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

Ulcerative Colitis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05809583
• Other study ID #: 2022P000954
• Status: Not yet recruiting
• Start date: May 1, 2023
• Est. completion date: April 1, 2024

Study information

• Verified date: April 2023
• Source: Beth Israel Deaconess Medical Center
• Contact: Laurie Grossberg, MD
• Phone: 617-667-2802
• Email: lgrossbe[@]bidmc.harvard.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: April 1, 2024
• Est. primary completion date: April 1, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• Ozanimod
Patients with established diagnosis of UC starting ozanimod therapy as part of their clinical care

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

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