Clinical trial NCT06092762: A Study to Evaluate the Safety and Efficacy of AK120 in Subjects With Moderate to Severe Atopic Dermatitis
Official title: a Multicenter, Randomized, Open Label Phase II Clinical Study to Evaluate the Safety and Efficacy of AK120 in the Treatment of Subjects With Moderate to Severe Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Lead sponsor: Akeso
Sponsor class: INDUSTRY
First posted: 2023-10-23
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multicenter, randomized, open label phase II clinical study to evaluate the safety and efficacy of AK120 in the treatment of subjects with moderate to severe atopic dermatitis.

Detailed description: This is a multicenter, randomized, open label phase II clinical study to evaluate the safety and efficacy of AK120 in the treatment of subjects with moderate to severe atopic dermatitis. The total duration of the study (including screening period) planned for each subject is approximately 29 weeks.

Eligibility criteria: Inclusion Criteria:

1. Male or female subjects aged ≥18≤75 years old.
2. Atopic dermatitis (AD) diagnosed at least half a year before screening.
3. Subject with EASI score ≥16, IGA ≥ 3, BSA ≥ 10% at screening and baseline.
4. Subjects with a history of an inadequate response or medically inappropriate use of topical drug treatment within 6 months

Exclusion Criteria:

1. Received systemic corticosteroids, immunosuppressive/immunomodulatory drugs, phototherapy within the 4 weeks before randomization.
2. Received systemic traditional Chinese medicine treatment within the 4 weeks before randomization or topical traditional Chinese medicine treatment within 1 week before randomization
3. Received treatment with other clinical study drugs within 1 month or 5 half-lives before randomization (whichever is longer)
4. Received or planned to receive live vaccine treatment within the 3 months before randomization or during the study period.
5. Received allergen specific immunotherapy within the 3 months before randomization.
6. 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 0 to week 24
Secondary outcomes:
measure: Percentage of subjects who achieved (Eczema Area and Severity Index) EASI-75
timeFrame: at week 2/4/8/12/16 /20 and 24
measure: Percentage of subjects who achieved (Eczema Area and Severity Index) EASI-50
timeFrame: at week 2/4/8/12/16 /20 and 24
measure: Percentage change in (Eczema Area and Severity Index) EASI scores from baseline
timeFrame: at week 2/4/8/12/16 /20 and 24
measure: Percentage of subjects who achieved 0/1 in the (Investigator's Global Assessment) IGA
timeFrame: at week 2/4/8/12/16 /20 and 24
measure: Percentage of subjects with a (Investigator's Global Assessment) IGA score decrease of ≥ 2 points from baseline
timeFrame: at week 2/4/8/12/16 /20 and 24
measure: Percentage change in (affected body surface area) BSA score from baseline
timeFrame: at week 2/4/8/12/16 /20 and 24
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
state: Anhui
city: Beijing
country: China
facility: Air Force Medical Center
state: Beijing
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Xiamen
country: China
facility: The Second Affiliated Hospital of Xiamen Medical College
state: Fujian
city: Dongguan
country: China
facility: Dongguan People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Dermatology Hospital of Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: Zhujiang Hospital of Southern Medical University
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
state: Guangdong
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
state: Hebei
city: Xingtai
country: China
facility: People Hospital of Xingtai
state: Hebei
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University Hubei General Hospital
state: Hubei
city: Nantong
country: China
facility: Affiliated Hospital of Nantong University
state: Jiangsu
city: Yancheng
country: China
facility: Yancheng No.1 People's Hospital
state: Jiangsu
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
state: Jiangxi
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
state: Ningxia
city: Qingdao
country: China
facility: Qingdao Municipal Hospital
state: Shandong
city: Baoji
country: China
facility: Baoji Central Hospital
state: Shanxi
city: Taiyuan
country: China
facility: Second Hospital of Shanxi Medical University
state: Shanxi
city: Taiyuan
country: China
facility: Taiyuan Central Hospital
state: Shanxi
city: Tianjin
country: China
facility: Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
state: Tianjin
city: Hangzhou
country: China
facility: The First Affiliated Hospital，Zhejiang University School of Medicine
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo No.2 Hospital
state: Zhejiang
city: Wenzhou
country: China
facility: The first affiliated Hospital of Wenzhou Medical University
state: Zhejiang
city: Yiwu
country: China
facility: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References: