Clinical trial NCT06756126: A Clinical Study of AK120 in Adolescents With Moderate-to-severe Atopic Dermatitis (AD)
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Atopic Dermatitis
Lead sponsor: Akeso
Sponsor class: INDUSTRY
First posted: 2025-01-01
Enrollment: 24
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of adverse events(AE)
timeFrame: week -4 to week 16
Secondary outcomes:
measure: PK evaluation: maximum plasma concentration (Cmax)
timeFrame: Baseline till last follow-up visit ( up to day 113)
measure: PK evaluation: time to maximum plasma concentration (Tmax)
timeFrame: Baseline till last follow-up visit ( up to day 113)
measure: PD evaluation: Thymus and activation regulated chemokine (TARC)/CCL17
timeFrame: Baseline till last follow-up visit ( up to day 113)
measure: Change in Eczema Area and Severity Index (EASI) scores
timeFrame: week 0/2/4/8/12/16
measure: Change in affected Body Surface Area (BSA) scores
timeFrame: week 0/2/4/8/12/16
measure: Subjects who achieved 0/1 in the Investigator's Global Assessment (IGA)
timeFrame: week 0/2/4/8/12/16
measure: Change in Children's Dermatology Life Quality Index (CDLQI) scores
timeFrame: week 0/2/4/8/12/16
measure: Change in Patient Oriented Eczema Measure (POEM) scores
timeFrame: week 0/2/4/8/12/16
Other outcomes:
Locations:
city: Dongguan
country: China
facility: Dongguan People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: The Second Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Shenzhen
country: China
facility: The University of Hong Kong - Shenzhen Hospital
state: Guangdong
city: Changsha
country: China
facility: Hunan Pediatric Medical Union
state: Hunan
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
city: Ningbo
country: China
facility: Ning Bo No.2 Hospital
state: Zhejiang
Study officials:
References: