A Study to Investigate the Efficacy and Safety of SHR-1905 in Patients With Moderate-to-severe Atopic Dermatitis

Phase 2RecruitingNCT07211542

Guangdong Hengrui Pharmaceutical Co., Ltd75 enrolled

Overview

This trial was designed to evaluate the efficacy and safety of SHR-1905 in patients with moderate-to-severe atopic dermatitis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Moderate-to-severe Atopic Dermatitis

Interventions

SHR-1905 InjectionDRUG

SHR-1905 injection.

SHR-1905 Injection Blank PreparationDRUG

SHR-1905 injection blank preparation.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. The subjects have voluntarily signed the informed consent form prior to the start of any procedures related to the study, are able to communicate smoothly with the researcher, understand and are willing to strictly abide by the requirements of this clinical research protocol to complete the study. 2. At the time of signing the informed consent, the subjects are ≥ 18 years old and ≤ 75 years old, male or female. 3. Have atopic dermatitis at screening. Exclusion Criteria: 1. Hypersensitivity to the study drug or any ingredient in the study drug. 2. Have other active skin disease or skin complications due to other conditions that may affect the evaluation of Atopic Dermatitis (AD). 3. Has malignancy or has a history of malignancy. 4. Have serious concomitant diseases and other conditions that the investigator considers inappropriate to participate in this trial. 5. Females who are pregnant or lactating.

Locations (1)

Dermatology Hospital of Southern Medical University

Guangzhou, Guangdong, China

RECRUITING

Outcomes

Primary Outcomes

The proportion of subjects whose Eczema Area and Severity Index (EASI) score decreased ≥ 75% compared to the baseline.

Eczema Area and Severity Index (EASI) score using the Eczema Area and Severity Index scale.

Time frame: Week 16.

Secondary Outcomes

The proportion of subjects with Investigator's Global Assessment (IGA) score of 0 or 1 (on a 0-4 scale) and a decrease of ≥2 points from the baseline.

Investigator's Global Assessment (IGA) score using the Investigator Global Assessment (IGA) scale.