RECRUITING

A Study to Assess Adverse Events and Change in Disease Activity of Risankizumab Subcutaneous Induction Treatment for Moderately to Severely Active Crohn's Disease.

Description

Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most often affecting the bowels. It can cause many different symptoms including abdominal pain, diarrhea, tiredness, and weight loss. This study will assess how safe and effective risankizumab subcutaneous (SC) induction treatment is in treating moderately to severely active CD in adult participants. Risankizumab is an approved drug for adults with CD. This study comprises of a Period A, a Period B, and a Period C. In Period A, participants are placed in 1 of 2 groups to receive either risankizumab SC Dose A or Placebo. In Period B, based on response, participants will receive risankizumab SC Dose B or Placebo. Participants who do not have improvement in CD symptoms at Week 12 will receive risankizumab SC Dose C and participants with worsening CD symptoms in period B will receive risankizumab SC. In Period C, eligible participants will receive open-label risankizumab SC Dose D. Approximately 276 adult participants with a diagnosis of moderately to severely active CD will be enrolled in approximately 250 sites globally. Participants will receive SC induction treatment of risankizumab or matching placebo for up to 24 weeks in Period A and B followed by an open-label risankizumab extension in Period C for 52 weeks. The duration of the study will be approximately 93 weeks.

Conditions

Crohn's Disease
Talk to us

Related Conditions:

Crohn's Disease

Study Overview

On this page

Study Details

Study overview

Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most often affecting the bowels. It can cause many different symptoms including abdominal pain, diarrhea, tiredness, and weight loss. This study will assess how safe and effective risankizumab subcutaneous (SC) induction treatment is in treating moderately to severely active CD in adult participants. Risankizumab is an approved drug for adults with CD. This study comprises of a Period A, a Period B, and a Period C. In Period A, participants are placed in 1 of 2 groups to receive either risankizumab SC Dose A or Placebo. In Period B, based on response, participants will receive risankizumab SC Dose B or Placebo. Participants who do not have improvement in CD symptoms at Week 12 will receive risankizumab SC Dose C and participants with worsening CD symptoms in period B will receive risankizumab SC. In Period C, eligible participants will receive open-label risankizumab SC Dose D. Approximately 276 adult participants with a diagnosis of moderately to severely active CD will be enrolled in approximately 250 sites globally. Participants will receive SC induction treatment of risankizumab or matching placebo for up to 24 weeks in Period A and B followed by an open-label risankizumab extension in Period C for 52 weeks. The duration of the study will be approximately 93 weeks.

A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of Risankizumab Subcutaneous Induction Treatment in Subjects With Moderately to Severely Active Crohn's Disease

A Study to Assess Adverse Events and Change in Disease Activity of Risankizumab Subcutaneous Induction Treatment for Moderately to Severely Active Crohn's Disease.

Condition
Crohn's Disease
Intervention / Treatment

-

Contacts and Locations

Sun City

Gi Alliance - Arizona Digestive Health - Sun City /ID# 268178, Sun City, Arizona, United States, 85351

Coronado

Southern California Res. Ctr. /ID# 256612, Coronado, California, United States, 92118-1408

Corona

Kindred Medical Institute - Corona /ID# 262075, Corona, California, United States, 92879-3104

Covina

Citrus Valley Gastroenterology /ID# 256610, Covina, California, United States, 91722-3797

Huntington Beach

Newport Huntington Medical Group /ID# 256622, Huntington Beach, California, United States, 92648-5994

Lancaster

Om Research LLC /ID# 259645, Lancaster, California, United States, 93534

Lancaster

Om Research LLC /ID# 267523, Lancaster, California, United States, 93534

Orange

Clinnova Research - Orange /ID# 270138, Orange, California, United States, 92868

Orange

University of California, Irvine Medical Center /ID# 259677, Orange, California, United States, 92868

Rancho Cucamonga

Prospective Research Innovations Inc. /ID# 267856, Rancho Cucamonga, California, United States, 91730

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Biopsy-confirmed diagnosis of CD for at least 3 months prior to Baseline.
  • * Participant meets the following disease activity criteria:
  • 1. Moderate to severe CD as assessed by CDAI
  • 2. Endoscopic evidence of mucosal inflammation as documented by a SES-CD
  • * Participant has demonstrated intolerance, loss of response or inadequate response to conventional or advanced therapies for CD.
  • * Participants with a current diagnosis of ulcerative colitis or indeterminate colitis.
  • * Participants with unstable doses of concomitant Crohn's disease therapy.
  • * Participants with prior exposure to p19 inhibitors.
  • * Participants with complications of Crohn's disease.
  • * Participants having an ostomy or ileoanal pouch.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AbbVie,

ABBVIE INC., STUDY_DIRECTOR, AbbVie

Study Record Dates

2029-02