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Anti-malarial drug

Hydroxychloroquine + Mesalamine for Ulcerative Colitis

Phase 1 & 2
Waitlist Available
Led By Judy H Cho, MD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Currently taking mesalamine
Clinical diagnosis of mild to severe active Ulcerative Colitis (confirmed by endoscopy at screening)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 4 months
Awards & highlights

Study Summary

This trial is testing whether Hydroxychloroquine, when combined with Mesalamine, is effective in reducing clinical and histologic disease activity in patients with active mild to severe Ulcerative Colitis. The trial will also assess the immunological effects of hydroxychloroquine in this population.

Who is the study for?
This trial is for African American and Hispanic adults with mild to severe active Ulcerative Colitis, confirmed by endoscopy. Participants must be taking mesalamine but not biologics, steroids or other UC medications. They should not have liver or kidney issues, be pregnant or breastfeeding, have a history of allergic reactions to Hydroxychloroquine-related compounds, macular disease or cardiac disease.Check my eligibility
What is being tested?
The study tests the effectiveness of Hydroxychloroquine combined with Mesalamine in reducing symptoms and inflammation in Ulcerative Colitis patients. It also examines how this combination affects immune cells (Tregs) using lab techniques like flow cytometry and suppression assays over a 4-month period.See study design
What are the potential side effects?
Potential side effects may include vision problems due to retinal damage, muscle weakness, headaches, ringing in ears, nausea or stomach cramps. There's also a risk of heart problems and changes in blood cell counts which can lead to increased infection susceptibility.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am currently taking mesalamine.
Select...
I have been diagnosed with active Ulcerative Colitis, confirmed by a recent endoscopy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 4 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 4 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in surface CTLA4 expression
Secondary outcome measures
Endoscopy (procedure)
Change in Partial Mayo Score

Side effects data

From 2016 Phase 3 trial • 217 Patients • NCT02057250
13%
Upper respiratory tract infection
6%
Neutropenia
6%
Sinusitis
5%
Alanine aminotransferase increased
5%
Urinary tract infection
4%
Injection site erythema
4%
Accidental overdose
4%
Bronchitis
3%
Injection site pruritus
2%
Thrombocytopenia
2%
Nasopharyngitis
2%
Contusion
1%
Arthralgia
1%
Anaemia
1%
Lumbar spinal stenosis
1%
Leukopenia
1%
Coronary artery occlusion
1%
Wolff-Parkinson-White syndrome
1%
Transient ischaemic attack
1%
Vertebrobasilar insufficiency
1%
Chronic obstructive pulmonary disease
1%
Small intestinal obstruction
1%
Nephrolithiasis
1%
Cataract
1%
Thrombophlebitis superficial
1%
Vomiting
1%
Endometrial hyperplasia
1%
Traumatic arthritis
1%
Hypertension
1%
Pneumonia
1%
Pancreatic carcinoma metastatic
1%
Osteoarthritis
1%
Rheumatoid lung
1%
Pharyngitis
1%
Femoral neck fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sarilumab 150 mg by PFS (Extension Phase)
Sarilumab 150 mg by AID (AID Assessment Phase)
Sarilumab 150 mg by PFS (AID Assessment Phase)
Sarilumab 200 mg by PFS (AID Assessment Phase)
Sarilumab 200 mg by AID (AID Assessment Phase)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Mesalamine and HydroxychloroquineExperimental Treatment2 Interventions
All participants will be on Mesalamine and Hydroxychloroquine
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hydroxychloroquine
2017
Completed Phase 4
~5360
Mesalamine
2016
Completed Phase 4
~2010

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
858 Previous Clinical Trials
524,266 Total Patients Enrolled
7 Trials studying Ulcerative Colitis
1,957 Patients Enrolled for Ulcerative Colitis
Crohn's and Colitis FoundationOTHER
43 Previous Clinical Trials
28,105 Total Patients Enrolled
17 Trials studying Ulcerative Colitis
12,955 Patients Enrolled for Ulcerative Colitis
Judy H Cho, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai

Media Library

Hydroxychloroquine (Anti-malarial drug) Clinical Trial Eligibility Overview. Trial Name: NCT05119140 — Phase 1 & 2
Ulcerative Colitis Research Study Groups: Mesalamine and Hydroxychloroquine
Ulcerative Colitis Clinical Trial 2023: Hydroxychloroquine Highlights & Side Effects. Trial Name: NCT05119140 — Phase 1 & 2
Hydroxychloroquine (Anti-malarial drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05119140 — Phase 1 & 2
Ulcerative Colitis Patient Testimony for trial: Trial Name: NCT05119140 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any other research papers which explore Hydroxychloroquine's effects?

"First researched in 2007 at the University of Nebraska Medical Center, hydroxychloroquine has since been studied 223 times. At this moment, there are 75 ongoing trials for the medication; many of which are based in Atlanta, Georgia."

Answered by AI

How many individuals are being given this opportunity to participate in this clinical trial?

"That is correct, the listing on clinicaltrials.gov does show that this trial is recruiting patients. This specific study was first posted on June 10th, 2022 and was last updated less than a month ago on September 26th, 2022. The team conducting the trial is looking for 20 individuals total from 2 different locations."

Answered by AI

What are the standard therapeutic uses for Hydroxychloroquine?

"Hydroxychloroquine is an effective treatment against malaria, but can also help patients who are struggling with q fever, rheumatoid arthritis, and ulcerative colitis."

Answered by AI

Are people with the specified condition still being recruited for this research project?

"That is correct. The clinicaltrials.gov website has the latest information on this trial, which showed that it was posted on 6/10/2022 and last edited 9/26/2022. Currently, they are looking for 20 patients from 2 different sites."

Answered by AI

Who else is applying?

What state do they live in?
Nebraska
Virginia
Other
New York
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Icahn School of Medicine at Mount Sinai/Mount Sinai Hospital
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I've been on lialda, asacol oral and mesalamine enemas and mesalamine suppositories. Not much luck with mesalamines. Now getting entyvio infusions every 4 weeks. It's helping some. Hydroxychloroquine, 200 mg twice a day seems to work better.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Administration of Hydroxychloroquine (Plaquenil) to African Americans and Hispanics for the Treatment of Mild to Severe Ulcerative Colitis
Judy Cho 2022. "Administration of Hydroxychloroquine (Plaquenil) to African Americans and Hispanics for the Treatment of Mild to Severe Ulcerative Colitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05119140.
All > Ulcerative Colitis > Colitis
~9 spots leftby Dec 2025
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