NCT05809583
Withdrawn
Not Applicable
Applying Precision Medicine to Define Predictors of Response to Ozanimod and Discovering Biomarkers in the Management of Ulcerative Colitis Using 7,000 Protein SOMAscan
Overview
- Phase
- Not Applicable
- Intervention
- Ozanimod
- Conditions
- Ulcerative Colitis
- Sponsor
- Beth Israel Deaconess Medical Center
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Clinical response
- Status
- Withdrawn
- Last Updated
- 11 months ago
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.
Investigators
Laurie Grossberg
Instructor in Medicine
Beth Israel Deaconess Medical Center
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
Arms & Interventions
ozanimod
Patients with UC starting ozanimod therapy as part of their clinical care
Intervention: Ozanimod
Outcomes
Primary Outcomes
Clinical response
Time Frame: 10 weeks
The primary endpoint measure is clinical response defined as a decrease of at least 50% in PRO2 at week 10 (end of induction)
Secondary Outcomes
- Clinical response(22 weeks)
- Clinical remission(10 weeks)
- Fecal calprotectin(2, 10, 22 weeks)
- CRP(2, 10, 22 weeks)
- Corticosteroid free remission(22 weeks)
Study Sites (1)
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