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NCT06548542 · ClinicalTrials.gov registry record · Phase 2
Study of Targeted Therapies for the Treatment of Adult Participants With Moderate to Severe Crohn's Disease
A Phase 2 study of Crohn's Disease, sponsored by AbbVie.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 540
- Enrollment target
- 20
- Study locations
NCT06548542: Recruiting Phase 2 study of Crohn's Disease, sponsored by AbbVie.
NCT06548542 is a Phase 2 study of Crohn's Disease that is actively recruiting participants, run by AbbVie. The registered enrollment target is 540 participants, below the 2,389-participant average among 105 other Crohn's Disease trials with a reported enrollment target (77% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06548542, a Phase 2 study of Crohn's Disease, is actively recruiting participants, sponsored by AbbVie.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 540 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
The Simple Endoscopic Score for Crohn's Disease (SES-CD) assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic Remission is defined as SES-CD ≤ 4 and no sub score greater than 1 in any individual variable, as scored by a central reader.
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 |
What NCT06548542 shows while recruiting
NCT06548542 is an interventional study that assigns participants to a tested intervention. The registered 540 participants enrollment target is mid-sized for trials with a published cap, below the 2,389-participant average among 105 other Crohn's Disease trials with a reported enrollment target (77% lower).
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.
NCT06548542 names 20 study sites across 5 states, led by Florida, California, Alabama.
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.
What interventions are being tested in trial NCT06548542?
The interventions under investigation include: Lutikizumab (DRUG), Risankizumab (DRUG), Trosunilimab (DRUG).
Who is sponsoring clinical trial NCT06548542?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06548542's enrollment target sits among peer trials
540 23rd of 105 higher than 83 of 105 other Crohn's Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Crohn's Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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