Cutaneous Lupus Erythematosus study: Quinacrine Hydrochloride
Official title A Study of Quinacrine in Participants With Cutaneous Lupus Erythematosus
ClinicalTrials.gov ID: NCT07694336
What this study is testing
What is Quinacrine Hydrochloride?
An investigational oral medication being studied for cutaneous lupus erythematosus (CLE).
Also referred to as Quinacrine.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see how safe and effective quinacrine is for treating CLE and how it works in the body.
- Who it's for
- Adults with cutaneous lupus erythematosus (CLE).
- What's involved
- Participants will take either quinacrine or a placebo for the first 12 weeks, then all will receive quinacrine for the next 12 weeks. They will have regular visits and tests to monitor skin symptoms and safety.
- Time commitment
- The study lasts about 28 weeks, with visits and tests scheduled throughout that period.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 28 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- ≥ 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...
- CLASI-A ≥8 at Screening and randomization
- Must have active CLE despite an adequate trial of conventional therapies (defined topical corticosteroids and HCQ used for at least 12 weeks prior to...
- If patients are using HCQ during screening, the same dose should be continued until the end of the study.
You likely can't join if
- Have any medical condition or laboratory abnormality during the Screening Period that, in the opinion of the Investigator, is clinically significant...
- 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...
- people receiving treatment with primaquine or any concomitant medication that is a substrate of CYP2D6 at screening or during the study.
- people receiving concomitant medications that are classified as moderate or strong inhibitors of CYP3A4/5 at screening or during the study.
See the full eligibility criteria
- ≥ 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...
- CLASI-A ≥8 at Screening and randomization
- 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...
- If patients are using HCQ during screening, the same dose should be continued until the end of the study.
- 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...
- 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.
- people receiving treatment with primaquine or any concomitant medication that is a substrate of CYP2D6 at screening or during the study.
- people receiving concomitant medications that are classified as moderate or strong inhibitors of CYP3A4/5 at screening or during the study.
- Have any of the following laboratory abnormalities at the Screening Visit (as per the central laboratory)
- Aspartate aminotransferase (AST) ≥ 1.5 x\~ upper limit of normal (ULN).
- Alanine aminotransferase (ALT) ≥ 1.5 x\~ ULN.
- 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.
- people with eGFR \< 45 at the time of screening..
- people with G6PD deficiency defined as \<30% of normal enzyme activity at the time of screening.
- 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.
- Have evidence of prolonged QT (QTcF \> 450 msec for males and \> 470 msec for females) on electrocardiogram (ECG) at the Screening Visit.
- 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...
- Have had any surgical procedure (except for minor procedures) within 4 weeks prior to the Screening Visit.
- Have known active nephritis or neuropsychiatric SLE.
- 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.
- 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.
- Use of high-potency topical corticosteroid and/or topical agents (immunosuppressant) for skin lesions within 7 days prior to randomization.
- Use of high-potency intralesional corticosteroid within 4 weeks prior to randomization.
- JAK or TYK2 inhibitors within 1 month before the visit 1.
- IFN1/IFN1R inhibitors within 3 months before the Screening visit.
The study team makes the final eligibility decision.
Where it is enrolling
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 28 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.