Study on the Treatment of Prurigo Nodularis With Stapokibart Injection

NCT06424470 | Completed Phase 3

• 1 other identifier: CM310-110201
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Prurigo Nodularis

Outcome Measures

Primary Outcomes (1)

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

  Up to week 24

Secondary Outcomes (13)

• 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

• 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

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

  Up to week 24

• Change from baseline in Skin Pain NRS at each visit

  Up to week 24

Study Arms (2)

Stapokibart

EXPERIMENTAL

Stapokibart Injection, subcutaneous injection (SC)

Biological: Stapokibart

Placebo

PLACEBO COMPARATOR

subcutaneous injection (SC)

Other: Placebo

Interventions

Stapokibart BIOLOGICAL

Stapokibart Injection

Stapokibart

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to understand and agree to comply with the experimental process of this study and voluntarily sign the informed consent form.
• ≤ Age ≤ 75 years old.
• Received at least 2 weeks of moderate or more potent topical corticosteroid therapy with insufficient efficacy.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Keymed Biosciences Co.Ltd: lead

Study Sites (1)

The First Hospital of China Medical University

Shenyang, Liaoning, China

Location

Study Officials

• Xinghua Gao

  First Hospital of China Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: May 22, 2024
• Study Start: June 25, 2024
• Primary Completion: February 11, 2026
• Study Completion: February 11, 2026
• Last Updated: June 2, 2026

Record last verified: 2026-05

Locations

CN (1)