[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cutaneous-lupus-erythematosus\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cutaneous-lupus-erythematosus":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,58,87],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":57},"100620253","phase-3-a-study-of-enpatoran-in-participants-with-cutaneous-manifestations-of-lupus-with-or-without-systemic-disease-elowen-2-100620253",false,"NCT07355218","A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease (ELOWEN-2)","A Phase 3, Randomized, Double-Blind,Placebo-Controlled Parallel Study to Evaluate the Efficacy and Safety of Enpatoran in Participants With Active Cutaneous Manifestations of Lupus Erythematosus With or Without Systemic Disease Receiving Standard of Care (ELOWEN-2)","Inclusion Criteria\n\n* Vaccinations are up to date according to local guidelines\u002Frecommendations. Recombinant zoster vaccination is encouraged but not mandatory.\n* Participants with diagnosis of Discoid Lupus Erythematosus (DLE) and\u002For Subacute Cutaneous Lupus Erythematosus (SCLE) documented in medical history, with or without Systemic Lupus Erythematosus (SLE).\n* Participants with active Acute Cutaneous Lupus Erythematosus (ACLE) as sole cutaneous manifestations is allowed in the presence of SLE and should be present for at least 6 weeks prior to the Screening visit.\n* Participants with diagnosis of SLE fulfilling the European Alliance of Associations for Rheumatology (EULAR)\u002FAmerican College of Rheumatology (ACR) 2019 classification criteria, must have active DLE and\u002For SCLE and\u002For ACLE.\n\nFor participants with SLE:\n\n* Participants with diagnosis of SLE and fulfill EULAR\u002FACR 2019 classification criteria.\n* Participants with disease duration (cutaneous disease and, where applicable, SLE) of \\>= 6 months from time of diagnosis to Screening.\n* Participants with CLASI-A score \\>= 8 at Screening and Day 1 visits.\n* Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria\n\n* Participants with primary diagnosis of autoimmune rheumatic disease (e.g., systemic sclerosis, rheumatoid arthritis) other than Cutaneous Lupus Erythematosus (CLE) and SLE.\n* Participants with any condition including dermatological diseases other than cutaneous manifestations of lupus (e.g. psoriasis), any uncontrolled disease (e.g. asthma, chronic obstructive pulmonary disease, interstitial lung disease, bronchiectasis, pulmonary arterial hypertension), or life-threatening manifestations of lupus (e.g. active systemic vasculitis) that in Investigator's or Sponsor\u002Fdesignee's opinion constitutes inappropriate risk or contraindication for participation.\n* Participants with drug-induced lupus (SLE or CLE).\n* Participants with active lupus nephritis on induction therapy, or induction therapy completed within 3 months of the Screening visit (stable maintenance therapy with either mycophenolate azathioprine or an oral calcineurin inhibitor is allowed).\n* Participants with Urine Protein-to-Creatinine Ratio (UPCR) greater than (\\>) 339 milligrams per millimole (mg\u002Fmmol), and\u002For estimated Glomerular Filtration Rate (eGFR) less than 40 milliliters per minute per 1.73 square meters of body surface area (mL\u002Fmin\u002F1.73 m\\^2), as calculated by the Modification of Diet in Renal Disease (MDRD) equation.\n* Participants with any active signs, symptoms, or diagnoses considered related to Central Nervous System (CNS) lupus within the past 3 months, or any history of uncontrolled seizures.\n* Other protocol-defined exclusion criteria may apply.","ALL","18 Years","75 Years",{"count":20,"type":21},202,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The purpose of this global, multicenter, Phase 3 study is to evaluate the efficacy and safety of enpatoran over 24 weeks in participants with active cutaneous manifestations of lupus erythematosus with or without systemic disease. Study details include:\n\nStudy Duration: Up to 35 weeks. Treatment Duration: 24 weeks. Visit Frequency: every 4 weeks, with the exception of the Week 2 televisit. Study Intervention Name: Enpatoran, Placebo.