NCT06468956CompletedPhase 3
Efficacy and Safety Study of SHR-1819 Injection in Adult Patients With Severe Atopic Dermatitis
A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of SHR-1819 Injection in Patients With Moderate to Severe Atopic Dermatitis
Source: ClinicalTrials.gov · Last updated 3 Sept 2026
Brief summary (registry, in English)
This trial was designed to evaluate the efficacy and safety of SHR-1819 injection in patients with atopic dermatitis.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 652 (actual)
- First submitted
- 24 May 2024
- Start date
- 14 Jun 2024
- Primary completion date
- 26 Aug 2026
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., Ltd
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT06468956
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 652
- From 14 Jun 2024 to the primary completion date, 26 Aug 2026
- 1 site 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
- History of previous atopic corneal conjunctivitis involving the cornea;
- Screening for people with a history of heavy alcohol consumption or substance abuse in the 3 months prior to screening;
- The drug has been used in the previous 6 months;
Other illness
- History of clinically significant diseases (e.g., circulatory system abnormalities, endocrine system abnormalities, neurological disorders, hematologic disorders, immune system disorders, psychiatric disorders, and metabolic instability) that the researcher believes that participation in the study poses a risk to the safety of the subject or that the disease/illness worsens during the study period will affect the effectiveness or safety analysis;
- Subjects have had or are currently clinically significant diseases or abnormalities;
- Screening of subjects with malignancy within the first 5 years (except completely cured cervical cancer in situ and non-metastatic cutaneous squamous cell carcinoma or basal cell carcinoma);
- Other comorbid (or co-occurring) skin disorders may be affected in the study evaluation;
Other
- Pregnant or lactating women;
- Major surgeries are planned for the duration of the study;
- Any cause that the researchers believe would prevent the participants from participating in the study.
Who the study is looking for
- Subjects voluntarily sign informed consent forms prior to the commencement of any proceedings related to the study, are able to communicate smoothly with the investigator, understand and are willing to complete the study in strict compliance with the requirements of this clinical research protocol；
- The age was ≥18 at the time of signing the informed consent and gender is unlimited;
- Atopic dermatitis at screening (according to the 2014 American Society of Dermatology guideline criteria, see Annex 1) and disease duration for at least 1 year before screening as judged by the investigator;
- EASI ≥ 16, IGA ≥ 3, BSA ≥ 10% during the screening and baseline periods;
- TCS was not optimal or not tolerated by the investigator.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Fudan University HuaShan Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.