ICP-332 versus placebo for moderate-to-severe plaque psoriasis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Shanghai Dermatology Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Yuling Shi — Shanghai Dermatology Hospital
• Study coordinator: Molly Lin
• Email: molly.lin@innocarepharma.com
• Phone: +86 15198230043

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.