Study on the Treatment of Prurigo Nodularis With Stapokibart Injection

Keymed Biosciences

Status and phase: Active, not recruiting; Phase 3

Conditions: Prurigo Nodularis

Treatments: Biological: Stapokibart; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06424470

CM310-110201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

Stapokibart

Experimental group

Description:

Stapokibart Injection, subcutaneous injection (SC)

Treatment:

Biological: Stapokibart

Placebo

Placebo Comparator group

Description:

subcutaneous injection (SC)

Treatment:

Other: Placebo