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NCT07321951Active, not recruitingPhase 2

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

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

Source: ClinicalTrials.gov · Last updated 4 Jun 2026

Brief summary (registry, in English)

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

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
201 (actual)
First submitted
21 Dec 2025
Start date
9 Jan 2026
Primary completion date
Jun 2027
Lead sponsor
Guangdong Hengrui Pharmaceutical Co., Ltd
NCT number
NCT07321951

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 201
  • From 9 Jan 2026 to the primary completion date, Jun 2027
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • A history of spring keratoconjunctivitis and/or atopic keratoconjunctivitis within 6 months prior to screening.
  • Have serious concomitant diseases and other conditions that the investigator considers inappropriate to participate in this trial.

Other illness

  • 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.
  • Hypersensitivity to the study drug or any ingredient in the study drug.

Other

  • Females who are pregnant or lactating.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Dermatology Hospital of Southern Medical University
Coordinator of this site? Confirm its status
GuangzhouChinaUnknown status
Hangzhou Third People's Hospital
Coordinator of this site? Confirm its status
HangzhouChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.