Efficacy and Safety of ICP-332 Versus Placebo in Participants With Moderate to Severe Plaque Psoriasis
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
1 other identifier
interventional
172
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2025
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 19, 2025
CompletedFirst Posted
Study publicly available on registry
November 26, 2025
CompletedStudy Start
First participant enrolled
December 22, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2027
December 31, 2025
December 1, 2025
9 months
November 19, 2025
December 24, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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
Day 1 to Day 85
Study Arms (4)
ICP-332 Dose A
EXPERIMENTALICP-332 Dose B
EXPERIMENTALICP-332 Dose C
EXPERIMENTALICP-332 Placebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai Dermatology Hospital
Shanghai, Shanghai Municipality, 200443, China
Study Officials
- PRINCIPAL INVESTIGATOR
Yuling Shi
Shanghai Dermatology Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2025
First Posted
November 26, 2025
Study Start
December 22, 2025
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
May 1, 2027
Last Updated
December 31, 2025
Record last verified: 2025-12