Pharmacodynamic Blood Characteristics of ICP-332 in Patients With Moderate to Severe Atopic Dermatitis

Phase 2

Recruiting

• Conditions: Moderate to Severe Atopic Dermatitis
• Interventions: Drug: ICP-332; Drug: ICP-332 Placebo

• Registration Number: NCT05702268
• Lead Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-10
• Study First Submitted QC: 2023-01-18
• Study First Posted: 2023-01-27
• Study Start: 2023-03-18
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-18
• Last Update Posted: 2023-05-22
• Primary Completion: 2023-07-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High-dose	ICP-332	40 mg ICP-332 tablet 3 tablets, once a day
Low-dose	ICP-332	40 mg ICP-332 2 tablets + 1 placebo tablet once daily
Low-dose	ICP-332 Placebo	40 mg ICP-332 2 tablets + 1 placebo tablet once daily
Blank control	ICP-332 Placebo	Placebo 3 tablets once daily

Primary Outcome Measures

Name	Time	Method
Number of participants with treatmentrelated adverse events as assessed by CTCAE v4.0	Up to 24 weeks
Systolic and Diastolic Blood Pressure	Up to 24 weeks
Pulse Rate	Up to 24 weeks
Adverse events (AEs)	Up to 24 weeks
Electrocardiogram (ECG) QT Interval	Up to 24 weeks

Secondary Outcome Measures

Name	Time	Method
Percentage change of EASI score from baseline in week 4	4 weeks

Trial Locations

Locations (28)

Beijing Friendship Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Beijing Hospital; 🇨🇳 Beijing, Beijing, China

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China

Second Hospital of the Army Medical University; 🇨🇳 Chongqing, Chongqing, China

Dermatology Hospital of Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China

The First Affiliated Hospital of Fujian Medical University; 🇨🇳 Fuzhou, Fujian, China

The Second Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China

The First Hospital of Hebei Medical University; 🇨🇳 Shijiazhuang, Hebei, China

The Affiliated Hospital of Chengde Medical College; 🇨🇳 Chengde, Hebei, China

Nanyang First People's Hospital; 🇨🇳 Nanyang, Henan, China

Shiyan City People's Hospital; 🇨🇳 Shiyan, Hubei, China

Wuhan University People's Hospital; 🇨🇳 Wuhan, Hubei, China

Changzhou First People's Hospital; 🇨🇳 Changzhou, Jiangsu, China

Wuxi Second People's Hospital; 🇨🇳 Wuxi, Jiangsu, China

Affiliated Hospital of Jiangsu University; 🇨🇳 Zhenjiang, Jiangsu, China

The First Affiliated Hospital of China Medical University; 🇨🇳 Shenyang, Liaoning, China

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China

Shanghai Dermatology Hospital; 🇨🇳 Shanghai, Shanghai, China

Huashan Hospital Affiliated to Fudan University; 🇨🇳 Shanghai, Shanghai, China

The Second Hospital of Shanxi Medical University; 🇨🇳 Taiyuan, Shanxi, China

Suining Central Hospital; 🇨🇳 Suining, Sichuan, China

Zhejiang Provincial People's Hospital; 🇨🇳 Hangzhou, Zhejiang, China

Affiliated Hospital of Tianjin Academy of Traditional Chinese Medicine; 🇨🇳 Tianjin, Tianjin, China

The First Affiliated Hospital of Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China

The Second Affiliated Hospital of Kunming Medical University; 🇨🇳 Kunming, Yunnan, China

The First Affiliated Hospital of Wenzhou Medical University; 🇨🇳 Wenzhou, Zhejiang, China

Hangzhou Third People's Hospital; 🇨🇳 Hangzhou, Zhejiang, China

Jiaxing First Hospital; 🇨🇳 Jiaxing, Zhejiang, China