Efficacy, Safety, Pharmacokinetics of ICP-488 in Patients With Moderate to Severe Plaque Psoriasis
- Conditions
- Plaque Psoriasis Patients
- Interventions
- Drug: ICP-488 TabletsDrug: ICP-488 Placebo
- Registration Number
- NCT06842199
- Lead Sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.
- Brief Summary
This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study to evaluate the efficacy, safety, PK characteristics of ICP-488 in Chinese adults with moderate to severe plaque psoriasis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 360
Eligible subjects must meet all of the following criteria:
- Subjects voluntarily participate in this study and have signed informed consent.
- Male or female subjects between the ages of 18 and 75 (including the threshold) at the time of signing the ICF.
- History of plaque psoriasis ≥6 months at baseline.
- Subjects need to receive systemic therapy and/or phototherapy.
- The following three criteria were met: a) psoriasis Area and Severity index (PASI) score ≥12; b) Psoriasis affected body surface area (BSA) ≥10%; c) Static physician overall assessment (sPGA) ≥3 scores
- The diagnosis was non-plaque psoriasis.
- Subjects with concurrent skin diseases that the investigator believes would interfere with the study assessments.
- Presence of infection or immune-related disease.
- Subjects with a history of TB or at risk for TB.
- Received related treatment within the time window specified in the protocol.
- An interval of less than 5 half-lives or 28 days (if any available half-life data) from the last dose of a strong CYP1A2/CYP3A4 inhibitor or inducer, or a plan to use concurrently medications, dietary supplements or food (e.g., grapefruit or grapefruit juice) with strong CYP1A2/CYP3A4 inhibitory or inductive effect during study participation.
- The investigator has determined that there are clinically significant test results and that participation in this trial would pose an unacceptable risk to patients; Or the laboratory values of the subjects in the screening period meet the criteria specified in the protocol.
- Pregnant or lactating women, or women who plan to become pregnant during study participation.
- A history of severe drug allergies.
- Any other conditions in which the investigator considers it unsuitable for the subject to participate in this study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ICP-488 Tablets ICP-488 Tablets - ICP-488 Placebo ICP-488 Placebo -
- Primary Outcome Measures
Name Time Method The proportion of subjects who achieve a score of clear (0) or almost clear (1) with an improvement of at least 2 points from baseline on the static Physician's Global Assessment (sPGA) at week 16 week 16 Percentage of subjects who achieved a PASI 75 response (a reduction of minimum 75% from baseline in PASI score) at Week 16 Week 16
- Secondary Outcome Measures
Name Time Method Adverse events Week 52 Percentage of subjects with PASI 50/75/90/100 in each planned visit Week 52 Percentage of subjects with sPGA score of 0 (clear) or 1 (almost clear) and an improvement of at least 2 points from baseline in planned visits. Week 52 The proportion of subjects with sPGA score of 0 in each planned visit. Week 52 PK parameter: ICP-488 and its metabolite. Week 52
Related Research Topics
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Trial Locations
- Locations (50)
Huashan Hospital, Fudan University
🇨🇳Shanghai, Shanghai, China
Shanghai Skin Disease Hospital skin Disease of tongji University
🇨🇳Shanghai, Shanghai, China
Taiyuan Central Hospital
🇨🇳Taiyuan, Shanxi, China
The First Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, Shanxi, China
The Second Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, Shanxi, China
Chengdu Second People's Hospital
🇨🇳Chengdu, Sichuan, China
Sichuan Provincial People's Hospital
🇨🇳Chengdu, Sichuan, China
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
🇨🇳Tianjin, Tianjin, China
The First Affiliated Hospital of Kunming Medical University
🇨🇳Kunming, Yunnan, China
The Second Affiliated Hospital Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
The Fourth Affiliated Hospital, Zhejiang University School of Medicine
🇨🇳Jinhua, Zhejiang, China
The First Affiliated Hospital Of Ningbo University
🇨🇳Ningbo, Zhejiang, China
The 1st School of Medicine，School of information and Engineering The 1st Affiliated Hospital of WMU
🇨🇳Wenzhou, Zhejiang, China
The First Affiliated Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
The Second Affiliated Hospital of Wannan Medical College
🇨🇳Wuhu, Anhui, China
Beijing Chao-Yang Hospital，Capital Medical University
🇨🇳Beijing, Beijing, China
Beijing Friendship Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Peking University Third Hospital
🇨🇳Beijing, Beijing, China
Beijing Tongren Hospital,CMU
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
Chongqing Traditional Chinese Medicine Hospital
🇨🇳Chongqing, Chongqing, China
Fujian Medical University Union Hospital
🇨🇳Fuzhou, Fujian, China
The First Affiliated Hospital of Fujian Medical University
🇨🇳Fuzhou, Fujian, China
Dermatology Hospital of Southern Medical University
🇨🇳Guangzhou, Guangdong, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
The Second Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China
Liuzhou People's Hospital
🇨🇳Liuzhou, Guangxi, China
The Affiliated Hospital of Guizhou Medical University
🇨🇳Guiyang, Guizhou, China
Affiliated Hospital of Chengde Medical University
🇨🇳Chengde, Hebei, China
Affiliated Hospital of Hebei University of Engineering
🇨🇳Handan, Hebei, China
The Second Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
The 2nd Affiliated Hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, China
The Second Affiliated Hospital of Henan University of Science and technology
🇨🇳Luoyang, Henan, China
Nanyang Central Hospital
🇨🇳Nanyang, Henan, China
Sanmenxia Central Hospital
🇨🇳Sanmenxia, Henan, China
Henan Provincial People's Hospital
🇨🇳Zhengzhou, Henan, China
Jingzhou Central Hospital
🇨🇳Jingzhou, Hubei, China
Wuhan Hospital Of Traditional Chinese and Western Medicine (Wuhan No.1 Hospital)
🇨🇳Wuhan, Hubei, China
Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
The Affiliated Hospital of Inner Mongolia Medical University
🇨🇳Hohhot, Inner Mongolia, China
The First People's Hospital of Changzhou
🇨🇳Changzhou, Jiangsu, China
The First People's Hospital of Lianyungang
🇨🇳Lianyungang, Jiangsu, China
Hospital for skin diseases,Institute of dermatology chinese academy of medical sciences，peking union medical college
🇨🇳Nanjing, Jiangsu, China
First Affiliated Hospital of Gannan Medical University
🇨🇳Ganzhou, Jiangxi, China
Dermatology Hospital of Jiangxi Province
🇨🇳Nanchang, Jiangxi, China
The First Hospital of Jilin University
🇨🇳Changchun, Jilin, China
Northeast International Hospital
🇨🇳Shenyang, Liaoning, China
Qilu Hospital of Shandong University
🇨🇳Jinan, Shandong, China
Shandong First Medical University Affiliated Dermatology Hospital
🇨🇳Jinan, Shandong, China
The Affiliated Hospital of Qingdao University
🇨🇳Qingdao, Shandong, China