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

Purpose

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.

Condition

  • Crohn's Disease

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion 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.

Exclusion Criteria

  • 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.

Study Design

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

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Period A: Risankizumab Dose A 		Participants randomized to receive risankizumab Dose A administered by subcutaneous (SC) injection for up to 12 weeks during Period A.
  • Drug: Risankizumab SC
    subcutaneous (SC) injection
    Other names:
    • ABBV-066
    • SKYRIZI
Placebo Comparator
Period A: Placebo 		Participants randomized to receive placebo for risankizumab administered by Subcutaneous (SC) injection for up to 12 weeks during Period A.
  • Drug: Placebo for risankizumab
    subcutaneous (SC) injection
Experimental
Period B: Risankizumab Dose B 		Participants randomized to receive risankizumab Dose A in Period A that achieved adequate response to receive risankizumab Dose B administered by subcutaneous (SC) injection for up to 12 weeks.
  • Drug: Risankizumab SC
    subcutaneous (SC) injection
    Other names:
    • ABBV-066
    • SKYRIZI
Placebo Comparator
Period B: Placebo 		Participants randomized to receive placebo risankizumab in Period A that achieved adequate response to continue to receive placebo for risankizumab administered by Subcutaneous (SC) injection for up to 12 weeks in Period B.
  • Drug: Placebo for risankizumab
    subcutaneous (SC) injection
Experimental
Period B: Risankizumab Dose C 		Participants with inadequate response in Period A to receive Dose C administered by Subcutaneous (SC) injection for up to 12 weeks during Period B.
  • Drug: Risankizumab SC
    subcutaneous (SC) injection
    Other names:
    • ABBV-066
    • SKYRIZI
Experimental
Period C: Open-Label Risankizumab Dose D 		Participants who complete the Period B Week 24 visit to receive open-label risankizumab Dose D administered by subcutaneous (SC) injection for up to 52 weeks during Period C.
  • Drug: Risankizumab SC
    subcutaneous (SC) injection
    Other names:
    • ABBV-066
    • SKYRIZI

Recruiting Locations

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

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

Kindred Medical Institute - Corona /ID# 262075
Corona, California 92879-3104
Contact:
Site Coordinator
951-220-4029

Valley Clinical Trials, LLC dba Flourish Research /ID# 256610
Covina, California 91723

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

Om Research LLC /ID# 259645
Lancaster, California 93534

Om Research LLC /ID# 267523
Lancaster, California 93534
Contact:
Site Coordinator
661-388-2239

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

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

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

University of California San Francisco - Mission Bay /ID# 267529
San Francisco, California 94158

Amicis Research Center - Valencia /ID# 269158
Valencia, California 91355

OM Research LLC /ID# 268735
Victorville, California 92395
Contact:
Site Coordinator
816-595-3958

Danbury Hospital, Western Connecticut Health Network /ID# 261851
Danbury, Connecticut 06810
Contact:
Site Coordinator
203-739-7870

Novum Research, LLC /ID# 269223
Clermont, Florida 34711
Contact:
Site Coordinator
352-558-8655

Research Associates of South Florida, LLC /ID# 261627
Coral Gables, Florida 33134-2442

University of Florida College of Medicine /ID# 261248
Gainesville, Florida 32610

Auzmer Research /ID# 261437
Lakeland, Florida 33813-4924

Cfagi Llc /Id# 262005
Maitland, Florida 32751-6108

Atlantic Medical Research /ID# 256471
Margate, Florida 33063-5737

University of Miami /ID# 256587
Miami, Florida 33136

Gastroenterology Group Naples /ID# 256566
Naples, Florida 34102
Contact:
Site Coordinator
239-649-1336

Sarkis Clinical Trials - Ocala /ID# 267840
Ocala, Florida 34474

Endoscopic Research, Inc. /ID# 256597
Orlando, Florida 32803

AdventHealth Medical Group Blood & Marrow Transplant at Orlando /ID# 261811
Orlando, Florida 32804-5505

GCP Clinical Research, LLC /ID# 260342
Tampa, Florida 33609

Avita Clinical Research /ID# 261640
Tampa, Florida 33613-1825

Winship Cancer Institute of Emory University /ID# 261877
Atlanta, Georgia 30322

Mount Vernon Clinical Research /ID# 271813
Atlanta, Georgia 30328

Atlanta Ctr. for Gastro /ID# 261181
Decatur, Georgia 30033

Gastroenterology Associates of Central Georgia, LLC /ID# 256611
Macon, Georgia 31201

Gastroenterology Consultants, P.C /ID# 260635
Roswell, Georgia 30076-4913

Grand Teton Research Group /ID# 267521
Idaho Falls, Idaho 83404
Contact:
Site Coordinator
208-528-4256

