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NCT06109818CompletedPhase 2

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

A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of ICP-488 in Patients with Moderate to Severe Plaque Psoriasis

Source: ClinicalTrials.gov · Last updated 28 Feb 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
129 (actual)
First submitted
26 Oct 2023
Start date
4 Jan 2024
Primary completion date
5 Aug 2024
Lead sponsor
Beijing InnoCare Pharma Tech Co., Ltd.
Diseases
Psoriasis
NCT number
NCT06109818

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 129
  • From 4 Jan 2024 to the primary completion date, 5 Aug 2024
  • 31 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • Presence of infection or immune-related disease.
  • Subjects with a history of TB or at risk for TB.
  • A history of severe drug allergies.
  • Any other conditions in which the investigator considers it unsuitable for the subject to participate in this study.

Lab values

  • 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.

Other

  • The diagnosis was non-plaque psoriasis.
  • Pregnant or lactating women, or women who plan to become pregnant during study participation.

Who the study is looking for

  • 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

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (31)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
China-Japan Friendship Hospital
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BeijingChinaUnknown status
Beijing Friendship Hospital, Capital Medical University
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BeijingChinaUnknown status
First Hospital of Jilin University
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ChangchunChinaUnknown status
Xiangya Hospital Central South University
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ChangshaChinaUnknown status
Changzhou First People's Hospital
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ChangzhouChinaUnknown status
The Affiliated Hospital of Chengde Medical College
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ChengdeChinaUnknown status
Chengdu Second People's Hospital
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ChengduChinaUnknown status
The First Affiliated Hospital of Chongqing Medical University
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ChongqingChinaUnknown status
The First Affiliated Hospital of Fujian Medical University
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FuzhouChinaUnknown status
Dermatology Hospital of Southern Medical University
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GuangzhouChinaUnknown status
Guangdong Hospital of Traditional Chinese Medicine
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GuangzhouChinaUnknown status
Affiliated Hospital of Guizhou Medical University
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GuiyangChinaUnknown status
Hangzhou First People's Hospital
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HangzhouChinaUnknown status
Zhejiang Provincial People's Hospital
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HangzhouChinaUnknown status
Affiliated Hospital of Inner Mongolia Medical University
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HohhotChinaUnknown status
The First Hospital Of Jiaxing
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JiaxingChinaUnknown status
Central Hospital affiliated to shandong first medical unversity
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JinanChinaUnknown status
The First Affiliated Hospital of Kunming Medical University
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KunmingChinaUnknown status
Lianyungang First People's Hospital
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LianyungangChinaUnknown status
Mei he kou central hospital
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MeihekouChinaUnknown status
Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences, Peking Union Medical College
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NanjingChinaUnknown status
Nanyang city first People's Hospital
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NanyangChinaUnknown status
Huashan Hospital Affiliated to Fudan University
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ShanghaiChinaUnknown status
Shanghai Dermatology Hospital
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ShanghaiChinaUnknown status
The First Hospital of Hebei Medical University
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ShijiazhuangChinaUnknown status
The Second Affiliated Hospital of Hebei Medical University
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ShijiazhuangChinaUnknown status
Shiyan City People's Hospital
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ShiyanChinaUnknown status
The First Affiliated Hospital of Wenzhou Medical University
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WenzhouChinaUnknown status
Wuhan NO.1 Hospital
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WuhanChinaUnknown status
Wuhan University People's Hospital
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WuhanChinaUnknown status
Henan Provincial People's Hospital
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ZhengzhouChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.