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Evaluation of 611 in Chinese Children and Adolescents With Moderate to Severe Atopic Dermatitis

NCT06324812 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2025-12-16

No results posted yet for this study

Summary

The primary objective of the study was to evaluate the safety and pharmacokinetic of 611 in Chinese children and adolescents with moderate to severe atopic dermatitis.

Conditions

  • Dermatitis, Atopic

Interventions

DRUG

Recombinant Anti-interleukin-4 Receptor Alpha Monoclonal Antibody Injection (611)

subcutaneous injection，611 450/600mg (loading dose) + 300mg once every 2 weeks/4 weeks

Sponsors & Collaborators

  • Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Lin Ma, MD · Beijing Children's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-10
Primary Completion
2026-08-31
Completion
2026-08-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06324812 on ClinicalTrials.gov