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

Primary Purpose

Moderate to Severe Atopic Dermatitis

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
ICP-332
ICP-332 Placebo
Sponsored by
Beijing InnoCare Pharma Tech Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Moderate to Severe Atopic Dermatitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or female subjects aged ≥18 years and ≤75 years. 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). During screening and baseline, were defined as meeting the moderate and severe AD criteria as assessed by the researchers. Documented history of inadequate response to topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) , or other medically unrecommended topical therapy. 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. 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. Subjects must voluntarily sign and date informed consent prior to the commencement of any screening or study specific procedures. Subject is willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures. 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: Pregnant female subjects and nursing female subjects. Subjects who had an active skin disease or skin infection that required systemic treatment or would interfere with the proper assessment of AD. 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. Active HBV, HCV or HIV, syphilis infection. 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. Except for atopic dermatitis, he has any clinically significant disease history or other clinically significant systemic diseases. Received the specified treatment plan within the specified time frame. 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. Those with a history of drug or alcohol abuse in the 6 months prior to baseline visit (as determined by the investigator). 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. The investigator considers for any reason that the subject is not suitable for participation in the study to receive ICP-332.

Sites / Locations

  • Beijing Hospital
  • Beijing Friendship Hospital, Capital Medical UniversityRecruiting
  • Peking University Third HospitalRecruiting
  • Second Hospital of the Army Medical University
  • The First Affiliated Hospital of Fujian Medical UniversityRecruiting
  • Dermatology Hospital of Southern Medical UniversityRecruiting
  • The Second Affiliated Hospital of Guangzhou Medical UniversityRecruiting
  • The Affiliated Hospital of Chengde Medical CollegeRecruiting
  • The First Hospital of Hebei Medical UniversityRecruiting
  • Nanyang First People's HospitalRecruiting
  • Shiyan City People's HospitalRecruiting
  • Wuhan University People's HospitalRecruiting
  • Changzhou First People's HospitalRecruiting
  • Wuxi Second People's HospitalRecruiting
  • Affiliated Hospital of Jiangsu UniversityRecruiting
  • The First Affiliated Hospital of China Medical UniversityRecruiting
  • Ruijin Hospital, Shanghai Jiao Tong University School of MedicineRecruiting
  • Shanghai Dermatology HospitalRecruiting
  • Huashan Hospital Affiliated to Fudan UniversityRecruiting
  • The Second Hospital of Shanxi Medical University
  • Suining Central HospitalRecruiting
  • Affiliated Hospital of Tianjin Academy of Traditional Chinese MedicineRecruiting
  • The Second Affiliated Hospital of Kunming Medical University
  • The First Affiliated Hospital of Zhejiang University School of MedicineRecruiting
  • Hangzhou Third People's HospitalRecruiting
  • Zhejiang Provincial People's Hospital
  • Jiaxing First HospitalRecruiting
  • The First Affiliated Hospital of Wenzhou Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

High-dose

Low-dose

Blank control

Arm Description

40 mg ICP-332 tablet 3 tablets, once a day

40 mg ICP-332 2 tablets + 1 placebo tablet once daily

Placebo 3 tablets once daily

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Percentage change of EASI score from baseline in week 4

