Efficacy, Safety, Pharmacokinetics of ICP-488 in Patients With Moderate to Severe Plaque Psoriasis
Recruiting · NCT06842199 · Interventional (participants receive a specific treatment) · Lead sponsor: Beijing InnoCare Pharma Tech Co., Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
ICP-488 PlaceboICP-488 Tablets
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
Exclusion criteria
- 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 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.
Where it is running
46 locations listed.
- 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 - Liuzhou, 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