Clinical trial NCT06926582: A Study to Evaluate Efficacy and Safety of HS-10374 for Mild-to-moderate Plaque Psoriasis
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Psoriasis
Lead sponsor: Hansoh BioMedical R&D Company
Sponsor class: INDUSTRY
First posted: 2025-04-13
Enrollment: 305
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients achieving sPGA 0/1 with at least 2 points improvement from baseline at Week 12
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Incidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation
timeFrame: Baseline to Week 16
measure: Number of participants with clinical laboratory abnormalities
timeFrame: Baseline to Week 16
measure: Incidence of clinically significant changes in electrocardiogram (ECG)
timeFrame: Baseline to Week 16
measure: Number of participants with abnormalities of physical examination
timeFrame: Baseline to Week 16
measure: Number of participants with abnormalities of vital signs
timeFrame: Baseline to Week 16
measure: Proportion of patients with sPGA 0/1 at specified time points
timeFrame: Baseline to Week 16
measure: Proportion of patients achieving BSA 75 response at specified time points
timeFrame: Baseline to Week 16
measure: Change from baseline in BSA at specified time points
timeFrame: Baseline to Week 16
measure: Proportion of patients who achieved BSA ≤ 1% at specified time points
timeFrame: Baseline to Week 16
measure: Change from baseline in PASI at specified time points
timeFrame: Baseline to Week 16
measure: Proportion of patients who achieved BSA ≤ 3% for patients with baseline BSA > 3% at specified time points
timeFrame: Baseline to Week 16
measure: Proportion of patients achieving ss-PGA 0/1 for patients with a baseline ss-PGA score ≥2 at specified time points
timeFrame: Baseline to Week 16
measure: Change from baseline in DLQI scores at specified time points
timeFrame: Baseline to Week 16
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Dermatology Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Dermatology Hospital
name: Yuling Shi, MD
role: PRINCIPAL_INVESTIGATOR
References: