Study on the Treatment of Prurigo Nodularis With Stapokibart Injection

Prurigo Nodularis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06424470
• Other study ID #: CM310-110201
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: July 30, 2024
• Est. completion date: July 30, 2026

Study information

• Verified date: May 2024
• Source: Keymed Biosciences Co.Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: July 30, 2026
• Est. primary completion date: July 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neurodermatitis
• Prurigo
• Prurigo Nodularis

Intervention

Biological:
• Stapokibart
Stapokibart Injection

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Keymed Biosciences Co.Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Propotion of subjects improved by = 4 points from baseline on the Worst Itch Numerical Rating Scale (WI-NRS) at week 24 of treatment.	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