Evaluating SHR-1819 injection for severe atopic dermatitis in adults

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

This study is testing a new injection called SHR-1819 to see if it can help adults with moderate to severe atopic dermatitis who haven't found relief from other treatments.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 650 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd (Industry-sponsored)
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT06468956 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the efficacy and safety of SHR-1819 injection in adult patients suffering from moderate to severe atopic dermatitis. Participants will receive either the SHR-1819 treatment or a placebo, with the study designed to measure improvements in their condition based on established dermatological criteria. The trial will include adults aged 18 and older who have had atopic dermatitis for at least one year and have not responded adequately to topical corticosteroids. The study will follow strict protocols to ensure compliance and safety throughout the trial period.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with moderate to severe atopic dermatitis that has persisted for at least one year.

Not a fit: Patients who are pregnant, lactating, or have planned major surgeries during the study period may not benefit from this trial.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with severe atopic dermatitis who have not responded to existing treatments.

How similar studies have performed: While this specific approach may be novel, similar studies evaluating new treatments for atopic dermatitis have shown promising results in the past.

Eligibility criteria

Inclusion Criteria:

1. 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；
2. The age was ≥18 at the time of signing the informed consent and gender is unlimited;
3. 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;
4. EASI ≥ 16, IGA ≥ 3, BSA ≥ 10% during the screening and baseline periods;
5. TCS was not optimal or not tolerated by the investigator.

Exclusion Criteria:

1. Pregnant or lactating women;
2. Major surgeries are planned for the duration of the study;
3. History of previous atopic corneal conjunctivitis involving the cornea;
4. 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;
5. Subjects have had or are currently clinically significant diseases or abnormalities;
6. Screening for people with a history of heavy alcohol consumption or substance abuse in the 3 months prior to screening;
7. The drug has been used in the previous 6 months;
8. 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);
9. Other comorbid (or co-occurring) skin disorders may be affected in the study evaluation;
10. Any cause that the researchers believe would prevent the participants from participating in the study.

Where this trial is running

Shanghai, Shanghai

• Shanghai Fudan University HuaShan Hospital — Shanghai, Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Xiaoyan Bai

Conditions Moderate to Severe Atopic Dermatitis