Phase 2 Study of Efficacy and Safety of AK120, in Subjects With Moderate-to-Severe Atopic Dermatitis
- Registration Number
- NCT05048056
- Lead Sponsor
- Akesobio Australia Pty Ltd
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 79
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo to AK120 Placebo Placebo subcutaneous injection every 2 weeks, then crossover to AK120 Regimen 1, subcutaneous injection at Week16, after primary endpoint evaluation AK120 Regimen 1 AK120 AK120 Regimen 1- subcutaneous injection every 2 weeks for 30 weeks. Placebo to AK120 AK120 Placebo subcutaneous injection every 2 weeks, then crossover to AK120 Regimen 1, subcutaneous injection at Week16, after primary endpoint evaluation AK120 Regimen 2 AK120 AK120 Regimen 2- subcutaneous injection every 2 weeks for 30 weeks.
- Primary Outcome Measures
Name Time Method Proportion of subjects achieving an Eczema Area and Severity Index (EASI) 75 response At week 16
- Secondary Outcome Measures
Name Time Method 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 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 Individual subject AK120 concentrations in serum at different time points after AK120 administration Baseline to Week 38 Change in SCORing Atopic Dermatitis (SCORAD) Baseline to Week 38 Change in pharmacodynamics studies TARC/CCL17 and IgE Baseline to week 24 Change in Patient Oriented Eczema Measure (POEM) Baseline to Week 38 Anti-drug antibodies(ADAs) Baseline to Week 38
Trial Locations
- Locations (23)
AkesoBio Investigative Site 2005
🇺🇸Rapid City, South Dakota, United States
AkesoBio Investigative Site 2003
🇺🇸Little Rock, Arkansas, United States
AkesoBio Investigative Site 2010
🇺🇸Canoga Park, California, United States
AkesoBio Investigative Site 2021
🇺🇸San Diego, California, United States
AkesoBio Investigative Site 2023
🇺🇸San Diego, California, United States
AkesoBio Investigative Site 2017
🇺🇸San Francisco, California, United States
AkesoBio Investigative Site 2020
🇺🇸Sherman Oaks, California, United States
AkesoBio Investigative Site 2009
🇺🇸Hialeah, Florida, United States
AkesoBio Investigative Site 2001
🇺🇸Hollywood, Florida, United States
AkesoBio Investigative Site 2011
🇺🇸Miami, Florida, United States
AkesoBio Investigative Site 2002
🇺🇸Weston, Florida, United States
AkesoBio Investigative Site 2022
🇺🇸Ridgeland, Mississippi, United States
AkesoBio Investigative Site 2015
🇺🇸Las Vegas, Nevada, United States
AkesoBio Investigative Site 2013
🇺🇸Spartanburg, South Carolina, United States
AkesoBio Investigative Site 2004
🇺🇸Houston, Texas, United States
AkesoBio Investigative Site 2018
🇺🇸Houston, Texas, United States
AkesoBio Investigative Site 3003
🇦🇺Sydney, New South Wales, Australia
AkesoBio Investigative Site 3002
🇦🇺Woolloongabba, Queensland, Australia
AkesoBio Investigative Site 3001
🇦🇺Camberwell, Victoria, Australia
AkesoBio Investigative Site 4003
🇳🇿Auckland, New Zealand
AkesoBio Investigative Site 4001
🇳🇿Auckland, New Zealand
AkesoBio Investigative Site 4005
🇳🇿Christchurch, New Zealand
AkesoBio Investigative Site 4004
🇳🇿Wellington, New Zealand