High Dimensional Mass Cytometry as a Tool to Understand Ozanimod's Mechanism of Action (MOA)
University of California, San Diego
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.
Description
Study Design/Methodology: Several gastroenterologists at our center have agreed to assist with biopsy collection at our hospitals: UCSD: Singh, Boland, Patel, VA: Rivera-Nieves). Dr. Brian Behm who cares for most IBD patients at the University of Virginia has also agreed to assist with biopsy/PBMC collection. During two visits (T0, T24-32) we will collect biopsies, endoscopies, histology, fecal and blood samples (Table 1), prospectively from a total of 10 UC patients scheduled for colonoscopy (before therapy with ozanimod and at 24-32 weeks post-treatment). A sample size of 10 patients per c…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Male or female patients aged 18 or older. 2. Have had UC diagnosed at least 3 months prior to screening. The diagnosis must be confirmed by endoscopic and histologic evidence. 3. Have active UC confirmed on endoscopy. 4. Ability to provide written informed consent to IBD biobank (UCSD) 5. Patients with above criteria being considered for ozanimod therapy and will not be treated in conjunction with biologics. Exclusion Criteria: 1. Have severe IBD as evidenced by:physician judgment that the patient is likely to require colectomy or ileostomy within 12 weeks of baseline…
Location
- University of California San DiegoSan Diego, California