A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of Stapokibart Injection in Subjects With Prurigo Nodularis
Overview
- Phase
- Phase 3
- Intervention
- Stapokibart
- Conditions
- Prurigo Nodularis
- Sponsor
- Keymed Biosciences Co.Ltd
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Proportion of subjects improved by ≥ 4 points from baseline on the Worst Itch Numerical Rating Scale (WI-NRS) at week 24 of treatment.
- Status
- Active, not recruiting
- Last Updated
- 11 months ago
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Stapokibart
Stapokibart Injection, subcutaneous injection (SC)
Intervention: Stapokibart
Placebo
subcutaneous injection (SC)
Intervention: Placebo
Outcomes
Primary Outcomes
Proportion of subjects improved by ≥ 4 points from baseline on the Worst Itch Numerical Rating Scale (WI-NRS) at week 24 of treatment.
Time Frame: 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.