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A Phase II Study to Evaluate the Safety and Efficacy of AK120 in Subjects With Moderate to Severe Atopic Dermatitis

Primary Purpose

Atopic Dermatitis

Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
AK120
Sponsored by
Akeso
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or female subjects aged ≥18≤75 years old. Atopic dermatitis (AD) diagnosed at least half a year before screening. Subject with EASI score ≥16, IGA ≥ 3, BSA ≥ 10% at screening and baseline. Subjects with a history of an inadequate response or medically inappropriate use of topical drug treatment within 6 months Exclusion Criteria: Received systemic corticosteroids, immunosuppressive/immunomodulatory drugs, phototherapy within the 4 weeks before randomization. Received systemic traditional Chinese medicine treatment within the 4 weeks before randomization or topical traditional Chinese medicine treatment within 1 week before randomization Received treatment with other clinical study drugs within 1 month or 5 half-lives before randomization (whichever is longer) Received or planned to receive live vaccine treatment within the 3 months before randomization or during the study period. Received allergen specific immunotherapy within the 3 months before randomization. Have a history of allergies to any component of AK120 and/or severe allergic reactions to monoclonal antibodies.

Sites / Locations

  • The First Affiliated Hospital of Anhui Medical University
  • Air Force Medical Center
  • China-Japan Friendship Hospital
  • Peking University Third Hospital
  • The Second Affiliated Hospital of Xiamen Medical College
  • Dongguan People's Hospital
  • Dermatology Hospital of Southern Medical University
  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
  • Zhujiang Hospital of Southern Medical University
  • Shenzhen People's Hospital
  • The Second Hospital of Hebei Medical University
  • People Hospital of Xingtai
  • Renmin Hospital of Wuhan University Hubei General Hospital
  • Affiliated Hospital of Nantong University
  • Yancheng No.1 People's Hospital
  • The Second Affiliated Hospital of Nanchang University
  • General Hospital of Ningxia Medical University
  • Qingdao Municipal Hospital
  • Baoji Central Hospital
  • Second Hospital of Shanxi Medical University
  • Taiyuan Central Hospital
  • Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
  • The First Affiliated Hospital，Zhejiang University School of Medicine
  • Ningbo No.2 Hospital
  • The first affiliated Hospital of Wenzhou Medical University
  • The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

AK120 300mg

AK120 450mg

Arm Description

AK120 loading dose 600mg, then 300mg subcutaneous injection every 2 weeks thereafter until week 14.

AK120 loading dose 600mg, then 450mg subcutaneous injection every 2 weeks thereafter until week 14.

Outcomes

Primary Outcome Measures

Incidence of adverse events(AE)
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment

Secondary Outcome Measures

Percentage of subjects who achieved (Eczema Area and Severity Index) EASI-75
Percentage of subjects who achieved (Eczema Area and Severity Index) EASI-50
Percentage change in (Eczema Area and Severity Index) EASI scores from baseline
Percentage of subjects who achieved 0/1 in the (Investigator's Global Assessment) IGA
Percentage of subjects with a (Investigator's Global Assessment) IGA score decrease of ≥ 2 points from baseline
Percentage change in (affected body surface area) BSA score from baseline

Full Information

First Posted
October 16, 2023
Last Updated
October 16, 2023
Sponsor
Akeso
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1. Study Identification

Unique Protocol Identification Number
NCT06092762
Brief Title
A Phase II Study to Evaluate the Safety and Efficacy of AK120 in Subjects With Moderate to Severe Atopic Dermatitis
Official Title
a Multicenter, Randomized, Open Label Phase II Clinical Study to Evaluate the Safety and Efficacy of AK120 in the Treatment of Subjects With Moderate to Severe Atopic Dermatitis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 6, 2023 (Anticipated)
Primary Completion Date
October 19, 2024 (Anticipated)
Study Completion Date
May 29, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Akeso

