Skip to main content
OpenTrials
Completed

NCT Number: NCT06109818

Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of ICP-488 in Patients with Moderate to Severe Plaque Psoriasis

This is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical study to evaluate ICP-488.Efficacy, safety, PK, and PD characteristics in Chinese adults with moderate to severe plaque psoriasis.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Moderate to Severe Plaque Psoriasis

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beijing Friendship Hospital, Capital Medical University, Beijing, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects voluntarily participate in this study and have signed informed consent.
  • Male or female subjects between the ages of 18 and 70 (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.
  • 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 halflife data) from the last dose of a strong CYP1A2 inhibitor or inducer, or a plan to use concurrently medications, dietary supplements or food with strong CYP1A2 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.

Treatment and study plan

ICP-488 Tablets

Drug

ICP-488 will be administered as tablet

ICP-488 Placebo

Drug

ICP-488 Placebo will be administered as tablet

Primary outcomes

  1. Percentage of subjects who achieved a PASI 75 response (a reduction of minimum 75% from baseline in PASI score) at Week 12.

    Time frame: Baseline up to Week 12

    Proportion of subjects who achieved PASI 75 (PASI score improvement of at least 75% from baseline) at week 12.

Sponsors and collaborators

Lead sponsor

Beijing InnoCare Pharma Tech Co., Ltd.

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of ICP-488 in Patients with Moderate to Severe Plaque Psoriasis

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 31, 2023
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.