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Purpose

Crohn's disease (CD) and Ulcerative colitis (UC) are 2 types of inflammatory bowel diseases which cause long-lasting, severe inflammation (redness, swelling) in the digestive tract. CD can affect any part of the digestive tract causing many different symptoms including belly pain, diarrhea, tiredness, and weight loss. UC affects the lining of the rectum and colon (large intestine) and can cause bleeding, belly pain, and diarrhea. This platform basket study will evaluate how safe and effective advanced therapies are in adults with moderately to severely active Crohn's Disease (CD) or Ulcerative Colitis (UC). This study currently includes 2 substudies evaluating different treatments in participants with CD or UC. Substudy 1 will evaluate the combination of risankizumab and trosunilimab (ABBV-466) and Substudy 2 will evaluate the combination of risankizumab and ABBV-701 (ABBV-7066). When adult participants with moderately to severely active CD or UC join the study, they will undergo a 2-step randomization within CD and UC substudies, respectively. The first unblinded randomization will assign participants into a substudy, and the second blinded randomization will assign participants to a treatment arm within the assigned substudy. Approximately 100 adult participants will be enrolled per treatment arm across both substudies at approximately 400 sites worldwide. There may be higher treatment burden for participants in this trial compared to their standard of care treatment without participating in this study. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, stool tests, endoscopies, checking for side effects and completing questionnaires and a daily diary.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

CD specific: - Crohn's Disease Activity Index (CDAI) score of ≥ 220 - Confirmed diagnosis of CD at least 90 days prior to Baseline - Endoscopic evidence of mucosal inflammation as documented by an Simple Endoscopic Score for Crohn's Disease (SES-CD) of ≥ 6 for ileocolonic or colonic disease or SES-CD of ≥ 4 for isolated ileal disease. - Demonstrated failure of 1 or more therapy for CD UC specific: - Confirmed diagnosis of UC at least 90 days prior to Baseline - Active UC with a modified Mayo Score (mMS) of 5 to 9 points and endoscopic subscore (ESS) of 2 to 3 - Demonstrated failure of 1 or more therapy for UC

Exclusion Criteria

  • Participants with demonstrated intolerance to p19 IL-23 inhibitors (including risankizumab) - Participants treated with any investigational drug within 30 days or 5 half-lives of the study treatments (whichever is longer) prior to the first dose of study treatment - Participants who received any ATs (biologic or small molecules) prior to first dose of study treatment within the protocol specified time frame - Participants with surgical bowel resection within the past 3 months prior to Baseline CD specific: - Participants with >3 prior bowel resections - Participants with previous small bowel resection(s) of combined length >100 cm UC specific: - Participants with prior colectomy (total or subtotal) - Participants with extent of disease limited to < 10 cm of rectum

