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AK120 in Moderate to Severe Atopic Dermatitis
NCT06700499Phase 2
Key facts
- Status
- Completed
- Start
- Jul 2024
- Primary completion
- Jul 2025
- Countries
- 1
- Sponsor
- Akeso, Inc.
- Modality
- Engineered Antibody Formats, Antibody Conjugates, Monoclonal Antibodies
- Drugs
- manfidokimab
- Conditions
- atopic dermatitis (AD)
01
Overview
Phase 2, open-label, single-arm trial of manfidokimab in atopic dermatitis (AD), sponsored by Akeso, Inc. Primary endpoint: Incidence of treatment emergent adverse events at 25 weeks. Started Jul 2024; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
AK120 300mg Q2W
AK120 600mg (first day) then 300mg Q2W SC until week 14.
03
Who it enrols
Adults aged 18-75 with moderate to severe atopic dermatitis (EASI >= 16, IGA >= 3, BSA >= 10%) diagnosed at least 6 months prior. Excludes patients with acute onset within 4 weeks, recent malignancies, immunosuppressive diseases, or recent major surgery.
04
Endpoints
Primary
Incidence of treatment emergent adverse events
Secondary
Eczema Area and Severity Index
Investigator's Global Assessment
Affected body surface area
Area under the curve
Anti-drug antibodies
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