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

NCT ID: NCT05549947

Last Updated: 2024-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 158 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-08
• Study Completion Date: 2023-11-23

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: SINGLE

Study Groups

Treatment group A：SHR-1819

Group Type: EXPERIMENTAL

SHR1819

Intervention Type: DRUG

Treatment group A：SHR-1819 injection dose 1， Treatment group B：SHR-1819 injection dose 2， Treatment group C：SHR-1819 injection dose 3，

Treatment group B：SHR-1819

Group Type: EXPERIMENTAL

SHR1819

Intervention Type: DRUG

Treatment group A：SHR-1819 injection dose 1， Treatment group B：SHR-1819 injection dose 2， Treatment group C：SHR-1819 injection dose 3，

Treatment group C：SHR-1819

Group Type: EXPERIMENTAL

SHR1819

Intervention Type: DRUG

Treatment group A：SHR-1819 injection dose 1， Treatment group B：SHR-1819 injection dose 2， Treatment group C：SHR-1819 injection dose 3，

Treatment group D：placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Treatment group D：placebo

Interventions

SHR1819

Treatment group A：SHR-1819 injection dose 1， Treatment group B：SHR-1819 injection dose 2， Treatment group C：SHR-1819 injection dose 3，

Intervention Type: DRUG

Placebo

Treatment group D：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. Age 18 to 75 years old (inclusive) at the time of signing the informed consent form, regardless of gender;

3. Have atopic dermatitis at the time of screening (according to the 2014 American College of Dermatology Guidelines) and have a course of at least 1 year before screening;

4. At the screening and baseline periods, EASI ≥ 16, IGA ≥3, BSA ≥ 10 %

5. The average daily peak pruritus (itch) numerical evaluation scale (P-NRS) score for the first 7 days of randomization ≥4 points (at least 4 days of daily peak pruritus P-NRS scores need to be collected);

6. According to the investigators, topical TCS treatment was poor or intolerant within 6 months prior to screening

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

Shanghai Hengrui Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Huashan Sub-Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

SHR-1819-201

Identifier Type: -

Identifier Source: org_study_id