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NCT Number: NCT07251998

Efficacy and Safety of ICP-332 Versus Placebo in Participants With Moderate to Severe Plaque Psoriasis

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.

Recruiting

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Key information

Conditions

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Shanghai Dermatology Hospital

Shanghai, Shanghai Municipality, 200443, China

Location status: Recruiting

Location contact

Yuling Shi, M.D.

CONTACT

[email protected]

021-36803154

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ICP-332 Tablets

Drug

ICP-332 will be administered as tablet for 12 weeks

ICP-332 Placebo Tablets

Other

Placebo will be administered as tablet for 12 weeks

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

    Time frame: Day 1 to Day 85

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Beijing InnoCare Pharma Tech Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Nov 26, 2025
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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