Efficacy and Safety of ICP-332 Versus Placebo in Participants With Moderate to Severe Plaque Psoriasis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ICP-332 Tablets, ICP-332 Tablets, ICP-332 Tablets, ICP-332 Placebo Tablets.
- Who it may be relevant to
- Registry conditions: Plaque Psoriasis. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Drug ICP-332 Tablets
ICP-332 will be administered as tablet for 12 weeks - Drug ICP-332 Tablets
ICP-332 will be administered as tablet for 12 weeks - Drug ICP-332 Tablets
ICP-332 will be administered as tablet for 12 weeks - Other ICP-332 Placebo Tablets
Placebo will be administered as tablet for 12 weeks
Primary outcome measures
- 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]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanghai Dermatology Hospital — Shanghai
Identifiers
NCT: NCT07251998 · ICP-CL-00603