Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of ICP-488 in Patients with Moderate to Severe Plaque Psoriasis
- Conditions
- Moderate to Severe Plaque Psoriasis
- Interventions
- Drug: ICP-488 PlaceboDrug: ICP-488 Tablets
- Registration Number
- NCT06109818
- Lead Sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.
- Brief Summary
This is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical study to evaluate ICP-488.Efficacy, safety, PK, and PD characteristics in Chinese adults with moderate to severe plaque psoriasis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 129
- Subjects voluntarily participate in this study and have signed informed consent.
- Male or female subjects between the ages of 18 and 70 (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.
- 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 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.
- 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 Placebo ICP-488 Placebo - ICP-488 low dose ICP-488 Placebo - ICP-488 high dose ICP-488 Tablets - ICP-488 low dose ICP-488 Tablets -
- Primary Outcome Measures
Name Time Method Percentage of subjects who achieved a PASI 75 response (a reduction of minimum 75% from baseline in PASI score) at Week 12. Baseline up to Week 12 Proportion of subjects who achieved PASI 75 (PASI score improvement of at least 75% from baseline) at week 12.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (31)
Beijing Friendship Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
China-Japan Friendship Hospital
🇨🇳Beijing, Beijing, China
Chengdu Second People's Hospital
🇨🇳Chengdu, Sichuan, China
The First Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, 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
🇨🇳Shijia Zhuang, 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 Autonomous Region, 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, China
Huashan Hospital Affiliated to Fudan University
🇨🇳Shanghai, Shanghai, 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