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Substudy 1: UC Arm 1 Risankizumab monotherapy 		Ulcerative Colitis (UC) participants will receive Risankizumab Dose A as induction treatment followed by Risankizumab Dose C as maintenance treatment.
  • Drug: Risankizumab
    Intravenous/Subcutaneous/Intramuscular Injection/Infusion
    Other names:
    • ABBV-066
Experimental
Substudy 1: CD Arm 1 Risankizumab monotherapy 		Crohn's Disease (CD) participants will receive Risankizumab Dose B as induction treatment followed by Risankizumab Dose D as maintenance treatment.
  • Drug: Risankizumab
    Intravenous/Subcutaneous/Intramuscular Injection/Infusion
    Other names:
    • ABBV-066
Experimental
Substudy 1: UC Arm 2 Trosunilimab monotherapy 		Ulcerative Colitis (UC) participants will receive Trosunilimab Dose A as induction treatment followed by Trosunilimab Dose C as maintenance treatment.
  • Drug: Trosunilimab
    Intravenous/Subcutaneous/Intramuscular Injection/Infusion
    Other names:
    • ABBV-382
Experimental
Substudy 1: CD Arm 2 Trosunilimab monotherapy 		Crohn's Disease (CD) participants will receive Trosunilimab Dose B as induction treatment followed by Trosunilimab Dose D as maintenance treatment.
  • Drug: Trosunilimab
    Intravenous/Subcutaneous/Intramuscular Injection/Infusion
    Other names:
    • ABBV-382
Experimental
Substudy 1: UC Arm 3 Trosunilimab monotherapy 		Ulcerative Colitis (UC) participants will receive Trosunilimab Dose E as induction treatment followed by Trosunilimab Dose G as maintenance treatment.
  • Drug: Trosunilimab
    Intravenous/Subcutaneous/Intramuscular Injection/Infusion
    Other names:
    • ABBV-382
Experimental
Substudy 1: CD Arm 3 Trosunilimab monotherapy 		Crohn's Disease (CD) participants will receive Trosunilimab Dose F as induction treatment followed by Trosunilimab Dose H as maintenance treatment.
  • Drug: Trosunilimab
    Intravenous/Subcutaneous/Intramuscular Injection/Infusion
    Other names:
    • ABBV-382
Experimental
Substudy 1: UC Arm 4 ABBV-466 (Risankizumab/Trosunilimab) 		Ulcerative Colitis (UC) participants will receive a combination induction treatment of ABBV-466 (Risankizumab/Trosunilimab) combo Dose A followed by a combination maintenance (Risankizumab/Trosunilimab) combo Dose C
  • Drug: Risankizumab
    Intravenous/Subcutaneous/Intramuscular Injection/Infusion
    Other names:
    • ABBV-066
  • Drug: Trosunilimab
    Intravenous/Subcutaneous/Intramuscular Injection/Infusion
    Other names:
    • ABBV-382
Experimental
Substudy 1: CD Arm 4 ABBV-466 (Risankizumab/Trosunilimab) 		Crohn's Disease (CD) participants will receive a combination induction treatment of ABBV-466 (Risankizumab/Trosunilimab) combo Dose B followed by a combination maintenance (Risankizumab/Trosunilimab) combo Dose D
  • Drug: Risankizumab
    Intravenous/Subcutaneous/Intramuscular Injection/Infusion
    Other names:
    • ABBV-066
  • Drug: Trosunilimab
    Intravenous/Subcutaneous/Intramuscular Injection/Infusion
    Other names:
    • ABBV-382
Experimental
Substudy 1: UC Arm 5 ABBV-466 (Risankizumab/Trosunilimab) 		Ulcerative Colitis (UC) participants will receive a combination induction treatment of ABBV-466 (Risankizumab/Trosunilimab) combo Dose E followed by a combination maintenance (Risankizumab/Trosunilimab) combo Dose G
  • Drug: Risankizumab
    Intravenous/Subcutaneous/Intramuscular Injection/Infusion
    Other names:
    • ABBV-066
  • Drug: Trosunilimab
    Intravenous/Subcutaneous/Intramuscular Injection/Infusion
    Other names:
    • ABBV-382
Experimental
Substudy 1: CD Arm 5 ABBV-466 (Risankizumab/Trosunilimab) 		Crohn's Disease (CD) participants will receive a combination induction treatment of ABBV-466 (Risankizumab/Trosunilimab) combo Dose F followed by a combination maintenance (Risankizumab/Trosunilimab) combo Dose H
  • Drug: Risankizumab
    Intravenous/Subcutaneous/Intramuscular Injection/Infusion
    Other names:
    • ABBV-066
  • Drug: Trosunilimab
    Intravenous/Subcutaneous/Intramuscular Injection/Infusion
    Other names:
    • ABBV-382
Experimental
Substudy 2: UC Arm 1 Risankizumab monotherapy 		Ulcerative Colitis (UC) participants will receive Risankizumab Dose A as induction treatment followed by Risankizumab Dose C as maintenance treatment.
  • Drug: Risankizumab
    Intravenous/Subcutaneous/Intramuscular Injection/Infusion
    Other names:
    • ABBV-066
Experimental
Substudy 2: CD Arm 1 Risankizumab monotherapy 		Crohn's Disease (CD) participants will receive Risankizumab Dose B as induction treatment followed by Risankizumab Dose D as maintenance treatment.
  • Drug: Risankizumab
    Intravenous/Subcutaneous/Intramuscular Injection/Infusion
    Other names:
    • ABBV-066
Experimental
Substudy 2: UC Arm 2 ABBV-701 monotherapy 		Ulcerative Colitis (UC) participants will receive ABBV-701 Dose A as induction treatment and Dose C maintenance treatment.
  • Drug: ABBV-701
    Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Experimental
Substudy 2: CD Arm 2 ABBV-701 monotherapy 		Crohn's Disease (CD) participants will receive ABBV-701 Dose B as induction treatment and Dose D maintenance treatment.
  • Drug: ABBV-701
    Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Experimental
Substudy 2: UC Arm 3 ABBV-701 monotherapy 		Ulcerative Colitis (UC) participants will receive ABBV-701 Dose E as induction treatment and Dose G maintenance treatment.
  • Drug: ABBV-701
    Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Experimental
Substudy 2: CD Arm 3 ABBV-701 monotherapy 		Crohn's Disease (CD) participants will receive ABBV-701 Dose F as induction treatment and Dose H maintenance treatment.
  • Drug: ABBV-701
    Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Experimental
Substudy 2: UC Arm 4 ABBV-7066 (Risankizumab/ABBV-701) 		Ulcerative Colitis (UC) participants will receive induction treatment of ABBV-7066 (Risankizumab/ABBV-701) combination Dose A followed by maintenance treatment of ABBV-7066 (Risankizumab/ABBV-701) combination Dose C.
  • Drug: Risankizumab
    Intravenous/Subcutaneous/Intramuscular Injection/Infusion
    Other names:
    • ABBV-066
  • Drug: ABBV-701
    Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Experimental
Substudy 2: CD Arm 4 ABBV-7066 (Risankizumab/ABBV-701) 		Crohn's Disease (CD) participants will receive induction treatment of ABBV-7066 (Risankizumab/ABBV-701) combination Dose B followed by maintenance treatment of ABBV-7066 (Risankizumab/ABBV-701) combination Dose D.
  • Drug: Risankizumab
    Intravenous/Subcutaneous/Intramuscular Injection/Infusion
    Other names:
    • ABBV-066
  • Drug: ABBV-701
    Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Experimental
Substudy 2: UC Arm 5 ABBV-7066 (Risankizumab/ABBV-701) 		Ulcerative Colitis (UC) participants will receive induction treatment of ABBV-7066 (Risankizumab/ABBV-701) combination Dose E followed by maintenance treatment of ABBV-7066 (Risankizumab/ABBV-701) combination Dose G.
  • Drug: Risankizumab
    Intravenous/Subcutaneous/Intramuscular Injection/Infusion
    Other names:
    • ABBV-066
  • Drug: ABBV-701
    Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Experimental
Substudy 2: CD Arm 5 ABBV-7066 (Risankizumab/ABBV-701) 		Crohn's Disease (CD) participants will receive induction treatment of ABBV-7066 (Risankizumab/ABBV-701) combination Dose F followed by maintenance treatment of ABBV-7066 (Risankizumab/ABBV-701) combination Dose H.
  • Drug: Risankizumab
    Intravenous/Subcutaneous/Intramuscular Injection/Infusion
    Other names:
    • ABBV-066
  • Drug: ABBV-701
    Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Experimental
Substudy 2: UC Arm 6 ABBV-7066 (Risankizumab/ABBV-701) 		Ulcerative Colitis (UC) participants will receive induction treatment of ABBV-7066 (Risankizumab/ABBV-701) combination Dose I followed by maintenance treatment of ABBV-7066 (Risankizumab/ABBV-701) combination Dose J
  • Drug: Risankizumab
    Intravenous/Subcutaneous/Intramuscular Injection/Infusion
    Other names:
    • ABBV-066
  • Drug: ABBV-701
    Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Experimental
Substudy 2: CD Arm 6 ABBV-7066 (Risankizumab/ABBV-701) 		Crohn's Disease (CD) participants will receive induction treatment of ABBV-7066 (Risankizumab/ ABBV-701) combination Dose K followed by maintenance treatment of ABBV-7066 (Risankizumab/ ABBV-701) combination Dose L
  • Drug: Risankizumab
    Intravenous/Subcutaneous/Intramuscular Injection/Infusion
    Other names:
    • ABBV-066
  • Drug: ABBV-701
    Intravenous/Subcutaneous/Intramuscular Injection/Infusion

