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Study of Targeted Therapies for the Treatment of Adult Participants With Moderate to Severe Crohn's Disease
NCT06548542 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Lutikizumab
- DRUG Risankizumab
- DRUG Trosunilimab
Study Locations (20)
Florida
- Novum Research /ID# 278128 — Clermont
- University of Florida College of Medicine /ID# 266930 — Gainesville
- Nature Coast Clinical Research - Inverness /ID# 265874 — Inverness
- Atlantic Medical Research /ID# 266207 — Margate
- A Plus Research /ID# 265878 — Miami
- Sanchez Clinical Research /ID# 265887 — Miami
- Advanced Research Institute, Inc /ID# 265548 — New Port Richey
- Hillcrest Medical Research, LLC /ID# 267237 — Orange City
- Endoscopic Research, Inc. /ID# 267211 — Orlando
- Gcp Clinical Research /ID# 278126 — Tampa
- AdventHealth Medical Group - Tampa - Bruce B Downs Boulevard /ID# 265538 — Tampa
California
- Southern California Res. Ctr /ID# 265549 — Coronado
- UC San Diego Health System /ID# 265565 — La Jolla
- uc davis medical center - patient support services building /ID# 265554 — Sacramento
- Clinical Applications Laboratories - San Diego - 3rd Avenue /ID# 267391 — San Diego
Alabama
- Digestive Health Specialists /ID# 266216 — Dothan
- East View Medical Research /ID# 270377 — Mobile
Connecticut
- Danbury Hospital, Western Connecticut Health Network /ID# 265556 — Danbury
- Yale University School of Medicine /ID# 266786 — New Haven
Colorado
- Peak Gastroenterology Associates - Colorado Springs - North Cascade Avenue /ID# 265557 — Colorado Springs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 540 participants |
| Start Date | 2024-09-04 |
| Est. Completion | 2028-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06548542
The ClinicalTrials.gov registry entry for NCT06548542 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 540 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Crohn's Disease appearing as the primary indexed condition, and to 3 interventions — of which Lutikizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06548542 reports 20 study locations spanning 5 distinct geographic areas — top geographies include Florida, California, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06548542 about?
NCT06548542 is a clinical study titled "Study of Targeted Therapies for the Treatment of Adult Participants With Moderate to Severe Crohn's Disease". 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 ...
What is the current status of trial NCT06548542?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 540 participants. The study started on 2024-09-04. Estimated completion is 2028-08.
What conditions does trial NCT06548542 study?
This clinical trial studies the following conditions: Crohn's Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06548542?
The interventions under investigation include: Lutikizumab (DRUG), Risankizumab (DRUG), Trosunilimab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06548542?
This trial is sponsored by AbbVie, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06548542 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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