A Phase 1/2 interventional study of Hydroxychloroquine and Mesalamine in Ulcerative Colitis (Disorder), sponsored by Icahn School of Medicine at Mount Sinai. Active, not recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-11.
Sponsored by Icahn School of Medicine at Mount Sinai · Phase 1/2, Interventional, and Basic science
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.
This is a single arm study to evaluate the efficacy and immunological effect of administering Hydroxychloroquine to patients of non-European ancestry who have active mild to severe Ulcerative Colitis in spite of Mesalamine therapy. 10 Participants will be recruited in Icahn School of Medicine at Mount Sinai and 10 in Emory University (20 across all sites).
Participants 18 years and above who identify as an individual of non-European ancestry with a diagnosis of Ulcerative Colitis will be approached for the study. Participants will be recruited from Mount Sinai IBD center prior to their standard of care endoscopy. Participants who meet the study's inclusion criteria i.e. If they currently have active disease, they will be able to receive the research medication.
Participants will be administered 400mg hydroxychloroquine tablets orally for four months in addition to Mesalamine. Pre and post medication clinical, endoscopic and immunological assessments will be compared. Participants will also be followed up with bi-monthly phone calls. Participants will have a post medication colonoscopy at the end of the 4 month period.
There is a risk of retinopathy and cardiomyopathy associated with long term use of the study drug at doses greater than 6.5mg/kg for more than 5 years. Participants will be screened for existing eye and heart disease and monitored pre and post medication for any new adverse effects.
1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.
This study's enrollment of 3 is below the median of 60 across 771 interventional studies indexed under Colitis.
Browse Colitis studies →Icahn School of Medicine at Mount Sinai is the lead sponsor of 764 studies on the registry; 181 are open to participants now.
Of its 121 completed or terminated interventional studies of FDA-regulated products, 82 (68%) have results posted.
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Exclusion Criteria
All participants will be on Mesalamine and Hydroxychloroquine
Drug: Hydroxychloroquine · Drug: Mesalamine
400mg of hydroxychloroquine per oral daily
the participant will maintain their current standard of care dose which can range from 1.5g to 4.8g of mesalamine per oral daily
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.
Time frame: baseline and 4 months
Change in Endoscopy Mayo Score
Endoscopic remission will be measured using the mayo score which ranges from 0-3 with 0 meaning remission and 3 indication severe disease. Premedication endoscopy mayo score will be compared to end of study mayo score (at 4 months)
Time frame: baseline and 4 months
Change in Partial Mayo Score
Change in patient reported symptoms for stool frequency and rectal bleeding are objective measures in the partial mayo score which ranges from 0-3 for both parameters. A score of zero indicates remission and a score on 3 indicates severe disease. Pre-medication partial mayo scores will be compared to end of study partial mayo scores (at 4 months)
Time frame: baseline and 4 months
Plan to share: Yes — Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Supporting information: Sap
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Icahn School of Medicine at Mount Sinai