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

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Male or female patients aged 18 or older.

• Have had UC diagnosed at least 3 months prior to screening. The diagnosis must be confirmed by endoscopic and histologic evidence.

• Have active UC confirmed on endoscopy.

• Ability to provide written informed consent to IBD biobank (UCSD)

• Patients with above criteria being considered for ozanimod therapy and will not be treated in conjunction with biologics.

Locations
United States
California
University of California San Diego
RECRUITING
San Diego
Contact Information
Primary
Jesus Rivera-Nieves, MD
jriveran@ucsd.edu
8585345495
Backup
Alyssa Blair
858-822-4939
Time Frame
Start Date: 2023-10-06
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 10
Treatments
patients with active ulcerative colitis
patients with active ulcerative colitis starting ozanimod therapy
Sponsors
Leads: University of California, San Diego

This content was sourced from clinicaltrials.gov

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