Overview

Monocyte Biomarkers in Moderate to Severe Plaque Psoriasis Subjects Treated With Apremilast

Status:
Active, not recruiting
Trial end date:
2021-09-30
Target enrollment:
Participant gender:
Summary
This is an open label pilot study of the impact of treatment with standard dosing of Otezla for 16 weeks on AM-endotype psoriasis patients, identified by elevated (>150% of normal): 1.) Intermediate (CD14++CD16+) monocytes, or 2.) circulating monocyte doublets, or 3.) circulating monocyte-platelet aggregates (MPA). Approximately 25 psoriasis patients with the AM-endotype will be followed during treatment over 16 weeks with 4 monthly individual blood draws will be enrolled. 10 untreated healthy controls will also be enrolled and will provide two blood draws (baseline and 16 weeks). These are needed to maintain quality control of the normal levels of the biomarkers being tested. All treated psoriasis subjects will receive apremilast through Week 16
Phase:
Phase 2
Details
Lead Sponsor:
University Hospitals Cleveland Medical Center
Treatments:
Apremilast
Thalidomide