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)
A Multicenter, Randomized Study to Evaluate the Safety and Efficacy of Lutikizumab for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis
🩺 Plain-English Summary (8th-Grade Level)
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 care. 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, checking for side effects and completing questionnaires.
Who can join: Review the eligibility criteria below.
Location: Gastro SB /ID# 258331 — Chula Vista, California
Age range: 18 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 (191 Sites)
Showing the first 25 of 191 sites.
- Gastro SB /ID# 258331 — Chula Vista, California
- Southern California Res. Ctr. /ID# 258391 — Coronado, California
- Newport Huntington Medical Group /ID# 258371 — Huntington Beach, California
- Om Research LLC /ID# 261383 — Lancaster, California
- UC Irvine Health /ID# 259824 — Orange, California
- University of Colorado Hospital /ID# 258388 — Aurora, Colorado
- Research Associates of South Florida, LLC /ID# 259813 — Coral Gables, Florida
- University of Florida College of Medicine /ID# 260402 — Gainesville, Florida
- Auzmer Research /ID# 260940 — Lakeland, Florida
- Atlantic Medical Research /ID# 258507 — Margate, Florida
- Homestead Associates in Research /ID# 260392 — Miami, Florida
- University of Miami /ID# 258396 — Miami, Florida
- JD Medical Group, LLC /ID# 261235 — Miami, Florida
- Gastroenterology Group Naples /ID# 258346 — Naples, Florida
- AdventHealth Medical Group Blood & Marrow Transplant at Orlando /ID# 260945 — Orlando, Florida
- GCP Clinical Research, LLC /ID# 260401 — Tampa, Florida
- Atlanta Ctr. for Gastro /ID# 259275 — Decatur, Georgia
- Gastroenterology Associates of Central Georgia, LLC /ID# 258359 — Macon, Georgia
- Gastroenterology Consultants, P.C /ID# 258352 — Roswell, Georgia
- Northwestern Medicine - Northwestern Memorial Hospital /ID# 259592 — Chicago, Illinois
- University of Chicago Medical Center /ID# 258491 — Chicago, Illinois
- IU Health University Hospital /ID# 260398 — Indianapolis, Indiana
- Univ Kansas Med Ctr /ID# 258489 — Kansas City, Kansas
- Louisiana Research Center, LLC /ID# 258330 — Shreveport, Louisiana
- Massachusetts General Hospital /Id# 259817 — Boston, Massachusetts
💰 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 Ulcerative Colitis
- A Study to Evaluate Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderately to Severely Active Ulcerative Colitis (MK-7240-001) — Dothan, Alabama
- Pharmacokinetics of IFX and TNF Concentrations in Serum, Stool, and Colonic Mucosa in Acute Severe Ulcerative Colitis — San Diego, California
- A Study to Evaluate the Safety of Ozanimod Exposure During Pregnancy in Women With Ulcerative Colitis and Their Infants — Eden Prairie, Minnesota
- CP101 for the Treatment of Ulcerative Colitis — Boston, Massachusetts
- A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Ulcerative Colitis — Los Angeles, California
- Angiographic Delivery of AD-MSC for Ulcerative Colitis — Rochester, Minnesota
Explore by condition: All Ulcerative Colitis clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.