Plaque Psoriasis
Conditions
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.
Interventions
DRUGICP-332 Tablets
ICP-332 will be administered as tablet for 12 weeks
Placebo will be administered as tablet for 12 weeks
Sponsors
Beijing InnoCare Pharma Tech Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects voluntarily participate in this study and have signed the Informed Consent Form (ICF). 2. Male or female subjects aged ≥ 18 years and ≤ 70 years 3. A history of plaque psoriasis for ≥6 months at baseline 4. Meet the following three criteria: 1. Psoriasis Area and Severity Index (PASI) score ≥12 2. Static Physician's Global Assessment (sPGA) score ≥3 3. Psoriasis affected Body Surface Area (BSA) ≥10% 5. The subject requires systemic treatment and/or phototherapy.
Exclusion criteria
1. Diagnosed with non-plaque psoriasis. 2. Subject had laboratory values meeting any of the protocol-specified criteria at Screening. 3. Presence of clinically serious, progressive, or uncontrolled disease. 4. Previous history of alcoholism or drug abuse (except for those who have been completely abstinent for more than 6 months before randomization). 5. Pregnant or lactating women. 6. The investigator accepts ICP-332 for any reason that the subject is not suitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
China
Contacts
Primary ContactMolly Lin
Outcome results
None listed