Understanding Ozanimod's MOA Via Mass Cytometry in Ulcerative Colitis

Launched by UNIVERSITY OF CALIFORNIA, SAN DIEGO · Mar 7, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called ozanimod to understand how it works in treating ulcerative colitis (UC), a condition that causes inflammation in the intestines. Researchers want to learn how ozanimod affects different types of immune cells in the body and whether these changes relate to the severity of the disease. To do this, they will collect samples from patients with active UC before they start taking ozanimod and again after treatment begins.

To participate in the study, individuals must be at least 18 years old and have a confirmed diagnosis of UC for at least three months. They should have active symptoms that can be seen during a medical examination. However, patients with severe cases of UC or certain other health issues won't be eligible for the trial. Participants will provide blood samples and tissue samples from their intestines, and they’ll be closely monitored to see how ozanimod affects their condition. This research could help improve understanding of UC and how to treat it more effectively.

Gender

ALL

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.