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

NCT05702268 | Unknown Phase 2

• 1 other identifier: ICP-CL-00602
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 28

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.

Conditions

Moderate to Severe Atopic Dermatitis

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Percentage change of EASI score from baseline in week 4

  4 weeks

Study Arms (3)

High-dose

EXPERIMENTAL

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

Drug: ICP-332

Low-dose

EXPERIMENTAL

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

Drug: ICP-332; Drug: ICP-332 Placebo

Blank control

PLACEBO COMPARATOR

Placebo 3 tablets once daily

Drug: ICP-332 Placebo

Interventions

ICP-332 DRUG

Tablet, 40 mg

High-dose; Low-dose

ICP-332 Placebo DRUG

Tablets, in appearance, size, color, dosage form, packaging, instructions, labels and other aspects of the corresponding specifications of ICP-332.

Blank control; Low-dose

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (28)

Beijing Hospital

Beijing, Beijing Municipality, 100006, China

NOT YET RECRUITING

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

RECRUITING

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

Second Hospital of the Army Medical University

Chongqing, Chongqing Municipality, 400037, China

NOT YET RECRUITING

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350004, China

RECRUITING

Dermatology Hospital of Southern Medical University

Guangzhou, Guangdong, 510091, China

RECRUITING

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510260, China

RECRUITING

The Affiliated Hospital of Chengde Medical College

Chengde, Hebei, 067020, China

RECRUITING

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050023, China

RECRUITING

Nanyang First People's Hospital

Nanyang, Henan, 473004, China

RECRUITING

Shiyan City People's Hospital

Shiyan, Hubei, 442099, China

RECRUITING

Wuhan University People's Hospital

Wuhan, Hubei, 430060, China

RECRUITING

Changzhou First People's Hospital

Changzhou, Jiangsu, 213004, China

RECRUITING

Wuxi Second People's Hospital

Wuxi, Jiangsu, 214001, China

RECRUITING

Affiliated Hospital of Jiangsu University

Zhenjiang, Jiangsu, 210031, China

RECRUITING

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, 110002, China

RECRUITING

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Shanghai Dermatology Hospital

Shanghai, Shanghai Municipality, 220443, China

RECRUITING

Huashan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, China

RECRUITING

The Second Hospital of Shanxi Medical University

Taiyuan, Shanxi, 030001, China

NOT YET RECRUITING

Suining Central Hospital

Suining, Sichuan, 629099, China

RECRUITING

Affiliated Hospital of Tianjin Academy of Traditional Chinese Medicine

Tianjin, Tianjin Municipality, 300120, China

RECRUITING

The Second Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650106, China

NOT YET RECRUITING

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

RECRUITING

Hangzhou Third People's Hospital

Hangzhou, Zhejiang, 310009, China

RECRUITING

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, 314408, China

NOT YET RECRUITING

Jiaxing First Hospital

Jiaxing, Zhejiang, 314001, China

RECRUITING

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325015, China

NOT YET RECRUITING

Related Publications (1)

• Xu J, Zhang L, Liang Y, Ji C, Xu A, Li Z, Li L, Lei T, Zhang C, Chen R, Tao X, Zhang R, Fang H, Zheng J, Yang W, Zhang G, Duan X, Ding Y, Yin W, Zhou W, Fan D, Du Y. Safety and Efficacy of ICP-332 for Moderate to Severe Atopic Dermatitis: A Phase 2 Randomized Clinical Trial. JAMA Dermatol. 2026 Jan 14. doi: 10.1001/jamadermatol.2025.5295. Online ahead of print.

  PMID: 41533373 DERIVED

Central Study Contacts

Pengcheng Lei

CONTACT

+86 18501252185; pengcheng.lei@innocarepharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: January 27, 2023
• Study Start: March 18, 2023
• Primary Completion: July 30, 2023
• Study Completion: December 30, 2023
• Last Updated: May 22, 2023

Record last verified: 2023-05

Locations

CN (28)