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

Phase 2

Not yet recruiting

• Conditions: Atopic Dermatitis
• Interventions: Drug: AK120

• Registration Number: NCT06756126
• Lead Sponsor: Akeso

Brief Summary

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

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 Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-25
• Study Start: 2024-12-30
• Study First Submitted QC: 2024-12-31
• Last Update Submitted: 2024-12-31
• Study First Posted: 2025-01-01
• Last Update Posted: 2025-01-01
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AK120 300mg every two weeks (Q2W) subcutaneous injection	AK120	Subjects with heavy weight
AK120 300mg every three weeks (Q3W) subcutaneous injection	AK120	Subjects with light weight

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events(AE)	week -4 to week 16	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

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

Trial Locations

Locations (6)

Dongguan People's Hospital; 🇨🇳 Dongguan, Guangdong, China

The Second Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China

The University of Hong Kong - Shenzhen Hospital; 🇨🇳 Shenzhen, Guangdong, China

Hunan Pediatric Medical Union; 🇨🇳 Changsha, Hunan, China

Xiangya Hospital Central South University; 🇨🇳 Changsha, Hunan, China

Ning Bo No.2 Hospital; 🇨🇳 Ningbo, Zhejiang, China