Plaque PsoriasisPhase 2NCT07251998
Efficacy and Safety of ICP-332 Versus Placebo in Participants With Moderate to Severe Plaque Psoriasis
A Phase 2 study testing ICP-332 Tablets in people with Plaque Psoriasis, run by Beijing InnoCare Pharma Tech Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to compare the efficacy and safety of ICP-332 to placebo in participants 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
- Plaque Psoriasis
- What is being tested?
- ICP-332 Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 172 participants
- Where
- 1 siteChina
- Study dates
- 22 Dec 2025to May 2027
- Phase
- Phase 2
- 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 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 the Informed Consent Form (ICF).
- Male or female subjects aged ≥ 18 years and ≤ 70 years
- A history of plaque psoriasis for ≥6 months at baseline
- Meet the following three criteria:
- Psoriasis Area and Severity Index (PASI) score ≥12
- Static Physician's Global Assessment (sPGA) score ≥3
- Psoriasis affected Body Surface Area (BSA) ≥10%
- The subject requires systemic treatment and/or phototherapy.
Who cannot join
- Diagnosed with non-plaque psoriasis.
- Subject had laboratory values meeting any of the protocol-specified criteria at Screening.
- Presence of clinically serious, progressive, or uncontrolled disease.
- Previous history of alcoholism or drug abuse (except for those who have been completely abstinent for more than 6 months before randomization).
- Pregnant or lactating women.
- The investigator accepts ICP-332 for any reason that the subject is not suitable for this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Dermatology Hospital
Shanghai, Shanghai Municipality, 200443
Yuling Shi, M.D., 021-36803154, shiyuling1973@126.com
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase 2 Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of ICP-332 in Patients With Moderate to Severe Plaque Psoriasis
The purpose of this study is to compare the efficacy and safety of ICP-332 to placebo in participants with moderate-to-severe plaque psoriasis.
- Conditions
- Plaque Psoriasis
- Being tested
- ICP-332 Tablets, ICP-332 Placebo Tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICP-332 TabletsDrug
ICP-332 will be administered as tablet for 12 weeks
ICP-332 TabletsDrug
ICP-332 will be administered as tablet for 12 weeks
ICP-332 TabletsDrug
ICP-332 will be administered as tablet for 12 weeks
ICP-332 Placebo TabletsOther
Placebo will be administered as tablet for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| ICP-332 Dose A | Experimental | Not described Receives: Drug: ICP-332 Tablets |
| ICP-332 Dose B | Experimental | Not described Receives: Drug: ICP-332 Tablets |
| ICP-332 Dose C | Experimental | Not described Receives: Drug: ICP-332 Tablets |
| ICP-332 Placebo | Placebo comparator | Not described Receives: Other: ICP-332 Placebo Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Percentage of Participants With Moderate to Severe Psoriasis Experiencing a 75% Improvement (Reduction From Baseline) in PASI Score (PASI-75 Response Rate) at Week 12
Measured: Day 1 to Day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start22 Dec 2025
- Primary completionOct 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuling Shi, Principal investigator, Shanghai Dermatology Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07251998
- Sponsor's protocol ID
- ICP-CL-00603
- Status last verified
- Dec 2025
- First submitted
- 19 Nov 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase 2 Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of ICP-332 in Patients With Moderate to Severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT07251998
- Acronym / sponsor ID
- ICP-CL-00603
- Conditions
- Plaque Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Dec 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 26 Nov 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.
The purpose of this study is to compare the efficacy and safety of ICP-332 to placebo in participants with moderate-to-severe plaque psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ICP-332 Dose A | Experimental | Drug: ICP-332 Tablets |
| ICP-332 Dose B | Experimental | Drug: ICP-332 Tablets |
| ICP-332 Dose C | Experimental | Drug: ICP-332 Tablets |
| ICP-332 Placebo | Placebo comparator | Other: ICP-332 Placebo Tablets |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects voluntarily participate in this study and have signed the Informed Consent Form (ICF).
- Male or female subjects aged ≥ 18 years and ≤ 70 years
- A history of plaque psoriasis for ≥6 months at baseline
- Meet the following three criteria:
- The subject requires systemic treatment and/or phototherapy.
Key exclusion criteria (6 listed)
- Diagnosed with non-plaque psoriasis.
- Subject had laboratory values meeting any of the protocol-specified criteria at Screening.
- Presence of clinically serious, progressive, or uncontrolled disease.
- Previous history of alcoholism or drug abuse (except for those who have been completely abstinent for more than 6 months before randomization).
- Pregnant or lactating women.
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-332 TabletsICP-332 will be administered as tablet for 12 weeks | Drug | ICP-332 Dose A |
| ICP-332 TabletsICP-332 will be administered as tablet for 12 weeks | Drug | ICP-332 Dose B |
| ICP-332 TabletsICP-332 will be administered as tablet for 12 weeks | Drug | ICP-332 Dose C |
| ICP-332 Placebo TabletsPlacebo will be administered as tablet for 12 weeks | Other | ICP-332 Placebo |
Primary outcome
The Percentage of Participants With Moderate to Severe Psoriasis Experiencing a 75% Improvement (Reduction From Baseline) in PASI Score (PASI-75 Response Rate) at Week 12
Time frame: Day 1 to Day 85
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 31 Dec 2025.
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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.
Yuling Shi principal investigator
Shanghai Dermatology Hospital
1 site 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-332 Tablets in people with Plaque Psoriasis, run by Beijing InnoCare Pharma Tech Co., Ltd. at 1 site 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 8 inclusion and 6 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 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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 Molly Lin (+86 15198230043, molly.lin@innocarepharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Percentage of Participants With Moderate to Severe Psoriasis Experiencing a 75% Improvement (Reduction From Baseline) in PASI Score (PASI-75 Response Rate) at Week 12 (time frame: Day 1 to Day 85). 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 31 Dec 2025.