[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639479":3},{"organization":4,"outcomesModule":7,"designInfo":38,"detailedDescription":44,"studyPopulation":37,"armGroups":45,"interventions":52,"overallOfficials":59,"centralContacts":63,"locations":73,"responsibleParty":94,"collaborators":97,"id":101,"slug":37,"hasResults":102,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":37,"eligibilityCriteria":106,"healthyVolunteers":102,"sex":107,"minAge":108,"maxAge":109,"enrollmentInfo":110,"targetDuration":37,"studyType":113,"phases":114,"briefSummary":116,"conditions":117,"keywords":119,"overallStatus":128,"whyStopped":37,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},{"fullName":5,"class":6},"University of Maryland, Baltimore","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":37},[9,13],{"measure":10,"description":11,"timeFrame":12},"Percent change from baseline in weekly average Peak Pruritus Numeric Rating Scale (PP-NRS) at week 24","The PP-NRS is a single-item measure assessing itch on a scale from 0 (\"no itch\") to 10 (\"worst imaginable itch\"). Participants will complete the PP-NRS daily, rating their worst level of itch during the past 24 hours.","Baseline; Week 24",{"measure":14,"description":15,"timeFrame":12},"Percentage of patients achieving an Investigator Global Assessment for Prurigo Nodularis Stage (IGA PN-S) score of 0 or 1","The percentage of patients achieving an IGA PN-S score of 0 or 1 with a ≥2-point reduction from baseline to Week 24. The IGA PN-S is a rating completed by the investigator during visits assessing the severity of the disease from 0 (Clear) to 4 (Severe)",[17,19,22,25,28,31,34],{"measure":18,"description":11,"timeFrame":12},"Percentage of subjects achieving at least a 4-point reduction from baseline in weekly average PP-NRS at Week 24",{"measure":20,"description":21,"timeFrame":12},"Percent change from baseline in Dermatology Life Quality Index (DLQI) scores at week 24","The DLQI is a 10-item questionnaire used to assess the impact of skin disease on the quality of life of the affected person. The 10 questions are scored from 0 to 3, giving a possible total score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life). Completed by participants during study visits specified in the protocol.",{"measure":23,"description":24,"timeFrame":12},"Percent change from baseline in The Sleep Disturbance Numerical Rating Scale (SD-NRS) at week 24","The SD-NRS is a single-item measure assessing sleep disturbance on a scale from 0 (\"no sleep disturbance\") to 10 (\"worst possible sleep disruption\"). Participants will complete the SD-NRS daily, rating their sleep quality.",{"measure":26,"description":27,"timeFrame":12},"Percent change from baseline in 5D-Pruritus Scale at week 24","5-D pruritus' scale is a questionnaire assessing duration, degree, direction, disability, and distribution of the affected person's itch. Completed by participants during study visits specified in the protocol.",{"measure":29,"description":30,"timeFrame":12},"Percent change from baseline in Prurigo Activity Score (PAS) at week 24","The PAS is a 7-item assessment completed by the investigator. The items of the PAS evaluate the type, number, distribution, size, and activity of skin lesions.",{"measure":32,"description":33,"timeFrame":12},"Percent change from baseline in HADS anxiety and depression scale at week 24","The Hospital Anxiety and Depression Survey is a questionnaire that evaluates and monitors mental health in adults. Completed by participants during study visits specified in the protocol.",{"measure":35,"description":36,"timeFrame":12},"Percent change from baseline in Patient Global Impression of Change (PGIC) at week 24","The PGIC is a questionnaire assessing overall satisfaction and perceived change due to treatment, ranging from \"very much improved\" to \"very much worse\". Completed by participants during study visits specified in the protocol.",null,{"allocation":39,"interventionModel":40,"interventionModelDescription":37,"primaryPurpose":41,"observationalModel":37,"timePerspective":37,"maskingInfo":42},"NA","SINGLE_GROUP","TREATMENT",{"masking":43,"maskingDescription":37,"whoMasked":37},"NONE","This study is a Phase II, single center, open-label, single-arm clinical trial. Study participation will last up to 32 weeks, including a 4-week screening period, a 24-week treatment period with all participants receiving lebrikizumab injections, and a 4-week safety follow up