Atopic Dermatitis
Conditions
Keywords
Atopic Dermatitis, Monoclonal Antibodies
Brief summary
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.
Detailed description
This phase 2 study is designed to explore the efficacy and safety, as well as pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of dose-ranging AK120 compared to placebo, which will generate information regarding the selection of dosing regimens with AK120 monotherapy treatment in adult subjects with moderate-to-severe AD. Primary Objectives: • To evaluate the efficacy of AK120 in the treatment of adult subjects with moderate-to-severe Atopic Dermatitis (AD). Secondary Objectives: * To evaluate the safety of AK120 in the treatment of adult subjects with moderate-to-severe AD. * To evaluate the Pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of AK120 in adult subjects with moderate-to-severe AD.
Interventions
DRUGPlacebo
Placebo subcutaneous injection every 2 weeks for 16 weeks then Crossover to AK120 Regimen 1
DRUGAK120
AK120 Regimen 1- subcutaneous injection every 2 weeks.
Sponsors
Akesobio Australia Pty Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double Blinded
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Male or female, over the age of 18 2. Chronic atopic dermatitis (AD) diagnosed at least 1 year. 3. 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. 4. Subjects with a history of an inadequate response or medically inappropriate use of topical drug treatment within 6 months. Key
Exclusion criteria
1. Inadequate washout period for prior drug therapy (eg. corticosteroids, immunosuppressive/ immunomodulating, biologics, phototherapy, Chinese traditional medicine, anti-infective agents). 2. History of exposure to active TB, and/or history or current evidence of TB infection. 3. Positive serology results at Screening for hepatitis B, hepatitis C or HIV. 4. Any history of vernal keratoconjunctivitis (VKC) or atopic keratoconjunctivitis (AKC) within 6 months before the baseline visit. 5. History of clinical parasite infection, recent or planned travel to an area with endemic parasite infection within 6 months before the Screening visit 6. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects achieving an Eczema Area and Severity Index (EASI) 75 response | At week 16 |
Secondary
| Measure | Time frame |
|---|---|
| Individual subject AK120 concentrations in serum at different time points after AK120 administration | Baseline to Week 38 |
| Change in pharmacodynamics studies TARC/CCL17 and IgE | Baseline to week 24 |
| Anti-drug antibodies(ADAs) | Baseline to Week 38 |
| Proportion of subjects achieving the Investigator Global Assessment (IGA, on a 5-point scale) for clear (0) or almost clear (1) | At week 16 |
| Change in Patient Oriented Eczema Measure (POEM) | Baseline to Week 38 |
| Change in Pruritus-Numerical Rating Scale (P-NRS) | Baseline to Week 38 |
| Change in Body Surface Area (BSA) of AD involvement | Baseline to Week 38 |
| Adverse events(AEs)/serious adverse events(SAEs) | Baseline to Week 38 |
| Change in SCORing Atopic Dermatitis (SCORAD) | Baseline to Week 38 |
Countries
Australia, New Zealand, United States
Outcome results
None listed