Hydroxychloroquine + Mesalamine for Ulcerative Colitis

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Judy H Cho

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Icahn School of Medicine at Mount Sinai

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests hydroxychloroquine with mesalamine for ulcerative colitis. It focuses on patients of non-European ancestry who still have symptoms despite using mesalamine. Hydroxychloroquine may help by controlling the immune system and reducing inflammation. Mesalamine has a well-established role in the management of ulcerative colitis.

Eligibility Criteria

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.

Inclusion Criteria

I am 18 years old or older.

I am currently taking mesalamine.

Only people who are not of European descent can participate.

Exclusion Criteria

I have a heart condition or a disease affecting my eyes.

I am currently using medication for ulcerative colitis, but not mesalamine.

Treatment with another investigational drug or other intervention within 4 weeks.

Participant Groups

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.

Group I: Mesalamine and Hydroxychloroquine Experimental Treatment 2 Interventions

All participants will be on Mesalamine and Hydroxychloroquine

Hydroxychloroquine is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Plaquenil for:

• Malaria
• Rheumatoid Arthritis
• Systemic Lupus Erythematosus

🇪🇺 Approved in European Union as Plaquenil for:

• Malaria
• Rheumatoid Arthritis
• Systemic Lupus Erythematosus

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Icahn School of Medicine at Mount Sinai/Mount Sinai Hospital New York, NY

Emory University School of Medicine Atlanta, GA

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai Lead Sponsor

Crohn's and Colitis Foundation Collaborator

References