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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Plaque Psoriasis Patients

In brief

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.

Key facts

Study ID

NCT06842199

Run by

Beijing InnoCare Pharma Tech Co., Ltd.

People needed

383

Starts

2025-03-20

Expected to finish

2027-02-01

Last updated by the study team

2026-02-09

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• The First Affiliated Hospital Of Ningbo University — Ningbo, Zhejiang, China (enrolling)
• The First Affiliated Hospital of Xi'an Jiaotong University — Xi’an, Shanxi, China (enrolling)
• 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

Full record on ClinicalTrials.gov

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