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This is a multicenter, randomized, open label phase II clinical study to evaluate the safety and efficacy of AK120 in the treatment of subjects with moderate to severe atopic dermatitis.
Detailed Description
This is a multicenter, randomized, open label phase II clinical study to evaluate the safety and efficacy of AK120 in the treatment of subjects with moderate to severe atopic dermatitis. The total duration of the study (including screening period) planned for each subject is approximately 29 weeks.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AK120 300mg
Arm Type
Experimental
Arm Description
AK120 loading dose 600mg, then 300mg subcutaneous injection every 2 weeks thereafter until week 14.
Arm Title
AK120 450mg
Arm Type
Experimental
Arm Description
AK120 loading dose 600mg, then 450mg subcutaneous injection every 2 weeks thereafter until week 14.
Intervention Type
Drug
Intervention Name(s)
AK120
Intervention Description
subcutaneous injection every 2 weeks
Primary Outcome Measure Information:
Title
Incidence of adverse events(AE)
Description
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment
Time Frame
week 0 to week 24
Secondary Outcome Measure Information:
Title
Percentage of subjects who achieved (Eczema Area and Severity Index) EASI-75
Time Frame
at week 2/4/8/12/16 /20 and 24
Title
Percentage of subjects who achieved (Eczema Area and Severity Index) EASI-50
Time Frame
at week 2/4/8/12/16 /20 and 24
Title
Percentage change in (Eczema Area and Severity Index) EASI scores from baseline
Time Frame
at week 2/4/8/12/16 /20 and 24
Title
Percentage of subjects who achieved 0/1 in the (Investigator's Global Assessment) IGA
Time Frame
at week 2/4/8/12/16 /20 and 24
Title
Percentage of subjects with a (Investigator's Global Assessment) IGA score decrease of ≥ 2 points from baseline
Time Frame
at week 2/4/8/12/16 /20 and 24
Title
Percentage change in (affected body surface area) BSA score from baseline
Time Frame
at week 2/4/8/12/16 /20 and 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female subjects aged ≥18≤75 years old. Atopic dermatitis (AD) diagnosed at least half a year before screening. Subject with EASI score ≥16, IGA ≥ 3, BSA ≥ 10% at screening and baseline. Subjects with a history of an inadequate response or medically inappropriate use of topical drug treatment within 6 months Exclusion Criteria: Received systemic corticosteroids, immunosuppressive/immunomodulatory drugs, phototherapy within the 4 weeks before randomization. Received systemic traditional Chinese medicine treatment within the 4 weeks before randomization or topical traditional Chinese medicine treatment within 1 week before randomization Received treatment with other clinical study drugs within 1 month or 5 half-lives before randomization (whichever is longer) Received or planned to receive live vaccine treatment within the 3 months before randomization or during the study period. Received allergen specific immunotherapy within the 3 months before randomization. Have a history of allergies to any component of AK120 and/or severe allergic reactions to monoclonal antibodies.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guoqin Wang
Phone
+86 (0760) 8987 3999
Email
global.trials@akesobio.com
Facility Information:
Facility Name
The First Affiliated Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
Country
China
Facility Name
Air Force Medical Center
City
Beijing
State/Province
Beijing
Country
China
Facility Name
China-Japan Friendship Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
The Second Affiliated Hospital of Xiamen Medical College
City
Xiamen
State/Province
Fujian
Country
China
Facility Name
Dongguan People's Hospital
City
Dongguan
State/Province
Guangdong
Country
China
Facility Name
Dermatology Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Zhujiang Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Shenzhen People's Hospital
City
Shenzhen
State/Province
Guangdong
Country
China
Facility Name
The Second Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
Country
China
Facility Name
People Hospital of Xingtai
City
Xingtai
State/Province
Hebei
Country
China
Facility Name
Renmin Hospital of Wuhan University Hubei General Hospital
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Affiliated Hospital of Nantong University
City
Nantong
State/Province
Jiangsu
Country
China
Facility Name
Yancheng No.1 People's Hospital
City
Yancheng
State/Province
Jiangsu
Country
China
Facility Name
The Second Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
Country
China
Facility Name
General Hospital of Ningxia Medical University
City
Yinchuan
State/Province
Ningxia
Country
China
Facility Name
Qingdao Municipal Hospital
City
Qingdao
State/Province
Shandong
Country
China
Facility Name
Baoji Central Hospital
City
Baoji
State/Province
Shanxi
Country
China
Facility Name
Second Hospital of Shanxi Medical University
City
Taiyuan
State/Province
Shanxi
Country
China
Facility Name
Taiyuan Central Hospital
City
Taiyuan
State/Province
Shanxi
Country
China
Facility Name
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Facility Name
The First Affiliated Hospital，Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
Ningbo No.2 Hospital
City
Ningbo
State/Province
Zhejiang
Country
China
Facility Name
The first affiliated Hospital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
Country
China
Facility Name
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
City
Yiwu
State/Province
Zhejiang
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Phase II Study to Evaluate the Safety and Efficacy of AK120 in Subjects With Moderate to Severe Atopic Dermatitis

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