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

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

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

Study Overview

• Status: Recruiting
• Conditions: Children and Adolescents With Moderate-to-severe Atopic Dermatitis
• Intervention / Treatment: Drug: SHR-1819 injection

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Xiaoyan Bai; Phone Number: 0518-82342973; Email: xiaoyan.bai.xb1@hengrui.com

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China, 110002
      • Recruiting
      • The First Affiliated Hospital of China Medical University
      • Contact: Xinghua Gao; Phone Number: 13940152467; Email: gaobarry@hotmail.com
      • Principal Investigator: Xinghua Gao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHR-1819 injection; Dose 1, dose 2 and dose 3.	Drug: SHR-1819 injection; SHR-1819 injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Adverse events	Up to 14 weeks.
Heart rate	Up to 14 weeks.
PR interval	Up to 14 weeks.
QT interval	Up to 14 weeks.
QRS duration	Up to 14 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The concentration of SHR-1819 in serum		From the beginning of administration to the 14th week.
Changes in the level of TARC/CCL17 in the serum	Changes in the level of biomarkers in serum.	From the beginning of administration to the 14th week.
Evaluate the incidence and timing of ADA positivity for SHR-1819	Changes in the level of immunogenicity in the body.	From the beginning of administration to the 14th week.

Collaborators and Investigators

• Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: November 24, 2024
• First Submitted That Met QC Criteria: November 27, 2024
• First Posted (Actual): December 3, 2024

Study Record Updates

• Last Update Posted (Actual): July 10, 2025
• Last Update Submitted That Met QC Criteria: July 9, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis, Atopic; Dermatitis; Eczema
• Other Study ID Numbers: SHR-1819-204

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No