Study of Targeted Therapies for the Treatment of Adult Participants With Moderate to Severe Crohn's Disease (NCT06548542)
A Phase 2a Multicenter, Randomized, Platform Study of Targeted Therapies for the Treatment of Adult Subjects With Moderate to Severe Crohn's Disease
🩺 Plain-English Summary (8th-Grade Level)
Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most frequently affecting the bowels. It can cause many different symptoms including belly pain, diarrhea, tiredness, and weight loss. Treatments are available but do not work the same for all patients or may stop working over time. This study will evaluate the effectiveness and adverse events of targeted therapies (TaTs) for adult participants with moderate to severe CD. The medicines assessed in this study are risankizumab, trosunilimab, lutikizumab, and ABBV-8736. When participants join the study, they will be randomized into available study treatment groups. Adult participants with CD will be enrolled. Around 540 participants will be enrolled in the study at approximately 300 sites worldwide. Risankizumab and trosunilimab are given as an injection under the skin or as an infusion into the vein. Lutikizumab is given as an injection under the skin. ABBV-8736 is given as an infusion into the vein. 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, 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# 266216 — 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 (255 Sites)
Showing the first 25 of 255 sites.
- Digestive Health Specialists /ID# 266216 — Dothan, Alabama
- East View Medical Research /ID# 270377 — Mobile, Alabama
- Southern California Res. Ctr /ID# 265549 — Coronado, California
- UC San Diego Health System /ID# 265565 — La Jolla, California
- uc davis medical center - patient support services building /ID# 265554 — Sacramento, California
- Clinical Applications Laboratories - San Diego - 3rd Avenue /ID# 267391 — San Diego, California
- Peak Gastroenterology Associates - Colorado Springs - North Cascade Avenue /ID# 265557 — Colorado Springs, Colorado
- Danbury Hospital, Western Connecticut Health Network /ID# 265556 — Danbury, Connecticut
- Yale University School of Medicine /ID# 266786 — New Haven, Connecticut
- Novum Research /ID# 278128 — Clermont, Florida
- University of Florida College of Medicine /ID# 266930 — Gainesville, Florida
- Nature Coast Clinical Research - Inverness /ID# 265874 — Inverness, Florida
- Atlantic Medical Research /ID# 266207 — Margate, Florida
- A Plus Research /ID# 265878 — Miami, Florida
- Sanchez Clinical Research /ID# 265887 — Miami, Florida
- Advanced Research Institute, Inc /ID# 265548 — New Port Richey, Florida
- Hillcrest Medical Research, LLC /ID# 267237 — Orange City, Florida
- Endoscopic Research, Inc. /ID# 267211 — Orlando, Florida
- Gcp Clinical Research /ID# 278126 — Tampa, Florida
- AdventHealth Medical Group - Tampa - Bruce B Downs Boulevard /ID# 265538 — Tampa, Florida
- Florida Medical Clinic - Zephyrhills /ID# 267392 — Zephyrhills, Florida
- Gastroenterology Associates of Central Georgia /ID# 265547 — Macon, Georgia
- Treasure Valley Medical Research /ID# 267114 — Boise, Idaho
- University of Chicago Medical Center /ID# 267400 — Chicago, Illinois
- OSF St. Francis Medical Center /ID# 266973 — Peoria, Illinois
📞 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.