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

Phase 1

Recruiting

• Conditions: Children and Adolescents With Moderate-to-severe Atopic Dermatitis
• Interventions: Drug: SHR-1819 injection

• Registration Number: NCT06713499
• Lead Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-24
• Study First Submitted QC: 2024-11-27
• Study First Posted: 2024-12-03
• Study Start: 2024-12-18
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-25
• Primary Completion: 2025-06
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SHR-1819 injection	SHR-1819 injection	Dose 1, dose 2 and dose 3.

Primary Outcome Measures

Name	Time	Method
Adverse events	Up to 14 weeks.
PR interval	Up to 14 weeks.
Heart rate	Up to 14 weeks.
QT interval	Up to 14 weeks.
QRS duration	Up to 14 weeks.

Secondary Outcome Measures

Name	Time	Method
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	From the beginning of administration to the 14th week.	Changes in the level of biomarkers in serum.
Evaluate the incidence and timing of ADA positivity for SHR-1819	From the beginning of administration to the 14th week.	Changes in the level of immunogenicity in the body.

Trial Locations

Locations (1)

The First Affiliated Hospital of China Medical University; 🇨🇳 Shenyang, Liaoning, China