Define Predictors of Response to Ozanimod in UC Discovering Biomarkers in the Management of Ulcerative Colitis

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Applying Precision Medicine to Define Predictors of Response to Ozanimod and Discovering Biomarkers in the Management of Ulcerative Colitis Using 7,000 Protein SOMAscan

Conditions
-----------------
Ulcerative Colitis

Intervention / Treatment
-----------------
* Drug: Ozanimod


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients ≥18 years of age with established diagnosis of UC starting ozanimod therapy as part of their clinical care Patients with moderate to severe UC, determined by a 3-component Mayo score of 5-9 with an endoscopic subscore ≥ 2.Endoscopy must be performed within 90 days of ozanimod initiation Elevated CRP (greater than upper limit of normal on assay) and/or fecal calprotectin (>250 mcg/g) within 90 days of drug initiation Exclusion Criteria: Diagnosis of Crohn's disease or indeterminate colitis Total (procto)colectomy Ileoanal pouch anastomosis Current ileostomy or colostomy Untreated Clostridium difficile infection Known pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ozanimod<br>Patients with UC starting ozanimod therapy as part of their clinical care | Drug: Ozanimod<br>* Patients with established diagnosis of UC starting ozanimod therapy as part of their clinical care<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response | Clinical response defined as a decrease of at least 50% in PRO2 at week 22 | 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. | 10 weeks | 
| Fecal calprotectin | Change from baseline in level of fecal calprotectin at weeks 2, 10, and 22 | 2, 10, 22 weeks | 
| CRP | Change from baseline in level of CRP at weeks 2, 10, 22 | 2, 10, 22 weeks | 
| Corticosteroid free remission | Corticosteroid free remission at week 22 | 22 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
biomarkers, ozanimod, somascan