A Phase II Efficacy and Safety Study of HSK44459 in Subjects With Moderate to Severe Plaque Psoriasis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-26

Study Completion Date

2026-11-06

Brief Summary

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The purpose of this study is to assess the efficacy and safety of HSK44459 administered orally for moderate to severe plaque psoriasis in adults.

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Detailed Description

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Patients with moderate to severe plaque psoriasis will be randomized into 3 cohorts (dose level 1, dose level 2 and placebo). Approximately 150 subjects will be enrolled. This study includes an 16-week treatment Period, then a 4-week safety visit period.

Conditions

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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HSK44459 dose level 1

HSK44459 dosage 1 oral administration

Group Type EXPERIMENTAL

HSK44459 dose level 1

Intervention Type DRUG

HSK44459 dose level 1 oral administration

HSK44459 dose level 2

HSK44459 dose level 2 oral administration

Group Type EXPERIMENTAL

HSK44459 dose level 2

Intervention Type DRUG

HSK44459 dose level 2 orally administration

Placebo control

placebo oral administration

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo oral adminisitration

Interventions

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HSK44459 dose level 1

HSK44459 dose level 1 oral administration

Intervention Type DRUG

HSK44459 dose level 2

HSK44459 dose level 2 orally administration

Intervention Type DRUG

placebo

placebo oral adminisitration

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Fully understand and voluntarily participate this trial, and sign the informed consent form;
* Age≥18 years, regardless of gender;
* Plaque psoriasis;
* A candidate for systemic therapy;
* Agree to use a highly effective method(s) of from the signing of the informed consent form to 3 months post-treatment.

Exclusion Criteria

* Can not discontinue the prohibited medications specified in the protocol before the first dose and throughout the entire study period;
* Laboratory abnormalities with clinical significance;
* Forms of psoriasis other than chronic plaque-type;
* Presence of other dermatological or autoimmune diseases;
* Presence of active infection requiring systemic therapy;
* Has undergone or plans to undergo major surgery;
* History of cardiovascular or cerebrovascular diseases;
* History of suicide attempts or major psychiatric disorders;
* History of malignant tumors;
* History of gastrointestinal surgery or diseases that may have impact on the study;
* History of drug abuse, illicit drug use, or alcohol abuse;
* History of severe drug allergies;
* Pregnant or lactating women;
* Subjects with any other factor considered by the investigator to be ineligible for participation in the trial.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No