Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Irvine
Dates
study started
completion around

Description

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 subjects with 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 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 open label lutikizumab. Around 200 adult participants with UC will be enrolled at approximately 280 sites worldwide.

In the Induction Period, participants will be randomized to receive intravenous (IV) and subcutaneous (SC) lutikizumab or SC adalimumab for 12 weeks. 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 until Week 52. Participants who do not respond to treatment will receive open-label SC lutikizumab until Week 52.

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.

Official Title

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

Keywords

Ulcerative Colitis, Lutikizumab, Adalimumab, Colitis, Ulcer, Maintenance Adalimumab

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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 exposure to adalimumab (including biosimilars). Note: Subject may be enrolled if he/she has been exposed to other advanced therapies, including anti-TNFs other than adalimumab.

Locations

  • UC Irvine Health /ID# 259824 accepting new patients
    Orange California 92868-3201 United States
  • Newport Huntington Medical Group /ID# 258371 accepting new patients
    Huntington Beach California 92648-5994 United States
  • Southern California Res. Ctr. /ID# 258391 accepting new patients
    Coronado California 92118-1408 United States
  • Gastro SB /ID# 258331 accepting new patients
    Chula Vista California 91910-5619 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
Links
Related Info
ID
NCT06257875
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 200 study participants
Last Updated