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Recruiting NCT07211542

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

Phase II Interventional Moderate-to-severe Atopic Dermatitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SHR-1905 Injection, SHR-1905 Injection Blank Preparation.
Who it may be relevant to
Registry conditions: Moderate-to-severe Atopic Dermatitis. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized, Double-blind, Placebo-controlled Phase IIa Study to Evaluate the Efficacy and Safety of SHR-1905 Injection in Patients With Moderate to Severe Atopic Dermatitis

Overview

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

Interventions

  • Drug SHR-1905 Injection
    SHR-1905 injection.
  • Drug SHR-1905 Injection Blank Preparation
    SHR-1905 injection blank preparation.

Primary outcome measures

  • The proportion of subjects whose Eczema Area and Severity Index (EASI) score decreased ≥ 75% compared to the baseline. [Time frame: Week 16.]
Secondary outcome measures (12)
  • 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. [Time frame: At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252.]
  • The proportion of subjects whose Investigator's Global Assessment (IGA) score decreased ≥ 2 points compared to the baseline. [Time frame: At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252.]
  • The change value of change in the Itch Numeric Rating Scale (Itch-NRS) score from the baseline. [Time frame: At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252.]
  • The percentage of change in the Itch Numeric Rating Scale (Itch-NRS) score from the baseline. [Time frame: At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252.]
  • The proportion of subjects whose EASI score decreased ≥ 75% compared to the baseline. [Time frame: At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252.]
  • The proportion of subjects whose EASI score decreased ≥ 90% compared to the baseline. [Time frame: At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252.]
  • The proportion of subjects whose EASI score decreased ≥ 50% compared to the baseline. [Time frame: At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252.]
  • The change value in EASI score from the baseline. [Time frame: At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252.]
  • The percentage of change in EASI score from the baseline. [Time frame: At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252.]
  • The change in Body Surface Area Involvement of Atopic Dermatitis (BSA) from the baseline. [Time frame: At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252.]
  • The percentage of change in Body Surface Area Involvement of Atopic Dermatitis (BSA) from the baseline. [Time frame: At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252.]
  • Adverse events (AEs). [Time frame: At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252.]

Eligibility criteria

Inclusion criteria

  • 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.
  • At the time of signing the informed consent, the subjects are ≥ 18 years old and ≤ 75 years old, male or female.
  • Have atopic dermatitis at screening.

Exclusion criteria

  • Hypersensitivity to the study drug or any ingredient in the study drug.
  • Have other active skin disease or skin complications due to other conditions that may affect the evaluation of Atopic Dermatitis (AD).
  • Has malignancy or has a history of malignancy.
  • Have serious concomitant diseases and other conditions that the investigator considers inappropriate to participate in this trial.
  • Females who are pregnant or lactating.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Dermatology Hospital of Southern Medical University — Guangzhou

Identifiers

NCT: NCT07211542 · SHR-1905-205

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