Study of Advanced Therapies for the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease or Ulcerative Colitis (NCT07697456)
A Phase 2 Platform Basket Study Evaluating Advanced Therapies in Subjects With Moderately to Severely Active Crohn's Disease or Ulcerative Colitis
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Digestive Health Specialists /ID# 280827 — Dothan, Alabama
Age range: 18 Years to 75 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (21 Sites)
- Digestive Health Specialists /ID# 280827 — Dothan, Alabama
- Elite Clinical Studies /ID# 280477 — Phoenix, Arizona
- Clinnova Research /ID# 280509 — Anaheim, California
- Gastro Care Institute /ID# 281071 — Lancaster, California
- United Medical Doctors - Los Alamitos /ID# 281125 — Los Alamitos, California
- Inland Empire Liver Foundation - Rialto /ID# 280775 — Rialto, California
- Peak Gastroenterology Associates - Colorado Springs - North Cascade Avenue /ID# 280507 — Colorado Springs, Colorado
- Clinical Research of Osceola /ID# 280593 — Kissimmee, Florida
- Research Associates of South Florida /ID# 280929 — Miami, Florida
- Advanced Research Institute, Inc /ID# 281062 — New Port Richey, Florida
- Gastroenterology Associates of Central Georgia /ID# 280464 — Macon, Georgia
- Gastroenterology Consultants - Roswell /ID# 281235 — Roswell, Georgia
- Treasure Valley Medical Research /ID# 281778 — Boise, Idaho
- Southwest Gastroenterology - Oak Lawn /ID# 280841 — Oak Lawn, Illinois
- Vector Clinical Trials /ID# 280843 — Las Vegas, Nevada
- New York Gastroenterology Associates - Upper East Side /ID# 281767 — New York, New York
- University Gastroenterology - Providence - Staniford Street /ID# 280919 — Providence, Rhode Island
- Novel Research - Bellaire /ID# 280925 — Bellaire, Texas
- Southern Star Research Institute /ID# 280822 — San Antonio, Texas
- Washington Gastroenterology - Tacoma /ID# 284143 — Tacoma, Washington
- The Vancouver Clinic /ID# 280497 — Vancouver, Washington
📞 Contact the Study Coordinator
Phone: (844) 663-3742
Email: abbvieclinicaltrials@abbvie.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Crohn's Disease
- A Non-Interventional Clinical Study to Evaluate Long-Term Safety and Effectiveness of HUMIRA (Adalimumab) in Pediatric Patients With Moderately to Severely Active Crohn's Disease (CD) — Birmingham, Alabama
- A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease — Birmingham, Alabama
- A Study to Assess Adverse Events and Change in Disease Activity of Risankizumab Subcutaneous Induction Treatment for Moderately to Severely Active Crohn's Disease. — Sun City, Arizona
- Study to Assess Speed of Onset and Durability of Effectiveness of Upadacitinib in Adult Participants With Moderate to Severe Crohn's Disease (CD) in Real World Clinical Practice. — Blacktown, New South Wales
- Transmural Healing and Disease-Modifying Effect of Guselkumab in Crohn's Disease Patients — San Francisco, California
- Dietary Therapy and Gut Microbiome in Crohn's Disease and Ulcerative Colitis — Boston, Massachusetts
Explore by condition: All Crohn's Disease clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.