NCT05119140Active, not recruitingPhase 1/2
Administration of Hydroxychloroquine (Plaquenil) to African Americans and Hispanics for the Treatment of Mild to Severe Ulcerative Colitis
Source: ClinicalTrials.gov · Last updated 11 Feb 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 3 (actual)
- First submitted
- 20 Oct 2021
- Start date
- 10 Jun 2022
- Primary completion date
- May 2025
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Diseases
- Ulcerative colitis
- NCT number
- NCT05119140
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 3
- From 10 Jun 2022 to the primary completion date, May 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current use of biologics, steroids or other UC medications not including mesalamine.
- Treatment with another investigational drug or other intervention within 4 weeks.
Other illness
- Presence of hepatic or renal insufficiency
- Known allergic reactions to components of the Hydroxychloroquine, Chloroquine or quinine products.
- Any pre-existing macular disease or cardiac disease.
Other
- Pregnancy or lactation
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Emory University School of Medicine Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Icahn School of Medicine at Mount Sinai, Mount Sinai Hospital Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.