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

NCT07042126 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2025-11-18

No results posted yet for this study

Summary

The primary objective of the study was to evaluate the efficacy of 611 in Chinese Adolescents with moderate to severe atopic dermatitis.

Conditions

  • Dermatitis, Atopic

Interventions

DRUG

611

Double blind treatment period : 611 600 mg/450 mg at day 1，then 300 mg subcutaneous injection Q2W thereafter until week 16 Maintenance treatment period : 611 300 mg subcutaneous injection Q2W/Q3W until week 52.（The subjects in the placebo group during the double-blind treatment period need to be given a loading dose at week 16.）

DRUG

Matching placebo

Double blind treatment period : placebo subcutaneous injection Q2W until week 16.

Sponsors & Collaborators

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

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-05
Primary Completion
2026-06-30
Completion
2027-09-30

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 NCT07042126 on ClinicalTrials.gov