Recruiting Locations

Digestive Health Specialists /ID# 280827
Dothan, Alabama 36301

Elite Clinical Studies /ID# 280477
Phoenix, Arizona 85018
Contact:
Site Coordinator
602-788-3437

Clinnova Research /ID# 280509
Anaheim, California 92805

Gastro Care Institute /ID# 281071
Lancaster, California 93534

United Medical Doctors - Los Alamitos /ID# 281125
Los Alamitos, California 90720

Inland Empire Liver Foundation - Rialto /ID# 280775
Rialto, California 92377

Peak Gastroenterology Associates - Colorado Springs - North Cascade Avenue /ID# 280507
Colorado Springs, Colorado 80907

Clinical Research of Osceola /ID# 280593
Kissimmee, Florida 34741

Research Associates of South Florida /ID# 280929
Miami, Florida 33134
Contact:
Site Coordinator
786-476-8790

Advanced Research Institute, Inc /ID# 281062
New Port Richey, Florida 34653
Contact:
Site Coordinator
727-835-3261

Gastroenterology Associates of Central Georgia /ID# 280464
Macon, Georgia 31201

Gastroenterology Consultants - Roswell /ID# 281235
Roswell, Georgia 30076
Contact:
Site Coordinator
404-596-4480

Treasure Valley Medical Research /ID# 281778
Boise, Idaho 83706

Southwest Gastroenterology - Oak Lawn /ID# 280841
Oak Lawn, Illinois 60453

Vector Clinical Trials /ID# 280843
Las Vegas, Nevada 89128

New York Gastroenterology Associates - Upper East Side /ID# 281767
New York, New York 10075

University Gastroenterology - Providence - Staniford Street /ID# 280919
Providence, Rhode Island 02905

Novel Research - Bellaire /ID# 280925
Bellaire, Texas 77401

Southern Star Research Institute /ID# 280822
San Antonio, Texas 78229

Washington Gastroenterology - Tacoma /ID# 284143
Tacoma, Washington 98405

The Vancouver Clinic /ID# 280497
Vancouver, Washington 98664
Contact:
Site Coordinator
360-397-3388

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.