Your session is about to expire
← Back to Search
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 belowSelect...
I am currently taking mesalamine.
Select...
I have been diagnosed with active Ulcerative Colitis, confirmed by a recent endoscopy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 4 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 4 months
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 • NCT0205725013%
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%
Lumbar spinal stenosis
1%
Arthralgia
1%
Anaemia
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
871 Previous Clinical Trials
527,231 Total Patients Enrolled
7 Trials studying Ulcerative Colitis
1,957 Patients Enrolled for Ulcerative Colitis
Crohn's and Colitis FoundationOTHER
43 Previous Clinical Trials
27,877 Total Patients Enrolled
17 Trials studying Ulcerative Colitis
12,727 Patients Enrolled for Ulcerative Colitis
Judy H Cho, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I have a heart condition or a disease affecting my eyes.I am currently using medication for ulcerative colitis, but not mesalamine.I have liver or kidney problems.I am currently taking mesalamine.Only people who are not of European descent can participate.I have been diagnosed with active Ulcerative Colitis, confirmed by a recent endoscopy.You have had allergic reactions to the ingredients found in hydroxychloroquine, chloroquine, or quinine products.
Research Study Groups:
This trial has the following groups:- Group 1: Mesalamine and Hydroxychloroquine
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Ulcerative Colitis Patient Testimony for trial: Trial Name: NCT05119140 — Phase 1 & 2
Share this study with friends
Copy Link
Messenger