Efficacy, Safety, Pharmacokinetics of ICP-488 in Patients With Moderate to Severe Plaque Psoriasis
NCT ID: NCT06842199
Last Updated: 2026-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
383 participants
INTERVENTIONAL
2025-03-20
2027-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ICP-488 Tablets
ICP-488 Tablets
Eligible patients will receive ICP-488 orally as per the protocol
ICP-488 Placebo
ICP-488 Placebo
Eligible patients will receive ICP-488 Placebo orally as per the protocol
Interventions
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ICP-488 Tablets
Eligible patients will receive ICP-488 orally as per the protocol
ICP-488 Placebo
Eligible patients will receive ICP-488 Placebo orally as per the protocol
Eligibility Criteria
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Inclusion Criteria
1. Subjects voluntarily participate in this study and have signed informed consent.
2. Male or female subjects between the ages of 18 and 75 (including the threshold) at the time of signing the ICF.
3. History of plaque psoriasis ≥6 months at baseline.
4. Subjects need to receive systemic therapy and/or phototherapy.
5. 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
Exclusion Criteria
2. Subjects with concurrent skin diseases that the investigator believes would interfere with the study assessments.
3. Presence of infection or immune-related disease.
4. Subjects with a history of TB or at risk for TB.
5. Received related treatment within the time window specified in the protocol.
6. 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 with strong CYP1A2/CYP3A4 inhibitory or inductive effect during study participation.
7. 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.
8. Pregnant or lactating women, or women who plan to become pregnant during study participation.
9. A history of severe drug allergies.
10. Any other conditions in which the investigator considers it unsuitable for the subject to participate in this study.
18 Years
75 Years
ALL
No
Sponsors
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Beijing InnoCare Pharma Tech Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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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 Municipality, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Beijing Tongren Hospital,CMU
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Chongqing Traditional Chinese Medicine Hospital
Chongqing, Chongqing Municipality, 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
Liuzhou People's Hospital
Liuchow, Guangxi, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
Affiliated Hospital of Chengde Medical University
Chengde, 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 Second Xiangya Hospital of Central South
Changsha, Hunan, 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
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Shanghai Skin Disease Hospital skin Disease of tongji University
Shanghai, Shanghai Municipality, 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 Municipality, 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 first Affiliated hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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kuanhou mou
Role: primary
bingjiang lin
Role: primary
Other Identifiers
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ICP-CL-01005
Identifier Type: -
Identifier Source: org_study_id
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