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NCT05702268 | Recruiting | Moderate to Severe Atopic Dermatitis

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

Condition or disease

Moderate to Severe Atopic Dermatitis

Intervention/treatment

ICP-332

ICP-332 Placebo

Phase

Phase 2

Study Type : Interventional
Estimated Enrollment : 75 participants
Masking : Quadruple
Primary Purpose : Treatment
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
Actual Study Start Date : March 18, 2023
Estimated Primary Completion Date : July 30, 2023
Estimated Study Completion Date : December 30, 2023
Arm Intervention/treatment

Experimental: High-dose

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

Drug: ICP-332

Experimental: Low-dose

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

Drug: ICP-332

Placebo Comparator: Blank control

Placebo 3 tablets once daily

Drug: ICP-332 Placebo
Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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.
Pharmacodynamic Blood Characteristics of ICP-332 in Patients With Moderate to Severe Atopic Dermatitis

Location Details

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

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

China, Beijing

Beijing Hospital

Beijing, Beijing, China, 100006

Recruiting

China, Beijing

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing, China, 100050

Recruiting

China, Beijing

Peking University Third Hospital

Beijing, Beijing, China, 100191

Not yet recruiting

China, Chongqing

Second Hospital of the Army Medical University

Chongqing, Chongqing, China, 400037

Recruiting

China, Fujian

The First Affiliated Hospital of Fujian Medical University

F U axis, Fujian, China, 350004

Recruiting

China, Guangdong

Dermatology Hospital of Southern Medical University

Guangzhou, Guangdong, China, 510091

Recruiting

China, Guangdong

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China, 510260

Recruiting

China, Hebei

The Affiliated Hospital of Chengde Medical College

Chengdu, Hebei, China, 067020

Recruiting

China, Hebei

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, China, 050023

Recruiting

China, Henan

Nanyang First People's Hospital

Nanyang, Henan, China, 473004

Recruiting

China, Hubei

Shiyan City People's Hospital

Shiyan, Hubei, China, 442099

Recruiting

China, Hubei

Wuhan University People's Hospital

Wuhan, Hubei, China, 430060

Recruiting

China, Jiangsu

Changzhou First People's Hospital

Changzhou, Jiangsu, China, 213004

Recruiting

China, Jiangsu

Wuxi Second People's Hospital

Wuxi, Jiangsu, China, 214001

Recruiting

China, Jiangsu

Affiliated Hospital of Jiangsu University

Zhenjiang, Jiangsu, China, 210031

Recruiting

China, Liaoning

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, China, 110002

Recruiting

China, Shanghai

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai, China, 200025

Recruiting

China, Shanghai

Shanghai Dermatology Hospital

Shanghai, Shanghai, China, 220443

Recruiting

China, Shanghai

Huashan Hospital Affiliated to Fudan University

Shanghai, Shanghai, China, 030001

Not yet recruiting

China, Shanxi

The Second Hospital of Shanxi Medical University

Taiyuan, Shanxi, China, 629099

Recruiting

China, Sichuan

Suining Central Hospital

Suing, Sichuan, China, 300120

Recruiting

China, Tianjin

Affiliated Hospital of Tianjin Academy of Traditional Chinese Medicine

Tianjin, Tianjin, China, 650106

Not yet recruiting

China, Yunnan

The Second Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China, 310003

Recruiting

China, Zhejiang

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China, 310009

Recruiting

China, Zhejiang

Hangzhou Third People's Hospital

Hangzhou, Zhejiang, China, 314408

Not yet recruiting

China, Zhejiang

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China, 314001

Recruiting

China, Zhejiang

Jiaxing First Hospital

Jiaxing, Zhejiang, China, 325015

Not yet recruiting

China, Zhejiang

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China,