Recruiting
Phase 2

Risankizumab & Trosunilimab, Risankizumab & ABBV-701

Sponsor:

AbbVie

Code:

NCT07697456

Conditions

Crohn's Disease

Ulcerative Colitis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Risankizumab

Trosunilimab

ABBV-701

Study Details

Brief summary:

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

Crohn's Disease

Ulcerative Colitis

Study ID

NCT07697456

Start date

Jul 31, 2026

Status verified date

Oct, 2026

Completion date

Oct, 2031

Anticipated

Primary completion date

Oct, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

2000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

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.

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.

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.

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.

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

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

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

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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

Interventions

Risankizumab

Intravenous/Subcutaneous/Intramuscular Injection/Infusion

Trosunilimab

Intravenous/Subcutaneous/Intramuscular Injection/Infusion

ABBV-701

Intravenous/Subcutaneous/Intramuscular Injection/Infusion

Primary outcome measure

  • Crohn's Disease Specific: Percentage of Participants Achieving Endoscopic Remission [ Time Frame: At Week 28 ]
  • Ulcerative Colitis Specific: Percentage of Participants who Achieve Endoscopic Remission [ Time Frame: At Week 28 ]
  • Number of Participants with Adverse Events (AEs) [ Time Frame: Up to 98 Weeks ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742abbvieclinicaltrials@abbvie.com

