NCT07386743

A Phase III Study of GS101 Injection to Dupixent®

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 572 (estimated)
• Sponsor: Jiangsu Genscend Biopharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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®

Conditions

• Atopic Dermatitis (AD)

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-02-01
• Primary completion: 2027-04-01
• Completion: 2028-01-01
• First posted: 2026-02-04
• Last updated: 2026-02-04

Locations

1 site across 1 country: China