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

Haisco Pharmaceutical Group

Status and phase: Not yet enrolling; Phase 2

Conditions: Psoriasis

Treatments: Drug: HSK44459 dose level 2; Drug: placebo; Drug: HSK44459 dose level 1

Study type: Interventional

Funder types: Industry

Identifiers

NCT07150988

HSK44459-206

Details and patient eligibility

About

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

Full description

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 3 patient groups, including a placebo group

HSK44459 dose level 1

Experimental group

Description:

HSK44459 dosage 1 oral administration

Treatment:

Drug: HSK44459 dose level 1

HSK44459 dose level 2

Experimental group

Description:

HSK44459 dose level 2 oral administration

Treatment:

Drug: HSK44459 dose level 2

Placebo control

Placebo Comparator group

Description:

placebo oral administration

Treatment:

Drug: placebo