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Not yet recruiting NCT07386743

A Phase III Study of GS101 Injection to Dupixent®

Phase III Interventional Atopic Dermatitis (AD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: GS101 injection, DUPIXENT®.
Who it may be relevant to
Registry conditions: Atopic Dermatitis (AD). Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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®

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

Primary outcome measures

  • Proportion of patients achieving EASI-75 at week 16 [Time frame: 16 weeks]
Secondary outcome measures (3)
  • Proportion of patients achieving EASI-75 [Time frame: Weeks 4, 8, 12, 16, 20, 28, 36, 44, 48, and 52]
  • Proportion of patients achieving EASI-50 [Time frame: Weeks 4, 8, 12, 16, 20, 28, 36, 44, 48, and 52]
  • Proportion of patients achieving EASI-90 [Time frame: Weeks 4, 8, 12, 16, 20, 28, 36, 44, 48, and 52]

Eligibility criteria

Inclusion criteria

  • Subjects, male or female, between the ages of 18 and 75 years (inclusive)
  • At the time of screening, the diagnosis of atopic dermatitis (AD) meets the Hanifin-Rajka criteria, with a disease history for at least 1 year prior to screening
  • During the screening period and at baseline, patients with moderate-to-severe atopic dermatitis, defined as meeting all of the following 3 criteria concurrently: a. IGA score ≥ 3; b. EASI score ≥ 16; c. BSA ≥ 10%.

Exclusion criteria

  • Hypersensitivity or known allergy to the investigational product(s) or any of their excipients
  • Treatment with any investigational drug, medical device, or other biologic agent within 8 weeks prior to randomization or within 5 half-lives (if the half-life is known), whichever is longer
  • Receipt of any live or live-attenuated vaccine within 3 months prior to randomization, or planned receipt of such vaccines during the study period

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • The First Hospital of China Medical University — Shenyang

Identifiers

NCT: NCT07386743 · GS101-03

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