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A Study of Quinacrine in Participants With Cutaneous Lupus Erythematosus

NCT07694336 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-08-12

No results posted yet for this study

Summary

The research study is being conducted to learn more about how patients with cutaneous lupus erythematosus (CLE) respond to the use of quinacrine. Quinacrine is a medication that was originally developed and used starting in the 1930's to treat malaria. It has been used for decades to help reduce inflammation in the body. Doctors have observed that quinacrine may also help improve skin symptoms in patients with CLE, a condition in which the immune system mistakenly attacks the skin, causing rashes, sores, and other skin problems. Although some doctors have prescribed quinacrine for CLE based on these observations, it has not yet been formally approved by the U.S. Food and Drug Administration (FDA) for this use. The purpose of this clinical trial is to carefully study how safe and effective quinacrine is for treating CLE, as well as how it works in the body. This can help researchers better understand whether it should become a standard treatment option.

Participation will last for about 28 weeks in total. This study is a randomized, double-blind, placebo-controlled study. "Placebo-controlled" means that participants may receive quinacrine or participants may receive a placebo for the first 12 weeks of the study. A placebo looks like the study drug but contains no active medication. It is used to help find out if the results of the study are due to the study drug or due to something else.

Randomized means participants will be put into the study drug group or the placebo group by chance. Participants have a 1:1 chance of receiving the study drug. This means for every 2 people in the study, 1 will receive the study drug and 1 will receive the placebo. Double-blind means that neither participants nor the study team will know which study group participants have been put in. For the next 12 weeks of the study (Week 12-Week 28), all participants will receive the study drug.

Conditions

  • Cutaneous Lupus Erythematosus (CLE)

Interventions

DRUG

Quinacrine Hydrochloride

Quinacrine Hydrochloride 100mg Daily

OTHER

Placebo

Matched Placebo

Sponsors & Collaborators

  • Victoria Werth

    lead OTHER

Principal Investigators

  • Victoria P Werth, MD · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2028-06-30
Completion
2028-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07694336 on ClinicalTrials.gov