Study on the Treatment of Prurigo Nodularis With Stapokibart Injection

Phase 3

Active, not recruiting

• Conditions: Prurigo Nodularis
• Interventions: Biological: Stapokibart; Other: Placebo

• Registration Number: NCT06424470
• Lead Sponsor: Keymed Biosciences Co.Ltd

Brief Summary

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.

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 Timeline

• Study First Submitted: 2024-05-16
• Study First Submitted QC: 2024-05-16
• Study First Posted: 2024-05-22
• Study Start: 2024-06-25
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-22
• Primary Completion: 2026-07-30
• Study Completion: 2026-07-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stapokibart	Stapokibart	Stapokibart Injection, subcutaneous injection (SC)
Placebo	Placebo	subcutaneous injection (SC)

Primary Outcome Measures

Name	Time	Method
Proportion of subjects improved by ≥ 4 points from baseline on the Worst Itch Numerical Rating Scale (WI-NRS) at week 24 of treatment.	Up to 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.

Trial Locations

Locations (1)

The First Hospital of China Medical University; 🇨🇳 Shenyang, Liaoning, China