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NCT Number: NCT07386743

A Phase III Study of GS101 Injection to Dupixent®

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®

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Key information

Conditions

Atopic Dermatitis (AD) Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Location contact

Xinghua Gao, M.D.

CONTACT

[email protected]

024-83282524

Xinghua Gao, M.D.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GS101 injection

Drug

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

Dupixent®

Drug

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 outcomes

  1. Proportion of patients achieving EASI-75 at week 16

    Time frame: 16 weeks

    EASI-75

Secondary outcomes

  1. 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 at Weeks 4, 8, 12, 16, 20, 28, 36, 44, 48, and 52

  2. 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-50 at Weeks 4, 8, 12, 16, 20, 28, 36, 44, 48, and 52

  3. Proportion of patients achieving EASI-90

    Time frame: Weeks 4, 8, 12, 16, 20, 28, 36, 44, 48, and 52

    Proportion of patients achieving EASI-90 at Weeks 4, 8, 12, 16, 20, 28, 36, 44, 48, and 52

Study contacts

Contact information is provided by the study sponsor or research team.

Sinian Li, Master

CONTACT

[email protected]

+086-15800767550

Tao Sun, Master

CONTACT

[email protected]

+086-15921575347

Sponsors and collaborators

Lead sponsor

Jiangsu Genscend Biopharmaceutical Co., Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Feb 4, 2026
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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