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

Not yet recruiting

• Conditions: Ulcerative Colitis
• Interventions: Drug: Ozanimod

• Registration Number: NCT05809583
• Lead Sponsor: Beth Israel Deaconess Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-30
• Study First Submitted QC: 2023-03-30
• Status Verified: 2023-04
• Study First Posted: 2023-04-12
• Last Update Submitted: 2023-04-14
• Last Update Posted: 2023-04-18
• Study Start: 2023-05-01
• Primary Completion: 2024-04-01
• Study Completion: 2024-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ozanimod	Ozanimod	Patients with UC starting ozanimod therapy as part of their clinical care

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States