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Recruiting NCT06842199

Efficacy, Safety, Pharmacokinetics of ICP-488 in Patients With Moderate to Severe Plaque Psoriasis

Phase III Interventional Plaque Psoriasis Patients

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ICP-488 Tablets, ICP-488 Placebo.
Who it may be relevant to
Registry conditions: Plaque Psoriasis Patients. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Oral ICP-488 in Patients With Moderate to Severe Plaque Psoriasis

Overview

This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study to evaluate the efficacy, safety, PK characteristics of ICP-488 in Chinese adults with moderate to severe plaque psoriasis.

Interventions

  • Drug ICP-488 Tablets
    Eligible patients will receive ICP-488 orally as per the protocol
  • Drug ICP-488 Placebo
    Eligible patients will receive ICP-488 Placebo orally as per the protocol

Primary outcome measures

  • The proportion of subjects who achieve a score of clear (0) or almost clear (1) with an improvement of at least 2 points from baseline on the static Physician's Global Assessment (sPGA) at week 16 [Time frame: week 16]
  • Percentage of subjects who achieved a PASI 75 response (a reduction of minimum 75% from baseline in PASI score) at Week 16 [Time frame: Week 16]
Secondary outcome measures (5)
  • Adverse events [Time frame: Week 52]
  • Percentage of subjects with PASI 50/75/90/100 in each planned visit [Time frame: Week 52]
  • Percentage of subjects with sPGA score of 0 (clear) or 1 (almost clear) and an improvement of at least 2 points from baseline in planned visits. [Time frame: Week 52]
  • The proportion of subjects with sPGA score of 0 in each planned visit. [Time frame: Week 52]
  • PK parameter: ICP-488 and its metabolite. [Time frame: Week 52]

Eligibility criteria

Inclusion criteria

Eligible subjects must meet all of the following criteria:

  • Subjects voluntarily participate in this study and have signed informed consent.
  • Male or female subjects between the ages of 18 and 75 (including the threshold) at the time of signing the ICF.
  • History of plaque psoriasis ≥6 months at baseline.
  • Subjects need to receive systemic therapy and/or phototherapy.
  • 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

  • The diagnosis was non-plaque psoriasis.
  • Subjects with concurrent skin diseases that the investigator believes would interfere with the study assessments.
  • Presence of infection or immune-related disease.
  • Subjects with a history of TB or at risk for TB.
  • Received related treatment within the time window specified in the protocol.
  • 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.
  • 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.
  • Pregnant or lactating women, or women who plan to become pregnant during study participation.
  • A history of severe drug allergies.
  • Any other conditions in which the investigator considers it unsuitable for the subject to participate in this study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 46 centers
  • The First Affiliated Hospital of Anhui Medical University — Hefei
  • The Second Affiliated Hospital of Wannan Medical College — Wuhu
  • Beijing Chao-Yang Hospital，Capital Medical University — Beijing
  • Beijing Friendship Hospital, Capital Medical University — Beijing
  • Peking University Third Hospital — Beijing
  • Beijing Tongren Hospital,CMU — Beijing
  • The First Affiliated Hospital of Chongqing Medical University — Chongqing
  • Chongqing Traditional Chinese Medicine Hospital — Chongqing
  • … and 38 more centers

Identifiers

NCT: NCT06842199 · ICP-CL-01005

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