[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"discoid-lupus-erythematosus\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:discoid-lupus-erythematosus":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,39],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100635841","phase-2-a-multicentre-randomised-double-blind-positive-control-clinical-trial-evaluating-dihydroartemisinin-tablets-for-the-treatment-of-discoid-lupus-erythematosus-100635841",false,"NCT07557927","A Multicentre, Randomised, Double-blind, Positive-control Clinical Trial Evaluating Dihydroartemisinin Tablets for the Treatment of Discoid Lupus Erythematosus","Inclusion Criteria:\n\n1. Participants are able to understand the purpose and risks of the study and voluntarily sign an informed consent form;\n2. Aged between 18 and 65 years (inclusive);\n3. Body weight ≥ 45 kg;\n4. Diagnosed with discoid lupus erythematosus (DLE) at the screening visit (refer to the '2021 Guidelines for the Diagnosis, Treatment and Long-term Management of Cutaneous Lupus Erythematosus'); new patients must undergo a skin biopsy and provide a pathology report, whilst existing patients must provide a biopsy pathology report dated within the last 5 years;\n5. At the time of screening, the Cutaneous Lupus Erythematosus Area and Severity Index (CLASI-A) must be ≥4.\n\nExclusion Criteria:\n\n1. Patients with systemic lupus erythematosus (SLE) or those at high risk of developing SLE;\n2. Drug-induced lupus;\n3. Patients with a history of resistance to antimalarial treatment;\n4. At screening, aspartate transaminase (AST) or alanine transaminase (ALT) or gamma-glutamyltransferase (GGT) levels exceeding twice the upper limit of normal (ULN); or alkaline phosphatase (ALP) or total bilirubin levels exceeding 1.5 times the upper limit of normal (ULN); or serum creatinine (Cr) or urea (UREA) levels exceeding 1.5 times the upper limit of normal (ULN);\n5. Patients diagnosed with anaemia within 3 months prior to randomisation, or patients with haemoglobin levels below 110 g\u002FL at screening;\n6. Patients who have used any antimalarial drug (hydroxychloroquine sulphate, chloroquine phosphate or chloroquine) within 4 weeks prior to randomisation;\n7. Patients who have used topical corticosteroids (e.g. mometasone furoate cream or others) or topical calcineurin inhibitors (e.g. tacrolimus ointment or others) within 2 weeks prior to randomisation;\n8. Patients treated with biologics (e.g. adalimumab, secukinumab or others) within 12 weeks prior to randomisation;\n9. Patients treated with immunomodulators (e.g. thalidomide, lenalidomide or others) within 4 weeks prior to randomisation;\n10. Patients who have received live vaccines (e.g. measles vaccine, varicella vaccine or others) within 4 weeks prior to randomisation;\n11. Patients who have used traditional Chinese medicinal preparations with lupus-modulating effects within 4 weeks prior to randomisation, such as Tripterygium preparations (e.g. Tripterygium glycosides), Paeonia lactiflora total glycosides capsules, Zhengqing Fengtongning, or Euphorbia root tablets;\n12. History of malignant tumours within the 5 years prior to screening;\n13. History of acute myocardial infarction, unstable angina, or severe arrhythmias (multifocal frequent premature ventricular contractions, ventricular tachycardia, ventricular fibrillation) within the 6 months prior to screening, or New York Heart Association (NYHA) Class III-IV;\n14. Conditions not effectively controlled at the time of screening or markedly unstable diseases (such as acute pneumonia, pulmonary arterial hypertension, diabetic ketoacidosis, acute pancreatitis, etc.), which, in the investigator's judgement, may confound the study results or expose the participant to undue risk;\n15. Patients with a history of major organ transplantation (e.g., heart, lung, kidney, liver) or haematopoietic stem cell and\u002For bone marrow transplantation within the 5 years prior to screening;\n16. A history of chronic, recurrent (three or more episodes of the same type of infection within 52 weeks) or recent severe infections (e.g. pneumonia, sepsis), including viral infections (particularly varicella and herpes zoster), or requiring anti-infective treatment during the screening period;\n17. Patients who have undergone any major surgery within 6 weeks prior to randomisation, such as abdominal, thoracic or joint replacement surgery, or who are scheduled to undergo major surgery during the study (including follow-up);\n18. Patients for whom the investigator, based on an ophthalmological examination prior to randomisation, considers the findings to be clinically significant and unsuitable for participation in this clinical trial, or who have diseases associated with retinal pathology;\n19. Pregnant or breastfeeding women, or women of childbearing potential who do not agree to use effective contraception during the clinical trial;\n20. Patients with known hypersensitivity to artemisinin-based drugs, hydroxychloroquine or excipients (lactose, microcrystalline cellulose, sodium carboxymethyl starch, sodium dodecyl sulphate, polyvinylpyrrolidone, magnesium stearate);\n21. Any other circumstances, as determined by the investigator, that may interfere with the assessment of efficacy.