Clinical trial NCT05702268: Pharmacodynamic Blood Characteristics of ICP-332 in Patients With Moderate to Severe Atopic Dermatitis
Official title: A Randomized, Double-blind, Placebo-controlled Phase II Trial Evaluating the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of ICP-332 in Moderate-to-severe Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Moderate to Severe Atopic Dermatitis
Lead sponsor: Beijing InnoCare Pharma Tech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-01-27
Enrollment: 75
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: The investigator, the subject, and the sponsor's project team will remain blind throughout the study. Subjects will be randomly assigned to one of the three treatment groups at a ratio of 1:1:1 to be given the drug once a day for 4 weeks.


Eligibility criteria: Inclusion Criteria:

1. Male or female subjects aged ≥18 years and ≤75 years.
2. A clinical diagnosis of atopic dermatitis or eczema was made at least 1 year prior to D1, and atopic dermatitis was identified at screening visit (according to Williams criteria).
3. During screening and baseline, were defined as meeting the moderate and severe AD criteria as assessed by the researchers.
4. Documented history of inadequate response to topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) , or other medically unrecommended topical therapy.
5. Able and willing to use an additive free mild emollient twice a day for at least 7 days prior to baseline and for the duration of the study.
6. The serum pregnancy test of all female subjects at screening visit was negative, and the urine pregnancy test of all fertile female subjects at baseline visit was negative before first dosing.
7. Subjects must voluntarily sign and date informed consent prior to the commencement of any screening or study specific procedures.
8. Subject is willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
9. Fertile women (WOCBP) menstruation must occur during the screening period and consent to use a supplementary screen contraceptive method in combination with a highly effective contraceptive method during the study period and for 90 days after the last use of the study drug .Male subjects must be willing not to donate sperm during this period.

Exclusion Criteria:

1. Pregnant female subjects and nursing female subjects.
2. Subjects who had an active skin disease or skin infection that required systemic treatment or would interfere with the proper assessment of AD.
3. Current or previous infection history, including a history of herpes; Known history of invasive infection; Chronic recurrent infection and/or active invasive infection. Known immunodeficiency syndrome; Subjects with tuberculosis; Non skin related active infection.
4. Active HBV, HCV or HIV, syphilis infection.
5. Potential medical diseases or problems, including but not limited to the following: clinically relevant or significant ECG abnormalities; History of moderate to severe congestive heart failure, recent cerebrovascular accident, myocardial infarction or coronary stent implantation, or uncontrolled hypertension; Have received organ transplantation; A history of gastrointestinal perforation, diverticulitis, or a significant increased risk of gastrointestinal perforation according to the investigator's judgment; Diseases that may interfere with drug absorption; Subjects suffering from any malignant tumor before screening.
6. Except for atopic dermatitis, he has any clinically significant disease history or other clinically significant systemic diseases.
7. Received the specified treatment plan within the specified time frame.
8. The time from the last use of powerful CYP3A inhibitor or inducer to the first trial medication is less than 5 clearance half-life, or it is planned to take powerful CYP3A inhibitor or inducer at the same time during this study.
9. Those with a history of drug or alcohol abuse in the 6 months prior to baseline visit (as determined by the investigator).
10. During the screening period before the first administration of the study drug (baseline visit), the abnormal laboratory values met at least one of the specified standards.
11. The investigator considers for any reason that the subject is not suitable for participation in the study to receive ICP-332.

Primary outcomes:
measure: Adverse events (AEs)
timeFrame: Up to 24 weeks
measure: Systolic and Diastolic Blood Pressure
timeFrame: Up to 24 weeks
measure: Pulse Rate
timeFrame: Up to 24 weeks
measure: Electrocardiogram (ECG) QT Interval
timeFrame: Up to 24 weeks
measure: Number of participants with treatmentrelated adverse events as assessed by CTCAE v4.0
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Percentage change of EASI score from baseline in week 4
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Chongqing
country: China
facility: Second Hospital of the Army Medical University
state: Chongqing
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
state: Fujian
city: Guangzhou
country: China
facility: Dermatology Hospital of Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: The Second Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Chengde
country: China
facility: The Affiliated Hospital of Chengde Medical College
state: Hebei
city: Shijiazhuang
country: China
facility: The First Hospital of Hebei Medical University
state: Hebei
city: Nanyang
country: China
facility: Nanyang First People's Hospital
state: Henan
city: Shiyan
country: China
facility: Shiyan City People's Hospital
state: Hubei
city: Wuhan
country: China
facility: Wuhan University People's Hospital
state: Hubei
city: Changzhou
country: China
facility: Changzhou First People's Hospital
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi Second People's Hospital
state: Jiangsu
city: Zhenjiang
country: China
facility: Affiliated Hospital of Jiangsu University
state: Jiangsu
city: Shenyang
country: China
facility: The First Affiliated Hospital of China Medical University
state: Liaoning
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Dermatology Hospital
state: Shanghai
city: Shanghai
country: China
facility: Huashan Hospital Affiliated to Fudan University
state: Shanghai
city: Taiyuan
country: China
facility: The Second Hospital of Shanxi Medical University
state: Shanxi
city: Suining
country: China
facility: Suining Central Hospital
state: Sichuan
city: Tianjin
country: China
facility: Affiliated Hospital of Tianjin Academy of Traditional Chinese Medicine
state: Tianjin
city: Kunming
country: China
facility: The Second Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Hangzhou Third People's Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
city: Jiaxing
country: China
facility: Jiaxing First Hospital
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
References: