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A Phase III Study of GS101 Injection to Dupixent®

ConditionAtopic Dermatitis (AD)
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJiangsu Genscend Biopharmaceutical Co., Ltd

About this trial

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®

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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%.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

572 Participants
are divided into 2 treatment groups
Group A: GS101 injectionExperimental treatment 1 intervention
Group B: Dupixent®Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of patients achieving EASI-75 at week 16

EASI-75

Time frame
16 weeks

Secondary outcomes

1

Proportion of patients achieving EASI-75

Proportion of patients achieving EASI-50 at Weeks 4, 8, 12, 16, 20, 28, 36, 44, 48, and 52

Time frame
Weeks 4, 8, 12, 16, 20, 28, 36, 44, 48, and 52
2

Proportion of patients achieving EASI-50

Proportion of patients achieving EASI-50 at Weeks 4, 8, 12, 16, 20, 28, 36, 44, 48, and 52

Time frame
Weeks 4, 8, 12, 16, 20, 28, 36, 44, 48, and 52
3

Proportion of patients achieving EASI-90

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jiangsu Genscend Biopharmaceutical Co., Ltd

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: