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

Official Summary

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 Requirements

• Minimum Age: 18 Years
• Maximum Age: 75 Years

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: QUADRUPLE
• Enrollment: 572 participants

Study Arms

• GS101 injection (EXPERIMENTAL)
• Dupixent® (ACTIVE_COMPARATOR)

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 Outcomes

• Proportion of patients achieving EASI-75 at week 16 (16 weeks)

Secondary Outcomes

• Proportion of patients achieving EASI-75 (Weeks 4, 8, 12, 16, 20, 28, 36, 44, 48, and 52)
• Proportion of patients achieving EASI-50 (Weeks 4, 8, 12, 16, 20, 28, 36, 44, 48, and 52)
• Proportion of patients achieving EASI-90 (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

Trial Locations

• The First Hospital of China Medical University, Shenyang, Liaoning, China

Contact Information

• Sinian Li, Master — CONTACT
  Phone: +086-15800767550
  Email: lisinian@jxingbio.com
• Tao Sun, Master — CONTACT
  Phone: +086-15921575347
  Email: suntao@jxingbio.com

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