Phase 2 Study of Efficacy and Safety of AK120, in Subjects With Moderate-to-Severe Atopic Dermatitis

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase 2, Multi-center, Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Dose-Ranging Study to Evaluate the Efficacy and Safety of AK120 in Adult Subjects With Moderate-to-Severe Atopic Dermatitis

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: Placebo
* Drug: AK120
* Drug: AK120


Participation Criteria
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Eligibility Criteria
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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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AK120 Regimen 1<br>AK120 Regimen 1- subcutaneous injection every 2 weeks for 30 weeks. | Drug: AK120<br>* AK120 Regimen 1- subcutaneous injection every 2 weeks.<br>|
| Experimental: AK120 Regimen 2<br>AK120 Regimen 2- subcutaneous injection every 2 weeks for 30 weeks. | Drug: AK120<br>* AK120 Regimen 2- subcutaneous injection every 2 weeks<br>|
| Experimental: Placebo to AK120<br>Placebo subcutaneous injection every 2 weeks, then crossover to AK120 Regimen 1, subcutaneous injection at Week16, after primary endpoint evaluation | Drug: Placebo<br>* Placebo subcutaneous injection every 2 weeks for 16 weeks then Crossover to AK120 Regimen 1<br>Drug: AK120<br>* AK120 Regimen 1- subcutaneous injection every 2 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects achieving an Eczema Area and Severity Index (EASI) 75 response |  | At week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 SCORing Atopic Dermatitis (SCORAD) |  | 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 | 
| Change in Patient Oriented Eczema Measure (POEM) |  | Baseline to Week 38 | 
| 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 | 
| Adverse events(AEs)/serious adverse events(SAEs) |  | Baseline to Week 38 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atopic Dermatitis, Monoclonal Antibodies