Understanding Ozanimod's MOA Via Mass Cytometry in Ulcerative Colitis

NCT06311123 | Recruiting

• 1 other identifier: ISR IM047-059
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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. 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. 2.Determine whether changes in cell subsets observed via mass cytometry correlate with with clinical or histologic parameters of disease activity.

Conditions

Ulcerative Colitis; Ulcerative Colitis Chronic Moderate

Keywords

colitis; ozanimod; mass cytometry

Outcome Measures

Primary Outcomes (1)

• difference in leukocyte subsets

  difference in leukocyte subsets as determined by mass cytometry analyses

  3 years

Study Arms (1)

patients with active ulcerative colitis

patients with active ulcerative colitis starting ozanimod therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with moderate to severe ulcerative colitis starting ozanimod therapy

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California San Diego

San Diego, California, 92093-006, United States

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative; Colitis

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Central Study Contacts

Jesus Rivera-Nieves, MD

CONTACT

8585345495; jriveran@ucsd.edu

Alyssa Blair

CONTACT

858-822-4939

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: March 15, 2024
• Study Start: October 6, 2023
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 10/2023 through 09/2026
• Access Criteria: Data will be posted at website

Locations

US (1)