A Phase III Study of GS101 Injection to Dupixent®

Jiangsu Genscend Biopharmaceutical Co., Ltd

Status and phase

Not yet enrolling

Phase 3

Conditions

Atopic Dermatitis (AD)

Treatments

Drug: DUPIXENT®

Drug: GS101 injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT07386743

GS101-03

Details and patient eligibility

About

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®

Enrollment

572 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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