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

NCT06842199 | Recruiting Phase 3 DMC

• 1 other identifier: ICP-CL-01005
• Study Type: interventional
• Target: 383
• Locations: 1 country
• Sites: 46

Brief Summary

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.

Conditions

Plaque Psoriasis Patients

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (5)

• Adverse events

  Week 52

• Percentage of subjects with PASI 50/75/90/100 in each planned visit

  Week 52

• Percentage of subjects with sPGA score of 0 (clear) or 1 (almost clear) and an improvement of at least 2 points from baseline in planned visits.

  Week 52

• The proportion of subjects with sPGA score of 0 in each planned visit.

  Week 52

• PK parameter: ICP-488 and its metabolite.

  Week 52

Study Arms (2)

ICP-488 Tablets

EXPERIMENTAL

Drug: ICP-488 Tablets

ICP-488 Placebo

PLACEBO COMPARATOR

Drug: ICP-488 Placebo

Interventions

ICP-488 Tablets DRUG

Eligible patients will receive ICP-488 orally as per the protocol

ICP-488 Tablets

ICP-488 Placebo DRUG

Eligible patients will receive ICP-488 Placebo orally as per the protocol

ICP-488 Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (46)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230022, China

COMPLETED

The Second Affiliated Hospital of Wannan Medical College

Wuhu, Anhui, 241000, China

COMPLETED

Beijing Chao-Yang Hospital，Capital Medical University

Beijing, Beijing Municipality, 100020, China

COMPLETED

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

COMPLETED

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

COMPLETED

Beijing Tongren Hospital,CMU

Beijing, Beijing Municipality, 100730, China

COMPLETED

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

COMPLETED

Chongqing Traditional Chinese Medicine Hospital

Chongqing, Chongqing Municipality, 400021, China

COMPLETED

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

COMPLETED

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350005, China

COMPLETED

Dermatology Hospital of Southern Medical University

Guangzhou, Guangdong, 510091, China

COMPLETED

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510120, China

COMPLETED

Liuzhou People's Hospital

Liuchow, Guangxi, 545006, China

COMPLETED

The Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, 550001, China

COMPLETED

Affiliated Hospital of Chengde Medical University

Chengde, Hebei, 067000, China

COMPLETED

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

COMPLETED

The 2nd Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150001, China

COMPLETED

The Second Affiliated Hospital of Henan University of Science and technology

Luoyang, Henan, 471000, China

COMPLETED

Nanyang Central Hospital

Nanyang, Henan, 473000, China

COMPLETED

Sanmenxia Central Hospital

Sanmenxia, Henan, 472000, China

COMPLETED

Henan Provincial People's Hospital

Zhengzhou, Henan, 450003, China

COMPLETED

Jingzhou Central Hospital

Jingzhou, Hubei, 434020, China

COMPLETED

Wuhan Hospital Of Traditional Chinese and Western Medicine (Wuhan No.1 Hospital)

Wuhan, Hubei, 430022, China

COMPLETED

Xiangya Hospital of Central South University

Changsha, Hunan, 410008, China

COMPLETED

The Second Xiangya Hospital of Central South

Changsha, Hunan, 410011, China

COMPLETED

The First People's Hospital of Changzhou

Changzhou, Jiangsu, 213003, China

COMPLETED

The First People's Hospital of Lianyungang

Lianyungang, Jiangsu, 222002, China

COMPLETED

Hospital for skin diseases,Institute of dermatology chinese academy of medical sciences，peking union medical college

Nanjing, Jiangsu, 210042, China

COMPLETED

First Affiliated Hospital of Gannan Medical University

Ganzhou, Jiangxi, 341000, China

COMPLETED

Dermatology Hospital of Jiangxi Province

Nanchang, Jiangxi, 330000, China

COMPLETED

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

COMPLETED

Northeast International Hospital

Shenyang, Liaoning, 110000, China

COMPLETED

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

COMPLETED

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200040, China

COMPLETED

Shanghai Skin Disease Hospital skin Disease of tongji University

Shanghai, Shanghai Municipality, 200443, China

COMPLETED

Taiyuan Central Hospital

Taiyuan, Shanxi, 030009, China

COMPLETED

The First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, 710061, China

RECRUITING

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, 710114, China

COMPLETED

Chengdu Second People's Hospital

Chengdu, Sichuan, 610017, China

COMPLETED

Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610072, China

COMPLETED

Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital

Tianjin, Tianjin Municipality, 300120, China

COMPLETED

The First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650032, China

COMPLETED

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

COMPLETED

The Fourth Affiliated Hospital, Zhejiang University School of Medicine

Jinhua, Zhejiang, 322000, China

COMPLETED

The First Affiliated Hospital Of Ningbo University

Ningbo, Zhejiang, 315000, China

RECRUITING

The first Affiliated hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

COMPLETED

Central Study Contacts

Alexia Lu

CONTACT

010-66609745; CO_HGRAC@innocarepharma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: February 18, 2025
• First Posted: February 24, 2025
• Study Start: March 20, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: February 9, 2026

Record last verified: 2026-02

Locations

CN (46)