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

• Status: Not yet recruiting
• Trial end date: 2027-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Geert D'Haens
• Collaborator: Bristol-Myers Squibb
• Treatments: Ozanimod

Criteria

Inclusion Criteria:

1. Male or non-pregnant, non-lactating female patients 18 years or older.

2. Documented diagnosis of UC.

3. Active symptomatic UC with endoscopic Mayo score 2-3.

4. Intention to start treatment with ozanimod.

5. Written informed consent.

6. Willing to utilize treatment as prescribed and undergo the procedures that our explained in detail in the informed consent form (ICF).

Exclusion Criteria:

1. 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.

2. Currently participating, or planning to participate in a study involving an investigational product.

3. 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.

4. Current gastro-intestinal infection (e.g. C. Diff or other pathogens).

5. Active or planned pregnancy in the year following inclusion.

6. Prior diagnosis of dysplasia in the colon (excluding dysplasia in resected adenomas).

7. History of malignancy in the 5 years prior to randomization except for non-melanoma skin cancer.

8. Abnormal liver function tests and/or abnormal ECG that precludes S1P receptor blocker treatment as per Summary of product characteristics (SmPC).

9. Previous treatment with Vedolizumab (Entyvio).

10. Use of prohibited medication as listed in the SmPC

-