A Study of Quinacrine in Participants With Cutaneous Lupus Erythematosus

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Victoria Werth
Study ID
NCT07694336
Phase
PHASE2
Status
Recruiting
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Conditions

  • Cutaneous Lupus Erythematosus (CLE)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Quinacrine Hydrochloride — DRUG
    Quinacrine Hydrochloride 100mg Daily
  • Placebo — OTHER
    Matched Placebo

Study Details

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.

Key Dates

First listed
Jul 9, 2026
Start date
Jun 30, 2026
Status verified
Aug 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Quinacrine (Experimental)
    Quinacrine 100mg Daily for 12 Weeks
  • Placebo Comparator: Placebo
    Placebo daily for 12 weeks
  • Experimental: Open Label Extension
    Quinacrine 100 mg daily for 12 weeks

Primary Outcome Measure

Change in Cutaneous Lupus Erythematosus Disease Area and Severity Index - Activity (CLASI-A) score [ Time Frame: 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Hospital of the University of Pennsylvania, Department of DermatologyPhiladelphiaPennsylvania19104
Victoria P Werth, MD
[email protected]
215-615-2940
Robert Haskins
[email protected]
215-615-2940

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By research site
Hospital of the University of Pennsylvania, Department of Dermatology· Philadelphia, PA

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