RecruitingPhase 2NCT07251998

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


Sponsor

Beijing InnoCare Pharma Tech Co., Ltd.

Enrollment

172 participants

Start Date

Dec 22, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria8

  • 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 Criteria6

  • 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.

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Interventions

DRUGICP-332 Tablets

ICP-332 will be administered as tablet for 12 weeks

DRUGICP-332 Tablets

ICP-332 will be administered as tablet for 12 weeks

DRUGICP-332 Tablets

ICP-332 will be administered as tablet for 12 weeks

OTHERICP-332 Placebo Tablets

Placebo will be administered as tablet for 12 weeks


Locations(1)

Shanghai Dermatology Hospital

Shanghai, Shanghai Municipality, China

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NCT07251998


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