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NCT05119140 · ClinicalTrials.gov registry record · Phase 1
Administration of Hydroxychloroquine (Plaquenil) to African Americans and Hispanics for the Treatment of Mild to Severe Ulcerative Colitis
A Phase 1 study of Ulcerative Colitis (Disorder), sponsored by Icahn School of Medicine at Mount Sinai.
- Active
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
- 2
- Study locations
NCT05119140: Active Phase 1 study of Ulcerative Colitis (Disorder), sponsored by Icahn School of Medicine at Mount Sinai.
NCT05119140 is a Phase 1 study of Ulcerative Colitis (Disorder) that is active but no longer recruiting, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 3 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05119140, a Phase 1 study of Ulcerative Colitis (Disorder), is active but no longer recruiting, sponsored by Icahn School of Medicine at Mount Sinai.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Hydroxychloroquine
- DRUG Mesalamine
Study Locations (2)
Georgia
- Emory University School of Medicine - Atlanta
New York
- Icahn School of Medicine at Mount Sinai/Mount Sinai Hospital - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2022-06-10 |
| Est. Completion | 2025-05 |
| Phase | Phase 1 |
What the registry record for NCT05119140 still lists
NCT05119140 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Ulcerative Colitis (Disorder) appearing as the primary indexed condition, and to 2 interventions - of which Hydroxychloroquine is the first listed.
NCT05119140 reports a single indexed study location in Georgia, New York.
Frequently Asked Questions
What is clinical trial NCT05119140 about?
NCT05119140 is a clinical study titled "Administration of Hydroxychloroquine (Plaquenil) to African Americans and Hispanics for the Treatment of Mild to Severe Ulcerative Colitis". 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 i...
What is the current status of trial NCT05119140?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2022-06-10. Estimated completion is 2025-05.
What conditions does trial NCT05119140 study?
This clinical trial studies the following conditions: Ulcerative Colitis (Disorder).
What interventions are being tested in trial NCT05119140?
The interventions under investigation include: Hydroxychloroquine (DRUG), Mesalamine (DRUG).
Who is sponsoring clinical trial NCT05119140?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05119140 being conducted?
This trial has 2 study locations across Georgia, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05119140's enrollment target sits among peer trials
3 1999th of 2000 higher than 1 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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