A Phase 4, Prospective, Open-label Study of Ozanimod to Explore the Safety, Efficacy, Quality of Life, and Biomarker Response in Participants with Moderate to Severe Ulcerative Colitis in Clinical Practice
Published: 11/03/2023
General Information:
To explore the safety, efficacy, effects on quality of life, and biomarker response of ozanimod in participants with moderate to severely active ulcerative colitis (UC).
Eligibility:
A diagnosis of ulcerative colitis (UC), with signs and symptoms consistent with UC for at least 3 months prior to the first study intervention administration
Moderate to severely active UC disease activity, defined as a modified Mayo score of 4 through 9, inclusive, with the following minimum subscores:
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An SF subscore ≥ 1
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An RB subscore ≥ 1
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An ES ≥ 2 (endoscopy performed within 60 days of the first study intervention administration).
Report of a previous colonoscopy that documents extent of disease
Exclusion Criteria:
Current or recent (within 3 months of screening) evidence of fulminant colitis, toxic megacolon, or bowel perforation
Extensive colonic resection or current stoma
Colonic dysplasia that has not been removed
*Other protocol-defined inclusion/exclusion criteria apply
Study Details:
This is an open label study, and all participants will receive ozanimod. The duration of the study will be up to 2.4 years and participants will have to visit the study doctor approximately 8 times during study period. The duration of each visit may vary from 2 to 7 hours depending on the tasks that need to be performed.
There is a 28-day screening period to determine if a participant can take part in the study. If the study doctor confirms that a participant meets all the criteria to participate in this study, he/she will enter into a 2-year treatment period receiving ozanimod. After the last ozanimod dose, there is a 84-day post-treatment follow-up period.
Description of treatment or intervention (mechanism of action):
Ozanimod is a selective S1P receptor modulator leading to internalization of S1P receptors in lymphocytes, thereby preventing exit of activated lymphocytes from lymphoid tissue resulting in decreased inflammation in people with ulcerative colitis.
Possible risks and side effects:
Potential risks related to study procedure: While endoscopy is considered to be a very safe procedure, rare complications may include perforation, bleeding, and infection. Risk of bleeding complications after an endoscopy is increased if the procedure involves biopsy.
Listed below are the common or very common side effects associated with ozanimod study treatment:
- Common cold, runny nose, and sore throat (nasopharyngitis, respiratory tract infection viral, pharyngitis)
- Reduced blood lymphocyte count (a type of white blood cell that fights infection; lymphopenia)
- Urinary tract infection (infection of your kidneys, urinary tract, or bladder)
- Headache
- Swelling of the legs or hands (edema peripheral)
- Elevations in liver enzymes, abnormal liver function test (changes in your liver functioning; alanine aminotransferase increased, gamma-glutamyl transferase increased)
- Elevation in blood bilirubin level (blood bilirubin increased)
- High blood pressure (hypertension)
- Painful rash known as shingles (herpes zoster)
- Herpes infection (a viral infection; herpes simplex)
- Slowing of heart rate (bradycardia)
- Blood pressure decrease on standing (orthostatic hypotension)
- Breathing test results altered (PFT abnormal)