Status:
NOT_YET_RECRUITING
A Phase Ⅲ Comparative Study of QL2108 to Dupixent®
Lead Sponsor:
Qilu Pharmaceutical Co., Ltd.
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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-s...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2028
Estimated Enrollment :
520 Patients enrolled
Trial Details
Trial ID
NCT06884891
Start Date
April 1 2025
End Date
April 1 2028
Last Update
March 21 2025
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