Recruiting

Ozanimod

Sponsor:

UCLA

Code:

NCT06311123

Conditions

Ulcerative Colitis

Ulcerative Colitis Chronic Moderate

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Ulcerative Colitis

Ulcerative Colitis Chronic Moderate

Study ID

NCT06311123

Start date

Oct 6, 2023

Status verified date

Mar, 2024

Completion date

Sep 30, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

10 participants

Anticipated

Interventions and Outcome Measures

Arms

patients with active ulcerative colitis

patients with active ulcerative colitis starting ozanimod therapy

Primary outcome measure

  • difference in leukocyte subsets [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Jesus Rivera-Nieves, MD

8585345495jriveran@ucsd.edu

Alyssa Blair

858-822-4939

Locations

University of California San Diego

Recruiting

San Diego, California, United States, 92093-006

Contacts

Jesus Rivera-Nieves, MD

858-534-5495jriveran@ucsd.edu

More Information

Sponsor

University of California, San Diego

Last update posted

Mar 15, 2024

Last verified

Mar, 2024

Keywords

  • colitis
  • ozanimod
  • mass cytometry

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2024-03-15.