Skip to content
Bored Studies
RecruitingPhase 2

Study of Advanced Therapies for the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease or Ulcerative Colitis

AbbVie · NCT07697456

View Study & Apply (opens in a new tab)

Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–75 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
2000
US sites recruiting
61
Study start
July 31, 2026
Record last updated
October 20, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Risankizumab; Trosunilimab; ABBV-701

Conditions: Crohn's Disease; Ulcerative Colitis

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • Digestive Health Specialists /ID# 280827

    Dothan, AL 36301

  • Elite Clinical Studies /ID# 280477

    Phoenix, AZ 85018

    Site contact: Site Coordinator · 602-788-3437

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

    Sun City, AZ 85351

  • Clinnova Research /ID# 280509

    Anaheim, CA 92805

  • Southern California Res. Ctr /ID# 280476

    Coronado, CA 92118

  • Gastro Care Institute /ID# 281071

    Lancaster, CA 93534

  • United Medical Doctors - Los Alamitos /ID# 281125

    Los Alamitos, CA 90720

  • Inland Empire Liver Foundation - Rialto /ID# 280775

    Rialto, CA 92377

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

    Colorado Springs, CO 80907

  • Synergy Healthcare - Bradenton /ID# 284157

    Bradenton, FL 34209

  • Clinical Research of Osceola /ID# 280593

    Kissimmee, FL 34741

  • Florida Center For Gastroenterology - Largo /ID# 281059

    Largo, FL 33777

  • Research Associates of South Florida /ID# 280929

    Miami, FL 33134

    Site contact: Site Coordinator · 786-476-8790

  • Advanced Research Institute, Inc /ID# 281062

    New Port Richey, FL 34653

    Site contact: Site Coordinator · 727-835-3261

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

    Orlando, FL 32825

  • Gcp Clinical Research /ID# 280469

    Tampa, FL 33609

  • Gastroenterology Associates of Central Georgia /ID# 280464

    Macon, GA 31201

  • Gastroenterology Consultants - Roswell /ID# 281235

    Roswell, GA 30076

    Site contact: Site Coordinator · 404-596-4480

  • Treasure Valley Medical Research /ID# 281778

    Boise, ID 83706

  • Midwest Digestive Health & Nutrition /ID# 285250

    Des Plaines, IL 60016

  • Gi Alliance - Glenview /ID# 283932

    Glenview, IL 60026

  • Illinois Gastroenterology Group /ID# 283933

    Gurnee, IL 60031

    Site contact: Site Coordinator · 224-441-2217

  • Southwest Gastroenterology - Oak Lawn /ID# 280841

    Oak Lawn, IL 60453

  • Gastroenterology Health Partners /ID# 284145

    New Albany, IN 47150

  • Gastroenterology Health Partners /ID# 284144

    Louisville, KY 40218

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

    Mandeville, LA 70471

  • Metropolitan Gastroenterology Associates - Metairie /ID# 283922

    Metairie, LA 70006

  • Willis-Knighton Medical Center /ID# 280572

    Shreveport, LA 71103

    Site contact: Site Coordinator · 318-212-2863

  • Lucida Clinical Trials /ID# 282000

    New Bedford, MA 02740

  • West Michigan Clinical Research Center /ID# 280480

    Wyoming, MI 49519

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

    Flowood, MS 39232

  • Gastroenterology Associates Of North Mississippi /ID# 285243

    Oxford, MS 38655

  • Specialists In Gastroenterology /ID# 283939

    St Louis, MO 63141

  • Vector Clinical Trials /ID# 280843

    Las Vegas, NV 89128

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

    New York, NY 10075

  • Digestive Health Partners /ID# 280490

    Asheville, NC 28803

    Site contact: Site Coordinator · (828) 254-0881

  • Dayton Gastroenterology - Beavercreek /ID# 284065

    Beavercreek, OH 45440

  • Gastro Intestinal Research Institute of Northern Ohio /ID# 283860

    Westlake, OH 44145

  • University Gastroenterology - Providence - Staniford Street /ID# 280919

    Providence, RI 02905

  • Gastroenterology Associates - Patewood /ID# 283870

    Greenville, SC 29607

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

    Knoxville, TN 37909

  • Gastro One - Memphis /ID# 283948

    Memphis, TN 38104

  • Novel Research - Bellaire /ID# 280925

    Bellaire, TX 77401

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

    Fort Worth, TX 76104

  • GI Alliance -Garland /ID# 284253

    Garland, TX 75044

    Site contact: Site Coordinator · 972-265-8201

  • Amel Med /ID# 283864

    Georgetown, TX 78628

  • Integrity Advanced Therapeutics /ID# 283871

    Houston, TX 77090

  • GI Alliance - Lubbock /ID# 283920

    Lubbock, TX 74910

  • Caprock Gastro Research - Lubbock /ID# 283921

    Lubbock, TX 79424

  • GI Alliance - Mansfield /ID# 283924

    Mansfield, TX 76063

  • Southern Star Research Institute /ID# 280822

    San Antonio, TX 78229

  • Center for Digestive Disease /ID# 280870

    Shenandoah, TX 77384

    Site contact: Site Coordinator · 832-234-1023

  • Texas Digestive Disease Consultants - Southlake /ID# 283931

    Southlake, TX 76092

    Site contact: Site Coordinator · 817-424-1525

  • Tyler Research Institute /ID# 284247

    Tyler, TX 75701

    Site contact: Site Coordinator · 903-630-6211

  • Texas Digestive Disease Consultants /ID# 284245

    Webster, TX 77598

  • Emeritas Research Group /ID# 284388

    Lansdowne Town Center, VA 20176

  • GI Alliance - Richmond /ID# 284244

    Richmond, VA 23229

  • Washington Gastroenterology - Bellevue /ID# 283966

    Bellevue, WA 98004

  • Washington Gastroenterology - Tacoma /ID# 284143

    Tacoma, WA 98405

  • The Vancouver Clinic /ID# 280497

    Vancouver, WA 98664

    Site contact: Site Coordinator · 360-397-3388

+ 1 more on the official record.

Study contacts (from the official record)

  • ABBVIE CALL CENTER · 844-663-3742 · abbvieclinicaltrials@abbvie.com
Study of Advanced Therapies for the Treatment of Adult… (NCT07697456) | Bored Studies