What side effects are associated with this type of intervention?

Common treatments for Ulcerative Colitis include Mesalamine, Hydroxychloroquine (HCQ), glucocorticoids, and biologics. Mesalamine can cause side effects such as nausea, headache, fever, rash, pancreatitis, and pneumonitis. HCQ, used for its immunomodulatory effects, may lead to gastrointestinal disturbances, skin rashes, and, rarely, retinal toxicity. Glucocorticoids, often used for short-term relief, can result in weight gain, hypertension, diabetes, osteoporosis, and increased infection risk. Biologics, such as anti-TNF agents, may cause injection site reactions, infections, and rare but serious conditions like hepatosplenic T-cell lymphoma.

What prior FDA approvals exist?

The FDA has approved several immunomodulatory drugs for the treatment of Ulcerative Colitis. These include biologics like infliximab, adalimumab, and vedolizumab, which target specific components of the immune system to reduce inflammation. Infliximab and adalimumab are anti-TNF agents, while vedolizumab is an anti-integrin agent. Additionally, immunosuppressive drugs such as azathioprine and 6-mercaptopurine have been approved for maintaining remission in UC. These treatments aim to modulate the immune response, similar to the mechanism being studied with Hydroxychloroquine in the context of CTLA-4 expression on Tregs.

What other types of research exist?

Promising novel alternatives to Hydroxychloroquine for Ulcerative Colitis patients include biologic agents such as Vedolizumab (an integrin inhibitor), Ustekinumab (an IL-12/23 inhibitor), and JAK inhibitors like Tofacitinib. These therapies target specific immune pathways and have shown efficacy in managing UC.

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Anti-malarial drug

Hydroxychloroquine + Mesalamine for Ulcerative Colitis

Phase 1 & 2

Waitlist Available

Led By Subra Kugathasan, 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)

Must not have

Any pre-existing macular disease or cardiac disease

Current use of biologics, steroids or other UC medications not including mesalamine

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 4 months

Awards & highlights

Summary

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.

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.

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.

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

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I am currently taking mesalamine.

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I have been diagnosed with active Ulcerative Colitis, confirmed by a recent endoscopy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I have liver or kidney problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 4 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in surface CTLA4 expression

Secondary study objectives

Endoscopy (procedure)

Change in Partial Mayo Score

Side effects data

From 2016 Phase 3 trial • 217 Patients • NCT02057250

13%

Upper respiratory tract infection

Neutropenia

Sinusitis

Alanine aminotransferase increased

Urinary tract infection

Injection site erythema

Accidental overdose

Bronchitis

Injection site pruritus

Thrombocytopenia

Nasopharyngitis

Contusion

Arthralgia

Wolff-Parkinson-White syndrome

Coronary artery occlusion

Anaemia

Leukopenia

Lumbar spinal stenosis

Transient ischaemic attack

Vertebrobasilar insufficiency

Chronic obstructive pulmonary disease

Small intestinal obstruction

Nephrolithiasis

Cataract

Thrombophlebitis superficial

Vomiting

Endometrial hyperplasia

Traumatic arthritis

Hypertension

Pneumonia

Pancreatic carcinoma metastatic

Osteoarthritis

Rheumatoid lung

Pharyngitis

Femoral neck fracture

100%

80%

60%

40%

20%

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

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Ulcerative Colitis (UC) include immunomodulators like Hydroxychloroquine (HCQ), which increases CTLA-4 expression on regulatory T cells (Tregs) to reduce inflammation, and Mesalamine, which directly reduces inflammation in the colon lining. Biologics such as anti-TNF agents block tumor necrosis factor, a key inflammatory cytokine. These mechanisms are important for UC patients as they help in tailoring treatments to target specific immune pathways involved in their condition, potentially improving efficacy and reducing side effects.