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Assessing the safety and effectiveness of lutikizumab for 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

Phase 2 Interventional AbbVie · NCT06257875

This study is testing a new treatment called lutikizumab to see if it is safe and effective for adults with moderate to severe ulcerative colitis compared to an existing medication called adalimumab.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment200 (estimated)
Ages18 Years and up
SexAll
SponsorAbbVie Industry-sponsored
Drugs / interventionsadalimumab, lutikizumab
Locations188 sites (Chula Vista, California and 187 other locations)
Trial IDNCT06257875 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of lutikizumab, an investigational treatment, in adults with moderate to severe ulcerative colitis (UC). Participants will be randomized into different treatment arms to receive either lutikizumab or adalimumab, with assessments of adverse events and changes in disease activity. The study consists of an Induction Period followed by a Maintenance Period for those who respond to treatment. The goal is to determine how lutikizumab compares to an established therapy, adalimumab, in managing UC.

Who should consider this trial

Good fit: Ideal candidates are adults diagnosed with moderate to severe ulcerative colitis who have not responded adequately to previous treatments.

Not a fit: Patients with Crohn's disease or those who have previously shown intolerance to adalimumab may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients suffering from moderate to severe ulcerative colitis.

How similar studies have performed: Other studies have shown success with similar biologic therapies for ulcerative colitis, indicating potential for lutikizumab as a viable treatment option.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Participant has had a diagnosis of Ulcerative Colitis (UC) for at least 90 days prior to Baseline. Appropriate documentation of biopsy results consistent with the diagnosis of UC in the assessment of the investigator, must be available.
* Active UC with a Modified Mayo Score (mMS) of 5 to 9 points and Mayo Endoscopic Subscore (ESS) of 2 to 3 (confirmed by central review).
* Demonstrated inadequate response to, loss of response to, or intolerance to at least one of the following: oral aminosalicylates, corticosteroids, immunomodulators, and/or advanced therapies.

Exclusion Criteria:

* Current diagnosis of Crohn's Disease (CD) or inflammatory bowel disease-unclassified.
* Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.
* Prior inadequate response, intolerance or loss of response to adalimumab (including biosimilars). Note: Participant may be enrolled if he/she discontinued adalimumab for reasons other than those listed above (e.g., loss of insurance) or he/she has been exposed to other advanced therapies, including anti-TNFs other than adalimumab.

Where this trial is running

Chula Vista, California and 187 other locations

+138 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Ulcerative ColitisLutikizumabAdalimumab
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.