Atopic Dermatitis
Conditions
Keywords
Atopic Dermatitis
Brief summary
It is a multicenter randomized, double-blinded, parallel, positive-controlled, Phase Ⅲ comparative study to evaluate the efficacy and safety of QL2108 to Dupixent® in adult subjects with moderate-to-severe atopic dermatitis. A total of 520 subjects are planned to be included and randomized at a ratio of 1:1 to receive QL2108 injection or Dupixent®
Interventions
DRUGQL2108 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
Qilu Pharmaceutical 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 aged from 18 to 75 years (including the boundary value) * At the time of screening, the diagnosis of atopic dermatitis (AD) meets the Hanifin-Rajka criteria, with a disease history of ≥1 year prior to screening. * During the screening period and prior to randomization: EASI score ≥16, IGA score ≥3, BSA ≥10%.
Exclusion criteria
* People who have previously used or participated in clinical trials of monoclonal antibody with the same target or dupilumab * Having participated in drug or device clinical trials within 12 weeks or 5 half-lives of other investigational drugs before the study administration. * Subjects who have received live vaccines or live-attenuated vaccines within 12 weeks prior to randomization or plan to receive such vaccines during the trial 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 at week 52 | 52 weeks | EASI-75 |
| Proportion of patients achieving IGA-TS (IGA score was 0 or 1 and decreased by ≥2 points from baseline) at week 16 and week 52 | 16 weeks and 52 weeks | IGA-TS |
Contacts
Primary ContactWangwang zhi, Project Manager
Backup ContactMengli Jiang
Outcome results
None listed