Study on the Treatment of Prurigo Nodularis With Stapokibart Injection

A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of Stapokibart Injection in Subjects With Prurigo Nodularis

This study is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study to evaluate the efficacy and safety of Stapokibart Injection in the treatment of subjects with prurigo nodularis, and observe pharmacokinetic characteristics, pharmacological effects, and immunogenicity.

Study Overview

• Status: Completed
• Conditions: Prurigo Nodularis
• Intervention / Treatment: Other: Placebo; Biological: Stapokibart

Detailed Description

Chronic prurigo (CPG) is an independent chronic inflammatory skin disease characterized by chronic itching and multiple local or systemic prurigo lesions. Prurigo nodularis (PN) is the main subtype of CPG.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China
      • The First Hospital of China Medical University

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Able to understand and agree to comply with the experimental process of this study and voluntarily sign the informed consent form.
• 18 ≤ Age ≤ 75 years old.
• Received at least 2 weeks of moderate or more potent topical corticosteroid therapy with insufficient efficacy.

Exclusion Criteria:

• With drug-induced prurigo nodularis.
• With clinically significant diseases.
• With severe liver and kidney function damage at the screening.
• With malignant tumors within the first 5 years before the screening.
• Plan to undergo major surgical procedures during 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: Stapokibart; Stapokibart Injection, subcutaneous injection (SC)	Biological: Stapokibart; Stapokibart Injection
Placebo Comparator: Placebo; subcutaneous injection (SC)	Other: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects with ≥4-point improvement from baseline in the Worst Itch Numerical Rating Scale (WI-NRS) at week 24	The Worst Itch Numerical Rating Scale (WI-NR) is a patient-reported outcome (PRO) consisting of individual items with scores ranging from 0 ("no itching") to 10 ("the most severe itching imaginable"). Subjects are required to use this scale to rate the severity of their most severe itching in the past 24 hours.	Up to week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects with Investigator's Global Assessment score of 0 or 1 for PN stage (IGA-CNPG S) at week 24	IGA-CNPG-S stands for Investigator Global Assessment of Chronic Nodular Prurigo - Severity scale, a clinical tool used to rate the overall severity of chronic nodular prurigo (CNPG) by evaluating lesion number, size, and inflammation.	Up to week 24
Change from the baseline in the WI-NRS at each other visit		Up to week 24
Proportion of subjects with Investigator's Global Assessment score of 0 or 1 for PN Activity (IGA-CNPG A) at each visit	A clinician-assessed scale to evaluate the overall appearance of lesions in chronic nodular prurigo	Up to week 24
Change from baseline in Dermatology Life Quality Index (DLQI) score at each visit	A patient-reported questionnaire measuring the impact of skin disorders on daily life and quality of life.	Up to week 24
Change from baseline in Skin Pain NRS at each visit	A numerical rating scale for patients to self-assess the intensity of skin pain.	Up to week 24
Change from baseline in Sleep NRS at each visit	A numeric scale used to quantify sleep disturbance caused by disease symptoms.	Up to week 24
Change from baseline in Hospital Anxiety and Depression Scale (HADS) at each visit	A validated scale for screening anxiety and depression symptoms in clinical populations.	Up to week 24
Change from baseline in the European Health Questionnaire 5 Dimensions (EQ-5D-5L) at each visit	A standard five-dimension tool to evaluate general health status and health-related quality of life.	Up to week 24
Safety parameters	Incidence of treatment-emergent adverse events (TEAEs).	Up to week 32
Pharmacokinetics (PK)	Concentration of CM310 in serum	Up to week 32
Pharmacodynamics (PD)	Change from baseline in serum thymus activation-regulated chemokine (TARC) concentration.	Up to week 32
Anti-drug antibodies (ADA)	Incidence of ADA.	Up to week 32
Pharmacodynamics (PD)	Change from baseline in serum total immunoglobulin E (IgE) concentration.	Up to week 32

Collaborators and Investigators

• Sponsor: Keymed Biosciences Co.Ltd
• Investigators: Principal Investigator: Xinghua Gao, First Hospital of China Medical University

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2024
• Primary Completion (Actual): February 11, 2026
• Study Completion (Actual): February 11, 2026

Study Registration Dates

• First Submitted: May 16, 2024
• First Submitted That Met QC Criteria: May 16, 2024
• First Posted (Actual): May 22, 2024

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 31, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Eczematous; Dermatitis; Prurigo; Neurodermatitis
• Other Study ID Numbers: CM310-110201

Drug and device information, study documents

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