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Completed

NCT Number: NCT06424470

Study on the Treatment of Prurigo Nodularis With Stapokibart Injection

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.

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Key information

Conditions

Prurigo Nodularis

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The First Hospital of China Medical University

Shenyang, Liaoning, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stapokibart

Biological

Stapokibart Injection

Placebo

Other

Placebo

Primary outcomes

  1. Proportion of subjects with ≥4-point improvement from baseline in the Worst Itch Numerical Rating Scale (WI-NRS) at week 24

    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.

Secondary outcomes

  1. Proportion of subjects with Investigator's Global Assessment score of 0 or 1 for PN stage (IGA-CNPG S) at week 24

    Time frame: 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.

  2. Change from the baseline in the WI-NRS at each other visit

    Time frame: Up to week 24

  3. Proportion of subjects with Investigator's Global Assessment score of 0 or 1 for PN Activity (IGA-CNPG A) at each visit

    Time frame: Up to week 24

    A clinician-assessed scale to evaluate the overall appearance of lesions in chronic nodular prurigo

  4. Change from baseline in Dermatology Life Quality Index (DLQI) score at each visit

    Time frame: Up to week 24

    A patient-reported questionnaire measuring the impact of skin disorders on daily life and quality of life.

  5. Change from baseline in Skin Pain NRS at each visit

    Time frame: Up to week 24

    A numerical rating scale for patients to self-assess the intensity of skin pain.

  6. Change from baseline in Sleep NRS at each visit

    Time frame: Up to week 24

    A numeric scale used to quantify sleep disturbance caused by disease symptoms.

  7. Change from baseline in Hospital Anxiety and Depression Scale (HADS) at each visit

    Time frame: Up to week 24

    A validated scale for screening anxiety and depression symptoms in clinical populations.

  8. Change from baseline in the European Health Questionnaire 5 Dimensions (EQ-5D-5L) at each visit

    Time frame: Up to week 24

    A standard five-dimension tool to evaluate general health status and health-related quality of life.

  9. Safety parameters

    Time frame: Up to week 32

    Incidence of treatment-emergent adverse events (TEAEs).

  10. Pharmacokinetics (PK)

    Time frame: Up to week 32

    Concentration of CM310 in serum

  11. Pharmacodynamics (PD)

    Time frame: Up to week 32

    Change from baseline in serum thymus activation-regulated chemokine (TARC) concentration.

  12. Anti-drug antibodies (ADA)

    Time frame: Up to week 32

    Incidence of ADA.

  13. Pharmacodynamics (PD)

    Time frame: Up to week 32

    Change from baseline in serum total immunoglobulin E (IgE) concentration.

Sponsors and collaborators

Lead sponsor

Keymed Biosciences Co.Ltd

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of Stapokibart Injection in Subjects With Prurigo Nodularis

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 22, 2024
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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