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
Verified date | May 2024 |
Source | Keymed Biosciences Co.Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Keymed Biosciences Co.Ltd |
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 |
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