Understanding Ozanimod's MOA Via Mass Cytometry in Ulcerative Colitis
Recruiting · NCT06311123 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of California, San Diego
View the official record on ClinicalTrials.gov →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.
Who can take part
Inclusion criteria
- 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.
Exclusion criteria
- Have severe IBD as evidenced by:physician judgment that the patient is likely to require colectomy or ileostomy within 12 weeks of baseline
- Current evidence of fulminant colitis, toxic megacolon or bowel perforation
- Previous total colectomy
- Platelet count\<100,000/μL
- Have positive stool culture for pathogens (O+P, bacteria) or positive test for C. difficile at screening. If C. difficile is positive, the patient may be treated and retested.
- Prisoners or subjects involuntarily detained will not be included.
Where it is running
1 location listed across 1 US state.
- University of California San Diego - San Diego, California, United States