NCT06311123 · University of California, San Diego
Understanding Ozanimod's MOA Via Mass Cytometry in Ulcerative Colitis
What this study 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.
View original scientific description
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.
Primary outcome measures
difference in leukocyte subsets
Time frame: 3 years
difference in leukocyte subsets as determined by mass cytometry analyses
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- San Diego, California
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 15, 2024 · Source of record for eligibility and locations