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

A Multicenter, Open Label Phase II Clinical Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of AK120 in Adolescents With Moderate-to-severe AD

This is a A multicenter, open label, phase II clinical study to evaluate the safety, pharmacokinetics (PK), pharmacodynamics(PD), and preliminary efficacy of AK120 in adolescents with moderate-to-severe atopic dermatitis

Study Overview

• Status: Not yet recruiting
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: AK120

Detailed Description

This is a A multicenter, open label, phase II clinical study aimed to evaluate the safety, PK, PD, and preliminary efficacy of AK120 in adolescents with moderate-to-severe AD. The entire study include screening period(week -4 to week 0), treatment and follow-up period(16 weeks). The duration of the study is about 20 weeks.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 2

Contacts and Locations

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

Study Locations

• China
  • Guangdong
    • Dongguan, Guangdong, China
      • Dongguan People's Hospital
    • Guangzhou, Guangdong, China
      • The Second Affiliated Hospital of Guangzhou Medical University
    • Shenzhen, Guangdong, China
      • The University of Hong Kong - Shenzhen Hospital
  • Hunan
    • Changsha, Hunan, China
      • Xiangya Hospital Central South University
    • Changsha, Hunan, China
      • Hunan Pediatric Medical Union
  • Zhejiang
    • Ningbo, Zhejiang, China
      • Ning Bo No.2 Hospital

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 at baseline.
• AD diagnosed at least half a year before screening.
• Subject with EASI score ≥16, IGA ≥ 3, BSA ≥ 10% at screening and baseline.

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 1 month or 5 half-lives 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: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AK120 300mg every two weeks (Q2W) subcutaneous injection; Subjects with heavy weight	Drug: AK120; AK120 subcutaneous injection
Experimental: AK120 300mg every three weeks (Q3W) subcutaneous injection; Subjects with light weight	Drug: AK120; AK120 subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 -4 to week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK evaluation: maximum plasma concentration (Cmax)	Assessment of Cmax after AK120 administration.	Baseline till last follow-up visit ( up to day 113)
PK evaluation: time to maximum plasma concentration (Tmax)	Assessment of Tmax after AK120 administration.	Baseline till last follow-up visit ( up to day 113)
PD evaluation: Thymus and activation regulated chemokine (TARC)/CCL17	Percentage change in TARC/CCL17 compared to baseline.	Baseline till last follow-up visit ( up to day 113)
Change in Eczema Area and Severity Index (EASI) scores	Percentage change in EASI scores from baseline.	week 0/2/4/8/12/16
Change in affected Body Surface Area (BSA) scores	Percentage change in BSA score from baseline.	week 0/2/4/8/12/16
Subjects who achieved 0/1 in the Investigator's Global Assessment (IGA)	Percentage of subjects who achieved IGA 0/1.	week 0/2/4/8/12/16
Change in Children's Dermatology Life Quality Index (CDLQI) scores	Percentage change in CDLQI score from baseline.	week 0/2/4/8/12/16
Change in Patient Oriented Eczema Measure (POEM) scores	Percentage change in POEM score from baseline.	week 0/2/4/8/12/16

Collaborators and Investigators

• Sponsor: Akeso

Study record dates

Study Major Dates

• Study Start (Estimated): December 30, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: December 25, 2024
• First Submitted That Met QC Criteria: December 31, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 31, 2024
• Last Verified: December 1, 2024

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: AK120-208

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