NCT06257875

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 156 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	Lutikizumab	Subcutaneous (SC) Injection
DRUG	Lutikizumab	Intravenous (IV) Infusion
DRUG	Adalimumab	SC Injection

Timeline

• Start date: 2024-03-23
• Primary completion: 2027-09-01
• Completion: 2027-09-01
• First posted: 2024-02-14
• Last updated: 2025-10-07

Locations

191 sites across 30 countries: United States, Australia, Austria, Belgium, Bulgaria, Canada, Croatia, Estonia, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Latvia, Lithuania, New Zealand, Norway, Poland, Puerto Rico, Serbia, Slovenia, South Africa, South Korea, Spain, Switzerland, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study