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
Sites (31)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| China-Japan Friendship Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Beijing Friendship Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| First Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| Xiangya Hospital Central South University Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Changzhou First People's Hospital Coordinator of this site? Confirm its status | Changzhou | China | Unknown status |
| The Affiliated Hospital of Chengde Medical College Coordinator of this site? Confirm its status | Chengde | China | Unknown status |
| Chengdu Second People's Hospital Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| The First Affiliated Hospital of Chongqing Medical University Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| The First Affiliated Hospital of Fujian Medical University Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| Dermatology Hospital of Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Guangdong Hospital of Traditional Chinese Medicine Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Affiliated Hospital of Guizhou Medical University Coordinator of this site? Confirm its status | Guiyang | China | Unknown status |
| Hangzhou First People's Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Zhejiang Provincial People's Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Affiliated Hospital of Inner Mongolia Medical University Coordinator of this site? Confirm its status | Hohhot | China | Unknown status |
| The First Hospital Of Jiaxing Coordinator of this site? Confirm its status | Jiaxing | China | Unknown status |
| Central Hospital affiliated to shandong first medical unversity Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| The First Affiliated Hospital of Kunming Medical University Coordinator of this site? Confirm its status | Kunming | China | Unknown status |
| Lianyungang First People's Hospital Coordinator of this site? Confirm its status | Lianyungang | China | Unknown status |
| Mei he kou central hospital Coordinator of this site? Confirm its status | Meihekou | China | Unknown status |
| Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences, Peking Union Medical College Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Nanyang city first People's Hospital Coordinator of this site? Confirm its status | Nanyang | China | Unknown status |
| Huashan Hospital Affiliated to Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Shanghai Dermatology Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| The First Hospital of Hebei Medical University Coordinator of this site? Confirm its status | Shijiazhuang | China | Unknown status |
| The Second Affiliated Hospital of Hebei Medical University Coordinator of this site? Confirm its status | Shijiazhuang | China | Unknown status |
| Shiyan City People's Hospital Coordinator of this site? Confirm its status | Shiyan | China | Unknown status |
| The First Affiliated Hospital of Wenzhou Medical University Coordinator of this site? Confirm its status | Wenzhou | China | Unknown status |
| Wuhan NO.1 Hospital Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Wuhan University People's Hospital Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Henan Provincial People's Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.