Summary

Eligibility
for people ages 16-80 (full criteria)
Location
at La Jolla, California and other locations
Dates
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.

Official Title

A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis

Keywords

Ulcerative Colitis (UC) ABBV-066 BI 655066 Colitis Colitis, Ulcerative Ulcer Antibodies, Monoclonal risankizumab IV risankizumab SC Substudy 1, Induction 1: Double-blind Risankizumab Dose 1 Substudy 1, Induction 1: Double-blind Risankizumab Dose 2 Substudy 1, Induction 1: Double-blind Risankizumab Dose 3 Substudy 1, Induction 1: Open-label Risankizumab Dose 1 Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a) Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b) Substudy 1, Induction 2: Double-blind Risankizumab Dose 2 Substudy 1, Induction 2: Double-blind Risankizumab Dose 3 Substudy 2, Induction 1: Double-blind Risankizumab Dose 1 Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a) Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b) Substudy 2, Induction 2: Double-blind Risankizumab Dose 2 Substudy 2, Induction 2: Double-blind 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 and Endoscopic Subscore.
  • Demonstrated intolerance or inadequate response to conventional therapy and tofacitinib (not a biologic) and one or more biologic therapies.
  • Females must be postmenopausal for more than 1 year or surgically sterile or practicing specific forms of birth control.

You CAN'T join if...

  • Participant with a current diagnosis of Crohn's disease (CD), inflammatory bowel disease-unclassified (IBD-U) or a history of radiation colitis or ischemic colitis.
  • Participant receiving prohibited medications and treatment.
  • Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.
  • Participant with currently known complications of UC (e.g., megacolon).
  • No known active Coronavirus Disease - 2019 (COVID-19) infection.

Locations

  • Moore UC San Diego Cancer Center /ID# 160452 accepting new patients
    La Jolla California 92093 United States
  • Southern California Res. Ctr. /ID# 169660 accepting new patients
    Coronado California 92118-1408 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
Links
This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.
ID
NCT03398148
Phase
Phase 2/3
Study Type
Interventional
Last Updated