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

Moderate to Severe Atopic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05702268
• Other study ID #: ICP-CL-00602
• Status: Recruiting
• Phase: Phase 2
• Start date: March 18, 2023
• Est. completion date: December 30, 2023

Study information

• Verified date: May 2023
• Source: Beijing InnoCare Pharma Tech Co., Ltd.
• Contact: Pengcheng Lei
• Phone: +86 18501252185
• Email: pengcheng.lei[@]innocarepharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: December 30, 2023
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Eczema
• Moderate to Severe Atopic Dermatitis

Intervention

Drug:
• ICP-332
Tablet, 40 mg
• ICP-332 Placebo
Tablets, in appearance, size, color, dosage form, packaging, instructions, labels and other aspects of the corresponding specifications of ICP-332.

Locations

Country	Name	City	State
China	Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing
China	Beijing Hospital	Beijing	Beijing
China	Peking University Third Hospital	Beijing	Beijing
China	Changzhou First People's Hospital	Changzhou	Jiangsu
China	The Affiliated Hospital of Chengde Medical College	Chengde	Hebei
China	Second Hospital of the Army Medical University	Chongqing	Chongqing
China	The First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian
China	Dermatology Hospital of Southern Medical University	Guangzhou	Guangdong
China	The Second Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong
China	Hangzhou Third People's Hospital	Hangzhou	Zhejiang
China	The First Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Zhejiang Provincial People's Hospital	Hangzhou	Zhejiang
China	Jiaxing First Hospital	Jiaxing	Zhejiang
China	The Second Affiliated Hospital of Kunming Medical University	Kunming	Yunnan
China	Nanyang First People's Hospital	Nanyang	Henan
China	Huashan Hospital Affiliated to Fudan University	Shanghai	Shanghai
China	Ruijin Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	Shanghai Dermatology Hospital	Shanghai	Shanghai
China	The First Affiliated Hospital of China Medical University	Shenyang	Liaoning
China	The First Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	Shiyan City People's Hospital	Shiyan	Hubei
China	Suining Central Hospital	Suining	Sichuan
China	The Second Hospital of Shanxi Medical University	Taiyuan	Shanxi
China	Affiliated Hospital of Tianjin Academy of Traditional Chinese Medicine	Tianjin	Tianjin
China	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang
China	Wuhan University People's Hospital	Wuhan	Hubei
China	Wuxi Second People's Hospital	Wuxi	Jiangsu
China	Affiliated Hospital of Jiangsu University	Zhenjiang	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Beijing InnoCare Pharma Tech Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events (AEs)		Up to 24 weeks
Primary	Systolic and Diastolic Blood Pressure		Up to 24 weeks
Primary	Pulse Rate		Up to 24 weeks
Primary	Electrocardiogram (ECG) QT Interval		Up to 24 weeks
Primary	Number of participants with treatmentrelated adverse events as assessed by CTCAE v4.0		Up to 24 weeks
Secondary	Percentage change of EASI score from baseline in week 4		4 weeks