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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
24
Quinacrine Hydrochloride 100mg Daily
Matched Placebo
Hospital of the University of Pennsylvania, Department of Dermatology
Philadelphia, Pennsylvania, United States
RECRUITINGChange in Cutaneous Lupus Erythematosus Disease Area and Severity Index - Activity (CLASI-A) score
Differences in the change in score from baseline to Week 12 between the Quinacrine arm versus placebo arm. Scores range from 0 to 70 with higher scores representing more severe, active disease.
Time frame: 12 weeks
Binary responder endpoints based on Cutaneous Lupus Erythematosus Disease Area and Severity Index - Activity (CLASI-A) improvement
1. ≥4 point reduction 2. ≥50% reduction 3. ≥70% reduction
Time frame: 24 Weeks
Low Cutaneous Lupus Activity - Investigator's Global Assessment (CLA-IGA) scores
Low activity defined as scores of 0-1 on a scale of 0 (Clear) to 4 (Severe Activity)
Time frame: 24 weeks
Change From Baseline in Cutaneous Lupus Erythematosus-Quality of Life (CLE-QoL) Score
Scores range from 0-100 where lower scores indicate a poorer quality of life
Time frame: 24 Weeks
Change From Baseline in Physician Global Assessment (PGA) Score
Scores range from 0 (Clear / no signs of disease) to 5 (Very severe disease activity)
Time frame: 24 Weeks
Change From Baseline in Patient Global Assessment (PtGA) Score
Scores range from 0 (Clear / no signs of disease) to 5 (Very severe disease activity)
Time frame: 24 Weeks
Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank 2.0 - Cognitive Function - Short Form 8a
Standardized measure of cognitive functioning where scores range from 0 - 100. Scores lower than 50 represent impairment, while scores above 50 represent better than average functioning.
Time frame: 24 Weeks
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