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A Study to Assess Adverse Events and Change in Disease Activity From Intravenous (IV) and Subcutaneous (SC) Lutikizumab in Adult Participants With Active Ulcerative Colitis
NCT06257875 · View on ClinicalTrials.gov ↗
Study Summary
Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). The purpose of this study is to assess how safe and effective lutikizumab is in adult participants with moderate to severe UC and how lutikizumab compares to adalimumab in the treatment of UC. Adverse events and changes in disease activity will be assessed. Lutikizumab is an investigational product being developed for the treatment of moderate to severe UC. Participants are placed in groups called treatment arms. Each group receives a different treatment. In the Induction Period, participants will be randomized into 1 of 3 arms receiving lutikizumab Dose 1, lutikizumab Dose 2, or adalimumab. In the Maintenance Period, participants who responded to lutikizumab will be randomized into 1 of 2 arms of lutikizumab maintenance and participants who responded to adalimumab will continue to receive adalimumab. All participants who did not achieve clinical response per modified Mayo Score at the end of the Induction period will receive lutikizumab. Around 200 adult participants with UC will be enrolled at approximately 200 sites worldwide. During the 12 week Induction Period, participants will be randomized to receive intravenous (IV) and subcutaneous (SC) lutikizumab or SC adalimumab. At the 12 week mark, participants who are on lutikizumab who have responded to treatment will be re-randomized to receive SC lutikizumab at different intervals until Week 52. Participants who are on adalimumab who are responding to treatment will continue to receive adalimumab. Participants who do not respond to treatment will receive SC lutikizumab. Participants who complete the Week 52 visit and in whom therapeutic benefit to study drug is confirmed by the investigator may roll over into an optional, 52-week long-term extension (LTE). There may be higher treatment burden for participants in this trial compared to their standard of
Conditions Studied
Interventions
- DRUG Adalimumab
- DRUG Lutikizumab
Study Locations (20)
Florida
- Research Associates of South Florida, LLC /ID# 259813 — Coral Gables
- University of Florida College of Medicine /ID# 260402 — Gainesville
- Auzmer Research /ID# 260940 — Lakeland
- Atlantic Medical Research /ID# 258507 — Margate
- Homestead Associates in Research /ID# 260392 — Miami
- University of Miami /ID# 258396 — Miami
- JD Medical Group, LLC /ID# 261235 — Miami
- Gastroenterology Group Naples /ID# 258346 — Naples
- AdventHealth Medical Group Blood & Marrow Transplant at Orlando /ID# 260945 — Orlando
- GCP Clinical Research, LLC /ID# 260401 — Tampa
California
- Gastro SB /ID# 258331 — Chula Vista
- Southern California Res. Ctr. /ID# 258391 — Coronado
- Newport Huntington Medical Group /ID# 258371 — Huntington Beach
- Om Research LLC /ID# 261383 — Lancaster
- UC Irvine Health /ID# 259824 — Orange
Georgia
- Atlanta Ctr. for Gastro /ID# 259275 — Decatur
- Gastroenterology Associates of Central Georgia, LLC /ID# 258359 — Macon
- Gastroenterology Consultants, P.C /ID# 258352 — Roswell
Colorado
- University of Colorado Hospital /ID# 258388 — Aurora
Illinois
- Northwestern Medicine - Northwestern Memorial Hospital /ID# 259592 — Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 156 participants |
| Start Date | 2024-03-23 |
| Est. Completion | 2027-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06257875
The ClinicalTrials.gov registry entry for NCT06257875 describes a study currently listed as active not 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 156 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 Ulcerative Colitis appearing as the primary indexed condition, and to 2 interventions — of which Adalimumab 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: NCT06257875 reports 20 study locations spanning 5 distinct geographic areas — top geographies include Florida, California, Georgia. 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 NCT06257875 about?
NCT06257875 is a clinical study titled "A Study to Assess Adverse Events and Change in Disease Activity From Intravenous (IV) and Subcutaneous (SC) Lutikizumab in Adult Participants With Active Ulcerative Colitis". Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). The purpose of this study is to assess how safe and effective lutikizumab is in adult participants with moderate to severe UC and how lutik...
What is the current status of trial NCT06257875?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 156 participants. The study started on 2024-03-23. Estimated completion is 2027-09.
What conditions does trial NCT06257875 study?
This clinical trial studies the following conditions: Ulcerative Colitis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06257875?
The interventions under investigation include: Adalimumab (DRUG), Lutikizumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06257875?
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 NCT06257875 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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