RecruitingPhase 3NCT06383468
A Phase III Study to Evaluate the Efficacy and Safety of AK120 in Patients With Moderate to Severe Atopic Dermatitis
a Randomized Double-blind, Placebo-controlled, Multicenter Phase III Clinical Study to Evaluate the Efficacy and Safety of AK120 in the Treatment of Patients With Moderate to Severe Atopic Dermatitis
Sponsor
Akeso
Enrollment
420 participants
Start Date
Apr 30, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
This is a randomized double-blind, placebo-controlled, multicenter phase III clinical study evaluating the efficacy and safety of AK120 injection in the treatment of patients with moderate to severe atopic dermatitis.
Eligibility
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria4
- Male or female subjects aged ≥18≤75 years old.
- Atopic dermatitis (AD) diagnosed at least 1 year before screening.
- Subject with eczema area and severity index (EASI) score ≥16, Investigator Global Assessment (IGA) score≥ 3, Body Surface Area (BSA) score ≥ 10% at screening and baseline.
- Previously received at least 4 weeks of moderate to strong or at least 2 weeks of strong local glucocorticoid (TCS) treatment for AD before screening, with poor efficacy or intolerable
Exclusion Criteria7
- Acute onset of AD within the first 4 weeks of randomization.
- Have participated in any clinical research on AK120 in the past
- Received systemic corticosteroids, immunosuppressive/immunomodulatory drugs, phototherapy within the 4 weeks before randomization.
- Received treatment with other clinical research drugs (non-biological agents) within the first 4 weeks or 5 half-lives of randomization (whichever is longer)
- Received or planned to receive live vaccine treatment within the 3 months before randomization or during the study period.
- Received allergen specific immunotherapy within the 3 months before randomization.
- Have a history of allergies to any component of AK120 and/or severe allergic reactions to monoclonal antibodies.
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Interventions
DRUGAK120
300mg Q2W subcutaneous injection thereafter until week 50.
Locations(59)
View Full Details on ClinicalTrials.gov
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NCT06383468
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