Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of ICP-488 in Patients with Moderate to Severe Plaque Psoriasis
NCT ID: NCT06109818
Last Updated: 2025-02-28
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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COMPLETED
PHASE2
129 participants
INTERVENTIONAL
2024-01-04
2024-09-18
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 low dose
ICP-488 Tablets
ICP-488 will be administered as tablet
ICP-488 Placebo
ICP-488 Placebo will be administered as tablet
ICP-488 high dose
ICP-488 Tablets
ICP-488 will be administered as tablet
Placebo
ICP-488 Placebo
ICP-488 Placebo will be administered as tablet
Interventions
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ICP-488 Tablets
ICP-488 will be administered as tablet
ICP-488 Placebo
ICP-488 Placebo will be administered as tablet
Eligibility Criteria
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Inclusion Criteria
2. Male or female subjects between the ages of 18 and 70 (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. Presence of infection or immune-related disease.
3. Subjects with a history of TB or at risk for TB.
4. Received related treatment within the time window specified in the protocol.
5. An interval of less than 5 half-lives or 28 days (if any available halflife data) from the last dose of a strong CYP1A2 inhibitor or inducer, or a plan to use concurrently medications, dietary supplements or food with strong CYP1A2 inhibitory or inductive effect during study participation.
6. 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.
7. Pregnant or lactating women, or women who plan to become pregnant during study participation.
8. A history of severe drug allergies.
9. Any other conditions in which the investigator considers it unsuitable for the subject to participate in this study.
18 Years
70 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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Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, China
Guangdong Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, China
Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
The Affiliated Hospital of Chengde Medical College
Chengde, Hebei, China
The first hospital of hebei medical university
Shijiazhuang, Hebei, China
The Second Affiliated Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Nanyang city first People's Hospital
Nanyang, Henan, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Shiyan City People's Hospital
Shiyan, Hubei, China
Wuhan University People's Hospital
Wuhan, Hubei, China
Wuhan No.1 hospital
Wuhan, Hubei, China
Xiangya hospital central south university
Changsha, Hunan, China
Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, China
Changzhou First People's Hospital
Changzhou, Jiangsu, China
Lianyungang First People's Hospital
Lianyungang, Jiangsu, China
Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of medical Sciences, Peking Union Medical College
Nanjing, Jiangsu, China
First Hospital of Jilin University
Changchun, Jilin, China
Mei he kou central hospital
Meihekou, Jilin, China
Central Hospital affiliated to shandong first medical unversity
Jinan, Shandong, China
Shanghai Dermatology Hospital
Shanghai, Shanghai Municipality, China
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
Chengdu Second People's Hospital
Chengdu, Sichuan, China
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Hangzhou First People's Hospital
Hangzhou, Zhejiang, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
The First Hospital of Jiaxing
Jiaxing, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Countries
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Other Identifiers
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ICP-CL-01002
Identifier Type: -
Identifier Source: org_study_id
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