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

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II/III Clinical Study of the Efficacy and Safety of SHR-1819 Injection in Adult Patients With Prurigo Nodularis

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

Study Overview

• Status: Recruiting
• Conditions: Prurigo Nodularis
• Intervention / Treatment: Drug: SHR-1819 Injection; Drug: SHR-1819 Injection Placebo

• Study Type: Interventional
• Enrollment (Estimated): 423
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Huiliu Wang; Phone Number: +86-0518-82342973; Email: huiliu.wang.hw330@hengrui.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100032
      • Recruiting
      • Peking University People's Hospital
      • Principal Investigator: Jianzhong Zhang
      • Contact: Jianzhong Zhang; Phone Number: +86-18001315877; Email: Rmzjz@126.com
      • Principal Investigator: Cheng Zhou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHR-1819 Injection Group; SHR-1819 injection with different doses.	Drug: SHR-1819 Injection; SHR-1819 injection.
Placebo Comparator: SHR-1819 Injection Placebo Group; SHR-1819 injection placebo.	Drug: SHR-1819 Injection Placebo; SHR-1819 injection placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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 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.	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 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.	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.	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.	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.	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.	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.	From the beginning of administration to the 24/60th week.

Collaborators and Investigators

• Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2024
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: August 5, 2024
• First Submitted That Met QC Criteria: August 13, 2024
• First Posted (Actual): August 15, 2024

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Dermatitis; Skin Diseases, Eczematous; Prurigo; Neurodermatitis
• Other Study ID Numbers: SHR-1819-302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No