[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655458":3},{"organization":4,"outcomesModule":7,"designInfo":32,"detailedDescription":41,"studyPopulation":31,"armGroups":42,"interventions":54,"overallOfficials":31,"centralContacts":65,"locations":73,"responsibleParty":189,"collaborators":31,"id":191,"slug":192,"hasResults":193,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":31,"eligibilityCriteria":197,"healthyVolunteers":193,"sex":198,"minAge":199,"maxAge":31,"enrollmentInfo":200,"targetDuration":31,"studyType":203,"phases":204,"briefSummary":206,"conditions":207,"keywords":209,"overallStatus":76,"whyStopped":31,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":224},{"fullName":5,"class":6},"Novartis","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":31},[9],{"measure":10,"description":11,"timeFrame":12},"Proportion of participants achieving ≥4 point reduction from baseline in Worst itch Numerical Rating Scale (WI NRS)","The WI-NRS is a patient-reported outcome (PRO) instrument consisting of a single question that asks participants to rate the severity of their worst itch over a defined period. The score range is from 0 (no itch) to 10 (worst imaginable itch).\n\nHigher scores indicate worse itch severity.","Baseline, Week 12",[14,18,22,24,27],{"measure":15,"description":16,"timeFrame":17},"Proportion of participants achieving ≥4 point reduction from baseline in WI NRS","The WI-NRS is a PRO instrument consisting of a single question that asks participants to rate the severity of their worst itch over a defined period. The score range is from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicate worse itch severity.","Baseline, Week 4",{"measure":19,"description":20,"timeFrame":21},"Proportion of participants achieving Patient Global Impression of Severity (PGIS) score of 0 (none) or 1 (mild)","The PGIS of pruritus is a PRO measure consisting of a single item that captures the participant's overall self-assessment of the severity of their pruritus (itch) over a defined recall period. The score range is from 0 (none) to 3 (severe). Lower scores indicate better outcome.","Week 12",{"measure":19,"description":20,"timeFrame":23},"Week 24",{"measure":25,"description":26,"timeFrame":21},"Change from baseline in Pruritus-related Sleep Disturbance Numerical Rating Scale (SD-NRS)","The SD-NRS is a PRO instrument used to assess the degree of sleep disturbance caused by pruritus (itch). The score range is from 0 (No sleep disturbance) to 10 (Worst possible sleep disturbance).\n\nHigher scores indicate greater sleep disturbance due to pruritus.",{"measure":28,"description":29,"timeFrame":30},"Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)","Number of participants with AEs and SAEs.","Up to Week 52",null,{"allocation":33,"interventionModel":34,"interventionModelDescription":31,"primaryPurpose":35,"observationalModel":31,"timePerspective":31,"maskingInfo":36},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":37,"maskingDescription":31,"whoMasked":38},"DOUBLE",[39,40],"PARTICIPANT","INVESTIGATOR","This is a global, phase 3 multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy, safety, and tolerability of remibrutinib in adult participants with severe CPUO.\n\nThe design includes 4 periods, for a total duration of up to 60 weeks:\n\n* Screening period: up to 4 weeks.\n* Double-blind treatment period (treatment period 1, TP1): 24 weeks of double-blind treatment with remibrutinib or matching placebo\n* Open-label treatment period (treatment period 2, TP2): 28 weeks of open-label treatment with remibrutinib. The participants randomized to the placebo arm will be switched to remibrutinib at Week 24.