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

July 4, 2022 updated by: Akesobio Australia Pty Ltd

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

105

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2145
        • Recruiting
        • AkesoBio Investigative Site 3003
    • Queensland
      • Woolloongabba, Queensland, Australia, 4102
        • Recruiting
        • AkesoBio Investigative Site 3002
    • Victoria
      • Camberwell, Victoria, Australia, 3145
        • Recruiting
        • AkesoBio Investigative Site 3001
  • New Zealand
      • Auckland, New Zealand, 0626
        • Recruiting
        • AkesoBio Investigative Site 4003
      • Auckland, New Zealand, 1010
        • Recruiting
        • AkesoBio Investigative Site 4001
      • Christchurch, New Zealand, 8013
        • Recruiting
        • AkesoBio Investigative Site 4005
      • Hamilton, New Zealand, 3204
        • Recruiting
        • AkesoBio Investigative Site 4004
      • Wellington, New Zealand, 6242
        • Recruiting
        • AkesoBio Investigative Site 4004
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72204
        • Recruiting
        • AkesoBio Investigative Site 2003
    • California
      • Canoga Park, California, United States, 91303
        • Recruiting
        • AkesoBio Investigative Site 2010
      • San Diego, California, United States, 92119
        • Recruiting
        • AkesoBio Investigative Site 2021
      • San Diego, California, United States, 92120
        • Recruiting
        • AkesoBio Investigative Site 2023
      • San Francisco, California, United States, 94127
        • Recruiting
        • AkesoBio Investigative Site 2017
      • Sherman Oaks, California, United States, 91043
        • Recruiting
        • AkesoBio Investigative Site 2020
    • Florida
      • Hialeah, Florida, United States, 33016
        • Recruiting
        • AkesoBio Investigative Site 2009
      • Hollywood, Florida, United States, 33021
        • Recruiting
        • AkesoBio Investigative Site 2001
      • Miami, Florida, United States, 33155
        • Recruiting
        • AkesoBio Investigative Site 2011
      • Weston, Florida, United States, 33331
        • Recruiting
        • AkesoBio Investigative Site 2002
    • Mississippi
      • Ridgeland, Mississippi, United States, 39157
        • Recruiting
        • AkesoBio Investigative Site 2022
    • Nevada
      • Las Vegas, Nevada, United States, 89145
        • Recruiting
        • AkesoBio Investigative Site 2015
    • South Carolina
      • Spartanburg, South Carolina, United States, 29303
        • Recruiting
        • AkesoBio Investigative Site 2013
    • South Dakota
      • Rapid City, South Dakota, United States, 57702
        • Recruiting
        • AkesoBio Investigative Site 2005
    • Texas
      • Houston, Texas, United States, 77065
        • Recruiting
        • AkesoBio Investigative Site 2004
      • Houston, Texas, United States, 77074
        • Recruiting
        • AkesoBio Investigative Site 2018

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Akesobio Australia Pty Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2021

Primary Completion (Anticipated)

October 30, 2023

Study Completion (Anticipated)

January 30, 2024

Study Registration Dates

First Submitted

September 9, 2021

First Submitted That Met QC Criteria

September 9, 2021

First Posted (Actual)

September 17, 2021

Study Record Updates

Last Update Posted (Actual)

July 7, 2022

Last Update Submitted That Met QC Criteria

July 4, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AK120-203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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