Locations

Digestive Health Specialists /ID# 280827

Recruiting

Dothan, Alabama, United States, 36301

Elite Clinical Studies /ID# 280477

Recruiting

Phoenix, Arizona, United States, 85018

Contacts

Site Coordinator

602-788-3437

Gi Alliance - Arizona Digestive Health - Sun City /ID# 284084

Recruiting

Sun City, Arizona, United States, 85351

Clinnova Research /ID# 280509

Recruiting

Anaheim, California, United States, 92805

Southern California Res. Ctr /ID# 280476

Recruiting

Coronado, California, United States, 92118

Gastro Care Institute /ID# 281071

Recruiting

Lancaster, California, United States, 93534

United Medical Doctors - Los Alamitos /ID# 281125

Recruiting

Los Alamitos, California, United States, 90720

Inland Empire Liver Foundation - Rialto /ID# 280775

Recruiting

Rialto, California, United States, 92377

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

Recruiting

Colorado Springs, Colorado, United States, 80907

Synergy Healthcare - Bradenton /ID# 284157

Recruiting

Bradenton, Florida, United States, 34209

Clinical Research of Osceola /ID# 280593

Recruiting

Kissimmee, Florida, United States, 34741

Florida Center For Gastroenterology - Largo /ID# 281059

Recruiting

Largo, Florida, United States, 33777

Research Associates of South Florida /ID# 280929

Recruiting

Miami, Florida, United States, 33134

Contacts

Site Coordinator

786-476-8790

Advanced Research Institute, Inc /ID# 281062

Recruiting

New Port Richey, Florida, United States, 34653

Contacts

Site Coordinator

727-835-3261

Digestive And Liver Center Of Florida - Orlando /ID# 280924

Recruiting

Orlando, Florida, United States, 32825

Gcp Clinical Research /ID# 280469

Recruiting

Tampa, Florida, United States, 33609

Gastroenterology Associates of Central Georgia /ID# 280464

Recruiting

Macon, Georgia, United States, 31201

Gastroenterology Consultants - Roswell /ID# 281235

Recruiting

Roswell, Georgia, United States, 30076

Contacts

Site Coordinator

404-596-4480

Treasure Valley Medical Research /ID# 281778

Recruiting

Boise, Idaho, United States, 83706

Midwest Digestive Health & Nutrition /ID# 285250

Recruiting

Des Plaines, Illinois, United States, 60016

Gi Alliance - Glenview /ID# 283932

Recruiting

Glenview, Illinois, United States, 60026

Illinois Gastroenterology Group /ID# 283933

Recruiting

Gurnee, Illinois, United States, 60031

Contacts

Site Coordinator

224-441-2217

Southwest Gastroenterology - Oak Lawn /ID# 280841

Recruiting

Oak Lawn, Illinois, United States, 60453

Gastroenterology Health Partners /ID# 284145

Recruiting

New Albany, Indiana, United States, 47150

Gastroenterology Health Partners /ID# 284144

Recruiting

Louisville, Kentucky, United States, 40218

Gastro Group and Endocenter: Mandeville, la /ID# 284186

Recruiting

Mandeville, Louisiana, United States, 70471

Metropolitan Gastroenterology Associates - Metairie /ID# 283922

Recruiting

Metairie, Louisiana, United States, 70006

Willis-Knighton Medical Center /ID# 280572

Recruiting

Shreveport, Louisiana, United States, 71103

Contacts

Site Coordinator

318-212-2863

Lucida Clinical Trials /ID# 282000

Recruiting

New Bedford, Massachusetts, United States, 02740

West Michigan Clinical Research Center /ID# 280480

Recruiting

Wyoming, Michigan, United States, 49519

Gi Associates - Gia And Endoscopy Center - Flowood /ID# 283967

Recruiting

Flowood, Mississippi, United States, 39232

Gastroenterology Associates Of North Mississippi /ID# 285243

Recruiting

Oxford, Mississippi, United States, 38655

Specialists In Gastroenterology /ID# 283939

Recruiting

St Louis, Missouri, United States, 63141

Vector Clinical Trials /ID# 280843

Recruiting

Las Vegas, Nevada, United States, 89128

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

Recruiting

New York, New York, United States, 10075

Digestive Health Partners /ID# 280490

Recruiting

Asheville, North Carolina, United States, 28803

Contacts

Site Coordinator

(828) 254-0881

Dayton Gastroenterology - Beavercreek /ID# 284065

Recruiting

Beavercreek, Ohio, United States, 45440

Gastro Intestinal Research Institute of Northern Ohio /ID# 283860

Recruiting

Westlake, Ohio, United States, 44145

University Gastroenterology - Providence - Staniford Street /ID# 280919

Recruiting

Providence, Rhode Island, United States, 02905

Gastroenterology Associates - Patewood /ID# 283870

Recruiting

Greenville, South Carolina, United States, 29607

Gastrointestinal Associates - Knoxville - Dowell Springs Boulevard /ID# 283861

Recruiting

Knoxville, Tennessee, United States, 37909

Gastro One - Memphis /ID# 283948

Recruiting

Memphis, Tennessee, United States, 38104

Novel Research - Bellaire /ID# 280925

Recruiting

Bellaire, Texas, United States, 77401

Gi Alliance - Texas Digestive Disease Consultants - Fort Worth /ID# 283977

Recruiting

Fort Worth, Texas, United States, 76104

GI Alliance -Garland /ID# 284253

Recruiting

Garland, Texas, United States, 75044

Contacts

Site Coordinator

972-265-8201

Amel Med /ID# 283864

Recruiting

Georgetown, Texas, United States, 78628

Integrity Advanced Therapeutics /ID# 283871

Recruiting

Houston, Texas, United States, 77090

GI Alliance - Lubbock /ID# 283920

Recruiting

Lubbock, Texas, United States, 74910

Caprock Gastro Research - Lubbock /ID# 283921

Recruiting

Lubbock, Texas, United States, 79424

GI Alliance - Mansfield /ID# 283924

Recruiting

Mansfield, Texas, United States, 76063

Southern Star Research Institute /ID# 280822

Recruiting

San Antonio, Texas, United States, 78229

Center for Digestive Disease /ID# 280870

Recruiting

Shenandoah, Texas, United States, 77384

Contacts

Site Coordinator

832-234-1023

Texas Digestive Disease Consultants - Southlake /ID# 283931

Recruiting

Southlake, Texas, United States, 76092

Contacts

Site Coordinator

817-424-1525

Tyler Research Institute /ID# 284247

Recruiting

Tyler, Texas, United States, 75701

Contacts

Site Coordinator

903-630-6211

Emeritas Research Group /ID# 284388

Recruiting

Lansdowne Town Center, Virginia, United States, 20176

GI Alliance - Richmond /ID# 284244

Recruiting

Richmond, Virginia, United States, 23229

Washington Gastroenterology - Bellevue /ID# 283966

Recruiting

Bellevue, Washington, United States, 98004

Washington Gastroenterology - Tacoma /ID# 284143

Recruiting

Tacoma, Washington, United States, 98405

The Vancouver Clinic /ID# 280497

Recruiting

Vancouver, Washington, United States, 98664

Contacts

Site Coordinator

360-397-3388

Wisconsin Center for Advanced Research /ID# 284250

Recruiting

Milwaukee, Wisconsin, United States, 53215

Diex Recherche Quebec Inc. /ID# 282307

Recruiting

Québec, Canada, G1V 4T3

More Information

Sponsor

AbbVie

Last update posted

Oct 15, 2026

Last verified

Oct, 2026

Keywords

  • Crohn's disease
  • Ulcerative colitis
  • Risankizumab
  • ABBV-701
  • Trosunilimab
  • ABBV-466
  • ABBV-7066

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-17. This information was provided to ClinicalTrials.gov by AbbVie on 2026-10-15. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.