What is quinacrine studying for cutaneous lupus erythematosus?

Quinacrine is being studied to see how well it works and how safe it is for treating cutaneous lupus erythematosus, a skin condition caused by the immune system attacking the skin. Researchers want to understand if quinacrine can improve skin symptoms and become a standard treatment option. The study is led by Victoria Werth.

Who may be eligible for this cutaneous lupus erythematosus clinical trial?

Adults aged 18 years or older with a confirmed diagnosis of subacute or discoid cutaneous lupus erythematosus may be eligible. Participants should have active skin symptoms despite prior treatment with hydroxychloroquine or topical corticosteroids. Both males and females can participate. Please review eligibility criteria for more details.

Is there any cost to participate in this cutaneous lupus erythematosus clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel and other expenses may vary and are not guaranteed to be covered during the trial.

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

ID07694336

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of Quinacrine in Adults With Active Cutaneous Lupus Erythematosus Including Subacute and Discoid Types

Led by Victoria Werth · Updated on 2026-08-12

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying how patients with cutaneous lupus erythematosus CLE respond to quinacrine, a medication originally used to treat malaria that might help improve skin symptoms in CLE. This randomized, double-blind, placebo-controlled trial aims to carefully evaluate the safety, effectiveness, and how quinacrine works in the body to better understand if it could become a standard treatment for CLE. Participants will be randomly assigned to receive either quinacrine 100 mg daily or a placebo for the first 12 weeks, with a 11 chance of being in either group. After this period, all participants will receive quinacrine for an additional 16 weeks, making the total treatment duration 28 weeks. The placebo looks like the study drug but contains no active medication, and neither participants nor the study team will know group assignments during the first 12 weeks. Throughout the study, participants will be assessed for changes in their skin condition using the Cutaneous Lupus Erythematosus Disease Area and Severity Index - Activity CLASI-A score at 12 weeks and other skin-related and quality of life measures up to 24 weeks. Safety, effectiveness, and patient-reported outcomes will be monitored during regular visits. Participation lasts about 28 weeks in total.

CONDITIONS

Brief Title

A Study of Quinacrine in Participants With Cutaneous Lupus Erythematosus

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

18 years of age or older at consent
Willing and able to provide written informed consent and follow study procedures
Diagnosed with subacute cutaneous lupus erythematosus (SCLE) or discoid lupus erythematosus (DLE) confirmed by biopsy
Active skin symptoms with a CLASI-A score of 8 or higher at screening and randomization
Active CLE despite at least 12 weeks of treatment with topical corticosteroids and hydroxychloroquine (HCQ), or previous failure or intolerance to these treatments
If using HCQ at screening, must continue the same dose through the study

You will not qualify if you...

Any medical condition or lab abnormality that could interfere with study participation
Blood removal of 500 mL or more within 30 days before screening
Blood transfusion within 60 days or plasma donation within 7 days before screening
Participation in another investigational study within 30 days or 5 half-lives before screening
Use of primaquine or medications that interact with CYP2D6 or moderate/strong CYP3A4/5 inhibitors
Elevated liver enzymes (AST or ALT) or bilirubin above 1.5 times normal, except Gilbert syndrome with approval
Estimated glomerular filtration rate (eGFR) below 45 at screening
G6PD deficiency with less than 30% normal enzyme activity
Cardiovascular events or revascularization procedures within 6 months before screening
Prolonged QT interval on ECG above specified limits
Recent serious infection or ongoing infection requiring antimicrobials
Surgical procedures within 4 weeks before screening except minor ones
Active nephritis or neuropsychiatric lupus
Other inflammatory skin diseases that may affect assessments
Use of immunosuppressive or disease-modifying treatments for SLE started less than 3 months before screening or unstable doses
Recent use of high-potency topical or intralesional corticosteroids within specified timeframes
Recent use of JAK, TYK2, or IFN1/IFN1R inhibitors within specified periods

Research Team

Victoria P Werth, MD

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A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of Quinacrine in Adults With Active Cutaneous Lupus Erythematosus Including Subacute and Discoid Types

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria