A Phase Ib/II Study to Investigate the Safety of SHR-1819 in Children and Adolescents With Moderate-to-severe Atopic Dermatitis

NCT ID: NCT06713499

Last Updated: 2025-07-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-18
• Study Completion Date: 2025-12-31

Brief Summary

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

Conditions

Children and Adolescents With Moderate-to-severe Atopic Dermatitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SHR-1819 injection

Dose 1, dose 2 and dose 3.

Group Type: EXPERIMENTAL

SHR-1819 injection

Intervention Type: DRUG

SHR-1819 injection.

Interventions

SHR-1819 injection

SHR-1819 injection.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Subjects and their parents or legal guardians 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 investigator, understand and are willing to strictly comply with the requirements of this clinical study protocol to complete the study;

2. At the time of signing the informed consent, the subjects were ≥ 6 years old and < 18 years old, male or female;

3. Have atopic dermatitis at screening.

Exclusion Criteria

1. Before enrollment, the subjects weighed < 15kg;

2. Females who are pregnant or lactating and have a positive pregnancy test result;

3. Have other active skin disease or skin complications due to other conditions that may affect the evaluation of AD;

4. Have serious concomitant diseases and other conditions that the investigator considers inappropriate to participate in this trial;

5. Treated with biologics targeting IL-4Rα , or participated in previous clinical studies of biologics targeting IL-4Rα, including SHR-1819 injection;

6. Has malignancy or has a history of malignancy;

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangdong Hengrui Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaoyan Bai

Role: CONTACT

xiaoyan.bai.xb1@hengrui.com

0518-82342973

Facility Contacts

Xinghua Gao

Role: primary

gaobarry@hotmail.com

13940152467

Other Identifiers

SHR-1819-204

Identifier Type: -

Identifier Source: org_study_id