## Protocol Section
### Identification Module
**NCT ID:** NCT06424470

**Brief Title:** Study on the Treatment of Prurigo Nodularis With Stapokibart Injection

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

#### Organization Study ID Info
**ID:** CM310-110201
#### Organization
**Class:** INDUSTRY
**Full Name:** Keymed Biosciences Co.Ltd
### Status Module
#### Completion Date
**Date:** 2026-07-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-16

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-07-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-07-30

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Keymed Biosciences Co.Ltd

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Prurigo Nodularis

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 150

**Type:** ESTIMATED

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Stapokibart Injection, subcutaneous injection (SC)

**Intervention Names:**

- Biological: Stapokibart

**Label:** Stapokibart

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** subcutaneous injection (SC)

**Intervention Names:**

- Other: Placebo

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Stapokibart

**Description:** Stapokibart Injection

**Name:** Stapokibart

**Type:** BIOLOGICAL

#### Intervention 2

**Arm Group Labels:**

- Placebo

**Description:** Placebo

**Name:** Placebo

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Propotion of subjects improved by ≥ 4 points from baseline on the Worst Itch Numerical Rating Scale (WI-NRS) at week 24 of treatment.

**Time Frame:** Up to week 24

### Eligibility Module

**Eligibility Criteria:** 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.

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012871

- Term: Skin Diseases

- ID: D000003872

- Term: Dermatitis

- ID: D000017443

- Term: Skin Diseases, Eczematous

### Condition Browse Module - Browse Branches

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M14395

- Name: Prurigo

- Relevance: HIGH

- As Found: Prurigo

- ID: M12394

- Name: Neurodermatitis

- Relevance: HIGH

- As Found: Prurigo Nodularis

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7067

- Name: Dermatitis

- Relevance: LOW

- As Found: Unknown

- ID: M19712

- Name: Skin Diseases, Eczematous

- Relevance: LOW

- As Found: Unknown

- ID: T4769

- Name: Prurigo Nodularis

- Relevance: HIGH

- As Found: Prurigo Nodularis

### Condition Browse Module - Meshes

- ID: D000011536

- Term: Prurigo

- ID: D000009450

- Term: Neurodermatitis

### Misc Info Module

- Version Holder: 2024-05-31
