Hydroxychloroquine for Lupus (SMILE Trial)

Phase 2

Waitlist Available

Led By Nancy J Olsen, MD

Research Sponsored by Milton S. Hershey Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Between 15 and 49 years of age, inclusive, at Visit 1

Be younger than 65 years old

Must not have

The subject has previously been or is currently being treated with oral antimalarial agents including hydroxychloroquine, chloroquine, or quinacrine

Co-morbidities requiring systemic corticosteroid therapy greater than 10 mg of prednisone per day, or equivalent, or a change in corticosteroid dose within the 3 months prior to Visit 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured after screening and prior to baseline and within 4 weeks after study completion

Summary

This trial is testing whether the drug hydroxychloroquine can prevent lupus in people at risk for the disease. Effects on the disease, patient symptoms, and changes in the immune system will be measured.

Who is the study for?

This trial is for individuals aged 15-49 with a risk of developing lupus, evidenced by certain immune system markers. They must have some but not all symptoms of lupus and cannot have been treated with immunosuppressants or antimalarials before. People with other autoimmune diseases (except thyroid conditions), significant eye disease, liver problems, psoriasis, porphyria, infections like HIV or hepatitis B/C, cancer (with exceptions), or those pregnant/breastfeeding are excluded.

What is being tested?

The study tests if Hydroxychloroquine can prevent the progression of lupus in at-risk patients compared to a placebo. It's randomized and double-blind meaning neither participants nor researchers know who gets the real medicine versus the placebo. The trial will measure symptom progression, patient-reported outcomes and changes in immune response markers.

What are the potential side effects?

Potential side effects include vision problems due to eye toxicity, digestive issues such as stomach pain or nausea, skin reactions like rashes, headaches and dizziness. Rarely it may cause mood changes or muscle weakness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 15 and 49 years old.

Exclusion Criteria

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

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I have taken or am taking antimalarial drugs like hydroxychloroquine.

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I take more than 10 mg of prednisone daily or changed my dose in the last 3 months.

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I do not have any ongoing serious infections.

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I have been diagnosed with fibromyalgia by a doctor.

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I have an autoimmune disorder that is not related to the thyroid.

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I am currently taking or have taken drugs that affect my immune system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured after screening and prior to baseline and within 4 weeks after study completion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured after screening and prior to baseline and within 4 weeks after study completion

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured after screening and prior to baseline and within 4 weeks after study completion for reporting.