\n* Safety follow-up period: 4 weeks of treatment-free safety follow-up.",[43,49],{"label":44,"type":45,"description":46,"interventionNames":47},"Remibrutinib","EXPERIMENTAL","Remibrutinib film coated tablets",[48],"Drug: Remibrutinib",{"label":50,"type":45,"description":51,"interventionNames":52},"Placebo followed by remibrutinib","Matching placebo. At the Week 24 visit, all participants will receive active treatment (remibrutinib).",[48,53],"Drug: Placebo",[55,61],{"type":56,"name":44,"description":57,"armGroupLabels":58,"otherNames":59},"DRUG","Oral administration of remibrutinib",[50,44],[60],"LOU064",{"type":56,"name":62,"description":63,"armGroupLabels":64,"otherNames":31},"Placebo","Oral administration of matching placebo.",[50],[66,71],{"name":67,"role":68,"phone":69,"phoneExt":31,"email":70},"Novartis Pharmaceuticals","CONTACT","1-888-669-6682","novartis.email@novartis.com",{"name":67,"role":68,"phone":72,"phoneExt":31,"email":31},"+41613241111",[74,96,113,130,147,164,179],{"facility":75,"status":76,"city":77,"state":78,"zip":79,"country":80,"countryCode":81,"cosmosGeoPoint":82,"geoPoint":87,"contacts":88},"TrueBlue Clinical Research","RECRUITING","Tampa","Florida","33607","United States","US",{"type":83,"coordinates":84},"Point",[85,86],-82.45843,27.94752,{"lat":86,"lon":85},[89,93],{"name":90,"role":68,"phone":91,"phoneExt":31,"email":92},"Rosemarie Acuna","+1 727 250 1115","Rosemarie.acuna@tbcrtampa.com",{"name":94,"role":95,"phone":31,"phoneExt":31,"email":31},"Stephen Lockwood","PRINCIPAL_INVESTIGATOR",{"facility":97,"status":76,"city":98,"state":99,"zip":100,"country":80,"countryCode":81,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"Metro Boston Clinical Partners","Brighton","Massachusetts","02135",{"type":83,"coordinates":102},[103,104],-71.15644,42.3501,{"lat":104,"lon":103},[107,111],{"name":108,"role":68,"phone":109,"phoneExt":31,"email":110},"Stella Schandorf","+1 617 783 7100","sschandorf@metrobostoncp.com",{"name":112,"role":95,"phone":31,"phoneExt":31,"email":31},"Mark Amster",{"facility":114,"status":76,"city":115,"state":116,"zip":117,"country":80,"countryCode":81,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"Michigan Center for Rsrch Company","Clarkston","Michigan","48346",{"type":83,"coordinates":119},[120,121],-83.41883,42.73586,{"lat":121,"lon":120},[124,128],{"name":125,"role":68,"phone":126,"phoneExt":31,"email":127},"Danielle Bartlett","+1 248 620 3376","dbartlett@docsdermgroup.com",{"name":129,"role":95,"phone":31,"phoneExt":31,"email":31},"Wendy McFalda",{"facility":131,"status":76,"city":132,"state":133,"zip":134,"country":80,"countryCode":81,"cosmosGeoPoint":135,"geoPoint":139,"contacts":140},"Apex Clinical Research Center LLC","Mayfield Heights","Ohio","44124",{"type":83,"coordinates":136},[137,138],-81.4579,41.51922,{"lat":138,"lon":137},[141,145],{"name":142,"role":68,"phone":143,"phoneExt":31,"email":144},"Melinda Delong","+1 440 616 8760","mdelong@apexskin.com",{"name":146,"role":95,"phone":31,"phoneExt":31,"email":31},"Jorge Garcia-Zuazaga",{"facility":148,"status":76,"city":149,"state":150,"zip":151,"country":80,"countryCode":81,"cosmosGeoPoint":152,"geoPoint":156,"contacts":157},"Dermatology Solutions","Grapevine","Texas","76051",{"type":83,"coordinates":153},[154,155],-97.07807,32.93429,{"lat":155,"lon":154},[158,162],{"name":159,"role":68,"phone":160,"phoneExt":31,"email":161},"Asma Zafar","+1 312 451 5962","Azafar@drstx.com",{"name":163,"role":95,"phone":31,"phoneExt":31,"email":31},"Sanober Amin",{"facility":165,"status":76,"city":166,"state":150,"zip":167,"country":80,"countryCode":81,"cosmosGeoPoint":168,"geoPoint":172,"contacts":173},"Progressive Clinical Research San Antonio","San Antonio","78213",{"type":83,"coordinates":169},[170,171],-98.49363,29.42412,{"lat":171,"lon":170},[174,177],{"name":175,"role":68,"phone":31,"phoneExt":31,"email":176},"Ryann Bizick-Magee","rmagee@progclin.com",{"name":178,"role":95,"phone":31,"phoneExt":31,"email":31},"Mark S. Lee",{"facility":180,"status":76,"city":181,"state":150,"zip":182,"country":80,"countryCode":81,"cosmosGeoPoint":31,"geoPoint":31,"contacts":183},"Complete Dermatology","Sugarland","77479",[184,187],{"name":185,"role":68,"phone":31,"phoneExt":31,"email":186},"Pam Laos","plaoschocano@complete-derm.com",{"name":188,"role":95,"phone":31,"phoneExt":31,"email":31},"Bartley Joseph