This trial was designed to evaluate the efficacy and safety of SHR-1819 injection in patients with Prurigo Nodularis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
423
SHR-1819 injection.
SHR-1819 injection placebo.
Peking University People's Hospital
Beijing, Beijing Municipality, China
RECRUITINGPhase 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.
Time frame: 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.
Time frame: Up to 24 weeks.
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.
Time frame: Up to 16 weeks.
Phase II: Proportion of subjects with IGA CNPG-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.
Time frame: 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.
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Time frame: Up to 16 weeks.
Phase III: Proportion of subjects with an IGA CNPG-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.
Time frame: Up to 24 weeks.
Phase III: Proportion of subjects with IGA CNPG-S score of 0/1 at every study visit
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.
Time frame: Up to 52 weeks.
Phase III: Change from baseline in Dermatology Life Quality Index (DLQI) score at every study visit
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.
Time frame: Up to 52 weeks.
Phase II/III: The concentration of SHR-1819 in serum (AUC)
The concentration of SHR-1819 in plasma will be determined.
Time frame: From the beginning of administration to the 24/60th week.
Phase II/III: Changes in the level of IgE in the serum
Changes in the level of biomarkers in serum.
Time frame: From the beginning of administration to the 24/60th week.
Phase II/III: Immunogenic endpoint - evaluate the incidence of ADA positivity for SHR-1819
Incidence of immunogenicity in the body.
Time frame: From the beginning of administration to the 24/60th week.