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

December 24, 2025 updated by: Beijing InnoCare Pharma Tech Co., Ltd.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

172

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200443
        • Recruiting
        • Shanghai Dermatology Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ICP-332 Dose A
Drug: ICP-332 Tablets
ICP-332 will be administered as tablet for 12 weeks
Experimental: ICP-332 Dose B
Drug: ICP-332 Tablets
ICP-332 will be administered as tablet for 12 weeks
Experimental: ICP-332 Dose C
Drug: ICP-332 Tablets
ICP-332 will be administered as tablet for 12 weeks
Placebo Comparator: ICP-332 Placebo
Other: ICP-332 Placebo Tablets
Placebo will be administered as tablet for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome 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
Time Frame: Day 1 to Day 85
Day 1 to Day 85

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing InnoCare Pharma Tech Co., Ltd.

Investigators

  • Principal Investigator: Yuling Shi, Shanghai Dermatology Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 22, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

November 19, 2025

First Submitted That Met QC Criteria

November 19, 2025

First Posted (Estimated)

November 26, 2025

Study Record Updates

Last Update Posted (Actual)

December 31, 2025

Last Update Submitted That Met QC Criteria

December 24, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • ICP-CL-00603

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Plaque Psoriasis

Clinical Trials on ICP-332 Tablets

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Korea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe