[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657955":3},{"organization":4,"outcomesModule":7,"designInfo":32,"detailedDescription":31,"studyPopulation":31,"armGroups":38,"interventions":45,"overallOfficials":52,"centralContacts":56,"locations":62,"responsibleParty":75,"collaborators":31,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":31,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":86,"maxAge":31,"enrollmentInfo":87,"targetDuration":31,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":31,"overallStatus":100,"whyStopped":31,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Mayo Clinic","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":31},[9],{"measure":10,"description":11,"timeFrame":12},"Mean percent change in the Peak Pruritus Numerical Rating Score (PNRS)","Pruritus severity is measured using the peak PNRS, a single self-administered item that captures the intensity of the worst itch experienced during the previous 24 hours. Patients respond to the question: \"On a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable,' how would you rate your itch at the worst moment during the previous 24 hours?\" Patients will record daily itch scores in a diary, which will be collected at follow-up visits. The baseline and Week 16 mean peak PNRS values will be calculated as the average of the daily scores recorded over the 7 days immediately preceding treatment initiation and 7 days preceding Week 16 follow up, respectively.","Baseline to Week 16",[14,18,21,25,28],{"measure":15,"description":16,"timeFrame":17},"Percentage of patients with an improvement in weekly average PNRS ≥4 from baseline","The proportion of participants with an improvement of at least 4 points from baseline in weekly average Peak Pruritus Numerical Rating Score will be assessed at each specified post-baseline time point.","Weeks 1,2,4,8, and 12",{"measure":19,"description":20,"timeFrame":17},"Change in Verbal Rating Scale of Pruritus","The Verbal Rating Scale of pruritus is assessed using a 4-point scale where 0 indicates none, 1 indicates mild, 2 indicates moderate, and 3 indicates severe or intense pruritus. Change from baseline will be summarized at each specified post-baseline time point.",{"measure":22,"description":23,"timeFrame":24},"Mean change of 5D pruritus score","This is a multidimensional questionnaire designed to assess the degree, duration, direction, disability and distribution of pruritus longitudinally with scoring ranging from 5=no pruritus\u002Fwell-controlled to 25=severe pruritus\u002Fpoorly controlled.","Baseline, Week 12",{"measure":26,"description":27,"timeFrame":24},"Change in Chronic Liver Disease Questionnaire (CLDQ) score","This is a validated quality life instrument for patients with chronic liver disease evaluating systemic symptoms, fatigue, physical activity, emotional function, and worry using a 7 point scale with 1=all of the time; 2=most of the time; 3=a good bit of the time; 4=some of the time; 5=a little of the time; 6=hardly any of the time; and 7=none of the time.",{"measure":29,"description":30,"timeFrame":24},"Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Item Bank mean score","The Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Item Banks assess a wide spectrum of self-reported fatigue symptoms, ranging from mild feelings of tiredness to overwhelming, debilitating, and sustained exhaustion that can significantly impair an individual's ability to perform daily activities and fulfill family or social roles. Each item is rated on a 5-point Likert scale, and the resulting raw scores are converted into T-scores, which are then compared to a standardized mean (T-score mean = 50, SD = 10).",null,{"allocation":33,"interventionModel":34,"interventionModelDescription":31,"primaryPurpose":35,"observationalModel":31,"timePerspective":31,"maskingInfo":36},"NA","SINGLE_GROUP","TREATMENT",{"masking":37,"maskingDescription":31,"whoMasked":31},"NONE",[39],{"label":40,"type":41,"description":42,"interventionNames":43},"Nemolizumab-ilto","EXPERIMENTAL","Participants will receive open-label nemolizumab-ilto by subcutaneous injection.",[44],"Drug: Nemolizumab-ilto",[46],{"type":47,"name":40,"description":48,"armGroupLabels":49,"otherNames":50},"DRUG","Participants will receive nemolizumab-ilto 60 mg subcutaneously at Week 0, followed by 30 mg subcutaneously every 4 weeks during the treatment period (total of 16 weeks).",[40],[51],"NEMLUVIO",[53],{"name":54,"affiliation":5,"role":55},"Jason Sluzevich, MD","PRINCIPAL_INVESTIGATOR",[57],{"name":58,"role":59,"phone":60,"phoneExt":31,"email":61},"Reagan E. Dukes, MHA","CONTACT","904-953-3302","dukes.reagan@mayo.edu",[63],{"facility":5,"status":31,"city":64,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":31},"Jacksonville","Florida","32224","United States","US",{"type":70,"coordinates":71},"Point",[72,73],-81.65565,30.33218,{"lat":73,"lon":72},{"type":55,"investigatorFullName":76,"investigatorTitle":77,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Jason Sluzevich MD","Principal Investigator","100657955","phase-2-nemolizumab-for-the-treatment-of-moderate-to-severe-chronic-hepatic-pruritus-100657955",false,"NCT07843420","Nemolizumab for the Treatment of Moderate to Severe Chronic Hepatic Pruritus","Nemolizumab for the Treatment of Moderate to Severe Chronic Hepatic Pruritus: An Open-Label, Single-Arm, Exploratory Study","Inclusion Criteria:\n\n* Cholestatic pruritus secondary primary biliary sclerosis (PBS) or primary sclerosing cholangitis (PSC)\n* Pruritus that is chronic in duration (greater equal to 6 months)\n* Pruritus severity with a peak pruritus numerical rating score of ≥ 5 (moderate severity)\n* Model for End-Stage Liver Disease (MELD) score \\\u003C 15. This will capture patients with chronic stable liver disease without significant comorbid conditions and\u002For signs of rapidly progressive or decompensated liver failure\n* Willingness and ability to comply with scheduled clinic visits, physical exams, laboratory tests, questionnaires, effective contraception use, and other trial procedures\n\nExclusion Criteria:\n\n* Pruritus due to a primary inflammatory skin dermatosis or other forms of psychogenic pruritus utilizing skin biopsies to exclude as needed\n* Pregnant females. Urine pregnancy test required at screening\n* History of intrahepatic cholestasis of pregnancy\n* Any form of chronic hepatic pruritus associated with underlying malignancy\n* Liver transplant recipients\n* Drug-induced liver pruritus\n* ALT or AST greater than 3 times the upper limit of normal or total bilirubin greater than 2 times upper normal limit\n* Advanced liver disease indicators including, ascites requiring therapeutic paracentesis, history of spontaneous bacterial peritonitis, any grade of hepatic encephalopathy, or a documented history of variceal bleeding within the preceding six months\n* Severe coagulopathy with INR \\> 15\n* Any form of acute cholestatic liver disease\n* Allergy to nemolizumab or its ingredients\n* Inability to provide informed consent","ALL","18 Years",{"count":88,"type":89},15,"ESTIMATED","INTERVENTIONAL",[92],"PHASE2","The purpose of this research is to investigate the efficacy of nemolizumab in the treatment of adults with moderate to severe chronic hepatic pruritus.",[95,96,97,98,99],"Chronic Hepatic Pruritus","Cholestatic Liver Disease","Primary Biliary Cholangitis","Cholestasis","Primary Sclerosing Cholangitis","NOT_YET_RECRUITING","2026-09-21",{"date":103,"type":104},"2026-09-28","ACTUAL",{"date":106,"type":89},"2026-11",{"date":108,"type":89},"2028-11",{"name":5,"class":6},1]