period.",[46],{"label":47,"type":48,"description":49,"interventionNames":50},"Lebrikizumab","EXPERIMENTAL","Participants will receive subcutaneous injections of Lebrikizumab",[51],"Drug: Lebrikizumab",[53],{"type":54,"name":47,"description":55,"armGroupLabels":56,"otherNames":57},"DRUG","Participants will receive subcutaneous injections of Lebrikizumab every two weeks for 24 weeks. The first two doses will be 500 mg, and following doses will be 250 mg.",[47],[58],"Ebglyss",[60],{"name":61,"affiliation":5,"role":62},"Kristin L Khan, MD","PRINCIPAL_INVESTIGATOR",[64,69],{"name":65,"role":66,"phone":67,"phoneExt":37,"email":68},"Brandon J Mangracina, MA","CONTACT","732-757-5831","bmangracina@som.umaryland.edu",{"name":70,"role":66,"phone":71,"phoneExt":37,"email":72},"Marie Vidaver, PhD","410-685-1726","MVidaver@som.umaryland.edu",[74],{"facility":75,"status":37,"city":76,"state":77,"zip":78,"country":79,"countryCode":80,"cosmosGeoPoint":81,"geoPoint":86,"contacts":87},"UM Dermatology at UM Professional Building","Baltimore","Maryland","21201","United States","US",{"type":82,"coordinates":83},"Point",[84,85],-76.61219,39.29038,{"lat":85,"lon":84},[88,89,90,91],{"name":65,"role":66,"phone":67,"phoneExt":37,"email":68},{"name":70,"role":66,"phone":71,"phoneExt":37,"email":72},{"name":61,"role":62,"phone":37,"phoneExt":37,"email":37},{"name":92,"role":93,"phone":37,"phoneExt":37,"email":37},"Carolyn Stolte, CRNP","SUB_INVESTIGATOR",{"type":62,"investigatorFullName":95,"investigatorTitle":96,"investigatorAffiliation":5,"oldNameTitle":37,"oldOrganization":37},"Kristin Khan","Assistant Professor",[98],{"name":99,"class":100},"Eli Lilly and Company","INDUSTRY","100639479",false,"NCT07620561","Efficacy and Speed of Response of Lebrikizumab in High-Burden Prurigo Nodularis Patients","Evaluating the Efficacy and Speed of Response of Lebrikizumab in High-Burden Prurigo Nodularis Patients: A 24-Week Study","Inclusion Criteria:\n\n* Age 18-80\n* Diagnosis of Prurigo Nodularis (PN) for at least 1 year\n* Active PN with moderate-to-severe itch, several nodules, and presence of nodules in more than one part of the body\n* Women of childbearing potential must agree to remain abstinent or use a highly effective contraceptive method during treatment and for at least 18 weeks after the last dose of study drug\n* Male participants must agree to use an effective barrier contraceptive if sexually active with a woman of childbearing potential during treatment and for at least 18 weeks after the last dose of study drug\n\nExclusion Criteria:\n\n* Prior participation in a lebrikizumab study\n* History of anaphylaxis\n* History of or active HIV\n* Active hepatitis or known liver cirrhosis\n* History of cancer in the past 5 years, except for fully treated early cervical cancer in situ or non-melanoma skin cancers (basal cell or squamous cell skin cancer) that have been successfully treated and resolved. This includes certain skin lymphomas such as mycosis fungoides.\n* Uncontrolled chronic conditions that may require intermittent oral steroid use, such as severe uncontrolled asthma\n* Current or recent parasitic infection\n* Immunocompromised individuals\n* Pregnant or breastfeeding women or those planning to become pregnant or breastfeed during the study period\n* Use of other treatments for PN during the study, such as topical, systemic, or light-based treatments\n* Current or recent treatment with biologic drugs\n* Use of drugs that have an effect on the immune system during the study and within 4 weeks of starting the study\n* Receipt of phototherapy or light-based therapy within 4 weeks before starting the study\n* Regular use of tanning booths or parlors within 4 weeks before starting the study\n* Receipt of a live vaccine within 12 weeks before starting the study or planned receipt during the study\n* Recent use of an experimental drug\n\nOther protocol-defined Inclusion\u002FExclusion Criteria apply.","ALL","18 Years","80 Years",{"count":111,"type":112},15,"ESTIMATED","INTERVENTIONAL",[115],"PHASE2","The purpose of this study is to evaluate the effectiveness of lebrikizumab in treating adults with moderate-to-severe Prurigo Nodularis (PN).",[118],"Prurigo Nodularis (PN)",[120,121,122,123,124,125,126,127],"prurigo nodularis","prurigo","lebrikizumab","ebglyss","itch","pruritus","dermatitis","skin diseases","NOT_YET_RECRUITING","2026-05-26",{"date":131,"type":132},"2026-06-02","ACTUAL",{"date":134,"type":112},"2026-06",{"date":136,"type":112},"2028-03",{"name":5,"class":6},1]