A diagnostic tool that identifies biomarkers that predict response prior to and during induction of ozanimod will have a major impact on improving outcomes in UC patients. Using SOMAscan from SomaLogic (Boulder, CO), our study aims to discover serum protein biomarkers in UC patients that predict response to ozanimod and to gain insight into the pathophysiological mechanisms underlying ozanimod response.
Study Type
OBSERVATIONAL
Patients with established diagnosis of UC starting ozanimod therapy as part of their clinical care
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Clinical response
The primary endpoint measure is clinical response defined as a decrease of at least 50% in PRO2 at week 10 (end of induction)
Time frame: 10 weeks
Clinical response
Clinical response defined as a decrease of at least 50% in PRO2 at week 22
Time frame: 22 weeks
Clinical remission
Symptomatic/PRO2 remission defined as stool frequency subscore of 0 or 1 and rectal bleeding subscore of 0 at weeks 10 and 22.
Time frame: 10 weeks
Fecal calprotectin
Change from baseline in level of fecal calprotectin at weeks 2, 10, and 22
Time frame: 2, 10, 22 weeks
CRP
Change from baseline in level of CRP at weeks 2, 10, 22
Time frame: 2, 10, 22 weeks
Corticosteroid free remission
Corticosteroid free remission at week 22
Time frame: 22 weeks
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