Trials / Active Not Recruiting
Active Not RecruitingNCT06424470
Study on the Treatment of Prurigo Nodularis With Stapokibart Injection
A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of Stapokibart Injection in Subjects With Prurigo Nodularis
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 200 (actual)
- Sponsor
- Keymed Biosciences Co.Ltd · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Stapokibart | Stapokibart Injection |
| OTHER | Placebo | Placebo |
Timeline
- Start date
- 2024-06-25
- Primary completion
- 2026-07-30
- Completion
- 2026-07-30
- First posted
- 2024-05-22
- Last updated
- 2025-05-22
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06424470. Inclusion in this directory is not an endorsement.