Actively Recruiting
Understanding Ozanimod's MOA Via Mass Cytometry in Ulcerative Colitis
Led by University of California, San Diego · Updated on 2024-03-15
10
Participants Needed
1
Research Sites
155 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Understanding Ozanimod's MOA Via Mass Cytometry in Ulcerative Colitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 18 or older
- Diagnosed with ulcerative colitis at least 3 months prior, confirmed by endoscopic and histologic evidence
- Have active ulcerative colitis confirmed by endoscopy
- Able to provide written informed consent to the IBD biobank at UCSD
- Considered for ozanimod therapy without concurrent biologic treatments
You will not qualify if you...
- Severe inflammatory bowel disease likely requiring colectomy or ileostomy within 12 weeks as judged by physician
- Current signs of fulminant colitis, toxic megacolon, or bowel perforation
- Previous total colectomy
- Platelet count below 100,000 per microliter
- Positive stool test for pathogens or Clostridium difficile at screening (may be treated and retested if positive)
- Prisoners or subjects involuntarily detained
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of California San Diego
San Diego, California, United States, 92093-006
Actively Recruiting
Research Team
J
Jesus Rivera-Nieves, MD
CONTACT
A
Alyssa Blair
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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