A Phase III Study of GS101 Injection to Dupixent®

February 2, 2026 updated by: Jiangsu Genscend Biopharmaceutical Co., Ltd

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

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®

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

572

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110001
        • The First Hospital of China Medical University
        • Contact:
        • Principal Investigator:
          • Xinghua Gao, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GS101 injection
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
Active Comparator: Dupixent®
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients achieving EASI-75 at week 16
Time Frame: 16 weeks
EASI-75
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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-50 at Weeks 4, 8, 12, 16, 20, 28, 36, 44, 48, and 52
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
Proportion of patients achieving EASI-90 at Weeks 4, 8, 12, 16, 20, 28, 36, 44, 48, and 52
Weeks 4, 8, 12, 16, 20, 28, 36, 44, 48, and 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu Genscend Biopharmaceutical Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

January 26, 2026

First Submitted That Met QC Criteria

February 2, 2026

First Posted (Actual)

February 4, 2026

Study Record Updates

Last Update Posted (Actual)

February 4, 2026

Last Update Submitted That Met QC Criteria

February 2, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS101-03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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