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NCT Number: NCT07321951

A Study of SHR-1819 in Patients With Moderate-to-severe Atopic Dermatitis

This trial was designed to evaluate the efficacy and safety of SHR-1819 in adult patients with moderate-to-severe atopic dermatitis.

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This study is active but is not currently recruiting participants.

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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, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • At the time of signing the informed consent, the subjects are ≥18 years old and ≤75 years old, male or female.
  • 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.
  • Topical emollients are applied at a stable dose twice daily for at least 7 days before the first dose in the run-in phase and continued for the duration of the study.
  • Have atopic dermatitis at the time of screening and have an investigator-assessed history of atopic dermatitis for at least 1 year before screening.
  • Have moderate to severe atopic dermatitis during the screening period and on the day of the first dose.

Exclusion criteria

  • Have other active skin disease or skin complications due to other conditions that may affect the evaluation of Atopic Dermatitis (AD).
  • A history of spring keratoconjunctivitis and/or atopic keratoconjunctivitis within 6 months prior to screening.
  • 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.
  • Hypersensitivity to the study drug or any ingredient in the study drug.
  • Females who are pregnant or lactating.

Treatment and study plan

SHR-1819 Injection

Drug

SHR-1819 injection.

SHR-1819 Injection Blank Preparation

Drug

SHR-1819 injection blank preparation.

Primary outcomes

  1. The proportion of participants who achieved EASI-75 (≥75% decrease in the score on the Eczema Area and Severity Index (EASI) from the baseline).

    Time frame: Week 24.

    Eczema Area and Severity Index score using the Eczema Area and Severity Index scale.

Secondary outcomes

  1. The proportion of participants with a baseline daily Itch Numeric Rating Scale (I-NRS) score of ≤4 per week.

    Time frame: Week 24.

    The Itch Numeric Rating Scale score using the Itch Numeric Rating Scale.

  2. Adverse events (AEs).

    Time frame: About 42 weeks.

  3. The concentration of SHR-1819 in serum.

    Time frame: From week -16 to week -8, about every 4 weeks; From week 0 to week 32, about every 8 weeks.

Sponsors and collaborators

Lead sponsor

Guangdong Hengrui Pharmaceutical Co., Ltd

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-blind, Phase II Study to Evaluate the Efficacy and Safety of SHR-1819 Injection in Adult Patients With Moderate to Severe Atopic Dermatitis

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 7, 2026
Registry last updated
Jun 4, 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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