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

Last updated: February 24, 2025
Sponsor: Akesobio Australia Pty Ltd
Overall Status: Terminated

Phase

2

Condition

Atopic Dermatitis

Allergy

Dermatitis, Atopic

Treatment

Placebo

AK120

Clinical Study ID

NCT05048056
AK120-203
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 ismoderate 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 oftopical drug treatment within 6 months.

Exclusion

Key Exclusion Criteria:

  1. Inadequate washout period for prior drug therapy (eg. corticosteroids,immunosuppressive/ immunomodulating, biologics, phototherapy, Chinese traditionalmedicine, anti-infective agents).

  2. History of exposure to active TB, and/or history or current evidence of TBinfection.

  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 withendemic parasite infection within 6 months before the Screening visit

  6. Any medical or psychiatric condition, laboratory, or ECG parameter which, in theopinion of the Investigator or the Sponsor's medical monitor, would place thesubject at risk, interfere with participation in the study, or interfere with theinterpretation of study results.

Study Design

Total Participants: 79
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
September 30, 2021
Estimated Completion Date:
May 17, 2023

Study 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.

Connect with a study center

  • AkesoBio Investigative Site 3003

    Sydney, New South Wales 2145
    Australia

    Site Not Available

  • AkesoBio Investigative Site 3002

    Woolloongabba, Queensland 4102
    Australia

    Site Not Available

  • AkesoBio Investigative Site 3001

    Camberwell, Victoria 3145
    Australia

    Site Not Available

  • AkesoBio Investigative Site 4001

    Auckland, 1010
    New Zealand

    Site Not Available

  • AkesoBio Investigative Site 4003

    Auckland, 0626
    New Zealand

    Site Not Available

  • AkesoBio Investigative Site 4005

    Christchurch, 8013
    New Zealand

    Site Not Available

  • AkesoBio Investigative Site 4004

    Hamilton, 3204
    New Zealand

    Site Not Available

  • AkesoBio Investigative Site 4004

    Wellington, 6242
    New Zealand

    Site Not Available

  • AkesoBio Investigative Site 2003

    Little Rock, Arkansas 72204
    United States

    Site Not Available

  • AkesoBio Investigative Site 2010

    Canoga Park, California 91303
    United States

    Site Not Available

  • AkesoBio Investigative Site 2021

    San Diego, California 92119
    United States

    Site Not Available

  • AkesoBio Investigative Site 2023

    San Diego, California 92120
    United States

    Site Not Available

  • AkesoBio Investigative Site 2017

    San Francisco, California 94127
    United States

    Site Not Available

  • AkesoBio Investigative Site 2020

    Sherman Oaks, California 91043
    United States

    Site Not Available

  • AkesoBio Investigative Site 2009

    Hialeah, Florida 33016
    United States

    Site Not Available

  • AkesoBio Investigative Site 2001

    Hollywood, Florida 33021
    United States

    Site Not Available

  • AkesoBio Investigative Site 2005

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • AkesoBio Investigative Site 2011

    Miami, Florida 33155
    United States

    Site Not Available

  • AkesoBio Investigative Site 2004

    Orlando, Florida 32801
    United States

    Site Not Available

  • AkesoBio Investigative Site 2002

    Weston, Florida 33331
    United States

    Site Not Available

  • AkesoBio Investigative Site 2022

    Ridgeland, Mississippi 39157
    United States

    Site Not Available

  • AkesoBio Investigative Site 2015

    Las Vegas, Nevada 89145
    United States

    Site Not Available

  • AkesoBio Investigative Site 2013

    Spartanburg, South Carolina 29303
    United States

    Site Not Available

  • AkesoBio Investigative Site 2005

    Rapid City, South Dakota 57702
    United States

    Site Not Available

  • AkesoBio Investigative Site 2004

    Houston, Texas 77065
    United States

    Site Not Available

  • AkesoBio Investigative Site 2018

    Houston, Texas 77074
    United States

    Site Not Available

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