ICP-332 versus placebo for 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

This will test whether ICP-332 helps adults with moderate-to-severe plaque psoriasis compared with a placebo.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 172 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. (industry)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07251998 on ClinicalTrials.gov

What this trial studies

This phase 2, placebo-controlled trial compares oral ICP-332 tablets with matching placebo in adults who have had plaque psoriasis for at least six months and meet predefined severity thresholds (PASI ≥12, sPGA ≥3, BSA ≥10%). Eligible participants require systemic treatment or phototherapy and will be monitored for skin clearance measures and side effects over the study period. Key exclusions include non-plaque psoriasis, significant uncontrolled medical conditions, recent substance abuse, and pregnancy or lactation. Safety labs and clinical assessments will guide continuation and evaluation of efficacy endpoints.

Who should consider this trial

Good fit: Adults aged 18–70 with a history of plaque psoriasis for at least six months who meet severity criteria (PASI ≥12, sPGA ≥3, BSA ≥10%) and require systemic therapy or phototherapy are ideal candidates.

Not a fit: People with non-plaque forms of psoriasis, pregnant or breastfeeding women, those with uncontrolled serious medical conditions, or recent substance abuse are unlikely to benefit or be eligible for this intervention.

Why it matters

Potential benefit: If successful, ICP-332 could provide an additional oral treatment option to reduce symptoms and improve skin clearance in people with moderate-to-severe plaque psoriasis.

How similar studies have performed: Other oral small-molecule and biologic therapies have shown meaningful benefit for moderate-to-severe plaque psoriasis, but ICP-332 appears to be a novel investigational agent with limited published data to date.

Eligibility criteria

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.

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai Dermatology Hospital — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Principal investigator: Yuling Shi — Shanghai Dermatology Hospital
• Study coordinator: Molly Lin

Conditions: Plaque Psoriasis