Ulcerative Colitis Leukocyte TRAfficking After Treatment With Zeposia: the ULTRAZ Study

NCT06188637 | Withdrawn Phase 4

• 1 other identifier: 2023-505382-88-00
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The ULTRAZ study is designed to better understand the mode of action of S1P receptor modulators. The alteration of leukocyte trafficking due to S1P receptors such as ozanimod is mainly investigated in rodent studies. Several previous studies show a reduced total leukocyte count in peripheral blood and only two study reported the effect of leukocyte subgroups before and after treatment with ozanimod. The change in leukocyte subgroups in peripheral blood as well as colonic mucosa and lymph nodes have not been investigated to our knowledge. Therefore, the aim of this study is to explore the changes in these three compartments.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• To investigate changes in inflammatory cell subpopulations in the colonic mucosa, the inguinal lymph nodes, and peripheral blood in response to ozanimod induction therapy in patients ulceratie colitis.

  To measure the concentration of neutrophils, lymphocytes, monocytes, and dendritic cells at week 0, 2,6 and 10 in the colonic mucosa, the inguinal lymph nodes and peripheral blood using the technique of single cell transcriptomics, spatial transcriptomics and cytometry by time of flight ( CyTOF) in response to ozanimod induction therapy in patients with moderate-to-severe ulcerative colitis.

  Baseline, week 2, 6 and 10.

Study Arms (1)

Open- label ozanimod

EXPERIMENTAL

All patients will receive open-label ozanimod

Drug: Ozanimod Oral Capsule

Interventions

Ozanimod Oral Capsule DRUG

open label ozanimod

Open- label ozanimod

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or non-pregnant, non-lactating female patients 18 years or older.
• Documented diagnosis of UC.
• Active symptomatic UC with endoscopic Mayo score 2-3.
• Intention to start treatment with ozanimod.
• Written informed consent.
• Willing to utilize treatment as prescribed and undergo the procedures that our explained in detail in the informed consent form (ICF).

You may not qualify if:

• Any conditions (e.g., history of alcohol or substance abuse, or lack of compliance) which, in the opinion of the investigator, may interfere with the patient's ability to comply with study procedures.
• Currently participating, or planning to participate in a study involving an investigational product.
• Current diagnosis of untreated active tuberculosis, active/chronic hepatitis B. Patients with latent tuberculosis can participate after at least 4 weeks of tuberculostatic treatment per local guidelines.
• Current gastro-intestinal infection (e.g. C. Diff or other pathogens).
• Prior diagnosis of dysplasia in the colon (excluding dysplasia in resected adenomas).
• History of malignancy in the 5 years prior to randomization except for non-melanoma skin cancer.
• Abnormal liver function tests and/or abnormal ECG that precludes S1P receptor blocker treatment as per Summary of product characteristics (SmPC).
• Previous treatment with Vedolizumab (Entyvio).
• Use of prohibited medication as listed in the SmPC

Sponsors & Collaborators

• Geert D'Haens: lead
• Bristol-Myers Squibb: collaborator

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

ozanimod

Condition Hierarchy (Ancestors)

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

Study Officials

• Geert DHaens

  AmsterdamUMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: This is a 2-center prospective open-label study with an 11 week follow-up period and extra disease activity check at week 26.

Study Record Dates

• First Submitted: December 15, 2023
• First Posted: January 3, 2024
• Study Start: August 1, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share