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

NCT07150988 | Not Yet Recruiting Phase 2

• 1 other identifier: HSK44459-206
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects who have ≥75% reduction in PASI (PASI-75).

  The proportion of subjects who have a reduction of 75% or more from baseline in the psoriasis area-and-severity index score (PASI 75) at week 16.

  16 weeks

Secondary Outcomes (4)

• Proportion of subjects achieving an IGA score of clear 0 or 1 with ≥2 point reduction from baseline.

  2, 4, 8, 12 and 16 weeks

• Proportion of subjects who have ≥75% reduction in PASI (PASI-75).

  2, 4, 8 and 12 weeks

• Proportion of subjects who have ≥50% reduction in PASI (PASI-50).

  2, 4, 8, 12 and 16 weeks

• Proportion of subjects who have ≥90% reduction in PASI (PASI-90).

  2, 4, 8, 12 and 16 weeks

Study Arms (3)

HSK44459 dose level 1

EXPERIMENTAL

HSK44459 dosage 1 oral administration

Drug: HSK44459 dose level 1

HSK44459 dose level 2

EXPERIMENTAL

HSK44459 dose level 2 oral administration

Drug: HSK44459 dose level 2

Placebo control

PLACEBO COMPARATOR

placebo oral administration

Drug: placebo

Interventions

HSK44459 dose level 1 DRUG

HSK44459 dose level 1 oral administration

HSK44459 dose level 1

HSK44459 dose level 2 DRUG

HSK44459 dose level 2 orally administration

HSK44459 dose level 2

placebo DRUG

placebo oral adminisitration

Placebo control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Haisco Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

Hangzhou First People's Hospital

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Yong Cao

CONTACT

028-67258779; caoyong@haisco.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: September 2, 2025
• Study Start: September 26, 2025
• Primary Completion (Estimated): November 6, 2026
• Study Completion (Estimated): November 6, 2026
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)