Full Information

First Posted
January 10, 2023
Last Updated
May 18, 2023
Sponsor
Beijing InnoCare Pharma Tech Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05702268
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 18, 2023 (Actual)
Primary Completion Date
July 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing InnoCare Pharma Tech Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate to Severe Atopic Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High-dose
Arm Type
Experimental
Arm Description
40 mg ICP-332 tablet 3 tablets, once a day
Arm Title
Low-dose
Arm Type
Experimental
Arm Description
40 mg ICP-332 2 tablets + 1 placebo tablet once daily
Arm Title
Blank control
Arm Type
Placebo Comparator
Arm Description
Placebo 3 tablets once daily
Intervention Type
Drug
Intervention Name(s)
ICP-332
Intervention Description
Tablet, 40 mg
Intervention Type
Drug
Intervention Name(s)
ICP-332 Placebo
Intervention Description
Tablets, in appearance, size, color, dosage form, packaging, instructions, labels and other aspects of the corresponding specifications of ICP-332.
Primary Outcome Measure Information:
Title
Adverse events (AEs)
Time Frame
Up to 24 weeks
Title
Systolic and Diastolic Blood Pressure
Time Frame
Up to 24 weeks
Title
Pulse Rate
Time Frame
Up to 24 weeks
Title
Electrocardiogram (ECG) QT Interval
Time Frame
Up to 24 weeks
Title
Number of participants with treatmentrelated adverse events as assessed by CTCAE v4.0
Time Frame
Up to 24 weeks
Secondary Outcome Measure Information:
Title
Percentage change of EASI score from baseline in week 4
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female subjects aged ≥18 years and ≤75 years. 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). During screening and baseline, were defined as meeting the moderate and severe AD criteria as assessed by the researchers. Documented history of inadequate response to topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) , or other medically unrecommended topical therapy. 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. 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. Subjects must voluntarily sign and date informed consent prior to the commencement of any screening or study specific procedures. Subject is willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures. 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: Pregnant female subjects and nursing female subjects. Subjects who had an active skin disease or skin infection that required systemic treatment or would interfere with the proper assessment of AD. 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. Active HBV, HCV or HIV, syphilis infection. 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. Except for atopic dermatitis, he has any clinically significant disease history or other clinically significant systemic diseases. Received the specified treatment plan within the specified time frame. 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. Those with a history of drug or alcohol abuse in the 6 months prior to baseline visit (as determined by the investigator). 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. The investigator considers for any reason that the subject is not suitable for participation in the study to receive ICP-332.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pengcheng Lei
Phone
+86 18501252185
Email
pengcheng.lei@innocarepharma.com
Facility Information:
Facility Name
Beijing Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100006
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhonghong Xie
Facility Name
Beijing Friendship Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linfeng Li
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chunlei Zhang
Facility Name
Second Hospital of the Army Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400037
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rupeng Wang
Facility Name
The First Affiliated Hospital of Fujian Medical University
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chao Ji
Facility Name
Dermatology Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510091
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yunsheng Liang
Facility Name
The Second Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510260
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenlin Yang
Facility Name
The Affiliated Hospital of Chengde Medical College
City
Chengde
State/Province
Hebei
ZIP/Postal Code
067020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinsuo Duan
Facility Name
The First Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050023
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guoqiang Zhang
Facility Name
Nanyang First People's Hospital
City
Nanyang
State/Province
Henan
ZIP/Postal Code
473004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rixin Chen
Facility Name
Shiyan City People's Hospital
City
Shiyan
State/Province
Hubei
ZIP/Postal Code
442099
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zudong Meng
Facility Name
Wuhan University People's Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tiechi Lei
Facility Name
Changzhou First People's Hospital
City
Changzhou
State/Province
Jiangsu
ZIP/Postal Code
213004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruzhi Zhang
Facility Name
Wuxi Second People's Hospital
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui Sun
Facility Name
Affiliated Hospital of Jiangsu University
City
Zhenjiang
State/Province
Jiangsu
ZIP/Postal Code
210031
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yumei Li
Facility Name
The First Affiliated Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110002
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Zhang
Facility Name
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Zheng
Facility Name
Shanghai Dermatology Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
220443
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yangfeng Ding
Facility Name
Huashan Hospital Affiliated to Fudan University
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinhua Xu
Phone
+86 13818978539
Email
xjhlcsy@163.com
Facility Name
The Second Hospital of Shanxi Medical University
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030001
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenli Feng
Facility Name
Suining Central Hospital
City
Suining
State/Province
Sichuan
ZIP/Postal Code
629099
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chunshui Yu
Facility Name
Affiliated Hospital of Tianjin Academy of Traditional Chinese Medicine
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Litao Zhang
Facility Name
The Second Affiliated Hospital of Kunming Medical University
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650106
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danqi Deng
Facility Name
The First Affiliated Hospital of Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Fang
Facility Name
Hangzhou Third People's Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aie Xu
Facility Name
Zhejiang Provincial People's Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
314408
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaohua Tao
Facility Name
Jiaxing First Hospital
City
Jiaxing
State/Province
Zhejiang
ZIP/Postal Code
314001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenhao Yin
Facility Name
The First Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325015
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhiming Li

12. IPD Sharing Statement

Learn more about this trial

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

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