Clinical trial NCT06109818: Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of ICP-488 in Patients with Moderate to Severe Plaque Psoriasis
Official title: A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of ICP-488 in Patients with Moderate to Severe Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Moderate to Severe Plaque Psoriasis
Lead sponsor: Beijing InnoCare Pharma Tech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-10-31
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 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:

1. The diagnosis was non-plaque psoriasis.
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.

Primary outcomes:
measure: Percentage of subjects who achieved a PASI 75 response (a reduction of minimum 75% from baseline in PASI score) at Week 12.
timeFrame: Baseline up to Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
state: Fujian
city: Guangzhou
country: China
facility: Dermatology Hospital of Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Hospital of Traditional Chinese Medicine
state: Guangdong
city: Guiyang
country: China
facility: Affiliated Hospital of Guizhou Medical University
state: Guizhou
city: Chengde
country: China
facility: The Affiliated Hospital of Chengde Medical College
state: Hebei
city: Shijia Zhuang
country: China
facility: The first hospital of hebei medical university
state: Hebei
city: Shijiazhuang
country: China
facility: The Second Affiliated Hospital of Hebei Medical University
state: Hebei
city: Nanyang
country: China
facility: Nanyang city first People's Hospital
state: Henan
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Shiyan
country: China
facility: Shiyan City People's Hospital
state: Hubei
city: Wuhan
country: China
facility: Wuhan University People's Hospital
state: Hubei
city: Wuhan
country: China
facility: Wuhan No.1 hospital
state: Hubei
city: Changsha
country: China
facility: Xiangya hospital central south university
state: Hunan
city: Hohhot
country: China
facility: Affiliated Hospital of Inner Mongolia Medical University
state: Inner Mongolia Autonomous Region
city: Changzhou
country: China
facility: Changzhou First People's Hospital
state: Jiangsu
city: Lianyungang
country: China
facility: Lianyungang First People's Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of medical Sciences, Peking Union Medical College
state: Jiangsu
city: Changchun
country: China
facility: First Hospital of Jilin University
state: Jilin
city: Meihekou
country: China
facility: Mei he kou central hospital
state: Jilin
city: Jinan
country: China
facility: Central Hospital affiliated to shandong first medical unversity
state: Shandong
city: Shanghai
country: China
facility: Shanghai Dermatology Hospital
state: Shanghai
city: Shanghai
country: China
facility: Huashan Hospital Affiliated to Fudan University
state: Shanghai
city: Chengdu
country: China
facility: Chengdu Second People's Hospital
state: Sichuan
city: Kunming
country: China
facility: The First Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Hangzhou
country: China
facility: Hangzhou First People's Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
city: Jiaxing
country: China
facility: The First Hospital of Jiaxing
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
References: