Clinical Study of the Efficacy and Safety of SHR-1819 Injection in Adult Patients With Prurigo Nodularis

Phase 2

Recruiting

• Conditions: Prurigo Nodularis
• Interventions: Drug: SHR-1819 injection; Drug: Placebo

• Registration Number: NCT06554509
• Lead Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-05
• Study First Submitted QC: 2024-08-13
• Study First Posted: 2024-08-15
• Study Start: 2024-09-19
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-08
• Last Update Posted: 2024-10-10
• Primary Completion: 2026-06-25
• Study Completion: 2026-08-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 236

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. Have prurigo Nodularis at screening.

Exclusion Criteria

1. Pregnant or lactating women.
2. Major surgeries are planned for the duration of the study.
3. Has an active skin disease (such as chronic lichen simplex, psoriasis, chronic photosensitive dermatitis, etc.) or skin complications due to other diseases that may affect the evaluation of PN.
4. 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.
5. Treated with biologics targeting IL-4Rα (such as dupliumab), or participated in previous clinical studies of biologics targeting IL-4Rα, including SHR-1819 injection.
6. Screening for people with a history of heavy alcohol consumption or substance abuse in the 6 months prior to screening.
7. Diagnosis of moderate to severe AD during the screening/lead-in period or prior to randomization.
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. Use of other biologics (such as omalizumab) within 3 months or 5 half-lives prior to screening, whichever is longer as confirmation.
10. Other conditions that, in the opinion of the investigator, are not suitable for participation in this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group A：SHR-1819 injection dose 1	SHR-1819 injection	-
Treatment group D：placebo	Placebo	-
Treatment group B：SHR-1819 injection dose 2	SHR-1819 injection	-
Treatment group C：SHR-1819 injection dose 3	SHR-1819 injection	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Phase III: Proportion of subjects with IGA CNPG-S score of 0/1 at weeks 4, 8, 12, 16, and 20	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 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 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 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: Change from baseline in Dermatology Life Quality Index (DLQI) score at weeks 4, 8, 12, 16, 20, 24	up to 24 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 24/32th 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 24/32th 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 24/32th week	Incidence of immunogenicity in the body

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China