Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
520 participants
INTERVENTIONAL
2025-04-30
2028-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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QL2108 injection
QL2108 injection; 300mg/2.0mL; subcutaneous injection
QL2108 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
Dupixent®
Dupixent®; 300mg/2.0mL; subcutaneous injection
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
Interventions
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QL2108 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
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Qilu Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Central Contacts
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Other Identifiers
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QL2108-301
Identifier Type: -
Identifier Source: org_study_id
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