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ACTIVE NOT RECRUITING
NCT06324812
PHASE1/PHASE2

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

Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: A Phase Ib/II Study to Evaluate the Safety, Pharmacokinetic and Efficacy of Recombinant Anti-interleukin-4 Receptor Alpha Monoclonal Antibody Injection (611) in Chinese Children and Adolescents (6 Years Old ≤ Age <18 Years Old) With Moderate to Severe Atopic Dermatitis

Key Details

Gender

All

Age Range

6 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

124

Start Date

2024-07-10

Completion Date

2026-08

Last Updated

2025-12-16

Healthy Volunteers

No

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

Locations (1)

Beijing Children's Hospital

Beijing, Beijing Municipality, China