RecruitingNCT06311123

Understanding Ozanimod's MOA Via Mass Cytometry in Ulcerative Colitis

High Dimensional Mass Cytometry as a Tool to Understand Ozanimod's Mechanism of Action (MOA)


Sponsor

University of California, San Diego

Enrollment

10 participants

Start Date

Oct 6, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

The goal of this observational study is to learn about the mechanism of action of ozanimod in patients with ulcerative colitis (UC). The main questions it aims to answer are: 1. Prospectively assess the effects of ozanimod on the cellular composition of intestinal lamina propria and blood by deep immunophenotyping (CyTOF) of immune cell subsets prior and after the drug's administration. 2. Determine whether changes in cell subsets observed via mass cytometry correlate with with clinical or histologic parameters of disease activity. Colonic biopsies and peripheral blood samples will be collected from patients with UC before and after the onset of ozanimod. Researchers will compare intestinal and peripheral leukocytes before and after the drug's administration.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study uses mass cytometry — a high-tech method that can measure dozens of immune cell types at once — to understand exactly how ozanimod (a medication approved for ulcerative colitis) works in the body. The goal is to learn more about the drug's mechanism and identify which patients are most likely to respond to it. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with ulcerative colitis (UC) for at least 3 months, confirmed by both camera examination (endoscopy) and tissue analysis - Your UC is currently active - Your doctor is already considering starting you on ozanimod and is not combining it with biologic medications **You may NOT be eligible if...** - Your doctor believes you may need surgery (colectomy or ileostomy) within 3 months - You have fulminant (extremely severe) colitis, toxic megacolon, or bowel perforation - You have had your colon surgically removed - You have a low platelet count or an active gut infection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

University of California San Diego

San Diego, California, United States

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NCT06311123


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