Clinical trial NCT06035354: A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of AK120 in Subjects With Atopic Dermatitis
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Phase Ib/II Clinical Study to Evaluate the Safety, Pharmacokinetics and Efficacy of AK120 in the Treatment of Subjects With Moderate to Severe Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Atopic Dermatitis
Lead sponsor: Akeso
Sponsor class: INDUSTRY
First posted: 2023-09-13
Enrollment: 427
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 randomized, double-blind, placebo-controlled, multicenter phase Ib/II clinical study to evaluate the safety, pharmacokinetics and efficacy of AK120 in the treatment of subjects with moderate to severe atopic dermatitis.

Detailed description: This is a randomized, double-blind, placebo-controlled, multicenter phase Ib/II clinical study to evaluate the safety, pharmacokinetics and efficacy of AK120 in subjects with moderate to severe atopic dermatitis.

Eligibility criteria: Inclusion Criteria:

1. Male or female with age 18 - 75 years (inclusive).
2. Atopic dermatitis (AD) diagnosed at least half an 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. Suffering from other inflammatory diseases that may affect efficacy outcomes (such as rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, mixed connective tissue disease, overlap syndrome, etc.).
2. History of exposure to active TB, and/or history or current evidence of TB infection.
3. Positive serology results at Screening for hepatitis B, hepatitis C or HIV.
4. Any history of vernal keratoconjunctivitis (VKC) or atopic keratoconjunctivitis (AKC) within 6 months before the baseline visit.
5. History of clinical parasite infection, recent or planned travel to an area with endemic parasite infection within 6 months before the Screening visit
6. Any medical or psychiatric condition, laboratory, or ECG parameter which, in the opinion of the Investigator or the Sponsor's medical monitor, would place the subject at risk, interfere with participation in the study, or interfere with the interpretation of study results.

Primary outcomes:
measure: Phase Ib
timeFrame: Baseline to week 12
measure: Phase Ib
timeFrame: Baseline to week 12
measure: Phase Ib
timeFrame: Baseline to week 12
measure: Phase Ib
timeFrame: Baseline to week 12
measure: Phase Ib
timeFrame: Baseline to week 12
measure: Phase II
timeFrame: at week 16
measure: Phase II Extension Study
timeFrame: Baseline to week 24
Secondary outcomes:
measure: Phase Ib
timeFrame: Baseline to week 12
measure: Phase Ib
timeFrame: Baseline to week 12
measure: Phase II
timeFrame: Baseline to week 58
measure: Phase II
timeFrame: Baseline to week 58
measure: Phase II Extension Study
timeFrame: Baseline to week 24
measure: Phase II Extension Study
timeFrame: Baseline to week 24
Other outcomes:
Locations:
city: Bengbu
country: China
facility: AkesoBio Investigative Site 2037, The First Affiliated Hospital of Bengbu Medical College
state: Anhui
city: Wuhu
country: China
facility: AkesoBio Investigative Site 2036, The First Affiliated Hospital of Wannan Medical College
state: Anhui
city: Beijing
country: China
facility: AkesoBio Investigative Site 1001, Peking University People's Hospital
state: Beijing
city: Beijing
country: China
facility: AkesoBio Investigative Site 2044, Beijing Friendship Hospital, Capital Medical University
state: Beijing
city: Chongqing
country: China
facility: AkesoBio Investigative Site 2023, Xinqiao Hospital Medical University
state: Chongqing
city: Chongqing
country: China
facility: AkesoBio Investigative Site 2024, Chongqing Three Gorges Medical College
state: Chongqing
city: Chongqing
country: China
facility: AkesoBio Investigative Site 2040, Chongqing Traditional Chinese Medicine Hospital
state: Chongqing
city: Chongqing
country: China
facility: AkesoBio Investigative Site 2052, The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Fuzhou
country: China
facility: AkesoBio Investigative Site 2038, The First Affiliated Hospital of Fujian Medical University
state: Fujian
city: Dongguan
country: China
facility: AkesoBio Investigative Site 2022, Dongguan People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: AkesoBio Investigative Site 1002, Guangdong Provincial People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: AkesoBio Investigative Site 2003, Dermatology Hospital of Southern Medical University
state: Guangdong
city: Guiyang
country: China
facility: AkesoBio Investigative Site 2049, The Affiliated Hospital of Guizhou Medical University
state: Guizhou
city: Haikou
country: China
facility: AkesoBio Investigative Site 2004, The First Affiliated Hospital of Hainan Medical University
state: Hainan
city: Chengde
country: China
facility: AkesoBio Investigative Site 2001, Affiliated Hospital of Chengde medical university
state: Hebei
city: Nanyang
country: China
facility: AkesoBio Investigative Site 2010, Nanyang First People's Hospital National Third Class A Hospital
state: Henan
city: Jingzhou
country: China
facility: AkesoBio Investigative Site 2051, Jingzhou Central Hospital
state: Hubei
city: Wuhan
country: China
facility: AkesoBio Investigative Site 1005, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: AkesoBio Investigative Site 2046, The Third Xiangya Hospital of Central South University
state: Hunan
city: Hohhot
country: China
facility: AkesoBio Investigative Site 2008, The Affiliated Hospital of Inner Mongolia Medical University
state: Inner Mongolia
city: Changzhou
country: China
facility: AkesoBio Investigative Site 2048, The First People's Hospital of Changzhou
state: Jiangsu
city: Wuxi
country: China
facility: AkesoBio Investigative Site 2050, Wuxi Second People's Hospital
state: Jiangsu
city: Zhenjiang
country: China
facility: AkesoBio Investigative Site 2025, Affiliated Hospital of Jiangsu University
state: Jiangsu
city: Ganzhou
country: China
facility: AkesoBio Investigative Site 2032, The First Affiliated Hospital of Gannan Medical College
state: Jiangxi
city: Shenyang
country: China
facility: AkesoBio Investigative Site 2011, Northeast International Hospital
state: Liaoning
city: Jinan
country: China
facility: AkesoBio Investigative Site 2039, Shandong Provincial Dermatology Hospital
state: Shandong
city: Jinan
country: China
facility: AkesoBio Investigative Site 2041, Qilu Hospital of Shandong University
state: Shandong
city: Shanghai
country: China
facility: AkesoBio Investigative Site 1003, Shanghai Skin Disease Hospital
state: Shanghai
city: Xianyang
country: China
facility: AkesoBio Investigative Site 2027, Medical School of Yanan University
state: Shanxi
city: Chengdu
country: China
facility: AkesoBio Investigative Site 2029, West China Hospital，Sichuan University
state: Sichuan
city: Chengdu
country: China
facility: AkesoBio Investigative Site 2034, Chengdu Second People's Hospital
state: Sichuan
city: Tianjin
country: China
facility: AkesoBio Investigative Site 2013, Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
state: Tianjin
city: Tianjin
country: China
facility: AkesoBio Investigative Site 2019, Tianjin Medical University General Hospital
state: Tianjin
city: Kunming
country: China
facility: AkesoBio Investigative Site 2043, First Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Hangzhou
country: China
facility: AkesoBio Investigative Site 1004, Zhejiang Provincial People's Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: AkesoBio Investigative Site 2006,Affiliated Hangzhou First People's Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: AkesoBio Investigative Site 2007, Hangzhou Third People's Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: AkesoBio Investigative Site 2035, The Second Affiliated Hospital Zhejiang University School of Medicine
state: Zhejiang
city: Jiaxing
country: China
facility: AkesoBio Investigative Site 2009, The First Hospital of Jiaxing
state: Zhejiang
Study officials:
References: