protocolSection identificationModule nctId: NCT06366750, orgStudyIdInfo id: CDX0159-10, secondaryIdInfos id: 2023-510279-80-00, type: OTHER, domain: EU CT, briefTitle: A Study of Barzolvolimab in Patients With Prurigo Nodularis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-01, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Celldex Therapeutics, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to assess the efficacy and safety of barzolvolimab in adults with prurigo nodularis., conditionsModule conditions: Prurigo Nodularis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: barzolvolimab, interventions name: Matching Placebo, outcomesModule primaryOutcomes measure: Proportion of participants with improvement in Worst Itch Numeric Rating Scale (WI-NRS) by ≥ 4 from baseline to Week 12., secondaryOutcomes measure: Proportion of participants with improvement in WI-NRS by ≥ 4 from baseline to Week 4., secondaryOutcomes measure: Proportion of participants with improvement in WI-NRS by ≥ 4 from baseline to Week 24., secondaryOutcomes measure: Proportion of participants with improvement in WI-NRS by ≥ 4 from baseline to Day 169 (week 24)., secondaryOutcomes measure: Proportion of participants with Investigator Global Assessment for stage of chronic nodular prurigo score (IGA-CNPG-S) of 0 or 1 at Weeks 4, 12 and 24., secondaryOutcomes measure: Proportion of participants with improvement in both WI-NRS by ≥ 4 from baseline and IGA-CNPG-S score of 0 or 1 at Weeks 4, 12 and 24., secondaryOutcomes measure: Proportion of participants with Investigator Global Assessment for activity of chronic prurigo (IGA-CPG-A) score of 0 or 1 at Weeks 4, 12 and 24., secondaryOutcomes measure: Absolute change from baseline in WI-NRS at Weeks 4, 12 and 24., secondaryOutcomes measure: Percentage change from baseline in WI-NRS at Weeks 4, 12 and 24., secondaryOutcomes measure: Absolute change from baseline in Sleep Quality Numerical Rating Scale (SQ-NRS) at Weeks 4, 12 and 24., secondaryOutcomes measure: Percentage change from baseline in SQ-NRS at Weeks 4, 12 and 24., secondaryOutcomes measure: Absolute change from baseline in Worst Pain Numerical Rating Scale (WP-NRS) at Weeks 4, 12 and 24., secondaryOutcomes measure: Percentage change from baseline in WP-NRS at Weeks 4, 12 and 24., secondaryOutcomes measure: Absolute change from baseline in Patient-Reported Outcomes Measurement Information System Fatigue - Short Form 7b Daily (PROMIS Fatigue-SF Daily) at Weeks 4, 12 and 24., secondaryOutcomes measure: Percentage change from baseline in PROMIS Fatigue-SF Daily at Weeks 4, 12 and 24., secondaryOutcomes measure: Absolute change from baseline in Dermatology Life Quality Index (DLQI) at Weeks 4, 12 and 24., secondaryOutcomes measure: Percentage change from baseline in Dermatology Life Quality Index (DLQI) at Weeks 4, 12 and 24., secondaryOutcomes measure: Proportion of participants with WI-NRS score < 2 at Weeks 4, 12 and 24., secondaryOutcomes measure: Proportion of participants with improvement in SQ-NRS by ≥ 4 from baseline to Week 4, 12 and 24., secondaryOutcomes measure: Proportion of participants with improvement in WP-NRS by ≥ 4 from baseline to Weeks 4, 12 and 24., secondaryOutcomes measure: Proportion of participants with improvement of ≥ 4 in DLQI from baseline to Weeks 4, 12 and 24., secondaryOutcomes measure: Proportion of participants achieving DLQI score of 0 or 1 at Weeks 4, 12 and 24., secondaryOutcomes measure: Absolute change from baseline in PGIS, PGIS-SD, PGIC and PGIC-SD., secondaryOutcomes measure: Percentage change from baseline in PGIS, PGIS-SD, PGIC and PGIC-SD at Weeks 4, 12 and 24., secondaryOutcomes measure: Number of participants with Treatment-Emergent Adverse Events (TEAEs) throughout the study., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Revival Research Institute, LLC, status: RECRUITING, city: Troy, state: Michigan, zip: 48084, country: United States, contacts name: Sikar Grewal, role: CONTACT, email: grewal@rev-research.com, geoPoint lat: 42.60559, lon: -83.14993, locations facility: Center for Clinical Studies, status: RECRUITING, city: Webster, state: Texas, zip: 77598, country: United States, contacts name: Perla Rivas, role: CONTACT, email: privas@ccstexas.com, geoPoint lat: 29.53773, lon: -95.11826, hasResults: False