NCT06311123 Understanding Ozanimod's MOA Via Mass Cytometry in Ulcerative Colitis
| NCT ID | NCT06311123 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, San Diego |
| Condition | Ulcerative Colitis |
| Study Type | OBSERVATIONAL |
| Enrollment | 10 participants |
| Start Date | 2023-10-06 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 10 participants in total. It began in 2023-10-06 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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 2. Current evidence of fulminant colitis, toxic megacolon or bowel perforation 3. Previous total colectomy 4. Platelet count\<100,000/μL 5. 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. 6. Prisoners or subjects involuntarily detained will not be included.
Frequently Asked Questions
Who can join the NCT06311123 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Ulcerative Colitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06311123 currently recruiting?
Yes, NCT06311123 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of California, San Diego to inquire about joining.
Where is the NCT06311123 trial being conducted?
This trial is being conducted at San Diego, United States.
Who is sponsoring the NCT06311123 clinical trial?
NCT06311123 is sponsored by University of California, San Diego. The trial plans to enroll 10 participants.
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