 2: Double-blind Risankizumab Dose 2 Substudy 2, Induction 1: Open-label Risankizumab Dose 2 Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a) Substudy 2, Induction 2: Double-blind Risankizumab Dose 3 Substudy 1, Induction 1: Double-blind Risankizumab Dose 1 Substudy 1, Induction 1: Double-blind Risankizumab Dose 2 Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a) Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b) Substudy 2, Induction 1: Double-blind Risankizumab Dose 1 Substudy 1, Induction 1: Double-blind Risankizumab Dose 3 Substudy 2, Induction 2: Double-blind Risankizumab Dose 2 Substudy 1, Induction 2: Double-blind Risankizumab Dose 3 Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b) Substudy 1, Induction 1: Open-label Risankizumab Dose 3

Eligibility

You can join if…

Open to people ages 16-80

  • 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.

You CAN'T join if...

  • 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).

Locations

  • UCSD not yet accepting patients
    La Jolla California 92037 United States
  • United Gastroenterologists not yet accepting patients
    Murrieta California 92563 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
ID
NCT03398148
Phase
Phase 2/3
Study Type
Interventional
Last Updated
June 13, 2018