Understanding how ozanimod works in ulcerative colitis patients
High Dimensional Mass Cytometry as a Tool to Understand Ozanimod's Mechanism of Action (MOA)
This study is testing how the drug ozanimod affects the immune system in people with ulcerative colitis by looking at changes in their blood and tissue samples before and after treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Diego Academic / other |
| Locations | 1 site (San Diego, California) |
| Trial ID | NCT06311123 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the mechanism of action of ozanimod in patients with ulcerative colitis (UC) by assessing changes in immune cell composition in the intestinal lamina propria and blood. Researchers will collect colonic biopsies and blood samples from 10 patients before and after ozanimod treatment, analyzing these samples using mass cytometry to identify cellular changes. The study will also correlate these changes with clinical parameters of disease activity to better understand the drug's effects. The findings could provide insights into the therapeutic potential of ozanimod for UC management.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older with a confirmed diagnosis of active ulcerative colitis who are being considered for ozanimod therapy.
Not a fit: Patients with severe IBD requiring immediate surgical intervention or those with certain infections or previous surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of ozanimod's effects, potentially leading to improved treatment strategies for ulcerative colitis.
How similar studies have performed: While this approach is novel in its specific focus on ozanimod and mass cytometry, similar studies have shown promise in understanding drug mechanisms in other conditions.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
San Diego, California
- University of California San Diego — San Diego, California, United States (Recruiting)
Study contacts
- Study coordinator: Jesus Rivera-Nieves, MD
- Email: jriveran@ucsd.edu
- Phone: 8585345495
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.