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NOT YET RECRUITING
NCT07386743
PHASE3

A Phase III Study of GS101 Injection to Dupixent®

Sponsor: Jiangsu Genscend Biopharmaceutical Co., Ltd

View on ClinicalTrials.gov

Summary

This is a a multicenter, randomized, double-blinded, parallel, positive-controlled, Phase III comparative study to evaluate GS101 Injection versus Dupixent® in participants with moderate-to-severe atopic dermatitis. A total of 572 subjects are planned to be included and randomized at a ratio of 1:1 to receive GS101 injection or Dupixent®

Official title: A Multicenter, Randomized, Double-blinded, Parallel, Positive-controlled, Phase III Comparative Study to Evaluate GS101 Injection Versus Dupixent® in Participants With Moderate-to-Severe Atopic Dermatitis

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

572

Start Date

2026-02

Completion Date

2028-01

Last Updated

2026-02-04

Healthy Volunteers

No

Interventions

DRUG

GS101 injection

300mg/2.0mL; an initial dose of 600 mg (two 300 mg injections), followed by 300 mg given every other week (Q2W);subcutaneous injection

DRUG

DUPIXENT®

300mg/2.0mL; an initial dose of 600 mg (two 300 mg injections), followed by 300 mg given every other week (Q2W); subcutaneous injection

Locations (1)

The First Hospital of China Medical University

Shenyang, Liaoning, China