Gill",{"type":190,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100655458","phase-3-a-study-to-evaluate-efficacy-safety-and-tolerability-of-remibrutinib-in-adult-participants-with-severe-chronic-pruritus-of-unknown-origin-cpuo-100655458",false,"NCT07811869","A Study to Evaluate Efficacy, Safety, and Tolerability of Remibrutinib in Adult Participants With Severe Chronic Pruritus of Unknown Origin (CPUO)","A 52-week Multi-center, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy, Safety and Tolerability of Remibrutinib in Adult Participants With Severe Chronic Pruritus of Unknown Origin (CPUO)","Key Inclusion Criteria:\n\n* Participant must be ≥ 18 years of age, at the time of signing the informed consent.\n* Participants with chronic pruritus for at least 4 months prior to screening.\n* Chronic pruritus considered of unknown origin as assessed by the investigator at baseline (e.g., excluding chronic pruritus related to primary dermatological or systemic conditions, neuropathic or psychogenic origin or secondary to drugs or other allergen exposures).\n* Chronic pruritus must affect at least 2 of the following body areas: trunk, arms, or legs (cannot be unilateral and\u002For dermatomal in distribution).\n* Participants with ongoing, severe chronic pruritus despite the use of emollients and who are candidates for systemic therapy.\n* Participants must have severe itch defined by a WI-NRS ≥7 at screening; score scale ranges from 0 to 10; higher score indicates worse itch.\n* Participants must have an average WI-NRS ≥7 over the 7 days prior to randomization\u002Fbaseline visit.\n* The average WI-NRS score over the preceding 7 days prior to the randomization\u002Fbaseline visit will be calculated based on the daily WI-NRS scores (0-10).\n* Participants must have PGIS of pruritus scored as 3 \"severe\" at screening and baseline visits.\n\nKey Exclusion Criteria:\n\n* Any active skin conditions (e.g., atopic dermatitis, psoriasis, etc.) that may interfere with the assessment of CPUO.\n* Known systemic condition(s) or medication(s) that are considered by the investigator to be the primary cause of current pruritus.\n* Known or suspected infectious disease that is active, chronic or recurrent which precludes the participant from participating in the clinical trial as per Investigator´s assessment. These infectious diseases include but are not limited to opportunistic infections (e.g., tuberculosis, atypical mycobacterioses, listeriosis or aspergillosis) and\u002For known or suspected HIV infection.\n* History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.\n* Significant bleeding risk or coagulation disorders. History of gastrointestinal bleeding, e.g., in association with use of nonsteroidal anti-inflammatory drugs (NSAIDs), that was clinically relevant (e.g., where intervention was indicated or requiring hospitalization or blood transfusion). Requirement for anti-platelet medication, except for acetylsalicylic acid up to 100 mg\u002Fd or clopidogrel up to 75 mg\u002Fd. The use of dual anti-platelet therapy (e.g., acetylsalicylic acid + clopidogrel) is prohibited.\n* History or current hepatic disease, including but not limited to, acute or chronic hepatitis, cirrhosis or hepatic failure or aspartate aminotransferase (AST)\u002F alanine aminotransferase (ALT) levels of more than 1.5 x upper limit of normal (ULN) or International Normalized Ratio (INR) of more than 1.5 at screening.","ALL","18 Years",{"count":201,"type":202},180,"ESTIMATED","INTERVENTIONAL",[205],"PHASE3","The purpose of this phase 3 study is to establish the efficacy, safety and tolerability of remibrutinib in adult participants with severe chronic pruritus of unknown origin (CPUO).",[208],"Chronic Pruritus of Unknown Origin",[210,211,212,213,214],"BTK inhibitor","chronic pruritus","chronic pruritus of unknown origin","CPUO","remibrutinib","2026-10-12",{"date":217,"type":218},"2026-10-13","ACTUAL",{"date":220,"type":218},"2026-10-07",{"date":222,"type":202},"2030-01-03",{"name":67,"class":6},7]