Prurigo Nodularis
Conditions
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.
Interventions
BIOLOGICALStapokibart
Stapokibart Injection
OTHERPlacebo
Placebo
Sponsors
Keymed Biosciences Co.Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects with ≥4-point improvement from baseline in the Worst Itch Numerical Rating Scale (WI-NRS) at week 24 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects with Investigator's Global Assessment score of 0 or 1 for PN stage (IGA-CNPG S) at week 24 | Up to week 24 | IGA-CNPG-S stands for Investigator Global Assessment of Chronic Nodular Prurigo - Severity scale, a clinical tool used to rate the overall severity of chronic nodular prurigo (CNPG) by evaluating lesion number, size, and inflammation. |
| Change from the baseline in the WI-NRS at each other visit | Up to week 24 | — |
| Proportion of subjects with Investigator's Global Assessment score of 0 or 1 for PN Activity (IGA-CNPG A) at each visit | Up to week 24 | A clinician-assessed scale to evaluate the overall appearance of lesions in chronic nodular prurigo |
| Change from baseline in Dermatology Life Quality Index (DLQI) score at each visit | Up to week 24 | A patient-reported questionnaire measuring the impact of skin disorders on daily life and quality of life. |
| Change from baseline in Skin Pain NRS at each visit | Up to week 24 | A numerical rating scale for patients to self-assess the intensity of skin pain. |
| Change from baseline in Sleep NRS at each visit | Up to week 24 | A numeric scale used to quantify sleep disturbance caused by disease symptoms. |
| Change from baseline in Hospital Anxiety and Depression Scale (HADS) at each visit | Up to week 24 | A validated scale for screening anxiety and depression symptoms in clinical populations. |
| Change from baseline in the European Health Questionnaire 5 Dimensions (EQ-5D-5L) at each visit | Up to week 24 | A standard five-dimension tool to evaluate general health status and health-related quality of life. |
| Safety parameters | Up to week 32 | Incidence of treatment-emergent adverse events (TEAEs). |
| Pharmacokinetics (PK) | Up to week 32 | Concentration of CM310 in serum |
| Pharmacodynamics (PD) | Up to week 32 | Change from baseline in serum thymus activation-regulated chemokine (TARC) concentration. |
| Anti-drug antibodies (ADA) | Up to week 32 | Incidence of ADA. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORXinghua Gao
First Hospital of China Medical University
Outcome results
None listed