\n22. Individuals who abuse drugs or alcohol;\n23. Participants who have taken part in any clinical trial within the three months prior to screening (excluding those who underwent safety checks only and did not receive any substantive medication or therapeutic.","ALL","18 Years","65 Years",{"count":19,"type":20},100,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This study is a multicentre, randomised, double-blind, double-dummy, phase II clinical trial with a positive-control group, designed to evaluate the efficacy and safety of dihydroartemisinin tablets in the treatment of discoid lupus erythematosus (DLE).",[26],"Discoid Lupus Erythematosus","NOT_YET_RECRUITING","2026-04-22",{"date":30,"type":31},"2026-04-30","ACTUAL",{"date":30,"type":20},{"date":34,"type":20},"2028-09-30",{"name":36,"class":37},"Kunming Pharmaceuticals, Inc.","INDUSTRY",10,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":46,"targetDuration":4,"studyType":21,"phases":48,"briefSummary":49,"conditions":50,"keywords":51,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":5},"100536145","phase-2-study-to-evaluate-the-efficacy-of-ruxolitinib-15-cream-in-adult-subjects-with-discoid-lupus-erythematosus-100536145","NCT06261021","Study to Evaluate the Efficacy of Ruxolitinib 1.5% Cream in Adult Subjects with Discoid Lupus Erythematosus","A Phase 2, Single-Blind, Intraindividual Study to Evaluate the Efficacy of Ruxolitinib 1.5% Cream in Adult Subjects with Discoid Lupus Erythematosus","Inclusion Criteria:\n\n* Male or female subject 18 years of age or older at the time of consent.\n* Confirmed DLE diagnosis.\n* Subject has moderate to severe DLE, as defined by an overall CLA IGA score of 3 (moderate) or 4 (severe) at screening and Day 1.\n* Female subject of childbearing potential must have a negative urine pregnancy test at screening and negative urine pregnancy test at Day 1.\n* Subject has no known history of latent or active tuberculosis (TB) infection.\n* Subject is willing to participate and is capable of giving informed consent. Note: Consent must be obtained prior to any study-related procedures.\n* Subjects must be willing to comply with all study procedures and must be available for the duration of the study.\n\nExclusion Criteria:\n\n* Female subject who is breastfeeding, pregnant, or who is planning to become pregnant during the study.\n* Subject has a history of skin disease or presence of skin condition that would interfere with the study assessments.\n* Subject has unstable or fluctuating use of nicotine-containing products within 4 weeks prior to screening.\n* Subject is known to have immune deficiency or is immunocompromised.\n* Subject is ≥ 50 years old AND has a history of heart attack, other clinically significant heart problems, stroke, or blood clots.\n* Subject has a known history of chronic infectious disease (e.g., hepatitis B, hepatitis C, or human immunodeficiency virus \\[HIV\\]).\n* Subject is known to have hepatitis B or hepatitis C viral infection.\n* Subject has used any topical medicated treatment that could affect DLE within 2 weeks prior to Day 1, including, but not limited to, topical corticosteroids, retinoids, calcineurin inhibitors, antimicrobials, and medical devices.\n* Subject has received any marketed or investigational biological agent within 12 weeks or 5 half lives (whichever is longer) prior to Day 1, including but not limited to ustekinumab and rituximab.\n* Subject is currently receiving a nonbiological investigational product or device or has received one within 4 weeks prior to Day 1.\n* Subject has a known or suspected allergy to ruxolitinib.\n* Subject has used ruxolitinib cream (OpzeluraTM).\n* Subject has used JAK inhibitors for conditions other than DLE or other forms of lupus within 4 weeks prior to Day 1.\n* Subject has a known history of clinically significant drug or alcohol abuse in the last year prior to Day 1.",{"count":47,"type":20},20,[23],"This study is a single-blind, intraindividual study to evaluate the efficacy of ruxolitinib 1.5 % cream in adult subjects with discoid lupus erythematosus.",[26],[52,53,54],"discoid lupus erythematosus","opzelura","ruxolitinib cream","RECRUITING","2025-03-21",{"date":58,"type":31},"2025-03-24",{"date":60,"type":31},"2024-04-19",{"date":62,"type":20},"2026-02-28",{"name":64,"class":65},"Innovaderm Research Inc.","OTHER"]