Evaluating ICP-488 for treating moderate to severe plaque psoriasis

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

This study is testing a new medication called ICP-488 to see if it can help adults in China with moderate to severe plaque psoriasis feel better and improve their skin health.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 383 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. (Industry-sponsored)
• Locations: 46 sites (Hefei, Anhui and 45 other locations)
• Trial ID: NCT06842199 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized, double-blind, placebo-controlled Phase III clinical study aims to assess the efficacy, safety, and pharmacokinetics of ICP-488 in Chinese adults suffering from moderate to severe plaque psoriasis. Participants will be randomly assigned to receive either ICP-488 tablets or a placebo, with the study focusing on measuring improvements in psoriasis severity and overall skin health. The study will include a diverse group of patients aged 18 to 75 who have a significant history of plaque psoriasis and require systemic therapy or phototherapy.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 75 with a history of moderate to severe plaque psoriasis requiring systemic therapy or phototherapy.

Not a fit: Patients with non-plaque psoriasis or those with concurrent skin diseases that may interfere with study assessments will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients with moderate to severe plaque psoriasis.

How similar studies have performed: Other studies have shown success with similar approaches in treating plaque psoriasis, indicating a promising avenue for this treatment.

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.

Where this trial is running

Hefei, Anhui and 45 other locations

• The First Affiliated Hospital of Anhui Medical University — Hefei, Anhui, China (Completed)
• The Second Affiliated Hospital of Wannan Medical College — Wuhu, Anhui, China (Completed)
• Beijing Chao-Yang Hospital，Capital Medical University — Beijing, Beijing Municipality, China (Completed)
• Beijing Friendship Hospital, Capital Medical University — Beijing, Beijing Municipality, China (Completed)
• Peking University Third Hospital — Beijing, Beijing Municipality, China (Completed)
• Beijing Tongren Hospital,CMU — Beijing, Beijing Municipality, China (Completed)
• The First Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (Completed)
• Chongqing Traditional Chinese Medicine Hospital — Chongqing, Chongqing Municipality, China (Completed)
• Fujian Medical University Union Hospital — Fuzhou, Fujian, China (Completed)
• The First Affiliated Hospital of Fujian Medical University — Fuzhou, Fujian, China (Completed)
• Dermatology Hospital of Southern Medical University — Guangzhou, Guangdong, China (Completed)
• Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (Completed)
• Liuzhou People's Hospital — Liuzhou, Guangxi, China (Completed)
• The Affiliated Hospital of Guizhou Medical University — Guiyang, Guizhou, China (Completed)
• Affiliated Hospital of Chengde Medical University — Chengde, Hebei, China (Completed)
• The Second Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (Completed)
• The 2nd Affiliated Hospital of Harbin Medical University — Harbin, Heilongjiang, China (Completed)
• The Second Affiliated Hospital of Henan University of Science and technology — Luoyang, Henan, China (Completed)
• Nanyang Central Hospital — Nanyang, Henan, China (Completed)
• Sanmenxia Central Hospital — Sanmenxia, Henan, China (Completed)
• Henan Provincial People's Hospital — Zhengzhou, Henan, China (Completed)
• Jingzhou Central Hospital — Jingzhou, Hubei, China (Completed)
• Wuhan Hospital Of Traditional Chinese and Western Medicine (Wuhan No.1 Hospital) — Wuhan, Hubei, China (Completed)
• Xiangya Hospital of Central South University — Changsha, Hunan, China (Completed)
• The Second Xiangya Hospital of Central South — Changsha, Hunan, China (Completed)
• The First People's Hospital of Changzhou — Changzhou, Jiangsu, China (Completed)
• The First People's Hospital of Lianyungang — Lianyungang, Jiangsu, China (Completed)
• Hospital for skin diseases,Institute of dermatology chinese academy of medical sciences，peking union medical college — Nanjing, Jiangsu, China (Completed)
• First Affiliated Hospital of Gannan Medical University — Ganzhou, Jiangxi, China (Completed)
• Dermatology Hospital of Jiangxi Province — Nanchang, Jiangxi, China (Completed)
• The First Hospital of Jilin University — Changchun, Jilin, China (Completed)
• Northeast International Hospital — Shenyang, Liaoning, China (Completed)
• Qilu Hospital of Shandong University — Jinan, Shandong, China (Completed)
• Huashan Hospital, Fudan University — Shanghai, Shanghai Municipality, China (Completed)
• Shanghai Skin Disease Hospital skin Disease of tongji University — Shanghai, Shanghai Municipality, China (Completed)
• Taiyuan Central Hospital — Taiyuan, Shanxi, China (Completed)
• The First Affiliated Hospital of Xi'an Jiaotong University — Xi’an, Shanxi, China (Recruiting)
• The Second Affiliated Hospital of Xi'an Jiaotong University — Xi’an, Shanxi, China (Completed)
• Chengdu Second People's Hospital — Chengdu, Sichuan, China (Completed)
• Sichuan Provincial People's Hospital — Chengdu, Sichuan, China (Completed)
• Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital — Tianjin, Tianjin Municipality, China (Completed)
• The First Affiliated Hospital of Kunming Medical University — Kunming, Yunnan, China (Completed)
• The Second Affiliated Hospital Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Completed)
• The Fourth Affiliated Hospital, Zhejiang University School of Medicine — Jinhua, Zhejiang, China (Completed)
• The First Affiliated Hospital Of Ningbo University — Ningbo, Zhejiang, China (Recruiting)
• The first Affiliated hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China (Completed)

Study contacts

• Study coordinator: Alexia Lu

Conditions Plaque Psoriasis Patients