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

InnoCare Pharma

Status and phase: Enrolling; Phase 2

Conditions: Plaque Psoriasis

Treatments: Drug: ICP-332 Tablets; Other: ICP-332 Placebo Tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT07251998

ICP-CL-00603

Details and patient eligibility

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.

Enrollment: 172 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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172 participants in 4 patient groups, including a placebo group

ICP-332 Dose A

Experimental group

Treatment:

Drug: ICP-332 Tablets

Drug: ICP-332 Tablets

Drug: ICP-332 Tablets

ICP-332 Dose B

Experimental group

Treatment:

Drug: ICP-332 Tablets

Drug: ICP-332 Tablets

Drug: ICP-332 Tablets

ICP-332 Dose C

Experimental group

Treatment:

Drug: ICP-332 Tablets

Drug: ICP-332 Tablets

Drug: ICP-332 Tablets

ICP-332 Placebo

Placebo Comparator group

Treatment:

Other: ICP-332 Placebo Tablets