A Study to Evaluate Efficacy and Safety of HS-10374 for Mild-to-moderate Plaque Psoriasis

A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase II Study to Evaluate Clinical Efficacy and Safety of HS-10374 in Adult Patients With Mild-to-moderate Plaque Psoriasis

This study has been designed to explore the clinical efficacy and safety of HS-10374 in the treatment of mild-to-moderate plaque psoriasis.

Study Overview

• Status: Not yet recruiting
• Conditions: Psoriasis
• Intervention / Treatment: Drug: HS-10374-matched placebo tablets; Drug: HS-10374 6mg tablets

Detailed Description

This is a 12-week, multi-center, randomized, double-blind, placebo-controlled, Phase II study. The study duration includes a 4-week screening period, a 12-week placebo-controlled treatment period, and a 4-week follow-up period. All eligible subjects will be randomly assigned in a 2:2:1 ratio to receive HS-10374 Dose 1, HS-10374 Dose 2, or placebo.

• Study Type: Interventional
• Enrollment (Estimated): 305
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yuling Shi, MD; Phone Number: (0086)021-61833000; Email: shiyuling1973@126.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200443
      • Shanghai Dermatology Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female subjects between the ages of 18-70 years
2. Diagnosis of plaque psoriasis for at least 6 months
3. sPGA score of 2-3, BSA 2-15%, PASI score 2-15
4. Subject must be inadequately controlled with, or intolerant of at least one topical therapy

Exclusion Criteria:

1. Diagnosis of non-plaque psoriasis or drug-induced psoriasis
2. Recent history of infection, history or risk of serious infection
3. Any major illness or evidence of unstable condition of major organ systems including psychiatric disease
4. Any condition possibly affecting the PK process of the study drug
5. Evidence of other skin conditions that would interfere with the evaluation of psoriasis
6. History of hypersensitivity to the ingredients of study drugs, history of anaphylaxis
7. Prior exposure to TYK2 inhibitors
8. Have received the prohibited treatment during the protocol required washout period
9. Any significant laboratory or procedure abnormalities that might place the subject at unacceptable risk during this study period

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: HS-10374-matched placebo tablets; Administered orally QD for 12 weeks
Experimental: HS-10374 Dose 1	Drug: HS-10374-matched placebo tablets; Administered orally QD for 12 weeks; Drug: HS-10374 6mg tablets; Administered orally QD for 12 weeks
Experimental: HS-10374 Dose 2	Drug: HS-10374 6mg tablets; Administered orally QD for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients achieving sPGA 0/1 with at least 2 points improvement from baseline at Week 12	Static physician's global assessment (sPGA) of psoriasis is an average assessment of all psoriatic lesions based on erythema, induration, and scale. It's a 5-point scale performed by investigators. A sPGA score of 0 or 1 means "clear" or "almost clear" respectively.	Baseline to Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation		Baseline to Week 16
Number of participants with abnormalities of vital signs	Vital signs measured include blood pressure, pulse rate, and temperature.	Baseline to Week 16
Number of participants with abnormalities of physical examination	Physical examination includes assessments of general appearance, skin, lymph nodes, head, neck, lung, heart, abdomen, spine, extremities, nervous system, etc.	Baseline to Week 16
Incidence of clinically significant changes in electrocardiogram (ECG)	ECG parameters include heart rate, PR interval, RR interval, QRS duration, QTcF interval.	Baseline to Week 16
Proportion of patients with sPGA 0/1 at specified time points	Static physician's global assessment (sPGA) of psoriasis is an average assessment of all psoriatic lesions based on erythema, induration, and scale. It's a 5-point scale performed by investigators. A sPGA score of 0 or 1 means "clear" or "almost clear" respectively.	Baseline to Week 16
Change from baseline in BSA at specified time points	Psoriasis body surface area (BSA) involvement is measured using the handprint method with the size of a patient's handprint representing ~1% of body surface area involved.	Baseline to Week 16
Change from baseline in DLQI scores at specified time points	The dermatology life quality index (DLQI) is a patient reported outcome measurement. It's a questionnaire consisting of 10 questions concerning patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the last week. Each question is scored on a scale of 0 to 3, and the sum of each scores range from 0 (no impairment of life quality) to 30 (maximum impairment).	Baseline to Week 16
Number of participants with clinical laboratory abnormalities	Clinical laboratory tests include hematology, coagulation testing, blood chemistry, urinalysis, stool analysis, C-reactive protein, etc.	Baseline to Week 16
Proportion of patients achieving BSA 75 response at specified time points	Psoriasis body surface area (BSA) involvement is measured using the handprint method with the size of a patient's handprint representing ~1% of body surface area involved. BSA 75 response is defined as 75% or greater improvement in BSA score from baseline.	Baseline to Week 16
Proportion of patients who achieved BSA ≤ 1% at specified time points	Psoriasis body surface area (BSA) involvement is measured using the handprint method with the size of a patient's handprint representing ~1% of body surface area involved.	Baseline to Week 16
Change from baseline in PASI at specified time points	Psoriasis Area and Severity Index (PASI) is a scoring system quantifying the severity of psoriasis based on both lesion severity and area of involvement. PASI assessment is performed by investigators, and the numeric score ranges from 0 to 72, with higher PASI scores denoting more severe disease activity.	Baseline to Week 16
Proportion of patients who achieved BSA ≤ 3% for patients with baseline BSA > 3% at specified time points	Psoriasis body surface area (BSA) involvement is measured using the handprint method with the size of a patient's handprint representing ~1% of body surface area involved.	Baseline to Week 16
Proportion of patients achieving ss-PGA 0/1 for patients with a baseline ss-PGA score ≥2 at specified time points	Scalp specific physician's global assessment (sPGA) of psoriasis is an assessment of the disease severity of scalp psoriasis based on erythema, thickness, and scale. It's a 5-point scale performed by investigators. A sPGA score of 0 or 1 means "absence of disease" or "very mild disease" respectively.	Baseline to Week 16

Collaborators and Investigators

• Sponsor: Hansoh BioMedical R&D Company
• Investigators: Principal Investigator: Yuling Shi, MD, Shanghai Dermatology Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 9, 2025
• Primary Completion (Estimated): July 9, 2026
• Study Completion (Estimated): December 9, 2026

Study Registration Dates

• First Submitted: April 10, 2025
• First Submitted That Met QC Criteria: April 10, 2025
• First Posted (Actual): April 13, 2025

Study Record Updates

• Last Update Posted (Actual): April 13, 2025
• Last Update Submitted That Met QC Criteria: April 10, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Psoriasis
• Other Study ID Numbers: HS-10374-205

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No