The University of Chicago DCAM /ID# 256577
Chicago, Illinois 60637

GI Alliance - Glenview /ID# 257744
Glenview, Illinois 60026-8000

GI Alliance - Gurnee /ID# 257735
Gurnee, Illinois 60031-5711

Southwest Gastroenterology /ID# 256619
Oak Lawn, Illinois 60453

IU Health University Hospital /ID# 259633
Indianapolis, Indiana 46202-5149

Univ Kansas Med Ctr /ID# 262551
Kansas City, Kansas 66160
Contact:
Site Coordinator
913-945-7830

Cotton O'Neil Clinical Research Center, Digestive Health /ID# 256592
Topeka, Kansas 66606

University of Louisville Hospital /ID# 256569
Louisville, Kentucky 40202

Louisiana Research Center, LLC /ID# 256598
Shreveport, Louisiana 71105-6800

Portland Gastroenterology Center - Portland - Congress Street /ID# 268428
Portland, Maine 04102
Contact:
Site Coordinator
207-773-7964

Massachusetts General Hospital /Id# 261051
Boston, Massachusetts 02114

Clin Res Inst of Michigan, LLC /ID# 256609
Chesterfield, Michigan 48047

Clin Res Inst of Michigan, LLC /ID# 261017
Chesterfield, Michigan 48047

Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 256568
Wyoming, Michigan 49519

Mayo Clinic - Rochester /ID# 256594
Rochester, Minnesota 55905-0001
Contact:
Site Coordinator
507-293-3507

Saint Luke's Hospital of Kansas City /ID# 271816
Kansas City, Missouri 64111

NY Scientific /ID# 261209
Brooklyn, New York 11235-3919

Columbia University Medical Center /ID# 261879
New York, New York 10032-3729

New York Gastroenterology Associates /ID# 257730
New York, New York 10075

Univ NC Chapel Hill /ID# 256368
Chapel Hill, North Carolina 27514-4220

Carolina Research /ID# 261435
Greenville, North Carolina 27834

Boice-Willis Clinic, P.A. /ID# 262209
Rocky Mount, North Carolina 27804

Plains Clinical Research Center, LLC /ID# 256602
Fargo, North Dakota 58104-5925
Contact:
Site Coordinator
+1-701-499-4851

Optimed Research, Ltd. /ID# 256573
Columbus, Ohio 43235

The Ohio State University - Hilliard /ID# 256623
Hilliard, Ohio 43210

Hightower Clinical /ID# 256613
Oklahoma City, Oklahoma 73102

Options Health Research /ID# 271243
Tulsa, Oklahoma 74104

Gastro One /ID# 256614
Cordova, Tennessee 38018

Quality Medical Research /ID# 262077
Nashville, Tennessee 37211

Amel Med LLC. /ID# 259642
Austin, Texas 78705

Novel Research - Bellaire /ID# 269788
Bellaire, Texas 77401

University of Texas - Southwestern Medical Center /ID# 268157
Dallas, Texas 75235

Digestive Health Associates of Texas (DHAT) Research Institute - Garland /ID# 256596
Garland, Texas 75044

Baylor College of Medicine /ID# 256600
Houston, Texas 77030

LinQ Research /ID# 267880
Houston, Texas 77087
Contact:
Site Coordinator
713-343-6360

GI Alliance/TDDC /ID# 261623
Lubbock, Texas 79410-2014

North Hills Medical Research - North Richard Hills /ID# 268411
North Richland Hills, Texas 76180

Clinical Associates in Research Therapeutics of America, LLC /ID# 256599
San Antonio, Texas 78212

Southern Star Research Institute, LLC /ID# 256601
San Antonio, Texas 78229-5390
Contact:
Site Coordinator
210-581-2812

Tyler Research Institute, LLC /ID# 256595
Tyler, Texas 75701

GI Alliance Bay Area Gastroenterology /ID# 261866
Webster, Texas 77598-4052

University Physicians and Surgeons Inc. /ID# 259636
Huntington, West Virginia 25701

Wisconsin Center for Advanced Research /ID# 256575
Milwaukee, Wisconsin 53215

Caribbean Medical Research Center /ID# 268398
San Juan, Puerto Rico 00918-3501

School of Medicine University of Puerto Rico-Medical Science Campus /ID# 262250
San Juan, Puerto Rico 00935

More Details

NCT ID
NCT06063967
Status
Recruiting
Sponsor
AbbVie

Study Contact

ABBVIE CALL CENTER
844-663-3742
abbvieclinicaltrials@abbvie.com

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center