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

NCT06713499 | Completed Phase 1

• 1 other identifier: SHR-1819-204
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• 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.

• Evaluate the incidence and timing of ADA positivity for SHR-1819

  From the beginning of administration to the 14th week.

Study Arms (1)

SHR-1819 injection

EXPERIMENTAL

Dose 1, dose 2 and dose 3.

Drug: SHR-1819 injection

Interventions

SHR-1819 injection DRUG

SHR-1819 injection.

SHR-1819 injection

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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;
• At the time of signing the informed consent, the subjects were ≥ 6 years old and \< 18 years old, male or female;
• Have atopic dermatitis at screening.

You may not qualify if:

• Before enrollment, the subjects weighed \< 15kg;
• Females who are pregnant or lactating and have a positive pregnancy test result;
• Have other active skin disease or skin complications due to other conditions that may affect the evaluation of AD;
• Have serious concomitant diseases and other conditions that the investigator considers inappropriate to participate in this trial;
• Treated with biologics targeting IL-4Rα , or participated in previous clinical studies of biologics targeting IL-4Rα, including SHR-1819 injection;
• Has malignancy or has a history of malignancy;
• Hypersensitivity to the study drug or any ingredient in the study drug.

Sponsors & Collaborators

• Guangdong Hengrui Pharmaceutical Co., Ltd: lead

Study Sites (2)

Beijing Children's Hospital, Capital Medical University

Beijing, Beijing Municipality, 100045, China

Location

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, 110002, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2024
• First Posted: December 3, 2024
• Study Start: December 18, 2024
• Primary Completion: November 22, 2025
• Study Completion: November 22, 2025
• Last Updated: July 2, 2026

Record last verified: 2026-06

Locations

CN (2)