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NCT Number: NCT07211542

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

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

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Key information

Conditions

Moderate-to-severe Atopic Dermatitis

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dermatology Hospital of Southern Medical University

Guangzhou, Guangdong, 510091, China

Location status: Recruiting

Location contact

Bin Yang

CONTACT

[email protected]

+86-13922207231

Bin Yang

PRINCIPAL_INVESTIGATOR

Suyun Ji

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SHR-1905 Injection

Drug

SHR-1905 injection.

SHR-1905 Injection Blank Preparation

Drug

SHR-1905 injection blank preparation.

Primary outcomes

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

    Time frame: Week 16.

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

Secondary outcomes

  1. 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.

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

  2. 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.

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

  3. 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 Itch Numeric Rating Scale (Itch-NRS) score using the the Worst Itch Numeric Rating Scale.

  4. 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 Itch Numeric Rating Scale (Itch-NRS) score using the the Worst Itch Numeric Rating Scale.

  5. 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.

    EASI score using the EASI scale.

  6. 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.

    EASI score using the EASI scale.

  7. 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.

    EASI score using the EASI scale.

  8. The change value in EASI score from the baseline.

    Time frame: At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252.

    EASI score using the EASI scale.

  9. The percentage of change in EASI score from the baseline.

    Time frame: At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252.

    EASI score using the EASI scale.

  10. 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.

    BSA score using the BSA scale.

  11. 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.

    BSA score using the BSA scale.

  12. Adverse events (AEs).

    Time frame: At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252.

Study contacts

Contact information is provided by the study sponsor or research team.

Ran Li

CONTACT

[email protected]

+86-0518-82342973

Sponsors and collaborators

Lead sponsor

Guangdong Hengrui Pharmaceutical Co., Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Oct 8, 2025
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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