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

NCT06554509 | Recruiting Phase 2

• 1 other identifier: SHR-1819-302
• Study Type: interventional
• Target: 423
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prurigo Nodularis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• 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.

• Phase II: Proportion of subjects with IGA CNPG-S score of 0/1 at weeks 4, 8, 12 and 16

  Up to 16 weeks.

• Phase II: Change from baseline in Dermatology Life Quality Index (DLQI) score at weeks 4, 8, 12, 16

  Up to 16 weeks.

• Phase III: Proportion of subjects with an IGA CNPG-S score of 0/1 at Week 24

  Up to 24 weeks.

• Phase III: Proportion of subjects with IGA CNPG-S score of 0/1 at every study visit

  Up to 52 weeks.

Study Arms (2)

SHR-1819 Injection Group

EXPERIMENTAL

SHR-1819 injection with different doses.

Drug: SHR-1819 Injection

SHR-1819 Injection Placebo Group

PLACEBO COMPARATOR

SHR-1819 injection placebo.

Drug: SHR-1819 Injection Placebo

Interventions

SHR-1819 Injection DRUG

SHR-1819 injection.

SHR-1819 Injection Group

SHR-1819 Injection Placebo DRUG

SHR-1819 injection placebo.

SHR-1819 Injection Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• The age was ≥18 at the time of signing the informed consent and gender is unlimited.
• Has prurigo nodularis at screening.

You may not qualify if:

• Pregnant or lactating women.
• Screening for people with a history of heavy alcohol consumption or substance abuse in the 6 months prior to screening.
• Has an active skin disease or skin complications due to other diseases that may affect the evaluation of PN.
• PN secondary to medical conditions such as neurological or psychiatric disorders.
• Diagnosis of moderate to severe AD during the screening/lead-in period or prior to randomization.
• 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.
• 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.
• 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).
• Major surgeries are planned for the duration of the study.
• Other conditions that, in the opinion of the investigator, are not suitable for participation in this study.

Sponsors & Collaborators

• Guangdong Hengrui Pharmaceutical Co., Ltd: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100032, China

RECRUITING

Central Study Contacts

Huiliu Wang

CONTACT

+86-0518-82342973; huiliu.wang.hw330@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: SHR-1819 compared with placebo

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: August 15, 2024
• Study Start: September 19, 2024
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

CN (1)