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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05048056
Other study ID # AK120-203
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date September 30, 2021
Est. completion date January 30, 2024

Study information

Verified date July 2022
Source Akeso
Contact Yu Zhang
Phone +86 (0760) 8987 3999
Email global.trials@akesobio.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Recruiting
Enrollment 105
Est. completion date January 30, 2024
Est. primary completion date October 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Placebo
Placebo subcutaneous injection every 2 weeks for 16 weeks then Crossover to AK120 Regimen 1
AK120
AK120 Regimen 1- subcutaneous injection every 2 weeks.
AK120
AK120 Regimen 2- subcutaneous injection every 2 weeks

Locations

Country Name City State
Australia AkesoBio Investigative Site 3001 Camberwell Victoria
Australia AkesoBio Investigative Site 3003 Sydney New South Wales
Australia AkesoBio Investigative Site 3002 Woolloongabba Queensland
New Zealand AkesoBio Investigative Site 4001 Auckland
New Zealand AkesoBio Investigative Site 4003 Auckland
New Zealand AkesoBio Investigative Site 4005 Christchurch
New Zealand AkesoBio Investigative Site 4004 Hamilton
New Zealand AkesoBio Investigative Site 4004 Wellington
United States AkesoBio Investigative Site 2010 Canoga Park California
United States AkesoBio Investigative Site 2009 Hialeah Florida
United States AkesoBio Investigative Site 2001 Hollywood Florida
United States AkesoBio Investigative Site 2004 Houston Texas
United States AkesoBio Investigative Site 2018 Houston Texas
United States AkesoBio Investigative Site 2015 Las Vegas Nevada
United States AkesoBio Investigative Site 2003 Little Rock Arkansas
United States AkesoBio Investigative Site 2011 Miami Florida
United States AkesoBio Investigative Site 2005 Rapid City South Dakota
United States AkesoBio Investigative Site 2022 Ridgeland Mississippi
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 2013 Spartanburg South Carolina
United States AkesoBio Investigative Site 2002 Weston Florida

Sponsors (1)

Lead Sponsor Collaborator
Akesobio Australia Pty Ltd

Countries where clinical trial is conducted

United States,  Australia,  New Zealand, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of subjects achieving an Eczema Area and Severity Index (EASI) 75 response At week 16
Secondary Proportion of subjects achieving the Investigator Global Assessment (IGA, on a 5-point scale) for clear (0) or almost clear (1) At week 16
Secondary Change in SCORing Atopic Dermatitis (SCORAD) Baseline to Week 38
Secondary Change in Pruritus-Numerical Rating Scale (P-NRS) Baseline to Week 38
Secondary Change in Body Surface Area (BSA) of AD involvement Baseline to Week 38
Secondary Change in Patient Oriented Eczema Measure (POEM) Baseline to Week 38
Secondary Individual subject AK120 concentrations in serum at different time points after AK120 administration Baseline to Week 38
Secondary Change in pharmacodynamics studies TARC/CCL17 and IgE Baseline to week 24
Secondary Anti-drug antibodies(ADAs) Baseline to Week 38
Secondary Adverse events(AEs)/serious adverse events(SAEs) Baseline to Week 38
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