Efficacy and Safety of ICP-332 Versus Placebo in Participants With Moderate to Severe Plaque Psoriasis
Recruiting · NCT07251998 · Interventional (participants receive a specific treatment) · Lead sponsor: Beijing InnoCare Pharma Tech Co., Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
ICP-332 Placebo TabletsICP-332 Tablets
What this trial is about
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.
Who can take part
Age range
18 Years to 70 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
- Shanghai Dermatology Hospital - Shanghai, Shanghai Municipality, China