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

Beth Israel Lahey Health

Status: Withdrawn

Conditions: Ulcerative Colitis

Treatments: Drug: Ozanimod

Study type: Observational

Funder types: Other

Identifiers

NCT05809583

2022P000954

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients ≥18 years of age with established diagnosis of UC starting ozanimod therapy as part of their clinical care
2. 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
3. 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

1. Diagnosis of Crohn's disease or indeterminate colitis
2. Total (procto)colectomy
3. Ileoanal pouch anastomosis
4. Current ileostomy or colostomy
5. Untreated Clostridium difficile infection
6. Known pregnancy

Trial design

0 participants in 1 patient group

ozanimod

Description:

Patients with UC starting ozanimod therapy as part of their clinical care

Treatment:

Drug: Ozanimod