Efficacy and Safety of ICP-332 Versus Placebo in Participants With Moderate to Severe Plaque Psoriasis

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorBeijing InnoCare Pharma Tech Co., Ltd.

About this trial

The purpose of this study is to compare the efficacy and safety of ICP-332 to placebo in participants with moderate-to-severe plaque psoriasis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects voluntarily participate in this study and have signed the Informed Consent Form (ICF).

Male or female subjects aged ≥ 18 years and ≤ 70 years

A history of plaque psoriasis for ≥6 months at baseline

Psoriasis Area and Severity Index (PASI) score ≥12

Disqualifiers

Diagnosed with non-plaque psoriasis.

Subject had laboratory values meeting any of the protocol-specified criteria at Screening.

Presence of clinically serious, progressive, or uncontrolled disease.

Previous history of alcoholism or drug abuse (except for those who have been completely abstinent for more than 6 months before randomization).

Trial design

Design model

Parallel

Treatments tested in this trial

  • ICP-332 Tablets

    Drug

    ICP-332 will be administered as tablet for 12 weeks

  • ICP-332 Tablets

    Drug

    ICP-332 will be administered as tablet for 12 weeks

  • ICP-332 Tablets

    Drug

    ICP-332 will be administered as tablet for 12 weeks

  • ICP-332 Placebo Tablets

    Other intervention

    Placebo will be administered as tablet for 12 weeks

Treatment groups

172 Participants
are divided into 4 treatment groups
Group A: ICP-332 Dose AExperimental treatment 1 intervention
Group B: ICP-332 Dose BExperimental treatment 1 intervention
Group C: ICP-332 Dose CExperimental treatment 1 intervention
Group D: ICP-332 PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

The Percentage of Participants With Moderate to Severe Psoriasis Experiencing a 75% Improvement (Reduction From Baseline) in PASI Score (PASI-75 Response Rate) at Week 12

Time frame
Day 1 to Day 85

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.