Atopic Dermatitis (AD)
Conditions
Brief 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®
Interventions
DRUGGS101 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
DRUGDUPIXENT®
300mg/2.0mL; an initial dose of 600 mg (two 300 mg injections), followed by 300 mg given every other week (Q2W); subcutaneous injection
Sponsors
Jiangsu Genscend Biopharmaceutical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients achieving EASI-75 at week 16 | 16 weeks | EASI-75 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients achieving EASI-75 | 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 |
| Proportion of patients achieving EASI-50 | 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 |
| Proportion of patients achieving EASI-90 | 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 |
Countries
China
Contacts
CONTACTSinian Li, Master
CONTACTTao Sun, Master
Outcome results
None listed