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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06424470
Other study ID # CM310-110201
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
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