\n\nIntervention Form: Film-coated tablet.",[27,28],"Systematic Lupus Erythematosus","Cutaneous Lupus Erythematosus",[30,31,32,33,34,35,36,37,38,39,40,41,42,43,44],"Toll-like Receptor 7","Toll-like Receptor 8","Adults","SLE","CLE","Lupus","Discoid lupus erythematosus","Subacute cutaneous lupus erythematosus","M5049","Enpatoran","Cutaneous manifestations","Lupus erythematosus","Acute cutaneous lupus erythematosus","Systemic lupus erythematosus","Interferon gene signature","RECRUITING","2026-07-01",{"date":48,"type":49},"2026-07-02","ACTUAL",{"date":51,"type":49},"2026-04-01",{"date":53,"type":21},"2029-05-25",{"name":55,"class":56},"EMD Serono Research & Development Institute, Inc.","INDUSTRY",9,{"id":59,"slug":60,"hasResults":11,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":4,"eligibilityCriteria":64,"healthyVolunteers":65,"sex":16,"minAge":17,"maxAge":66,"enrollmentInfo":67,"targetDuration":4,"studyType":22,"phases":69,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":4},"100624382","phase-1-safety-tolerability-and-pharmacokineticpharmacodynamic-pkpd-profile-of-act100-in-healthy-participants-100624382","NCT07408908","Safety, Tolerability, and Pharmacokinetic\u002FPharmacodynamic (PK\u002FPD) Profile of ACT100 in Healthy Participants..","A Single-Center, Randomized, Double-Blind, Dose-Escalation, Placebo-Controlled, Phase Ia Study to Evaluate the Safety, Tolerability, and Pharmacokinetic\u002FPharmacodynamic (PK\u002FPD) Profile of ACT100 in Healthy Participants.","Inclusion Criteria:\n\n1. Participants must voluntarily participate and sign the informed consent form after being informed of the entire trial process and the potential adverse reactions of the investigational product.\n2. Healthy male and female participants aged between 18 and 55 years (inclusive) at the time of signing the informed consent form.\n3. Body mass index (BMI) at screening: 18.5 kg\u002Fm\\^2 ≤ BMI \\\u003C 28 kg\u002Fm\\^2; body weight ≥ 50 kg (for males) \u002F ≥ 45 kg (for females).\n4. At screening, physical examination, vital signs, laboratory tests, electrocardiogram (ECG), etc., are all normal or show abnormalities judged by the investigator as having no clinical significance.\n5. Females of childbearing potential and males must agree to use highly effective contraceptive methods (e.g., intrauterine device, condom) from screening until 3 months after administration of the investigational product and have no plan for sperm or egg donation.\n\nExclusion Criteria:\n\n1. History of treatment with any drug targeting the same molecule (BDCA2) as the investigational product.\n2. A 12-lead electrocardiogram (ECG) at screening showing abnormalities considered clinically significant by the investigator (e.g., QTcF \\> 450 ms for males or \\> 470 ms for females).\n3. History of severe diseases of major organ systems, including but not limited to neurological, cardiovascular, hematological, autoimmune, renal, hepatic, gastrointestinal, pulmonary, endocrine, metabolic, or psychiatric disorders.\n4. Presence of severe bacterial or viral infection (e.g., pneumonia, sepsis, herpes zoster), or fungal\u002Fparasitic infection within 2 months prior to screening; or any symptoms of active or suspected infection within 1 week prior to dosing.\n5. Chronic infectious diseases such as chronic hepatitis B or C, AIDS, tuberculosis, etc. Exclusion applies if any of the following tests are positive at screening: Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAb), Hepatitis C antibody (HCVAb), Treponema pallidum antibody, Human Immunodeficiency Virus antibody (HIVAb); or if there is evidence of active or latent Mycobacterium tuberculosis infection at screening.\n6. History of primary immunodeficiency, splenectomy, or any other underlying condition deemed by the investigator to confer a high risk of severe infection.\n7. History of severe food or drug allergy, or known allergy to monoclonal antibodies.\n8. Vaccination with a live attenuated vaccine within 1 month prior to screening, or any other vaccination within half a month prior to screening, or plans to receive any vaccine during the study period.\n9. Use of any prescription drugs, over-the-counter medications (including Chinese herbal medicines, health supplements, etc.) within 14 days prior to the first dose of the investigational product, unless deemed by both the investigator and sponsor to have no impact on the study.\n10. History of drug abuse, illicit drug use, or alcohol abuse (history of drug abuse or illicit drug use within the past 5 years; or habitual alcohol intake exceeding 14 units per week within 3 months prior to screening: 1 unit ≈ 285 mL beer, or 25 mL spirits, or 100 mL wine). Participants with a positive alcohol breath test or positive urine drug abuse screening at screening will be excluded.\n11. Heavy smoking (averaging \\>5 cigarettes per day) within 3 months prior to screening, or unwillingness to refrain from smoking during the study period.