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

NCT ID: NCT07251998

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

172 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-22

Study Completion Date

2027-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Plaque Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ICP-332 Dose A

Group Type EXPERIMENTAL

ICP-332 Tablets

Intervention Type DRUG

ICP-332 will be administered as tablet for 12 weeks

ICP-332 Dose B

Group Type EXPERIMENTAL

ICP-332 Tablets

Intervention Type DRUG

ICP-332 will be administered as tablet for 12 weeks

ICP-332 Dose C

Group Type EXPERIMENTAL

ICP-332 Tablets

Intervention Type DRUG

ICP-332 will be administered as tablet for 12 weeks

ICP-332 Placebo

Group Type PLACEBO_COMPARATOR

ICP-332 Placebo Tablets

Intervention Type OTHER

Placebo will be administered as tablet for 12 weeks

Interventions

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ICP-332 Tablets

ICP-332 will be administered as tablet for 12 weeks

Intervention Type DRUG

ICP-332 Tablets

ICP-332 will be administered as tablet for 12 weeks

Intervention Type DRUG

ICP-332 Tablets

ICP-332 will be administered as tablet for 12 weeks

Intervention Type DRUG

ICP-332 Placebo Tablets

Placebo will be administered as tablet for 12 weeks

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing InnoCare Pharma Tech Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yuling Shi

Role: PRINCIPAL_INVESTIGATOR

Shanghai Dermatology Hospital

Locations

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Shanghai Dermatology Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Molly Lin

Role: CONTACT

Phone: +86 15198230043

Email: [email protected]

Facility Contacts

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Yuling Shi, M.D.

Role: primary

Other Identifiers

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ICP-CL-00603

Identifier Type: -

Identifier Source: org_study_id