Prurigo Nodularis
Conditions
Brief summary
This trial was designed to evaluate the efficacy and safety of SHR-1819 injection in patients with Prurigo Nodularis.
Interventions
SHR-1819 injection.
SHR-1819 injection placebo.
Sponsors
Guangdong Hengrui Pharmaceutical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
SHR-1819 compared with placebo
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects voluntarily sign informed consent forms prior to the commencement of any proceedings related to the study, are able to communicate smoothly with the investigator, understand and are willing to complete the study in strict compliance with the requirements of this clinical research protocol. 2. The age was ≥18 at the time of signing the informed consent and gender is unlimited. 3. Has prurigo nodularis at screening.
Exclusion criteria
1. Pregnant or lactating women. 2. Screening for people with a history of heavy alcohol consumption or substance abuse in the 6 months prior to screening. 3. Has an active skin disease or skin complications due to other diseases that may affect the evaluation of PN. 4. PN secondary to medical conditions such as neurological or psychiatric disorders. 5. Diagnosis of moderate to severe AD during the screening/lead-in period or prior to randomization. 6. History of clinically significant diseases (e.g., circulatory system abnormalities, endocrine system abnormalities, neurological disorders, hematologic disorders, immune system disorders, psychiatric disorders, and metabolic instability) that the researcher believes that participation in the study poses a risk to the safety of the subject or that the disease/illness worsens during the study period will affect the effectiveness or safety analysis. 7. Phase II: Treated with biologics targeting IL-4Rα, or participated in previous clinical studies of biologics targeting IL-4Rα, including SHR-1819 injection. Phase III: Subjects who have previously received anti-IL-4Rα biologics for any indication including atopic dermatitis (AD), asthma, sinusitis, etc., and were judged by the investigator to have an inadequate response or intolerance (e.g., experienced drug-related adverse reactions requiring treatment discontinuation) must be excluded even if the washout requirement is met. 8. Subjects with malignancy prior to screening (except for squamous cell carcinoma of the skin, basal cell carcinoma, or carcinoma in situ of the cervix that are completely resected and have no evidence of recurrence). 9. Major surgeries are planned for the duration of the study. 10. Other conditions that, in the opinion of the investigator, are not suitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Up to 16 weeks. | 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. |
| 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 | Up to 24 weeks. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase II: Weekly mean change from baseline and percentage change in weeks 2, 4, 8, 12, and 16 of WI-NRS | Up to 16 weeks. | 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. |
| Phase II: Proportion of subjects with IGA CNPG-S score of 0/1 at weeks 4, 8, 12 and 16 | Up to 16 weeks. | 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. |
| Phase II: Change from baseline in Dermatology Life Quality Index (DLQI) score at weeks 4, 8, 12, 16 | Up to 16 weeks. | 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. |
| Phase III: Proportion of subjects with an IGA CNPG-S score of 0/1 at Week 24 | Up to 24 weeks. | 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. |
| Phase III: Proportion of subjects with IGA CNPG-S score of 0/1 at every study visit | Up to 52 weeks. | 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. |
| Phase III: Change from baseline in Dermatology Life Quality Index (DLQI) score at every study visit | Up to 52 weeks. | 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. |
| Phase II/III: The concentration of SHR-1819 in serum (AUC) | From the beginning of administration to the 24/60th week. | The concentration of SHR-1819 in plasma will be determined. |
| Phase II/III: Changes in the level of IgE in the serum | From the beginning of administration to the 24/60th week. | Changes in the level of biomarkers in serum. |
| Phase II/III: Immunogenic endpoint - evaluate the incidence of ADA positivity for SHR-1819 | From the beginning of administration to the 24/60th week. | Incidence of immunogenicity in the body. |
Countries
China
Contacts
CONTACTHuiliu Wang
Outcome results
None listed