Administration of Hydroxychloroquine (Plaquenil) to African Americans and Hispanics for the Treatment of Mild to Severe Ulcerative Colitis

NCT05119140 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: GCO 20-0187
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Ulcerative Colitis (Disorder)

Keywords

Ulcerative Colitis; Plaquenil; Hydroxychloroquine; CTLA-4; Inflammatory Bowel Disease; Non European Ancestry

Outcome Measures

Primary Outcomes (1)

• Change in surface CTLA4 expression

  Flow cytometry will be used to measure the expression of CTLA-4 on activated CD4+CD25+CD127- Tregs from patients prior to treatment with Hydroxychloroquine, and then at the end of a 4 month follow up period.

  baseline and 4 months

Secondary Outcomes (2)

• Change in Endoscopy Mayo Score

  baseline and 4 months

• Change in Partial Mayo Score

  baseline and 4 months

Study Arms (1)

Mesalamine and Hydroxychloroquine

EXPERIMENTAL

All participants will be on Mesalamine and Hydroxychloroquine

Drug: Hydroxychloroquine; Drug: Mesalamine

Interventions

Hydroxychloroquine DRUG

400mg of hydroxychloroquine per oral daily

Mesalamine and Hydroxychloroquine

Mesalamine DRUG

the participant will maintain their current standard of care dose which can range from 1.5g to 4.8g of mesalamine per oral daily

Mesalamine and Hydroxychloroquine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Crohn's and Colitis Foundation: collaborator

Study Sites (2)

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

Location

Icahn School of Medicine at Mount Sinai/Mount Sinai Hospital

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Colitis, Ulcerative; Diabetes Mellitus, Insulin-Dependent, 12; Inflammatory Bowel Diseases

Interventions

Hydroxychloroquine; Mesalamine

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; meta-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Aminosalicylic Acids; Salicylates; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols

Study Officials

• Judy H Cho, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Subra Kugathasan, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: The gastroenterologist who will review pre- and post-intervention endoscopy and pathology reports will be masked to any and all information about the study participants including disease severity and medication.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean of Translational Genetics, Director, The Charles Bronfman Institute for Personalized Medicine

Model Details: This is an Open Label study with blinded scorer for endoscopy and pathology reports.

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: November 12, 2021
• Study Start: June 10, 2022
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: February 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. To achieve aims in the approved proposal. Investigators should contact study team.

Locations

US (2)