Plaque Psoriasis PatientsPhase 3NCT06842199
Efficacy, Safety, Pharmacokinetics of ICP-488 in Patients With Moderate to Severe Plaque Psoriasis
A Phase 3 study testing ICP-488 Tablets in people with Plaque Psoriasis Patients, run by Beijing InnoCare Pharma Tech Co., Ltd. at 46 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Plaque Psoriasis Patients
- What is being tested?
- ICP-488 Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 383 participants
- Where
- 46 sitesChina
- Study dates
- 20 Mar 2025to Feb 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
46 sites in 1 country. Contact the study team or a site near you to ask about taking part.
46 sites in 1 country
China46 sites, 2 recruiting
- Completed
Beijing Chao-Yang Hospital，Capital Medical University
Beijing, Beijing Municipality, 100020
- Completed
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
- Completed
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
- Completed
Beijing Tongren Hospital,CMU
Beijing, Beijing Municipality, 100730
- Completed
The First Hospital of Jilin University
Changchun, Jilin, 130021
- Completed
Xiangya Hospital of Central South University
Changsha, Hunan, 410008
- Completed
The Second Xiangya Hospital of Central South
Changsha, Hunan, 410011
- Completed
The First People's Hospital of Changzhou
Changzhou, Jiangsu, 213003
- Completed
Affiliated Hospital of Chengde Medical University
Chengde, Hebei, 067000
- Completed
Chengdu Second People's Hospital
Chengdu, Sichuan, 610017
- Completed
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
- Completed
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
- Completed
Chongqing Traditional Chinese Medicine Hospital
Chongqing, Chongqing Municipality, 400021
- Completed
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
- Completed
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005
- Completed
First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi, 341000
- Completed
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, 510091
- Completed
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510120
- Completed
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, 550001
- Completed
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
- Completed
The 2nd Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001
- Completed
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022
- Completed
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
- Completed
Jingzhou Central Hospital
Jingzhou, Hubei, 434020
- Completed
The Fourth Affiliated Hospital, Zhejiang University School of Medicine
Jinhua, Zhejiang, 322000
- Completed
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032
- Completed
The First People's Hospital of Lianyungang
Lianyungang, Jiangsu, 222002
- Completed
Liuzhou People's Hospital
Liuzhou, Guangxi, 545006
- Completed
The Second Affiliated Hospital of Henan University of Science and technology
Luoyang, Henan, 471000
- Completed
Dermatology Hospital of Jiangxi Province
Nanchang, Jiangxi, 330000
- Completed
Hospital for skin diseases,Institute of dermatology chinese academy of medical sciences，peking union medical college
Nanjing, Jiangsu, 210042
- Completed
Nanyang Central Hospital
Nanyang, Henan, 473000
- Recruiting
The First Affiliated Hospital Of Ningbo University
Ningbo, Zhejiang, 315000
bingjiang lin
- Completed
Sanmenxia Central Hospital
Sanmenxia, Henan, 472000
- Completed
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040
- Completed
Shanghai Skin Disease Hospital skin Disease of tongji University
Shanghai, Shanghai Municipality, 200443
- Completed
Northeast International Hospital
Shenyang, Liaoning, 110000
- Completed
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
- Completed
Taiyuan Central Hospital
Taiyuan, Shanxi, 030009
- Completed
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
Tianjin, Tianjin Municipality, 300120
- Completed
The first Affiliated hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
- Completed
Wuhan Hospital Of Traditional Chinese and Western Medicine (Wuhan No.1 Hospital)
Wuhan, Hubei, 430022
- Completed
The Second Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, 241000
- Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710061
kuanhou mou
- Completed
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710114
- Completed
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003
About this study
Official title: 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 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.
- Conditions
- Plaque Psoriasis Patients
- Being tested
- ICP-488 Tablets, ICP-488 Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICP-488 TabletsDrug
Eligible patients will receive ICP-488 orally as per the protocol
ICP-488 PlaceboDrug
Eligible patients will receive ICP-488 Placebo orally as per the protocol
| Study group | Role | What they receive |
|---|---|---|
| ICP-488 Tablets | Experimental | Not described Receives: Drug: ICP-488 Tablets |
| ICP-488 Placebo | Placebo comparator | Not described Receives: Drug: ICP-488 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects who achieve a score of clear (0) or almost clear (1) with an improvement of at least 2 points from baseline on the static Physician's Global Assessment (sPGA) at week 16
Measured: week 16
Percentage of subjects who achieved a PASI 75 response (a reduction of minimum 75% from baseline in PASI score) at Week 16
Measured: Week 16
Secondary outcomes (5)
Adverse events
Measured: Week 52
Percentage of subjects with PASI 50/75/90/100 in each planned visit
Measured: Week 52
Percentage of subjects with sPGA score of 0 (clear) or 1 (almost clear) and an improvement of at least 2 points from baseline in planned visits.
Measured: Week 52
The proportion of subjects with sPGA score of 0 in each planned visit.
Measured: Week 52
PK parameter: ICP-488 and its metabolite.
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start20 Mar 2025
- Primary completionMay 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque Psoriasis PatientsStudies of the same condition, open and under way.
- More trials run by Beijing InnoCare Pharma Tech Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 383 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06842199
- Sponsor's protocol ID
- ICP-CL-01005
- Status last verified
- Feb 2026
- First submitted
- 18 Feb 2025
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06842199
- Acronym / sponsor ID
- ICP-CL-01005
- Conditions
- Plaque Psoriasis Patients
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 383 participants (estimated)
- Lead sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 24 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICP-488 Tablets | Experimental | Drug: ICP-488 Tablets |
| ICP-488 Placebo | Placebo comparator | Drug: ICP-488 Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICP-488 TabletsEligible patients will receive ICP-488 orally as per the protocol | Drug | ICP-488 Tablets |
| ICP-488 PlaceboEligible patients will receive ICP-488 Placebo orally as per the protocol | Drug | ICP-488 Placebo |
Primary outcome
The proportion of subjects who achieve a score of clear (0) or almost clear (1) with an improvement of at least 2 points from baseline on the static Physician's Global Assessment (sPGA) at week 16
Time frame: week 16
Percentage of subjects who achieved a PASI 75 response (a reduction of minimum 75% from baseline in PASI score) at Week 16
Time frame: Week 16
5 secondary outcomes
Adverse events
Time frame: Week 52
Percentage of subjects with PASI 50/75/90/100 in each planned visit
Time frame: Week 52
Percentage of subjects with sPGA score of 0 (clear) or 1 (almost clear) and an improvement of at least 2 points from baseline in planned visits.
Time frame: Week 52
The proportion of subjects with sPGA score of 0 in each planned visit.
Time frame: Week 52
PK parameter: ICP-488 and its metabolite.
Time frame: Week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
46 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ICP-488 Tablets in people with Plaque Psoriasis Patients, run by Beijing InnoCare Pharma Tech Co., Ltd. at 46 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexia Lu (010-66609745, CO_HGRAC@innocarepharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of subjects who achieve a score of clear (0) or almost clear (1) with an improvement of at least 2 points from baseline on the static Physician's Global Assessment (sPGA) at week 16 (time frame: week 16). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.