\n12. Donation or loss of \\>400 mL of blood within 3 months prior to screening, or \\>200 mL within 1 month prior to screening; or receipt of blood transfusion or blood products within 3 months prior to screening.\n13. Participation in another clinical trial involving an investigational drug\u002Ftherapy within 1 month prior to screening, or within 5 half-lives (based on the known half-life of the prior investigational product, the Investigator's Brochure, or the informed consent form, whichever specifies the longer period).\n14. History of blood\u002Fneedle phobia or intolerance to venipuncture, or abnormalities at the potential injection site deemed by the investigator to be unsuitable for subcutaneous administration.\n15. Females who are pregnant or lactating.\n16. Any other condition that, in the judgment of the investigator, makes the participant unsuitable for participation in this study.",true,"55 Years",{"count":68,"type":21},48,[70],"PHASE1","This study is a Phase Ia, single-center, randomized, double-blind, dose-escalation, placebo-controlled clinical trial designed to evaluate the safety, tolerability, and pharmacokinetic\u002Fpharmacodynamic (PK\u002FPD) profile of ACT100 in healthy participants. A total of 6 dose cohorts are planned, with each cohort enrolling 8 participants (including both male and female participants, where 6 will receive the investigational drug and 2 will receive placebo). The total planned enrollment is 48 healthy participants.",[73,28],"Systemic Lupus Erythematosus",[73,28,75,76],"ACT100","Pharmacokinetics and Pharmacodynamics","NOT_YET_RECRUITING","2026-02-06",{"date":80,"type":49},"2026-02-13",{"date":82,"type":21},"2026-03-06",{"date":84,"type":21},"2027-10-30",{"name":86,"class":56},"Xiamen Amoytop Biotech Co., Ltd.",{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":65,"sex":16,"minAge":17,"maxAge":95,"enrollmentInfo":96,"targetDuration":4,"studyType":22,"phases":98,"briefSummary":100,"conditions":101,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":111},"100598524","early-phase-1-clinical-trial-to-evaluate-safety-tolerability-and-pharmacokinetics-of-sof-skn-in-healthy-participants-100598524","NCT07072611","Clinical Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of SOF-SKN in Healthy Participants","A Double-Blind, Placebo-Controlled Phase I Clinical Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of SOF-SKN in Healthy Participants","HERACLES","Inclusion Criteria:\n\n* Healthy Volunteers 18 to 64 years.\n* Participants with Fitzpatrick skin type I to IV.\n* Participants must have a back surface area of at least 24 × 30 cm to accommodate two - 10 × 30 cm application areas with a 4 cm separation between them.\n* No Allergies.\n* Contraception.\n* Must be willing to abstain from the use of moisturizers and other topical applications on the back 24 hours prior and for the duration of the study.\n\nExclusion Criteria:\n\n* Allergic constitution.\n* Within 72 hours of the start of study treatment, the use of antihistamines or use of topical drugs at the application site.\n* Hair removing interventions including laser treatment, shaving and waxing in the target area within 1 week before Screening.\n* Hypertrichosis on the back; no tattoos that cover greater than 30% of the back surface area.\n* Presence of an inflammatory dermatosis (including, but not limited to, atopic dermatitis, eczema, psoriasis, extensive acne), and\u002For suntan\u002Fburn that could interfere with the test field evaluation.\n* Non-inflammatory skin lesions and changes (including, but not limited to, hyperpigmentation, multiple naevi, tattoos, blemishes, birthmarks, abrasions, ulcers, eschar, and\u002For scabs) present in the target area on the back that could interfere with the test field evaluation.\n* Any history of or presence of in situ melanoma and non-melanoma skin cancer within the last 3 years.\n* Any other skin disease or other visible skin condition noted on physical examination which in the Investigator's opinion might interfere with the evaluation of the test field reaction.","64 Years",{"count":97,"type":21},32,[99],"EARLY_PHASE1","The goal of this study is to investigate the safety and tolerability of the topical application of SOF-SKN in healthy volunteers. The study will be divided into part 1 and part 2.\n\nPart 1, is a single ascending dose (SAD) design, while Part 2 is a multiple ascending dose (MAD) design.",[28],"2025-07-17",{"date":104,"type":49},"2025-07-20",{"date":106,"type":49},"2025-07-14",{"date":108,"type":21},"2026-03",{"name":110,"class":56},"Noxopharm Limited",1]