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

Primary Purpose

Atopic Dermatitis

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
AK120
AK120
Sponsored by
Akesobio Australia Pty Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Atopic Dermatitis, Monoclonal Antibodies

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • AkesoBio Investigative Site 2003Recruiting
  • AkesoBio Investigative Site 2010Recruiting
  • AkesoBio Investigative Site 2021Recruiting
  • AkesoBio Investigative Site 2023Recruiting
  • AkesoBio Investigative Site 2017Recruiting
  • AkesoBio Investigative Site 2020Recruiting
  • AkesoBio Investigative Site 2009Recruiting
  • AkesoBio Investigative Site 2001Recruiting
  • AkesoBio Investigative Site 2011Recruiting
  • AkesoBio Investigative Site 2002Recruiting
  • AkesoBio Investigative Site 2022Recruiting
  • AkesoBio Investigative Site 2015Recruiting
  • AkesoBio Investigative Site 2013Recruiting
  • AkesoBio Investigative Site 2005Recruiting
  • AkesoBio Investigative Site 2004Recruiting
  • AkesoBio Investigative Site 2018Recruiting
  • AkesoBio Investigative Site 3003Recruiting
  • AkesoBio Investigative Site 3002Recruiting
  • AkesoBio Investigative Site 3001Recruiting
  • AkesoBio Investigative Site 4003Recruiting
  • AkesoBio Investigative Site 4001Recruiting
  • AkesoBio Investigative Site 4005Recruiting
  • AkesoBio Investigative Site 4004Recruiting
  • AkesoBio Investigative Site 4004Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

AK120 Regimen 1

AK120 Regimen 2

Placebo to AK120

Arm Description

AK120 Regimen 1- subcutaneous injection every 2 weeks for 30 weeks.

AK120 Regimen 2- subcutaneous injection every 2 weeks for 30 weeks.

Placebo subcutaneous injection every 2 weeks, then crossover to AK120 Regimen 1, subcutaneous injection at Week16, after primary endpoint evaluation

Outcomes

Primary Outcome Measures

Proportion of subjects achieving an Eczema Area and Severity Index (EASI) 75 response

Secondary Outcome Measures

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

Full Information

First Posted
September 9, 2021
Last Updated
July 4, 2022
Sponsor
Akesobio Australia Pty Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05048056
Brief Title
Phase 2 Study of Efficacy and Safety of AK120, in Subjects With Moderate-to-Severe Atopic Dermatitis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 30, 2021 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
January 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Akesobio Australia Pty Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Atopic Dermatitis, Monoclonal Antibodies

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double Blinded
Allocation
Randomized
Enrollment
105 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AK120 Regimen 1
Arm Type
Experimental
Arm Description
AK120 Regimen 1- subcutaneous injection every 2 weeks for 30 weeks.
Arm Title
AK120 Regimen 2
Arm Type
Experimental
Arm Description
AK120 Regimen 2- subcutaneous injection every 2 weeks for 30 weeks.
Arm Title
Placebo to AK120
Arm Type
Experimental
Arm Description
Placebo subcutaneous injection every 2 weeks, then crossover to AK120 Regimen 1, subcutaneous injection at Week16, after primary endpoint evaluation
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo subcutaneous injection every 2 weeks for 16 weeks then Crossover to AK120 Regimen 1
Intervention Type
Drug
Intervention Name(s)
AK120
Intervention Description
AK120 Regimen 1- subcutaneous injection every 2 weeks.
Intervention Type
Drug
Intervention Name(s)
AK120
Intervention Description
AK120 Regimen 2- subcutaneous injection every 2 weeks
Primary Outcome Measure Information:
Title
Proportion of subjects achieving an Eczema Area and Severity Index (EASI) 75 response
Time Frame
At week 16
Secondary Outcome Measure Information:
Title
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
Title
Change in SCORing Atopic Dermatitis (SCORAD)
Time Frame
Baseline to Week 38
Title
Change in Pruritus-Numerical Rating Scale (P-NRS)
Time Frame
Baseline to Week 38
Title
Change in Body Surface Area (BSA) of AD involvement
Time Frame
Baseline to Week 38
Title
Change in Patient Oriented Eczema Measure (POEM)
Time Frame
Baseline to Week 38
Title
Individual subject AK120 concentrations in serum at different time points after AK120 administration
Time Frame
Baseline to Week 38
Title
Change in pharmacodynamics studies TARC/CCL17 and IgE
Time Frame
Baseline to week 24
Title
Anti-drug antibodies(ADAs)
Time Frame
Baseline to Week 38
Title
Adverse events(AEs)/serious adverse events(SAEs)
Time Frame
Baseline to Week 38

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yu Zhang
Phone
+86 (0760) 8987 3999
Email
global.trials@akesobio.com
Facility Information:
Facility Name
AkesoBio Investigative Site 2003
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72204
Country
United States
Individual Site Status
Recruiting
Facility Name
AkesoBio Investigative Site 2010
City
Canoga Park
State/Province
California
ZIP/Postal Code
91303
Country
United States
Individual Site Status
Recruiting
Facility Name
AkesoBio Investigative Site 2021
City
San Diego
State/Province
California
ZIP/Postal Code
92119
Country
United States
Individual Site Status
Recruiting
Facility Name
AkesoBio Investigative Site 2023
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Individual Site Status
Recruiting
Facility Name
AkesoBio Investigative Site 2017
City
San Francisco
State/Province
California
ZIP/Postal Code
94127
Country
United States
Individual Site Status
Recruiting
Facility Name
AkesoBio Investigative Site 2020
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91043
Country
United States
Individual Site Status
Recruiting
Facility Name
AkesoBio Investigative Site 2009
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Individual Site Status
Recruiting
Facility Name
AkesoBio Investigative Site 2001
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Individual Site Status
Recruiting
Facility Name
AkesoBio Investigative Site 2011
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Individual Site Status
Recruiting
Facility Name
AkesoBio Investigative Site 2002
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Individual Site Status
Recruiting
Facility Name
AkesoBio Investigative Site 2022
City
Ridgeland
State/Province
Mississippi
ZIP/Postal Code
39157
Country
United States
Individual Site Status
Recruiting
Facility Name
AkesoBio Investigative Site 2015
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89145
Country
United States
Individual Site Status
Recruiting
Facility Name
AkesoBio Investigative Site 2013
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Individual Site Status
Recruiting
Facility Name
AkesoBio Investigative Site 2005
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57702
Country
United States
Individual Site Status
Recruiting
Facility Name
AkesoBio Investigative Site 2004
City
Houston
State/Province
Texas
ZIP/Postal Code
77065
Country
United States
Individual Site Status
Recruiting
Facility Name
AkesoBio Investigative Site 2018
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Individual Site Status
Recruiting
Facility Name
AkesoBio Investigative Site 3003
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Individual Site Status
Recruiting
Facility Name
AkesoBio Investigative Site 3002
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Individual Site Status
Recruiting
Facility Name
AkesoBio Investigative Site 3001
City
Camberwell
State/Province
Victoria
ZIP/Postal Code
3145
Country
Australia
Individual Site Status
Recruiting
Facility Name
AkesoBio Investigative Site 4003
City
Auckland
ZIP/Postal Code
0626
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
AkesoBio Investigative Site 4001
City
Auckland
ZIP/Postal Code
1010
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
AkesoBio Investigative Site 4005
City
Christchurch
ZIP/Postal Code
8013
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
AkesoBio Investigative Site 4004
City
Hamilton
ZIP/Postal Code
3204
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
AkesoBio Investigative Site 4004
City
Wellington
ZIP/Postal Code
6242
Country
New Zealand
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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