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

NCT06767540 · tracked via the Priya Life Science China tracker

Sponsor

Akeso

Phase

Phase 3

Started

2025-01-23

Last updated

2025-01-10

Condition(s) studied

Atopic Dermatitis

Investigational drug(s) / intervention(s)

Placeboplacebo

Placebo: placebo subcutaneous injection Q2W until week 46.

placebo: placebo subcutaneous injection Q3W until week 45.

Study summary

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.

Eligibility

Sex

ALL

Min age

12 Years

Max age

18 Years

Healthy volunteers

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.

Primary outcome measure(s)

Percentage of subjects who achieved Eczema Area and Severity Index (EASI)-75 — at week 18 （day 127)
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).
Percentage of subjects with the Investigator's Global Assessment (IGA) score decrease of ≥ 2 points — at week 18 （day 127)
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).

Trial sites (28)

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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06767540 on ClinicalTrials.gov ↗ ← All trials in China