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CompletedNCT06109818Updated Feb 28, 2025

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

A Phase 2 interventional study of ICP-488 Tablets and ICP-488 Placebo in Moderate to Severe Plaque Psoriasis, sponsored by Beijing InnoCare Pharma Tech Co., Ltd.. Completed at 31 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-02-28.

Sponsored by Beijing InnoCare Pharma Tech Co., Ltd. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
129
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Moderate to Severe Plaque Psoriasis

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03

In context

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

This study's enrollment of 129 is above the median of 70 across 1,447 interventional studies indexed under Psoriasis.

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Lead sponsor

Beijing InnoCare Pharma Tech Co., Ltd. is the lead sponsor of 57 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
129 participants (actual)

Study arms

  • Experimental
    ICP-488 low dose

    Drug: ICP-488 Tablets · Drug: ICP-488 Placebo

  • Experimental
    ICP-488 high dose

    Drug: ICP-488 Tablets

  • Placebo comparator
    Placebo

    Drug: ICP-488 Placebo

Interventions

  • DrugICP-488 Tablets

    ICP-488 will be administered as tablet

  • DrugICP-488 Placebo

    ICP-488 Placebo will be administered as tablet

06

What researchers measure

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.

    Time frame: Baseline up to Week 12

07

Study locations

31 sites
  • Beijing Friendship Hospital, Capital Medical University
    Beijing, Beijing 100000, China
  • China-Japan Friendship Hospital
    Beijing, Beijing 100000, China
  • The First Affiliated Hospital of Chongqing Medical University
    Chongqing, Chongqing 400000, China
  • The First Affiliated Hospital of Fujian Medical University
    Fuzhou, Fujian 350000, China
  • Dermatology Hospital of Southern Medical University
    Guangzhou, Guangdong 510000, China
  • Guangdong Hospital of Traditional Chinese Medicine
    Guangzhou, Guangdong 510120, China
  • Affiliated Hospital of Guizhou Medical University
    Guiyang, Guizhou 550081, China
  • The Affiliated Hospital of Chengde Medical College
    Chengde, Hebei 067032, China
  • The first hospital of hebei medical university
    Shijia Zhuang, Hebei 050000, China
  • The Second Affiliated Hospital of Hebei Medical University
    Shijiazhuang, Hebei 050000, China
  • Nanyang city first People's Hospital
    Nanyang, Henan 473000, China
  • Henan Provincial People's Hospital
    Zhengzhou, Henan 450000, China
  • Shiyan City People's Hospital
    Shiyan, Hubei 442000, China
  • Wuhan University People's Hospital
    Wuhan, Hubei 430000, China
  • Wuhan No.1 hospital
    Wuhan, Hubei 430030, China
  • Xiangya hospital central south university
    Changsha, Hunan 410008, China
  • Affiliated Hospital of Inner Mongolia Medical University
    Hohhot, Inner Mongolia Autonomous Region 010000, China
  • Changzhou First People's Hospital
    Changzhou, Jiangsu 213000, China
  • Lianyungang First People's Hospital
    Lianyungang, Jiangsu 222000, China
  • Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of medical Sciences, Peking Union Medical College
    Nanjing, Jiangsu 210042, China
  • First Hospital of Jilin University
    Changchun, Jilin 130000, China
  • Mei he kou central hospital
    Meihekou, Jilin 135099, China
  • Central Hospital affiliated to shandong first medical unversity
    Jinan, Shandong 250013, China
  • Shanghai Dermatology Hospital
    Shanghai, Shanghai 200000, China
  • Huashan Hospital Affiliated to Fudan University
    Shanghai, Shanghai 200040, China
  • Chengdu Second People's Hospital
    Chengdu, Sichuan 610000, China
  • The First Affiliated Hospital of Kunming Medical University
    Kunming, Yunnan 650000, China
  • Hangzhou First People's Hospital
    Hangzhou, Zhejiang 310000, China
  • Zhejiang Provincial People's Hospital
    Hangzhou, Zhejiang 310000, China
  • The First Hospital of Jiaxing
    Jiaxing, Zhejiang 314000, China
  • The First Affiliated Hospital of Wenzhou Medical University
    Wenzhou, Zhejiang 325000, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06109818
Lead sponsor
Beijing InnoCare Pharma Tech Co., Ltd.
Responsible party
Sponsor
First posted
Oct 31, 2023
Start date
Jan 4, 2024
Primary completion
Aug 5, 2024
Completion
Sep 18, 2024
Last update
Feb 28, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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