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

NCT05809583 | Withdrawn FDA Drug

• 1 other identifier: 2022P000954
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis

Keywords

biomarkers; ozanimod; somascan

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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 Arms (1)

ozanimod

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

Drug: Ozanimod

Interventions

Ozanimod DRUG

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

ozanimod

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Diagnosis of Crohn's disease or indeterminate colitis
• Total (procto)colectomy
• Ileoanal pouch anastomosis
• Current ileostomy or colostomy
• Untreated Clostridium difficile infection
• Known pregnancy

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

ozanimod

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Laurie Grossberg, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor in Medicine

Study Record Dates

• First Submitted: March 30, 2023
• First Posted: April 12, 2023
• Study Start: April 12, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)