[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07681271":3,"trial-entities:NCT07681271":108,"trial-summary:NCT07681271":111},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":45,"secondary_outcomes":50,"sex":57,"minimum_age":58,"maximum_age":59,"healthy_volunteers":15,"eligibility_criteria":60,"std_ages":78,"locations":81,"central_contacts":99,"overall_officials":105,"references":106,"see_also_links":107},"NCT07681271","CLOU064Q12201","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)","RECRUITING","2027-12-07","2026-07","2026-07-13","2026-07-29","Novartis Pharmaceuticals","INDUSTRY",false,"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.","This is a multicenter, randomized, participant and Investigator-blinded, placebo-controlled, parallel-group Phase 2 study designed to evaluate the efficacy, safety, and tolerability of remibrutinib in adults with moderate-to-severe PPR. Following a screening period of up to 30 days, which can be extended by a further 2 weeks only to allow washout from rosacea treatments and other systemic therapies as specified in the prohibited medication section, eligible participants will be randomized at baseline to receive either remibrutinib or matching placebo for a 16-week double-blind treatment phase. A safety follow up visit will occur approximately 30 days after the final dose.",[19],"Papulopustular Rosacea",[19,21,22,23,24,25],"PPR","Ph2","efficacy","safety","tolerability","INTERVENTIONAL","TREATMENT",[29],"PHASE2",{"count":31,"type":32},80,"ESTIMATED",[34,41],{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"DRUG","LOU064","LOU064 administered by oral route",[36],[40],"Remibrutinib",{"type":35,"name":42,"description":43,"armGroupLabels":44},"Placebo","Matching placebo",[42],[46],{"measure":47,"description":48,"timeFrame":49},"Absolute change from baseline in facial inflammatory lesion count","The facial inflammatory lesion count is defined as the sum of papules, pustules, and nodules present on the face. Lesions are visually counted across the full facial area (forehead, cheeks, nose, chin). A negative value indicates a reduction in lesions (clinical improvement), as lower counts reflect less inflammatory activity.","Baseline, Week 16",[51,54],{"measure":52,"description":53,"timeFrame":49},"Proportion of participants with Investigator's Global Assessment (IGA,modified scale without erythema) grade 0 or 1, with at least 2 grade reduction from baseline","The Investigator's Global Assessment is a clinician-reported outcome using a 5-point ordinal scale (0-4). Higher scores indicate more severe disease; lower scores indicate improvement.\n\n0 = Clear\n\n1. = Near clear\n2. = Mild\n3. = Moderate\n4. = Severe",{"measure":55,"description":56,"timeFrame":49},"Percentage change from baseline in facial inflammatory lesion count","The facial inflammatory lesion count is defined as the sum of papules, pustules, and nodules present on the face. Lesions are visually counted across the full facial area (forehead, cheeks, nose, chin). Lower values indicate fewer lesions. A reduction from baseline represents clinical improvement.","ALL","18 Years",null,{"inclusion":61,"exclusion":68,"raw_text":77},[62,63,64,65,66,67],"Signed informed consent must be obtained prior to participation in the study.","Adult ≥18 years with a clinical diagnosis of PPR.","Moderate-to-severe disease defined by a modified Investigator's Global Assessment (IGA) score of 3 or 4","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).","Completed requisite washout of systemic antibiotics (30 days) and other prohibited systemic therapies before randomization.","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.",[69,70,71,72,73,74,75,76],"Presence of more than 2 nodular inflammatory lesions","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).","History of hypersensitivity to any of the study treatments or its excipients or to drugs of similar chemical classes","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","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","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.","History of live attenuated vaccine within 6 weeks prior to randomization or requirement to receive these vaccinations at any time while on study treatment.","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.","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.",[79,80],"ADULT","OLDER_ADULT",[82],{"facility":83,"status":8,"city":84,"state":85,"zip":86,"country":87,"contacts":88,"geoPoint":96},"Three A Research","El Paso","Texas","79902","United States",[89,93],{"name":90,"role":91,"email":92},"Genesis Jaramillo","CONTACT","genesis@3aresearch.com",{"name":94,"role":95},"Brenda Simpson","PRINCIPAL_INVESTIGATOR",{"lat":97,"lon":98},31.75872,-106.48693,[100,103],{"name":13,"role":91,"phone":101,"email":102},"1-888-669-6682","novartis.email@novartis.com",{"name":13,"role":91,"phone":104},"+41613241111",[],[],[],{"nct_id":4,"conditions":109,"biomarkers":110},[19],[],{"nct_id":4,"found":112,"summary":113,"prompt_version":123},true,{"design":114,"status":115,"heading":116,"summary":117,"follow_up":118,"word_count":119,"commitments":120,"compensation":121,"drugs_mentioned":122},"This is a randomized, participant and investigator-blinded, placebo-controlled Phase 2 study involving about 80 participants. Participants will receive either remibrutinib or a matching placebo.","completed","Phase 2 Study of Remibrutinib for Papulopustular Rosacea","This Phase 2 study is looking at an oral medication called remibrutinib (LOU064) for adults with moderate-to-severe papulopustular rosacea (PPR). PPR is a skin condition that causes red bumps and pus-filled pimples on the face. Researchers want to see if remibrutinib can reduce these inflammatory lesions and if it is safe and well-tolerated. The study will compare remibrutinib to a placebo (an inactive substance that looks like the study drug). About 80 people are expected to join. To be eligible, you must be at least 18 years old and have a clinical diagnosis of moderate-to-severe PPR, with 15 to 60 inflammatory lesions.","A safety follow-up visit will occur approximately 30 days after your final dose of the study medication.",102,"After a screening period of up to 30 days (which can be extended), eligible participants will take either remibrutinib or placebo for 16 weeks.","Not stated in the trial record.",[36,42],"v2"]