WithdrawnNo phase
Define Predictors of Response to Ozanimod in UC Discovering Biomarkers in the Management of Ulcerative Colitis
Key facts
- Who runs it
- Beth Israel Deaconess Medical Center
- Where
- Boston, United StatesSee the site
- Trial code
- Status
- Withdrawn
- Started
- 12 Apr 2023
- Ended
- 1 Dec 2024
- Type of study
- Observational
- Treatments tested
- Ozanimod
- Record updated
- 4 June 2025
- Why it stopped
- Funding withdrawn
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- 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
Who cannot take part
- Diagnosis of Crohn's disease or indeterminate colitis
- Untreated Clostridium difficile infection
- Total (procto)colectomy
- Ileoanal pouch anastomosis
- Current ileostomy or colostomy
- Known pregnancy
Where in United States
- Beth Israel Deaconess Medical CenterBoston, United StatesNo longer taking part
About the trial
What the trial wants to find out
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.
The group in the trial
- ozanimod
Patients with UC starting ozanimod therapy as part of their clinical care
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Record updated
- 4 June 2025