[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"papulopustular-rosacea\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:papulopustular-rosacea":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,59],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100054216","phase-2-a-phase-2-study-to-investigate-the-efficacy-safety-and-tolerability-of-remibrutinib-lou064-in-adult-patients-with-papulopustular-rosacea-ppr-100054216",false,"NCT07681271","A Phase 2 Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib (LOU064) in Adult Patients With Papulopustular Rosacea (PPR)","A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2 Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib (LOU064) in Adult Patients With Papulopustular Rosacea (PPR)","Key Inclusion Criteria:\n\n* Signed informed consent must be obtained prior to participation in the study.\n* Adult ≥18 years with a clinical diagnosis of PPR.\n* Moderate-to-severe disease defined by a modified Investigator's Global Assessment (IGA) score of 3 or 4\n* The presence of 15 - 60 inflammatory (papular\u002Fpustular, max. 2 nodular) facial lesions at screening, with at least 15 lesions present at Day 1 (Baseline).\n* Completed requisite washout of systemic antibiotics (30 days) and other prohibited systemic therapies before randomization.\n* Willingness to refrain from initiating treatments or undergoing procedures that target or impact PPR during the double-blind period, and to use only protocol-allowed products.\n\nKey Exclusion Criteria:\n\n* Presence of more than 2 nodular inflammatory lesions\n* Any active facial dermatoses or skin disease or condition that may interfere with assessment of PPR (e.g., seborrheic dermatitis, perioral dermatitis, acne, acneiform eruptions from biologic medications, steroid-induced dermatitis resembling rosacea or acne).\n* History of hypersensitivity to any of the study treatments or its excipients or to drugs of similar chemical classes\n* Use of biologics within five half-lives prior to screening or until the expected pharmacodynamic (PD) effect has returned to baseline, whichever is longer; or longer if required by local regulations\n* Use of small molecules and\u002For immunosuppressants that are not corticosteroids within 5 half-lives or within 30 days prior to screening, whichever is longer; or longer if required by local regulations\n* Any use of systemic corticosteroids, systemic antibiotics, or topical treatments (including corticosteroids, antibiotics, ivermectin, azelaic acid, or metronidazole) within 30 days prior to randomization, or any planned use of these agents during the study treatment period.\n* History of live attenuated vaccine within 6 weeks prior to randomization or requirement to receive these vaccinations at any time while on study treatment.\n* Use, planned use, or failure to meet the protocol-defined washout periods for prohibited therapies. In particular, patients with pretreatment with remibrutinib or another BTK-inhibitor within 4 months prior to randomization.\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.","ALL","18 Years",{"count":19,"type":20},80,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This Phase 2 study aims to evaluate whether Bruton's tyrosine kinase (BTK) inhibition with remibrutinib can produce a clinically meaningful reduction in inflammatory lesions in adults with moderate-to-severe papulopustular rosacea, while also assessing safety and tolerability of remibrutinib in this indication.",[26],"Papulopustular Rosacea",[26,28,29,30,31,32],"PPR","Ph2","efficacy","safety","tolerability","RECRUITING","2026-07-09",{"date":36,"type":37},"2026-07-13","ACTUAL",{"date":39,"type":20},"2026-07-29",{"date":41,"type":20},"2027-12-07",{"name":43,"class":44},"Novartis Pharmaceuticals","INDUSTRY",1,{"id":47,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":49,"briefSummary":24,"conditions":50,"keywords":51,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":56,"completionDateStruct":57,"leadSponsor":58,"locationsCount":4},"100645354",{"count":19,"type":20},[23],[26],[26,28,29,30,31,32],"NOT_YET_RECRUITING","2026-06-26",{"date":55,"type":37},"2026-07-02",{"date":39,"type":20},{"date":41,"type":20},{"name":43,"class":44},{"id":60,"slug":61,"hasResults":11,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":4,"eligibilityCriteria":65,"healthyVolunteers":66,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":67,"targetDuration":4,"studyType":21,"phases":69,"briefSummary":70,"conditions":71,"keywords":74,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":45},"100589292","phase-2-efficacy-and-safety-of-topical-clascoterone-winlevi-cream-1-in-patients-with-facial-acneiform-rosacea-100589292","NCT06952517","Efficacy and Safety of Topical Clascoterone (WINLEVI) Cream 1% in Patients With Facial Acneiform Rosacea","Efficacy and Safety of Topical Clascoterone Cream 1% in Patients With Facial Acneiform Rosacea","Inclusion Criteria:\n\n* Men and women ages 18+.\n* Diagnosis of rosacea type 2 (papulopustular).\n* Available and willing to comply with study instructions and attend all study visits.\n* Able and willing to provide written and verbal informed consent.\n* Subject has used the same type and brand of make-up, other facial products, and hair products (e.g., shampoo, gel, hair spray, mousse, etc.) for at least one month prior to the baseline visit and agrees to continue his\u002Fher other general skin and hair care products and regimen for the entire study.\n\nExclusion Criteria:\n\n* Subject has any skin pathology or condition that could interfere with the evaluation of the test products or requires the use of interfering topical or systemic therapy.\n* Subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.\n* Pregnant, lactating, or is planning to become pregnant during the study.\n* Subject is currently enrolled in an investigational drug or device study.\n* Subject has received an investigational drug or has been treated with an investigational device within 30 days prior to the initiation of treatment (baseline).\n* Study participant has facial hair that could interfere with the study assessments in the opinion of the investigator.\n* Study participant is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function.\n* Subject has known hypersensitivity or previous allergic reaction to any of the active or inactive components of the test articles.\n* Subject has the need or plans to be exposed to artificial tanning devices or excessive sunlight during the trial.",true,{"count":68,"type":20},20,[23],"To demonstrate the efficacy of Clascoterone cream 1% in reducing the size of sebaceous glands in study participants with acneiform rosacea.",[72,73,26],"Papular-pustular Rosacea","Papulopustular Rosacea (PPR)",[75,76,77,28],"rosacea","papulopustular rosacea","acneiform rosacea","2025-05-01",{"date":80,"type":37},"2025-05-06",{"date":82,"type":37},"2025-03-14",{"date":84,"type":20},"2025-09-30",{"name":86,"class":87},"Narrows Institute for Biomedical Research","OTHER"]