nctId: NCT06366750 id: CDX0159-10 id: 2023-510279-80-00 type: OTHER domain: EU CT briefTitle: A Study of Barzolvolimab in Patients With Prurigo Nodularis overallStatus: RECRUITING date: 2024-04 date: 2026-01 date: 2026-06 date: 2024-04-16 date: 2024-04-16 name: Celldex Therapeutics class: INDUSTRY briefSummary: The purpose of this study is to assess the efficacy and safety of barzolvolimab in adults with prurigo nodularis. conditions: Prurigo Nodularis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: barzolvolimab name: Matching Placebo measure: Proportion of participants with improvement in Worst Itch Numeric Rating Scale (WI-NRS) by ≥ 4 from baseline to Week 12. measure: Proportion of participants with improvement in WI-NRS by ≥ 4 from baseline to Week 4. measure: Proportion of participants with improvement in WI-NRS by ≥ 4 from baseline to Week 24. measure: Proportion of participants with improvement in WI-NRS by ≥ 4 from baseline to Day 169 (week 24). 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. 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. 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. measure: Absolute change from baseline in WI-NRS at Weeks 4, 12 and 24. measure: Percentage change from baseline in WI-NRS at Weeks 4, 12 and 24. measure: Absolute change from baseline in Sleep Quality Numerical Rating Scale (SQ-NRS) at Weeks 4, 12 and 24. measure: Percentage change from baseline in SQ-NRS at Weeks 4, 12 and 24. measure: Absolute change from baseline in Worst Pain Numerical Rating Scale (WP-NRS) at Weeks 4, 12 and 24. measure: Percentage change from baseline in WP-NRS at Weeks 4, 12 and 24. 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. measure: Percentage change from baseline in PROMIS Fatigue-SF Daily at Weeks 4, 12 and 24. measure: Absolute change from baseline in Dermatology Life Quality Index (DLQI) at Weeks 4, 12 and 24. measure: Percentage change from baseline in Dermatology Life Quality Index (DLQI) at Weeks 4, 12 and 24. measure: Proportion of participants with WI-NRS score < 2 at Weeks 4, 12 and 24. measure: Proportion of participants with improvement in SQ-NRS by ≥ 4 from baseline to Week 4, 12 and 24. measure: Proportion of participants with improvement in WP-NRS by ≥ 4 from baseline to Weeks 4, 12 and 24. measure: Proportion of participants with improvement of ≥ 4 in DLQI from baseline to Weeks 4, 12 and 24. measure: Proportion of participants achieving DLQI score of 0 or 1 at Weeks 4, 12 and 24. measure: Absolute change from baseline in PGIS, PGIS-SD, PGIC and PGIC-SD. measure: Percentage change from baseline in PGIS, PGIS-SD, PGIC and PGIC-SD at Weeks 4, 12 and 24. measure: Number of participants with Treatment-Emergent Adverse Events (TEAEs) throughout the study. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Revival Research Institute, LLC status: RECRUITING city: Troy state: Michigan zip: 48084 country: United States name: Sikar Grewal role: CONTACT email: grewal@rev-research.com lat: 42.60559 lon: -83.14993 facility: Center for Clinical Studies status: RECRUITING city: Webster state: Texas zip: 77598 country: United States name: Perla Rivas role: CONTACT email: privas@ccstexas.com lat: 29.53773 lon: -95.11826 hasResults: False