Moderate to Severe Plaque PsoriasisPhase 2NCT06109818
Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of ICP-488 in Patients with Moderate to Severe Plaque Psoriasis
A Phase 2 study testing ICP-488 Tablets in people with Moderate to Severe Plaque Psoriasis, run by Beijing InnoCare Pharma Tech Co., Ltd. at 31 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Moderate to Severe Plaque Psoriasis
- 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
- 129 participants
- Where
- 31 sitesChina
- Study dates
- 4 Jan 2024to 18 Sep 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- The diagnosis was non-plaque psoriasis.
- 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 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.
- 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.
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- 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
31 sites in 1 country.
31 sites in 1 country
China31 sites
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100000
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100000
First Hospital of Jilin University
Changchun, Jilin, 130000
Xiangya hospital central south university
Changsha, Hunan, 410008
Changzhou First People's Hospital
Changzhou, Jiangsu, 213000
The Affiliated Hospital of Chengde Medical College
Chengde, Hebei, 067032
Chengdu Second People's Hospital
Chengdu, Sichuan, 610000
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400000
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350000
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, 510000
Guangdong Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, 510120
Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, 550081
Hangzhou First People's Hospital
Hangzhou, Zhejiang, 310000
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310000
Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, 010000
The First Hospital of Jiaxing
Jiaxing, Zhejiang, 314000
Central Hospital affiliated to shandong first medical unversity
Jinan, Shandong, 250013
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650000
Lianyungang First People's Hospital
Lianyungang, Jiangsu, 222000
Mei he kou central hospital
Meihekou, Jilin, 135099
Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of medical Sciences, Peking Union Medical College
Nanjing, Jiangsu, 210042
Nanyang city first People's Hospital
Nanyang, Henan, 473000
Shanghai Dermatology Hospital
Shanghai, Shanghai Municipality, 200000
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200040
The first hospital of hebei medical university
Shijiazhuang, Hebei, 050000
The Second Affiliated Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
Shiyan City People's Hospital
Shiyan, Hubei, 442000
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Wuhan University People's Hospital
Wuhan, Hubei, 430000
Wuhan No.1 hospital
Wuhan, Hubei, 430030
Henan Provincial People's Hospital
Zhengzhou, Henan, 450000
About this study
Official title: 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
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.
- Conditions
- Moderate to Severe Plaque Psoriasis
- 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
ICP-488 will be administered as tablet
ICP-488 PlaceboDrug
ICP-488 Placebo will be administered as tablet
| Study group | Role | What they receive |
|---|---|---|
| ICP-488 low dose | Experimental | Not described Receives: Drug: ICP-488 Tablets; Drug: ICP-488 Placebo |
| ICP-488 high dose | Experimental | Not described Receives: Drug: ICP-488 Tablets |
| 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.
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.
Measured: Baseline up to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start4 Jan 2024
- Primary completion5 Aug 2024
- Study completion18 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe Plaque PsoriasisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 129 participants (actual)
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
- NCT06109818
- Sponsor's protocol ID
- ICP-CL-01002
- Status last verified
- Feb 2025
- First submitted
- 26 Oct 2023
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06109818
- Acronym / sponsor ID
- ICP-CL-01002
- Conditions
- Moderate to Severe Plaque Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Jan 2024 (actual)
- Primary completion
- 5 Aug 2024 (actual)
- Study completion
- 18 Sep 2024 (actual)
- First posted
- 31 Oct 2023 (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 II clinical study to evaluate ICP-488.Efficacy, safety, PK, and PD characteristics 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
- 3
| Arm | Type | Receives |
|---|---|---|
| ICP-488 low dose | Experimental | Drug: ICP-488 Tablets, Drug: ICP-488 Placebo |
| ICP-488 high dose | Experimental | Drug: ICP-488 Tablets |
| Placebo | Placebo comparator | Drug: ICP-488 Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- The diagnosis was non-plaque psoriasis.
- 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 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.
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 TabletsICP-488 will be administered as tablet | Drug | ICP-488 high dose, ICP-488 low dose |
| ICP-488 PlaceboICP-488 Placebo will be administered as tablet | Drug | ICP-488 low dose, Placebo |
Primary outcome
Percentage of subjects who achieved a PASI 75 response (a reduction of minimum 75% from baseline in PASI score) at Week 12.
Time frame: Baseline up to Week 12
Proportion of subjects who achieved PASI 75 (PASI score improvement of at least 75% from baseline) at week 12.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ICP-488 Tablets in people with Moderate to Severe Plaque Psoriasis, run by Beijing InnoCare Pharma Tech Co., Ltd. at 31 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 5 inclusion and 9 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: finished, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of subjects who achieved a PASI 75 response (a reduction of minimum 75% from baseline in PASI score) at Week 12. (time frame: Baseline up to Week 12). 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 28 Feb 2025; AzTrials last refreshed its copy on 8 Nov 2026.