Phase 2 Study of Efficacy and Safety of AK120, in Subjects With Moderate-to-Severe Atopic Dermatitis
About the study
This is a phase 2, multi-center, randomized, placebo-controlled, double-blind, parallel-group, dose-ranging study, conducted in subjects with moderate-to-severe atopic dermatitis.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Key Inclusion Criteria:
- Male or female, over the age of 18
- Chronic atopic dermatitis (AD) diagnosed at least 1 year.
- Subject with EASI score ≥16, IGA ≥ 3 (on the 0 to 4 IGA scale, in which 3 is moderate and 4 is severe), ≥ 10% body surface area (BSA) of AD involvement.
- Subjects with a history of an inadequate response or medically inappropriate use of topical drug treatment within 6 months.
EXCLUSION CRITERIA
Key Exclusion Criteria:
- Inadequate washout period for prior drug therapy (eg. corticosteroids, immunosuppressive/ immunomodulating, biologics, phototherapy, Chinese traditional medicine, anti-infective agents).
- History of exposure to active TB, and/or history or current evidence of TB infection.
- Positive serology results at Screening for hepatitis B, hepatitis C or HIV.
- Any history of vernal keratoconjunctivitis (VKC) or atopic keratoconjunctivitis (AKC) within 6 months before the baseline visit.
- History of clinical parasite infection, recent or planned travel to an area with endemic parasite infection within 6 months before the Screening visit
- Any medical or psychiatric condition, laboratory, or ECG parameter which, in the opinion of the Investigator or the Sponsor's medical monitor, would place the subject at risk, interfere with participation in the study, or interfere with the interpretation of study results.
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Atopic Dermatitis
Age (in years)
18+
Phase
Phase 2
Participants needed
105
Est. Completion Date
Jan 30, 2024
Treatment type
Interventional
Sponsor
Akeso
ClinicalTrials.gov identifier
NCT05048056
Study number
AK120-203
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