A Study of Quinacrine in Participants With Cutaneous Lupus Erythematosus
ConditionCutaneous Lupus Erythematosus (CLE)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorVictoria Werth
About this trial
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.
Eligibility criteria
Qualifiers
≥ 18 years of age at the time of signing the informed consent form.
Willing and capable of giving written informed consent, which includes being able to comply with all aspects of the study treatment and assessments schedule, including the ability to receive or self-administer study treatment at home or outside of the study site clinic.
Must have diagnosis of SCLE or DLE that has been histologically confirmed (in the past or at Screening), with or without systemic LE manifestations. For participants without historical biopsy data, a skin biopsy must be performed at Screening to confirm CLE diagnosis prior to randomization.
CLASI-A ≥8 at Screening and randomization
Disqualifiers
Have any medical condition or laboratory abnormality during the Screening Period that, in the opinion of the Investigator, is clinically significant and could interfere with the participant's ability to be included in the study.
Have undergone phlebotomy with removal of ≥ 500 mL of blood within 30 days prior to the Screening Visit.
Have received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to the Screening Visit.
Have participated in any other study involving an investigational product within the last 30 days or 5 half-lives, whichever is greater, prior to the Screening Visit.
Trial design
Treatments tested in this trial
- Quinacrine Hydrochloride
- Placebo
Treatment groups
24 Participants
are divided into 3 treatment groupsSponsors and collaborators
Victoria Werth
Lead sponsor
University of Pennsylvania
Sponsor institution
Source ClinicalTrials.gov