TrialPath
← Back to searchRecruiting

Efficacy, Safety, Pharmacokinetics of ICP-488 in Patients With Moderate to Severe Plaque Psoriasis

NCT06842199 · Beijing InnoCare Pharma Tech Co., Ltd.
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

Official title
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Oral ICP-488 in Patients With Moderate to Severe Plaque Psoriasis
About this study
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.
Eligibility criteria
Inclusion Criteria: Eligible subjects must meet all of the following 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: 1. The diagnosis was non-plaque psoriasis. 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.
Study design
Enrollment target: 383 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2025-03-20
Estimated completion: 2027-02
Last updated: 2026-02-09
Interventions
Drug: ICP-488 TabletsDrug: ICP-488 Placebo
Primary outcomes
  • 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)
Sponsor
Beijing InnoCare Pharma Tech Co., Ltd. · industry
Contacts & investigators
ContactAlexia Lu · contact · CO_HGRAC@innocarepharma.com · 010-66609745
All locations (46)
The First Affiliated Hospital of Anhui Medical UniversityCompleted
Hefei, Anhui, China
The Second Affiliated Hospital of Wannan Medical CollegeCompleted
Wuhu, Anhui, China
Beijing Chao-Yang Hospital,Capital Medical UniversityCompleted
Beijing, Beijing Municipality, China
Beijing Friendship Hospital, Capital Medical UniversityCompleted
Beijing, Beijing Municipality, China
Peking University Third HospitalCompleted
Beijing, Beijing Municipality, China
Beijing Tongren Hospital,CMUCompleted
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical UniversityCompleted
Chongqing, Chongqing Municipality, China
Chongqing Traditional Chinese Medicine HospitalCompleted
Chongqing, Chongqing Municipality, China
Fujian Medical University Union HospitalCompleted
Fuzhou, Fujian, China
The First Affiliated Hospital of Fujian Medical UniversityCompleted
Fuzhou, Fujian, China
Dermatology Hospital of Southern Medical UniversityCompleted
Guangzhou, Guangdong, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen UniversityCompleted
Guangzhou, Guangdong, China
Liuzhou People's HospitalCompleted
Liuchow, Guangxi, China
The Affiliated Hospital of Guizhou Medical UniversityCompleted
Guiyang, Guizhou, China
Affiliated Hospital of Chengde Medical UniversityCompleted
Chengde, Hebei, China
The Second Hospital of Hebei Medical UniversityCompleted
Shijiazhuang, Hebei, China
The 2nd Affiliated Hospital of Harbin Medical UniversityCompleted
Harbin, Heilongjiang, China
The Second Affiliated Hospital of Henan University of Science and technologyCompleted
Luoyang, Henan, China
Nanyang Central HospitalCompleted
Nanyang, Henan, China
Sanmenxia Central HospitalCompleted
Sanmenxia, Henan, China
Henan Provincial People's HospitalCompleted
Zhengzhou, Henan, China
Jingzhou Central HospitalCompleted
Jingzhou, Hubei, China
Wuhan Hospital Of Traditional Chinese and Western Medicine (Wuhan No.1 Hospital)Completed
Wuhan, Hubei, China
Xiangya Hospital of Central South UniversityCompleted
Changsha, Hunan, China
The Second Xiangya Hospital of Central SouthCompleted
Changsha, Hunan, China
The First People's Hospital of ChangzhouCompleted
Changzhou, Jiangsu, China
The First People's Hospital of LianyungangCompleted
Lianyungang, Jiangsu, China
Hospital for skin diseases,Institute of dermatology chinese academy of medical sciences,peking union medical collegeCompleted
Nanjing, Jiangsu, China
First Affiliated Hospital of Gannan Medical UniversityCompleted
Ganzhou, Jiangxi, China
Dermatology Hospital of Jiangxi ProvinceCompleted
Nanchang, Jiangxi, China
The First Hospital of Jilin UniversityCompleted
Changchun, Jilin, China
Northeast International HospitalCompleted
Shenyang, Liaoning, China
Qilu Hospital of Shandong UniversityCompleted
Jinan, Shandong, China
Huashan Hospital, Fudan UniversityCompleted
Shanghai, Shanghai Municipality, China
Shanghai Skin Disease Hospital skin Disease of tongji UniversityCompleted
Shanghai, Shanghai Municipality, China
Taiyuan Central HospitalCompleted
Taiyuan, Shanxi, China
The First Affiliated Hospital of Xi'an Jiaotong UniversityRecruiting
Xi’an, Shanxi, China
The Second Affiliated Hospital of Xi'an Jiaotong UniversityCompleted
Xi’an, Shanxi, China
Chengdu Second People's HospitalCompleted
Chengdu, Sichuan, China
Sichuan Provincial People's HospitalCompleted
Chengdu, Sichuan, China
Tianjin Academy of Traditional Chinese Medicine Affiliated HospitalCompleted
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital of Kunming Medical UniversityCompleted
Kunming, Yunnan, China
The Second Affiliated Hospital Zhejiang University School of MedicineCompleted
Hangzhou, Zhejiang, China
The Fourth Affiliated Hospital, Zhejiang University School of MedicineCompleted
Jinhua, Zhejiang, China
The First Affiliated Hospital Of Ningbo UniversityRecruiting
Ningbo, Zhejiang, China
The first Affiliated hospital of Wenzhou Medical UniversityCompleted
Wenzhou, Zhejiang, China
Efficacy, Safety, Pharmacokinetics of ICP-488 in Patients With Moderate to Severe Plaque Psoriasis · TrialPath