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AkesoA Clinical Study of AK120 in Adolescents With Moderate-to-severe Atopic Dermatitis Phase 3 198 Randomized Double-Blind Placebo-Controlled Adolescent
Clinical Trial NCT06767540 is designed to study Treatment for Atopic Dermatitis. This Phase 3 interventional study is not yet recruiting. Enrollment is planned to begin on January 23, 2025 until the study accrues 198 participants. Led by Akeso, this study is expected to complete by July 10, 2027. The latest data from ClinicalTrials.gov was last updated on January 10, 2025.
Brief 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.
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.
Official Title
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
Conditions
Atopic DermatitisOther Study IDs
- AK120-302
NCT ID Number
Start Date (Actual)
2025-01-23
Last Update Posted
2025-01-10
Completion Date (Estimated)
2027-07-10
Enrollment (Estimated)
198
Study Type
Interventional
PHASE
Phase 3
Status
Not yet recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Double
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalAK120 600mg every two weeks (Q2W) subcutaneous injection AK120 600mg at day 1, then 300mg subcutaneous injection Q2W thereafter until week 46. | Placebo placebo subcutaneous injection Q2W until week 46. |
ExperimentalAK120 600mg every three weeks (Q3W) subcutaneous injection AK120 600mg at day 1, then 300mg subcutaneous injection Q3W thereafter until week 45. | Placebo placebo subcutaneous injection Q3W until week 45. |
Primary Outcome Measures
Secondary 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) |
| 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 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Child, Adult
Minimum Age
12 Years
Eligible Sexes
All
- 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.
- 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.
AkesoStudy Central Contact
Contact: Guoqin Wang, 86 (0760) 8987 3999, [email protected]
28 Study Locations in 1 Countries
Anhui
The Second Affiliated Hospital of Wannan Medical College, Wuhu, Anhui, China
Beijing Municipality
Peking University People's Hospital, Beijing, Beijing Municipality, China
Chongqing Municipality
Chongqing Traditional Chinese Medicine Hospital, Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing Municipality, China
Guangdong
Dongguan People's Hospital, Dongguan, 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, Guangzhou, Guangdong, China
The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China
Jiangmen Central Hospital, Jiangmen, Guangdong, China
The University of Hong Kong - Shenzhen Hospital, Shenzhen, Guangdong, China
The Third People's Hospital of Zhuhai, Zhuhai, Guangdong, China
Guangxi
Liuzhou Worker's Hospital, Liuchow, Guangxi, China
Hubei
Jinzhou Central Hospital, Jinzhou, Hubei, China
Tongji Hospital, Wuhan, Hubei, China
Hunan
Hunan Children's Hospital, Changsha, Hunan, China
XiangYa Hospital CentralSouth University, Changsha, Hunan, China
Jiangsu
Affiliated Hospital of Jiangsu University, Zhenjiang, Jiangsu, China
Jiangxi
Dermatology Hospital of Jiangxi Province, Nanchang, Jiangxi, China
Shandong
Shandong Provincial Dermatology Hospital, Jinan, Shandong, China
Jining First People's Hospital, Jining, Shandong, China
Shanghai Municipality
Huashan Hospital, Fudan University, Shanghai, Shanghai Municipality, China
Longhua Hospital Shanghai University of Traditional Chinese Medicine, Shanghai, Shanghai Municipality, China
Shanghai Skin Disease Hospital, Shanghai, Shanghai Municipality, China
Shanxi
The First Affiliated Hospital of Xi'an Jiao Tong University, Xi’an, Shanxi, China
Sichuan
Sichuan Provincial People's Hospital, Chengdu, Sichuan, China
Yunnan
The First Affiliated Hospital of Kunming Medical University, Kunming, Yunnan, China
Zhejiang
The First Hospital of Jiaxing, Jiaxing, Zhejiang, China