Clinical Study of the Efficacy and Safety of SHR-1819 Injection in Adult Patients With Prurigo Nodularis
NCT Number: NCT06554509
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2|PHASE3
Conditions: Prurigo Nodularis
Interventions: DRUG: SHR-1819 injection|DRUG: Placebo
Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 236
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-20
Completion Date: 2026-08-20
Locations: Peking University People's Hospital, Beijing, Beijing, 100032, China

Summary:
This trial was designed to evaluate the efficacy and safety of SHR-1819 injection in patients with Prurigo Nodularis.

Primary Outcome Measures: Phase II: Proportion of subjects with a ≥4-point reduction from baseline in the weekly mean of the Most Intense Pruritus Numeric Rating Scale (WI-NRS) at Week 16, Participants were asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicated more severity., up to 16 weeks|Phase III: Proportion of subjects with a ≥4-point reduction from baseline in the weekly mean of the Most Intense Pruritus Numeric Rating Scale (WI-NRS) at Week 24, Participants were asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicated more severity., up to 24 weeks
Secondary Outcome Measures: Phase II: Weekly mean change from baseline and percentage change in weeks 2, 4, 8, 12, and 16 of WI-NRS, Participants were asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicated more severity., up to 16 weeks|Phase II: Proportion of subjects with IGA PN-S score of 0/1 at weeks 4, 8, 12 and 16, It consists of a 5-point scale ranging from 0 to 4 where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. Higher scores indicate severe PN., up to 16 weeks|Phase II: Change from baseline in Dermatology Life Quality Index (DLQI) score at weeks 4, 8, 12, 16, It comprises of set of 10 questions. Responses to each question were assessed on a 4-point Likert scale ranged from 0 (not at all) to 3 (very much). Scores from all 10 questions added up to give total DLQI scores ranged from 0 (not at all) to 30 (very much), higher scores indicated more impact on quality of life., up to 16 weeks|Phase III: Proportion of subjects with an IGA PN-S score of 0/1 at week 24, It consists of a 5-point scale ranging from 0 to 4 where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. Higher scores indicate severe PN., up to 24 weeks|Phase III: Proportion of subjects with IGA PN-S score of 0/1 at weeks 4, 8, 12, 16, and 20, It consists of a 5-point scale ranging from 0 to 4 where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. Higher scores indicate severe PN., up to 24 weeks|Phase III: Change from baseline in Dermatology Life Quality Index (DLQI) score at weeks 4, 8, 12, 16, 20, 24, It comprises of set of 10 questions. Responses to each question were assessed on a 4-point Likert scale ranged from 0 (not at all) to 3 (very much). Scores from all 10 questions added up to give total DLQI scores ranged from 0 (not at all) to 30 (very much), higher scores indicated more impact on quality of life., up to 24 weeks|Phase II/III: The concentration of SHR-1819 in serum: AUC, The concentration of SHR-1819 in plasma will be determined, From the beginning of administration to the 24/32th week|Phase II/III: Changes in the level of IgE in the serum, Changes in the level of biomarkers in serum, From the beginning of administration to the 24/32th week|Phase II/III: Immunogenic endpoint: evaluate the incidence of ADA positivity for SHR-1819, Incidence of immunogenicity in the body, From the beginning of administration to the 24/32th week