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

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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05809583

Enrollment

Registered

2023-04-12

Start date

2023-04-12

Completion date

2024-12-01

Last updated

2025-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis

Keywords

biomarkers, ozanimod, somascan

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.

Interventions

DRUGOzanimod

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Clinical response	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

Measure	Time frame	Description
Clinical response	22 weeks	Clinical response defined as a decrease of at least 50% in PRO2 at week 22
Clinical remission	10 weeks	Symptomatic/PRO2 remission defined as stool frequency subscore of 0 or 1 and rectal bleeding subscore of 0 at weeks 10 and 22.
Fecal calprotectin	2, 10, 22 weeks	Change from baseline in level of fecal calprotectin at weeks 2, 10, and 22
CRP	2, 10, 22 weeks	Change from baseline in level of CRP at weeks 2, 10, 22
Corticosteroid free remission	22 weeks	Corticosteroid free remission at week 22

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026