HCQ for Non Europeans With Mild to Severe UC

• Status: Not yet recruiting
• Trial end date: 2023-12-29
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborator: Crohn's and Colitis Foundation
• Treatments: Hydroxychloroquine; Mesalamine

Criteria

Inclusion Criteria:

• Clinical diagnosis of mild to severe active Ulcerative Colitis (confirmed by endoscopy at screening),

• Currently taking mesalamine,

• Be an individual of non-European ancestry.

• Adult 18 years and older

Exclusion Criteria

• Current use of biologics, steroids or other UC medications not including mesalamine.

• Presence of hepatic or renal insufficiency

• Pregnancy or lactation

• Known allergic reactions to components of the Hydroxychloroquine, Chloroquine or quinine products.

• Any pre-existing macular disease or cardiac disease.

• Treatment with another investigational drug or other intervention within 4 weeks.