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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Moderate to Severe Atopic Dermatitis
• Intervention / Treatment: Drug: ICP-332; Drug: ICP-332 Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Pengcheng Lei; Phone Number: +86 18501252185; Email: pengcheng.lei@innocarepharma.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Recruiting
      • Peking University Third Hospital
      • Contact: Chunlei Zhang
    • Beijing, Beijing, China, 100050
      • Recruiting
      • Beijing Friendship Hospital, Capital Medical University
      • Contact: Linfeng Li
    • Beijing, Beijing, China, 100006
      • Not yet recruiting
      • Beijing Hospital
      • Contact: Zhonghong Xie
  • Chongqing
    • Chongqing, Chongqing, China, 400037
      • Not yet recruiting
      • Second Hospital of the Army Medical University
      • Contact: Rupeng Wang
  • Fujian
    • Fuzhou, Fujian, China, 350004
      • Recruiting
      • The First Affiliated Hospital of Fujian Medical University
      • Contact: Chao Ji
  • Guangdong
    • Guangzhou, Guangdong, China, 510091
      • Recruiting
      • Dermatology Hospital of Southern Medical University
      • Contact: Yunsheng Liang
    • Guangzhou, Guangdong, China, 510260
      • Recruiting
      • The second Affiliated Hospital of Guangzhou Medical University
      • Contact: wenlin yang
  • Hebei
    • Chengde, Hebei, China, 067020
      • Recruiting
      • The Affiliated Hospital of Chengde Medical College
      • Contact: Xinsuo Duan
    • Shijiazhuang, Hebei, China, 050023
      • Recruiting
      • The First Hospital of Hebei Medical University
      • Contact: Guoqiang Zhang
  • Henan
    • Nanyang, Henan, China, 473004
      • Recruiting
      • Nanyang First People's Hospital
      • Contact: Rixin Chen
  • Hubei
    • Shiyan, Hubei, China, 442099
      • Recruiting
      • Shiyan City People's Hospital
      • Contact: Zudong Meng
    • Wuhan, Hubei, China, 430060
      • Recruiting
      • Wuhan University People's Hospital
      • Contact: Tiechi Lei
  • Jiangsu
    • Changzhou, Jiangsu, China, 213004
      • Recruiting
      • Changzhou First People's Hospital
      • Contact: Ruzhi Zhang
    • Wuxi, Jiangsu, China, 214001
      • Recruiting
      • Wuxi Second People's Hospital
      • Contact: Hui Sun
    • Zhenjiang, Jiangsu, China, 210031
      • Recruiting
      • Affiliated Hospital of Jiangsu University
      • Contact: Yumei Li
  • Liaoning
    • Shenyang, Liaoning, China, 110002
      • Recruiting
      • The First Affiliated Hospital of China Medical University
      • Contact: Li Zhang
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Recruiting
      • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
      • Contact: Jie Zheng
    • Shanghai, Shanghai, China
      • Recruiting
      • Huashan Hospital Affiliated to Fudan University
      • Contact: Jinhua Xu; Phone Number: +86 13818978539; Email: xjhlcsy@163.com
    • Shanghai, Shanghai, China, 220443
      • Recruiting
      • Shanghai Dermatology Hospital
      • Contact: Yangfeng Ding
  • Shanxi
    • Taiyuan, Shanxi, China, 030001
      • Not yet recruiting
      • The Second Hospital of Shanxi Medical University
      • Contact: Wenli Feng
  • Sichuan
    • Suining, Sichuan, China, 629099
      • Recruiting
      • Suining Central Hospital
      • Contact: chunshui yu
  • Tianjin
    • Tianjin, Tianjin, China, 300120
      • Recruiting
      • Affiliated Hospital of Tianjin Academy of Traditional Chinese Medicine
      • Contact: Litao Zhang
  • Yunnan
    • Kunming, Yunnan, China, 650106
      • Not yet recruiting
      • The Second Affiliated Hospital of Kunming Medical University
      • Contact: Danqi Deng
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • Recruiting
      • The First Affiliated Hospital of Zhejiang University School of Medicine
      • Contact: Hong Fang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • Hangzhou Third People's Hospital
      • Contact: Aie Xu
    • Hangzhou, Zhejiang, China, 314408
      • Not yet recruiting
      • Zhejiang Provincial People's Hospital
      • Contact: Xiaohua Tao
    • Jiaxing, Zhejiang, China, 314001
      • Recruiting
      • Jiaxing First Hospital
      • Contact: Wenhao Yin
    • Wenzhou, Zhejiang, China, 325015
      • Not yet recruiting
      • The First Affiliated Hospital of Wenzhou Medical University
      • Contact: Zhiming Li

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High-dose; 40 mg ICP-332 tablet 3 tablets, once a day	Drug: ICP-332; Tablet, 40 mg
Experimental: Low-dose; 40 mg ICP-332 2 tablets + 1 placebo tablet once daily	Drug: ICP-332; Tablet, 40 mg; Drug: ICP-332 Placebo; Tablets, in appearance, size, color, dosage form, packaging, instructions, labels and other aspects of the corresponding specifications of ICP-332.
Placebo Comparator: Blank control; Placebo 3 tablets once daily	Drug: ICP-332 Placebo; Tablets, in appearance, size, color, dosage form, packaging, instructions, labels and other aspects of the corresponding specifications of ICP-332.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage change of EASI score from baseline in week 4	4 weeks

Collaborators and Investigators

• Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2023
• Primary Completion (Anticipated): July 30, 2023
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: January 10, 2023
• First Submitted That Met QC Criteria: January 18, 2023
• First Posted (Actual): January 27, 2023

Study Record Updates

• Last Update Posted (Actual): May 22, 2023
• Last Update Submitted That Met QC Criteria: May 18, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: ICP-CL-00602

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No