Efficacy and Safety Study of SHR-1819 Injection in Adult Patients With Severe Atopic Dermatitis

NCT ID: NCT06468956

Last Updated: 2025-09-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 652 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-14
• Study Completion Date: 2026-03-31

Brief Summary

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

Conditions

Moderate to Severe Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

SHR-1819 injection dose 1

Group Type: EXPERIMENTAL

SHR-1819

Intervention Type: DRUG

SHR-1819 injection

SHR-1819 injection dose 2

Group Type: EXPERIMENTAL

SHR-1819

Intervention Type: DRUG

SHR-1819 injection

placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

placebo

Interventions

SHR-1819

SHR-1819 injection

Intervention Type: DRUG

Placebo

placebo

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangdong Hengrui Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Fudan University HuaShan Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

SHR-1819-301

Identifier Type: -

Identifier Source: org_study_id