Understanding Ozanimod's MOA Via Mass Cytometry in Ulcerative Colitis

Part of paid clinical trials in San Diego, California.

Sponsor
University of California, San Diego
Study ID
NCT06311123
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Oct 6, 2023
Status verified
Mar 2024
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
10 participants (estimated)

Arms

  • Arm: patients with active ulcerative colitis
    patients with active ulcerative colitis starting ozanimod therapy

Primary Outcome Measure

difference in leukocyte subsets [ Time Frame: 3 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California San DiegoSan DiegoCalifornia92093-006
Jesus Rivera-Nieves, MD
[email protected]
858-534-5495

Find similar trials in San Diego, CA

By condition
Ulcerative colitis
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
University of California San Diego· San Diego, CA

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