A Clinical Study of AK120 in Adolescents With Moderate-to-severe Atopic Dermatitis

A Randomized Double-blind, Placebo-controlled, Multicenter Phase III Clinical Study Evaluating the Efficacy and Safety of AK120 in the Treatment of Moderate-to-severe Atopic Dermatitis (AD) in Adolescents

This is a randomized double-blind, placebo-controlled, multicenter phase III clinical study evaluating the efficacy and safety of AK120 in the treatment of moderate-to-severe AD in adolescents.

Study Overview

• Status: Not yet recruiting
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Placebo; Drug: placebo

Detailed Description

This is a randomized double-blind, placebo-controlled, multicenter phase III clinical study to evaluate the safety and efficacy of AK120 in the treatment of moderate-to-severe AD in adolescents. The total duration of the study planned is approximately 57 weeks.

• Study Type: Interventional
• Enrollment (Estimated): 198
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Guoqin Wang; Phone Number: 86 (0760) 8987 3999; Email: global.trials@akesobio.com

Study Locations

• China
  • Anhui
    • Wuhu, Anhui, China
      • The Second Affiliated Hospital of Wannan Medical College
  • Beijing
    • Beijing, Beijing, China
      • Peking University People's Hospital
  • Chongqing
    • Chongqing, Chongqing, China
      • The First Affiliated Hospital of Chongqing Medical University
    • Chongqing, Chongqing, China
      • Chongqing Traditional Chinese Medicine Hospital
  • Guangdong
    • Dongguan, Guangdong, China
      • Dongguan People's Hospital
    • Guangzhou, Guangdong, China
      • The Second Affiliated Hospital of Guangzhou Medical University
    • Guangzhou, Guangdong, China
      • Dermatology Hospital of Southern Medical University
    • Guangzhou, Guangdong, China
      • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
    • Guangzhou, Guangdong, China
      • The First Affiliated Hospital of Jinan University
    • Jiangmen, Guangdong, China
      • Jiangmen Central Hospital
    • Shenzhen, Guangdong, China
      • The University of Hong Kong - Shenzhen Hospital
    • Zhuhai, Guangdong, China
      • The Third People's Hospital of Zhuhai
  • Guangxi
    • Liuzhou, Guangxi, China
      • Liuzhou Worker's Hospital
  • Hubei
    • Jinzhou, Hubei, China
      • Jinzhou Central Hospital
    • Wuhan, Hubei, China
      • Tongji Hospital
  • Hunan
    • Changsha, Hunan, China
      • Hunan Children's Hospital
    • Changsha, Hunan, China
      • XiangYa Hospital CentralSouth University
  • Jiangsu
    • Zhenjiang, Jiangsu, China
      • Affiliated Hospital of Jiangsu University
  • Jiangxi
    • Nanchang, Jiangxi, China
      • Dermatology Hospital of Jiangxi Province
  • Shandong
    • Jinan, Shandong, China
      • Shandong Provincial Dermatology Hospital
    • Jining, Shandong, China
      • Jining First People's Hospital
  • Shanghai
    • Shanghai, Shanghai, China
      • Huashan Hospital, Fudan University
    • Shanghai, Shanghai, China
      • Shanghai Skin Disease Hospital
    • Shanghai, Shanghai, China
      • Longhua Hospital Shanghai University of Traditional Chinese Medicine
  • Shanxi
    • Xi'an, Shanxi, China
      • The First Affiliated Hospital of Xi'an Jiao Tong University
  • Sichuan
    • Chengdu, Sichuan, China
      • Sichuan Provincial People'S Hospital
  • Yunnan
    • Kunming, Yunnan, China
      • The First Affiliated Hospital of Kunming Medical University
  • Zhejiang
    • Jiaxing, Zhejiang, China
      • The First Hospital of Jiaxing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male or female subjects aged ≥12<18 years old, weight ≥ 30kg.
• AD diagnosed at least half a year before screening.
• Subject with EASI score ≥16, IGA ≥ 3, BSA ≥ 10% at screening and baseline
• Daily peak P-NRS scores (weekly average) at baseline visit ≥ 4.

Exclusion Criteria:

• Acute onset of AD in 4 weeks prior to enrollment.
• Undergone or planned surgery during the study period within the 4 weeks prior to enrollment, or unable to fully recover from surgery before enrollment.
• Previously suffered from vernal keratoconjunctivitis (VKC) or atopic keratoconjunctivitis (AKC).
• 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 4 weeks or 5 halflives before randomization (whichever is longer).
• Have a history of allergies to any component of AK120 and/or severe allergic reactions to monoclonal antibodies.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AK120 600mg every two weeks (Q2W) subcutaneous injection; AK120 600mg at day 1, then 300mg subcutaneous injection Q2W thereafter until week 46.	Drug: Placebo; placebo subcutaneous injection Q2W until week 46.
Experimental: AK120 600mg every three weeks (Q3W) subcutaneous injection; AK120 600mg at day 1, then 300mg subcutaneous injection Q3W thereafter until week 45.	Drug: placebo; placebo subcutaneous injection Q3W until week 45.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of subjects who achieved Eczema Area and Severity Index (EASI)-75	At week 18, the percentage of subjects who achieved EASI-75 compared to baseline. The EASI score ranges from 0 (no eczema) to 72 (maximum severity).	at week 18 （day 127)
Percentage of subjects with the Investigator's Global Assessment (IGA) score decrease of ≥ 2 points	At week 18, the percentage of subjects with the IGA score decrease of ≥ 2 points from baseline. The IGA is a five-point scale ranging from 0 to 4 ( 0 indicates clear, 4 indicates severe).	at week 18 （day 127)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage change in affected Body Surface Area (BSA)	Percentage change in BSA from baseline.	week 0 to week 52
percentage change of Peak Pruritus Numerical Rating Scale (P-NRS) scores	percentage change of P-NRS scores from baseline at each visit. The scale ranging from 0 to 10 ( 0=no itch; 10=worst itch imaginable).	week 0 to week 52
Percentage changes in the Children's Dermatology Life Quality Index (CDLQI) score	Percentage changes in the CDLQI score compared to baseline at each visit. The total score range from 0 to 30, with higher scores indicating a greater impact on the patient's quality of life.	week 0 to week 52
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.	week 0 to week 52

Collaborators and Investigators

• Sponsor: Akeso

Study record dates

Study Major Dates

• Study Start (Estimated): January 23, 2025
• Primary Completion (Estimated): July 10, 2027
• Study Completion (Estimated): July 10, 2027

Study Registration Dates

• First Submitted: January 8, 2025
• First Submitted That Met QC Criteria: January 8, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 8, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis, Atopic; Dermatitis; Eczema
• Other Study ID Numbers: AK120-302

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: No
• Studies a U.S. FDA-regulated device product: No