Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of ICP-488 in Patients with Moderate to Severe Plaque Psoriasis

NCT06109818 | Completed Phase 2

• 1 other identifier: ICP-CL-01002
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 31

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.

Conditions

Moderate to Severe Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• Percentage of subjects who achieved a PASI 75 response (a reduction of minimum 75% from baseline in PASI score) at Week 12.

  Proportion of subjects who achieved PASI 75 (PASI score improvement of at least 75% from baseline) at week 12.

  Baseline up to Week 12

Study Arms (3)

ICP-488 low dose

EXPERIMENTAL

Drug: ICP-488 Tablets; Drug: ICP-488 Placebo

ICP-488 high dose

EXPERIMENTAL

Drug: ICP-488 Tablets

Placebo

PLACEBO COMPARATOR

Drug: ICP-488 Placebo

Interventions

ICP-488 Tablets DRUG

ICP-488 will be administered as tablet

ICP-488 high dose; ICP-488 low dose

ICP-488 Placebo DRUG

ICP-488 Placebo will be administered as tablet

ICP-488 low dose; Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing InnoCare Pharma Tech Co., Ltd.: lead

Study Sites (31)

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100000, China

Location

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100000, China

Location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400000, China

Location

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350000, China

Location

Dermatology Hospital of Southern Medical University

Guangzhou, Guangdong, 510000, China

Location

Guangdong Hospital of Traditional Chinese Medicine

Guangzhou, Guangdong, 510120, China

Location

Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, 550081, China

Location

The Affiliated Hospital of Chengde Medical College

Chengde, Hebei, 067032, China

Location

The first hospital of hebei medical university

Shijiazhuang, Hebei, 050000, China

Location

The Second Affiliated Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

Location

Nanyang city first People's Hospital

Nanyang, Henan, 473000, China

Location

Henan Provincial People's Hospital

Zhengzhou, Henan, 450000, China

Location

Shiyan City People's Hospital

Shiyan, Hubei, 442000, China

Location

Wuhan University People's Hospital

Wuhan, Hubei, 430000, China

Location

Wuhan No.1 hospital

Wuhan, Hubei, 430030, China

Location

Xiangya hospital central south university

Changsha, Hunan, 410008, China

Location

Affiliated Hospital of Inner Mongolia Medical University

Hohhot, Inner Mongolia, 010000, China

Location

Changzhou First People's Hospital

Changzhou, Jiangsu, 213000, China

Location

Lianyungang First People's Hospital

Lianyungang, Jiangsu, 222000, China

Location

Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of medical Sciences, Peking Union Medical College

Nanjing, Jiangsu, 210042, China

Location

First Hospital of Jilin University

Changchun, Jilin, 130000, China

Location

Mei he kou central hospital

Meihekou, Jilin, 135099, China

Location

Central Hospital affiliated to shandong first medical unversity

Jinan, Shandong, 250013, China

Location

Shanghai Dermatology Hospital

Shanghai, Shanghai Municipality, 200000, China

Location

Huashan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location

Chengdu Second People's Hospital

Chengdu, Sichuan, 610000, China

Location

The First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650000, China

Location

Hangzhou First People's Hospital

Hangzhou, Zhejiang, 310000, China

Location

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, 310000, China

Location

The First Hospital of Jiaxing

Jiaxing, Zhejiang, 314000, China

Location

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: October 31, 2023
• Study Start: January 4, 2024
• Primary Completion: August 5, 2024
• Study Completion: September 18, 2024
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (31)