Overview

HCQ for Non Europeans With Mild to Severe UC

Status:
Not yet recruiting
Trial end date:
2023-12-29
Target enrollment:
Participant gender:
Summary
The objective of this study is to assess the efficacy of hydroxychloroquine (HCQ) when combined with Mesalamine in reducing clinical and histologic disease activity in patients who have active mild to severe Ulcerative Colitis (UC) and also to assess the immunological effects of hydroxychloroquine in this population. These outcomes will be evaluated both clinically and experimentally. In vitro, flow cytometry will be employed to measure the expression of CTLA-4 on activated CD4+CD25+CD127- Tregs from patients prior to treatment with HCQ, and then at the end of a 4 month follow up period. Suppression assays will be used to determine the functional capacity of the patient derived Tregs. Clinically, patients will be monitored for remission as defined by reduction in patient reported stool frequency and rectal bleeding (mayo sub-score 0 or 1) and endoscopically, by improvement in mucosal appearance (mayo sub-score 0 or 1), all objective measures in the mayo score.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborator:
Crohn's and Colitis Foundation
Treatments:
Hydroxychloroquine
Mesalamine