Understanding Ozanimod's MOA Via Mass Cytometry in Ulcerative Colitis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of California, San Diego
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial population
Patients with moderate to severe ulcerative colitis starting ozanimod therapy
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
10 Participants
are grouped into 1 trial groupGroup A: patients with active ulcerative colitis
Trial outcomes
Primary outcomes
1
difference in leukocyte subsets
difference in leukocyte subsets as determined by mass cytometry analyses
Time frame
3 yearsSponsors and contacts
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Source ClinicalTrials.gov