Evaluating ICP-488 for treating 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 multicenter, randomized, double-blind, placebo-controlled Phase III clinical study aims to assess the efficacy, safety, and pharmacokinetics of ICP-488 in Chinese adults suffering from moderate to severe plaque psoriasis. Participants will be randomly assigned to receive either ICP-488 tablets or a placebo, with the study focusing on measuring improvements in psoriasis severity and overall skin health. The study will include a diverse group of patients aged 18 to 75 who have a significant history of plaque psoriasis and require systemic therapy or phototherapy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Eligible subjects must meet all of the following criteria:

1. Subjects voluntarily participate in this study and have signed informed consent.
2. Male or female subjects between the ages of 18 and 75 (including the threshold) at the time of signing the ICF.
3. History of plaque psoriasis ≥6 months at baseline.
4. Subjects need to receive systemic therapy and/or phototherapy.
5. The following three criteria were met: a) psoriasis Area and Severity index (PASI) score ≥12; b) Psoriasis affected body surface area (BSA) ≥10%; c) Static physician overall assessment (sPGA) ≥3 scores

Exclusion Criteria:

1. The diagnosis was non-plaque psoriasis.
2. Subjects with concurrent skin diseases that the investigator believes would interfere with the study assessments.
3. Presence of infection or immune-related disease.
4. Subjects with a history of TB or at risk for TB.
5. Received related treatment within the time window specified in the protocol.
6. An interval of less than 5 half-lives or 28 days (if any available half-life data) from the last dose of a strong CYP1A2/CYP3A4 inhibitor or inducer, or a plan to use concurrently medications with strong CYP1A2/CYP3A4 inhibitory or inductive effect during study participation.
7. The investigator has determined that there are clinically significant test results and that participation in this trial would pose an unacceptable risk to patients; Or the laboratory values of the subjects in the screening period meet the criteria specified in the protocol.
8. Pregnant or lactating women, or women who plan to become pregnant during study participation.
9. A history of severe drug allergies.
10. Any other conditions in which the investigator considers it unsuitable for the subject to participate in this study.

Where it's running

• The First Affiliated Hospital of Xi'an Jiaotong University
  Xi’an, Shanxi, China Recruiting
• The First Affiliated Hospital Of Ningbo University
  Ningbo, Zhejiang, China Recruiting
• The First Affiliated Hospital of Anhui Medical University
  Hefei, Anhui, China Completed
• The Second Affiliated Hospital of Wannan Medical College
  Wuhu, Anhui, China Completed
• Beijing Chao-Yang Hospital，Capital Medical University
  Beijing, Beijing Municipality, China Completed
• Beijing Friendship Hospital, Capital Medical University
  Beijing, Beijing Municipality, China Completed

Study contacts

• Study coordinator: Alexia Lu
• Email: CO_HGRAC@innocarepharma.com
• Phone: 010-66609745

Similar studies

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

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• ICP-488 for Cutaneous Lupus Erythematosus: a 2nd phase study to test safety and efficacy

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  Recruiting at 10 sites Phase 2 Beijing InnoCare Pharma Tech Co., Ltd. · Hefei, Anhui and 26 other locations · NCT07440537

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

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

  Recruiting Phase 2 Beijing InnoCare Pharma Tech Co., Ltd. · Shanghai, Shanghai Municipality · NCT07251998

• ICP-332 for adults with prurigo nodularis

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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.