Status:
WITHDRAWN
Ulcerative Colitis Leukocyte TRAfficking After Treatment With Zeposia: the ULTRAZ Study
Lead Sponsor:
Geert D'Haens
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18-90 years
Phase:
PHASE4
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...
Detailed Description
Ozanimod is a sphingosine-1-phosphate (S1P) receptor modulator, which binds with high affinity to receptor subtypes 1 (S1P1) and 5 (S1P5). Many cell types express S1P1, including vascular endothelial ...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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).
- Active or planned pregnancy in the year following inclusion.
- 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
- \-
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2027
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06188637
Start Date
August 1 2024
End Date
March 1 2027
Last Update
September 19 2024
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