RecruitingPhase 2

A Study of Quinacrine in Participants With Cutaneous Lupus Erythematosus

A Randomized, Double-blind, Placebo-controlled Study of Quinacrine (QC) in Participants With Active Cutaneous Lupus Erythematosus (CLE), Including Subacute CLE (SCLE) and/or Discoid LE (DLE), With or Without Concurrent Systemic Manifestations

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 28 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participation will last for about 28 weeks in total."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how safe quinacrine is and how well it treats cutaneous lupus, a disease in which the body's immune system attacks the skin. It is for adults with certain types of skin lupus that have not improved with usual treatment or who could not tolerate that treatment. The study lasts about 28 weeks, and some people will get a placebo—a pill with no active medicine—for the first 12 weeks.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 or older.
  • You can give written consent and follow the study schedule, including taking study medicine at home or outside the clinic.
  • You have subacute cutaneous lupus (SCLE) or discoid lupus (DLE), two types of skin lupus. A skin sample must confirm this, either before or during screening.
  • Your skin lupus is active, with a skin disease score called CLASI-A of at least 8 at screening and when you are assigned to a study group.
  • Your skin lupus has not improved after at least 12 weeks of steroid skin treatments and hydroxychloroquine (HCQ), or you had to stop these medicines because of side effects.
  • If you take HCQ at screening, you must keep taking the same dose through the study.

Who can't join

  • You have a health problem or abnormal test result that the study doctor thinks could prevent you from taking part, or another skin disease that could affect study ratings.
  • You had at least 500 mL of blood removed in the past 30 days, a blood transfusion in the past 60 days, or donated plasma in the past 7 days.
  • You recently joined another study testing a medicine. The waiting time is at least 30 days and may be longer depending on how long that medicine stays in your body.
  • You take primaquine or certain medicines affected by liver enzymes called CYP2D6 or CYP3A4/5. The study team must check your medicines.
  • You have high liver blood test results, a kidney filtering score below 45, or very low G6PD, an enzyme that helps protect red blood cells. Some people with Gilbert syndrome may qualify despite a high bilirubin result.
  • You had a heart attack, stroke, or procedure to restore blood flow in the past 6 months, or a heart test shows a longer-than-allowed pause in the heart's electrical cycle.
  • You recently had a serious infection, an infection needing medicine, or surgery other than a minor procedure. You have active kidney inflammation or lupus affecting the brain or mental health.
  • You recently started or changed certain lupus treatments, or recently used strong steroid skin treatments, steroid shots into skin sores, or certain medicines that block immune signals. Required waiting times range from 7 days to 3 months, depending on the treatment.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. ≥ 18 years of age at the time of signing the informed consent form. 2. 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. 3. 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. All participants must also have active skin manifestations that fulfill the following: 4. CLASI-A ≥8 at Screening and randomization 5. Must have active CLE despite an adequate trial of conventional therapies (defined topical corticosteroids and HCQ used for at least 12 weeks prior to Screening) OR previously documented failure to respond to these agents when used for at least 12 weeks OR the requirement to discontinue these agents due to side effects or poor tolerability. 6. If patients are using HCQ during screening, the same dose should be continued until the end of the study. Exclusion Criteria: 1. 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. 2. Have undergone phlebotomy with removal of ≥ 500 mL of blood within 30 days prior to the Screening Visit. 3. Have received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to the Screening Visit. 4. 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. 5. Subjects receiving treatment with primaquine or any concomitant medication that is a substrate of CYP2D6 at screening or during the study. 6. Subjects receiving concomitant medications that are classified as moderate or strong inhibitors of CYP3A4/5 at screening or during the study. 7. Have any of the following laboratory abnormalities at the Screening Visit (as per the central laboratory) 1. Aspartate aminotransferase (AST) ≥ 1.5 x\~ upper limit of normal (ULN). 2. Alanine aminotransferase (ALT) ≥ 1.5 x\~ ULN. 3. Total bilirubin ≥ 1.5 ULN. Note: A participant with elevated fasting unconjugated serum bilirubin with documented Gilbert syndrome may be enrolled at the Investigator's discretion. 8. Subjects with eGFR \< 45 at the time of screening.. 9. Subjects with G6PD deficiency defined as \<30% of normal enzyme activity at the time of screening. 10. Have had a cardiovascular event (e.g., acute myocardial infarction, stroke) or revascularization procedure (e.g., percutaneous coronary intervention, coronary artery bypass graft) within 6 months of the Screening Visit. 11. Have evidence of prolonged QT (QTcF \> 450 msec for males and \> 470 msec for females) on electrocardiogram (ECG) at the Screening Visit. 12. Have a recent serious infection requiring injectable antimicrobial therapy or hospitalization within the 4 weeks prior to Screening Visit or any ongoing febrile illness or infection requiring oral antimicrobial therapy within 1 week of the Screening Visit. 13. Have had any surgical procedure (except for minor procedures) within 4 weeks prior to the Screening Visit. 14. Have known active nephritis or neuropsychiatric SLE. 15. Have current inflammatory skin disease other than SCLE/DLE that, in the opinion of the Investigator, could interfere with the inflammatory skin assessments or confound the disease activity assessments. 16. Use of immunosuppressive or disease-modifying treatments for SLE that were initiated less than 3 months prior to Screening, have not been at a stable dose for at least 1 month prior to Screening. 17. Have received/used any of the following prior medications or undergone any of the following therapeutic procedures: 1. Use of high-potency topical corticosteroid and/or topical agents (immunosuppressant) for skin lesions within 7 days prior to randomization. 2. Use of high-potency intralesional corticosteroid within 4 weeks prior to randomization. 3. JAK or TYK2 inhibitors within 1 month before the visit 1. 4. IFN1/IFN1R inhibitors within 3 months before the Screening visit.

Study sites (1)

PA